otc & biosimilar directory 2010
TRANSCRIPT
© Copyright 2008-2009
Please contact us now to receive a booking form Email: [email protected] or Phone: +44 8707524105
OTC & Biosimilar Directory Supplement
Edition 1, 2010
See our Global Generic Licensing Directory for over
7000 DOSSIERSor visit
www.genericlicensing.com
OTC & Biosimilar Directory Supplement
OTC COMPANY LISTFEATURED COMPANYGeiser Pharma
ABC Farma
Biogened
Bioxtract
Diapharm
EMS
Farmalider
Helvetia Pharma
Oystershell
Progressare
✔ Regulatory filings, variations and license maintenance
✔ Dossier creation, formatting and auditing (NTA, CTD, eCTD, ANDA)
✔ Manufacturing GMP inspection preparation
✔ Manufacturing technical transfers
✔ Formulation development projects
Europe – North America – AustralasiaExpertise is offered both in-house and through industry leading partners.
Talk to us about your technical service requirements today.
CALL +44 (0)870 [email protected]
Registration dossiers are only promoted by Genericlicensing Limited; always consider international and local patent laws before local submission.
Services Offered
Geiser Pharma is a pharmaceutical company dedicated to developing both generic andOTC products purely to be out-licensed to third parties. Apart from our own developments,Geiser Pharma offers its partners the possibility to increase their R&D capacity throughoutsourcing our R&D services, allowing partners to have access to value addedtechnologies.
FEATURED COMPANY: Geiser Pharma
Contact Preson: Lourine Lenderink ([email protected])Contact Telephone Number: 0034 948 101943 / 0034 607 616 045
PACK SHOTS
OTC PRODUCTS
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Stick Pack Doxylamine Succinate
OTC
12,5 / 25,0 mg Doxylamine Succinate
Night time sleep aid. Hygroscopic formulationwhich allows product to dissolve directly inthe mouth. No water needed.
Insomnia
10 Alu Foil sticks / box. Pre-cut opening,child proof. Stick size 70 x 23 mm
Under development
T.B.D.
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Stick Pack Ranitidine
OTC
75 / 150 mg Ranitidine
Hygroscopic formulation that inhibits stomachacid production. No water needed.
Heart burn
10 Alu Foil sticks / box. Pre-cut opening,child proof. Stick size 70 x 23 mm
Under development
T.B.D.
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Carbocysteine Lysine Syrup
OTC
2,7 g Carbocysteine
Mucolytic that reduces sputum viscosity
Cough & Cold
20 sachets / unit
Under development
T.B.D.
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Pharma lozenges with Lidocaine
OTC
2,0 Lidocaine / 1,2 mg DichlorobencilicAlcolhol / 0,6 mg Amylmetacresol
Pharma lozenges with topical anestheticeffect
Sore throat relief
ALU blister containing 24 lozenges
Under development
T.B.D
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Pharma lozenges
OTC
1,2 mg Dichlorobencilic Alcolhol / 0,6 mgAmylmetacresol
Pharma lozenges with topical anestheticeffect
Sore throat relief
ALU blister containing 24 lozenges
Under development
T.B.D
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Vegetal Laxative
OTC
Rhamnus Frangula, Rhamnus Pushianus,Fucus Thallus
100% vegetal laxative, indicated for diabetics
Constipation
PVC / ALU blister containing 2 x 20 capsulesType 0
Available
T.B.D
OTC & Biosimilar Directory Supplement
COMPANY PROFILECOMPANY NAME
Geiser Pharma
CITYPamplona
COUNTRYSpain
OTC & Biosimilar Directory Supplement
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Warming Patch
Medical Device
Iron powder, activated carbon, water and salt
8 hours of constant and penetrating heat thatrelaxes tense and contracted muscles
Pain relief
Patch size 15 x 10 cm / 22 x 10 cm. 2patches per unit
Under development
T.B.D.
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Hydrating vaginal gel
Medical Device
Cranberry / chamomile extract
Pharma quality hydrating vaginal gel withcranberry extract, paraben free. Reliefsvaginal dryness and facilitates sexualintercourse.
Female Hygiene
Innovative dispenser with valve, 30 ml
Available
T.B.D.
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Hypertonic Sea Water Earspray
Medical Device
Sea Water
Safest alternative to cotton buds for a regularrisk-free ear hygiene
External auditory canal hygiene
50 ml metallic flask, innovative nozzle
Available
T.B.D.
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Earspray Special Babies
Medical Device
Sea Water
Safest alternative to cotton buds for a regularrisk-free ear hygiene in young children
External auditory canal hygiene
50 ml metallic flask, innovative nozzle
Available
T.B.D.
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
High Hyalplus
Medical Device
Injectable Sodium Hyaluronate 2 ml / 20 mg
HA for pain relief and decreasing of synoviuminflammation.
Pain relief
Prefilled syringes
Available
T.B.D.
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Ice Cold Pain Relief Patch
Medical Device
Natural Menthol (5%)
Pain relief cooling therapy
Pain relief
5 patches in resealable pouch. Patch size 10 x20 cm
Available
T.B.D.
OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Icy Pads forehead cooling pads Children
Medical Device
Menthol oil, Lavender oil, Eucaluptus oil
Soothing cooling relief for fever discomfort &headaches during 6 hours to children
Pain relief
2 x 2 pads per unit. Pad size 5 x 12 cm.
Available
T.B.D.
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Luteine + Multivitamin Soft Gel Capsules
Food supplement
Multivitamins + Luteine
Soft gel capsules containing Luteine,vitamins and essential fatty acids
Sight Care
Alu blister 2 x 15 / 4 x 15 soft gel capsules
Available
T.B.D.
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Thermal Spring Water Mouth Spray
Cosmetic
Thermal spring water
Thermal spring water mouth spray forsensible gums, dry mouth, bad breath
Dental Hygiene
200 ml metallic flask, 2 application devices
Available
T.B. D
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Thermal Spring Water Tooth Paste
Cosmetic
1100 ppm Fluor
Thermal spring water tooth paste / 1100 ppmFluor
Dental Hygiene
75 ml Polyethylene tube HDPE
Available
T.B. D
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Thermal Spring Water Sensible Gums
Cosmetic
Thermal spring water
Toothpaste gel provides a gentle care forsensitive gums, weakened teeth, or teeth witheroded enamel. Mentholated gel helpsreduce occasional bleedings and gingival ordental sensitivities. No fluoride, paraben free.
Dental Hygiene
75 ml Polyethylene tube HDPE
Available
T.B.D.
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Thermal Spring Water Tooth Whitener & Care
Cosmetic
1100 ppm NaF
Thermal spring water dental whitening toothpaste / 1100 ppm NaF
Dental Hygiene
75 ml Polyethylene tube HDPE
Available
T.B. D
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Thermal Spring Water Tooth PasteChildren
Cosmetic
250 ppm Fluor
Prevention of tooth decay in temporary teeth.The stabilized alkaline pH of the Thermalspring water neutralises acids and reinforcesthe brushing action for an improved efficiencyagainst tooth decay. Mango flavour.
Dental Hygiene
50 ml Polyethylene tube HDPE
Available
T.B.D.
OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Greaseless Balsamic DecongestiveMenthol Chest Rub
Cosmetic
Camphor, Eucalyptus, Menthol
Pharma quality non greasy decongestivementhol chest rub, paraben free
Cough & Cold
50 ml, Flip Top or normal Polyethylene tube,diam. 35 mm HDPE
Available
T.B. D
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Thermal Spring Water Tooth Paste Junior
Cosmetic
1000 ppm Fluor
Specifically designed for children between 7and 12 years old to prevent tooth decay inpermanent teeth. Mint flavour.
Dental Hygiene
50 ml Polyethylene tube HDPE
Available
T.B. D
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Thermal Spring Water First Teeth
Cosmetic
Spring water, Chamomile
Thermal water teething gel with natural,soothing and anti-irritating properties.Marshmallow flavour. Chamomile extract. Nosugar. No alcohol.
Dental Hygiene
50 ml Polyethylene tube HDPE
Available
T.B.D.
OTC & Biosimilar Directory Supplement
COMPANY PROFILEAbc Farma Internacional is chiefly engaged in the development and design of newtechnologies for application in the cosmetics and pharmaceutical industry. Specialised inthe manufacturing and distribution of the transdermal and topical patches, Fast-Ediblemedical films, mechanical action strips, impregnated masks, Wet wipes, technologicalfabrics loaded with medical or cosmetic ingredients as well as Hyaluronic acid products.
Contact Preson: Anna Guimerá ([email protected])Contact Telephone Number: 0034 93487 9670 / 00 601 18 65 11 mobile
PACK SHOTS
OTC PRODUCTS
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Capillari HAIR LOSS PATCH
Cosmetic
Adenosine, Cysteine, Ruscus, Bamboo, SerenoaSerrulata, Vitis Vinifera
The main objective it is to fight hair loss. Itscomponents have a direct impact on the formationof hair and blood circulation at the scalp, thusavoiding so the weakest hairs fall down
To prevent hair loss
2 sachet (56 p.), 2 months treatment
Full develop
In various EU, Russia
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
FÒRFORA PLUS
Cosmetic
Copaifera Officinalis, Brasil Nut, Vitamin E,Vitamin B, L-Cysteine
It is a novel product with action Anti-dandrufffor exclusive use by the dermatologist.
Dermatitis seborrhea
2 sachets (56 p.), 2 months treatment
Full develop
In various EU, Russia
COMPANY NAMEABC Farma
CITYBarcelona
COUNTRYSpain
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Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
IALUPATCH
CE mark class 1
Laluzero. Special Hyaluronic acid having amolecular weight lower than 50 KDa and solutionviscosity close to zero.
Specially designed to help the skin to regain itsfunctionality and appearance following theformation of a scar. Thanks to H.A. helps reducesthe time of the physiological healing process.
Stretch mark
1 sachet (2 p.)
Full develop
Spain, Italy
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
PSORIPATCH
Cosmetic
UREA, ALOE VERA, IALUZERO®(Hyaluronic Acid), Mangnesio Ascrobil fosfato
It is a patch of Hydro gel to treat the plaquesof psoriasis and the scales
Dry and scaling skin
1 sachet (3 p.)
Full develop
Spain, Italy
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
ABBRONZANTE QUICK SUN PATCH
Cosmetic
μeta-carontene, Tyrosine, Lutein, Lycopne,Vitamin E
To enhance the natural defences of skin againstthe sun and mitigate the effects of aging
Patch for a more efficient and safer exposition toUV rays
4 sachets (56 p.), 2 months treatment
Full develop
Iberia, Italy, Fr, Mx
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
LEGPATCH Tired Legs
Cosmetic
Ruscus aculeatus, Centella Asiatica, HorseChestnut, Vaccinium Myrtillus
It has a firming action, strengthen andRefreshing of the skin of the legs
Fatigued legs: Patch that relieves swellingand heaviness
01 sachet 28 patches, 01 month treatment
Full develop
Iberia, Italy, France
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
IALURAPID ZERO Vaginal Douche
CE mark class 2a
Laluzero. Special Hyaluronic acid having amolecular weight lower than 50 KDa and solutionviscosity close to zero.
Intimate cleansing: first aid solution for vaginalirritation and small lesions
Intimate cleansing
3 uds. (30 ml.)
Full develop
Spain, Italy
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
IALURAPID ZERO Gel
CE mark class 2a
Laluzero. Special Hyaluronic acid having amolecular weight lower than 50 KDa andsolution viscosity close to zero.
Provides hydration protection and hygienemucosa damaged or injured
Daily vaginal moisturizing gel
1 unit (50ml)
Full develop
Spain, Italy
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
QUELOPATCH
Cosmetic
Laluzero. Special Hyaluronic acid having amolecular weight lower than 50 KDa and solutionviscosity close to zero.
Quelopatch Scar Reducer is specially designedto help the scar to regain its function andappearance go back to being normal skin.
Scars treatment
1 sachet (2 p.)
Full develop
Spain, Italy
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
CICADIL
CE mark IIB
Laluzero. Special Hyaluronic acid having amolecular weight lower than 50 KDa andsolution viscosity close to zero.
Lesions: Barrier function sterile gauzespreventing additional infection and improvingthe healing process
Sterile Gauze for breached skin
Consumer unit of 20 sterile gauze in a twinsachet
Full develop
Spain, Italy
OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
IALUPATCH
CE mark class 1
Laluzero. Special Hyaluronic acid having amolecular weight lower than 50 KDa and solutionviscosity close to zero.
Specially designed to help the skin to regain itsfunctionality and appearance following theformation of a scar. Thanks to H.A. helps reducesthe time of the physiological healing process.
Stretch mark
1 sachet (2 p.)
Full develop
Spain, Italy
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
PSORIPATCH
Cosmetic
UREA, ALOE VERA, IALUZERO®(Hyaluronic Acid), Mangnesio Ascrobil fosfato
It is a patch of Hydro gel to treat the plaquesof psoriasis and the scales
Dry and scaling skin
1 sachet (3 p.)
Full develop
Spain, Italy
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
ABBRONZANTE QUICK SUN PATCH
Cosmetic
μeta-carontene, Tyrosine, Lutein, Lycopne,Vitamin E
To enhance the natural defences of skin againstthe sun and mitigate the effects of aging
Patch for a more efficient and safer exposition toUV rays
4 sachets (56 p.), 2 months treatment
Full develop
Iberia, Italy, Fr, Mx
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
LEGPATCH Tired Legs
Cosmetic
Ruscus aculeatus, Centella Asiatica, HorseChestnut, Vaccinium Myrtillus
It has a firming action, strengthen andRefreshing of the skin of the legs
Fatigued legs: Patch that relieves swellingand heaviness
01 sachet 28 patches, 01 month treatment
Full develop
Iberia, Italy, France
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
IALURAPID ZERO Vaginal Douche
CE mark class 2a
Laluzero. Special Hyaluronic acid having amolecular weight lower than 50 KDa and solutionviscosity close to zero.
Intimate cleansing: first aid solution for vaginalirritation and small lesions
Intimate cleansing
3 uds. (30 ml.)
Full develop
Spain, Italy
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
IALURAPID ZERO Gel
CE mark class 2a
Laluzero. Special Hyaluronic acid having amolecular weight lower than 50 KDa andsolution viscosity close to zero.
Provides hydration protection and hygienemucosa damaged or injured
Daily vaginal moisturizing gel
1 unit (50ml)
Full develop
Spain, Italy
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
QUELOPATCH
Cosmetic
Laluzero. Special Hyaluronic acid having amolecular weight lower than 50 KDa and solutionviscosity close to zero.
Quelopatch Scar Reducer is specially designedto help the scar to regain its function andappearance go back to being normal skin.
Scars treatment
1 sachet (2 p.)
Full develop
Spain, Italy
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
CICADIL
CE mark IIB
Laluzero. Special Hyaluronic acid having amolecular weight lower than 50 KDa andsolution viscosity close to zero.
Lesions: Barrier function sterile gauzespreventing additional infection and improvingthe healing process
Sterile Gauze for breached skin
Consumer unit of 20 sterile gauze in a twinsachet
Full develop
Spain, Italy
OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
VNO PIKAN No mosquitoes patch
General sale
Citronella essential oils
Self-adhesive strips saturated with resin-embedded microcapsules on the outer patchsurface that gradually release the aromaticcharge of their essential oils over time.
To keep mosquito’s away
01 consumer unit with 48 patches
Full develop
Launched in various EU markets
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Protection of the Buccal Mucosa
CE mark class 2a
Laluzero. Special Hyaluronic acid having amolecular weight lower than 50 KDa and solutionviscosity close to zero.
Palate and gums: mouthwash, gum gel, activesprays for irritation problems and small lesion ingums and palate
To preserve the integrity of the oral mucousmembrane
Fluid 250ml, Gel Tube 20ml
Full develop
Spain, Italy
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
VRR
CE mark class 2a
Mechanical barrier, perfect occlusion of thezone affected by the wart.
Warts: Healing protection patch for barriereffect and infection prevention
Wart Patch, Topical application
4 sachets (48 patches)
Full develop
Spain, Italy
OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement
COMPANY PROFILEWe are a flexible and innovative team, open to new ideas for future developments.We have high quality marketing and regulatory affairs management as well as acomprehensive sales network, enabling us to bring new ideas to market efficiently.Our production is compliant with GMP standards. Biogened as generic company isinterested in buying licenses from CNS, oncology, Dermatology, Respiratory system,OTC - Cold. Contact Preson: Karolina Lichanska ([email protected])Contact Telephone Number: 48 42 651 31 52
PACK SHOTS
OTC PRODUCTSProduct name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
"Dermedic" dermocosmetics
OTC
Many active substances, without colorants, flavors,irritants, parabens
Comprehensive taking care of the skin, stimulateits regeneration, increase resistance, delay agingprocesses, reduction skin defects
Problematic skin
15g, 50g, 150g, 200g
Available
Arabian countries, Nordic Countries, Slovakia
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
"Ellexir" dermocosmetics
OTC
Active substances: hialuronic acid, peptides (a unique composition of technologicallyadvanced active substances)
Very exclusive series of dermocosmeticscreated for immediate delay of appearing thewrinkles
Mimic wrinkles and physiological wrinkles
50g
Available
Portugal, Arabian countries, Nordic Countries,Czech Republic, U.S
COMPANY NAMEBiogened
CITYLodz
COUNTRYPoland
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
“ProLady" supplements
OTC
Red clover, Salvia, Melissa, Guarana, YerbaMate, Acai, Aloe, Vitamins, Spiruline, Seleniumetc.
For taking care of woman's health
Typical woman's problems
30 and 90
Available
Arabian countries, Nordic Countries, Portugal
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
"Rutimal" supplements
OTC
Vitamins, Sage, Minerals, Rutoside, Garil,Honey, lemon ,grapefruit juice
Lollypops for children and capsules for adultsin states of decreased immunity
Sore throat, decreased immunity, loss ofappetite," journey" problems
10, 30 , 120 pack of lollypops and 30/90capsules
Available
Arabian countries, Nordic Countries,Portugal, Balkans
OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement
COMPANY PROFILEBioxtract develops evidence based, natural food supplements, in unique andproprietary formulations, offering improved bio availability and efficacy. We workbusiness to business, offering finished products in bulk, ready for commercialisation bymarketing partners worldwide.
Contact Preson: Camilla Mackenzie ([email protected])Contact Telephone Number: +32-10-222870
PACK SHOTS
OTC PRODUCTS
Product name
Category
Ingredients
Use/Claim
Main Indication
Form
Status
Sold In (Countries)
Arantal
Food supplement
Curcumin
A new formulation of highly bioavailable curcumin,with efficacy on pain and inflammation
Osteoarthritis
Soft gelatin capsules, supplied in bulk
EU Food supplement, TGA listing (Australia)
EU
Product name
Category
Ingredients
Use/Claim
Main Indication
Form
Status
Sold In (Countries)
Nasaler
Food supplement
Curcumin + quercetin
A new formulation of highly bioavailablecurcumin, combined with quercetin to treatsymptoms of allergic rhinitis, having anthi-histamine and anti-inflammatory properties.
Allergic rhinitis
Soft gelatin capsules, supplied in bulk
EU Food supplement, TGA listing (Australia)
EU
COMPANY NAMEBioXtract
CITYLouvain-la-Neuve
COUNTRYBelgium
Product name
Category
Ingredients
Use/Claim
Main Indication
Form
Status
Sold In (Countries)
Cognityl
Food supplement
Theobromine + caffeine
A product based on cocoa and tea extracts, withproven effect on focus, attention and mentalenergy Mental alertness
Tablets, supplied in bulk
EU Food supplement, TGA listing (Australia),Malaysian health supplement registration
EU, SE Asia
Product name
Category
Ingredients
Use/Claim
Main Indication
Form
Status
Sold In (Countries)
Regulid
Food supplement
Vinyldithiins + sulfides
An innovative formulation of highperformance garlic active principals, with acombined activity on cholesterol parametersinvolved in metabolic syndrome.
Metabolic syndrome
Liquid filled hard gelatin capsules, supplied inbulk
EU Food supplement, TGA listing (Australia),Malaysian health supplement registration
EU, SE Asia
OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement
COMPANY PROFILEDiapharm is a full-service provider for the healthcare industry. With about 100employees, Diapharm supports pharmaceutical companies in all questions concerningregulatory affairs, medical & clinical development, quality management and businessdevelopment. Its activities focus on the sectors of medicinal products, foodsupplements and dietetic food, medical devices and cosmetics. Diapharm is at theservice of multinational companies as well as start-ups and mid-sized businesses.Contact Preson: Karim Sultan ([email protected])Contact Telephone Number: +44 203 178 2790
PACK SHOTS
OTC PRODUCTS
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (homeopathic)
Medicinal product (homeopathic)
Aesculus hippocastanum Dil D1, Arnica montana,Silybum marianum Dil. D1, Hamamelis virginianaDil. D1, Lachesis mutus Dil. D6, Lycopediumclavatum Dil. D4, Melilotus officinalis Dil. D3
Varicosis
Homoeopathic medicinal product for intake againstvaricose veins /varices
Mixture in amber bottle, 50 ml
Marketing authorization
DE
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (homeopathic)
Medicinal product (homeopathic)
Drosera Dil. D4, Cephalis Ipecacuanha Dil.D6, Rumex crispus Dil. D4, Eriodictyoncalifornicum Dil. D4, Echinacea
Cough and cold
Homoeopathic medicinal product for intakeagainst infects of the upper respiratory tract
Mixture in amber bottle, 50 ml
Marketing authorization
DE
COMPANY NAMEDiapharm UK
CITYLondon / Munster
COUNTRYUK / Germany
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Black cohosh rhizome 6.5 mg
Climacteric symptoms, menstrual disturbances
Well-established use: For improvement ofclimacteric (menopausal) symptoms anddysmenorrhoeic neurovegetative disorders. -Traditional Use: Traditional herbal medicinalproduct used to relieve the symptoms of themenopause, such as hot flushes, night sweatsand temporary changes in mood.
Film-coated tablet
Marketing authorization
UK
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Black cohosh rhizome 6.5 mg
Climacteric symptoms, menstrualdisturbances
Well-established use: For improvement ofclimacteric (menopausal) symptoms anddysmenorrhoeic neurovegetative disorders. -Traditional Use: Traditional herbal medicinalproduct used to relieve the symptoms of themenopause, such as hot flushes, nightsweats and temporary changes in mood.
Film-coated tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Artichoke leaf 400 mg
Digestion & liver
For dyspeptic complaints. Stimulates healthy bileproduction. This helps improve blood lipid levels.
Capsule
Marketing authorization
UK
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Artichoke leaf 400 mg
Digestion & liver
For dyspeptic complaints. Stimulates healthybile production. This helps improve blood lipidlevels.
Capsule
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medical Device
Medical device
Chitosan 500 mg
Treatment of elevated blood lipid levels (Weightcontrol)
Binding of nutritional fat in order to support thetreatment of overweight people on a fat reduceddiet, maintenance of bodyweight within a fatconscious diet, reduction of cholesterol intake
Tablet
CE mark
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Devil´s claw root 600 mg
Aches
Traditional Use: Traditional herbal medicinalproduct used for the relief of backache,rheumatic or muscular pain, and generalaches and pain in the muscles and joints -HMPC monograph: Traditional HMP for reliefof minor articular pain
Film-coated tablet
Marketing authorization
UK
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Chaste tree fruit 4 mg
Climacteric symptoms, menstrual disturbances
Well-established use: Irregularities of themenstrual cycle, menstrual disturbances; tensionand swelling of the breasts (mastodynia);premenstrual syndrome. - Traditional Use:Traditional herbal medicinal product used to helprelieve symptoms associated with premenstrualsyndrome
Film-coated tablet
Marketing authorization
UK
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Chaste tree fruit 4 mg
Climacteric symptoms, menstrual disturbances
Well-established use: Irregularities of themenstrual cycle, menstrual disturbances;tension and swelling of the breasts(mastodynia); premenstrual syndrome. -Traditional Use: Traditional herbal medicinalproduct used to help relieve symptomsassociated with premenstrual syndrome
Film-coated tablet
Dossier
All European countries
OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Devil´s claw root 600 mg
Aches
Traditional Use: Traditional herbal medicinalproduct used for the relief of backache, rheumaticor muscular pain, and general aches and pain inthe muscles and joints - HMPC monograph:Traditional HMP for relief of minor articular pain
Film-coated tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Feverfew herb 100 mg
Aches and migraine
Traditional herbal medicinal product used forthe prevention of migraine headaches, basedon traditional use only
Capsule
Dossier
All European Countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Devil´s claw root 600 mg
Aches
Traditional Use: Traditional herbal medicinalproduct used for the relief of backache,rheumatic or muscular pain, and general achesand pain in the muscles and joints - HMPCmonograph: Traditional HMP for relief of minorarticular pain
Film-coated tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Feverfew herb 100 mg
Aches and migraine
Traditional herbal medicinal product used forthe prevention of migraine headaches, basedon traditional use only
Capsule
Marketing authorization
UK
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Hawthorn leaf and flower 300 mg
Mild cardiac insufficiency
Mild cardiac insufficiency, senile heart.
Coated tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Hawthorn leaf and flower 40 mg, Potassiumaspartat 150 mg, Magnesium aspartat 150 mg
Mild cardiac insufficiency
A traditional herbal medicinal product used forthe relief of mild cardiac injuries (senile heart),based on traditional use only
Coated tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Hawthorn leaf and flower 450 mg
Mild cardiac insufficiency
Mild cardiac insufficiency, senile heart.
Film-coated tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Hawthorn leaf and flower 300 mg
Mild cardiac insufficiency
Mild cardiac insufficiency, senile heart.
Coated tablet
Marketing authorization
DE
OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Nettle root 460 mg
Prostate
Traditional herbal medicinal product used torelieve urinary discomfort in men with an enlarged prostate (BPH).
Film-coated tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Passionflower herb 425 mg
Mild nervous tension, sleep disorder
Well-established Use: For the relief of mildnervous tension. - Traditional Use: Traditionalherbal medicinal product for relief of mildsymptoms of mental stress and to aid sleep.
Coated tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medical device
Medical device
Lactobacillus-johnsonii EU1 4x10^5 - 4x10^7CFU/cap.
Treatment of gastro-intestinal disorders
Treatment and prophylaxis of non-specificdiarrhea,Treatment and prevention ofrecurrences of antibiotic-induced diarrhea
Opaque hard capsule, size 1
CE mark
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Milk Thistle fruit 177.4 - 240.4 mg, corresp. to108.2 mg Silymarin
Digestion & liver
Supportive treatment of chronic-inflammableliver injuries, cirrhosis of the liver and toxicliver injuries (caused by hepatotoxic agents)
Capsule
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Pelargonium root 20 mg
Cough and cold
Traditional herbal medicinal product for the reliefof symptoms of upper respiratory tract infectionsincluding common cold, such as sore throat,cough and blocked or runny nose.
Film-coated tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Plantain herb 300 mg
Cough and cold
Catarrh of the respiratory tract, inflammationsof the oral and pharyngeal mucosa.
Effervescent tablet
Marketing authorization
DE
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Passionflower herb 250 mg, Valerian root 125 mg
Mild nervous tension, sleep disorder
Well-established Use: For the relief of mildnervous tension and difficulty in falling asleep. -Traditional Use: Traditional herbal medicinalproduct used for the temporary relief of sleepdisturbances due to symptoms of mild anxiety.
Coated tablet
Marketing authorisation
UK, PL
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Passionflower herb 250 mg, Valerian root 125 mg
Mild nervous tension, sleep disorder
Well-established Use: For the relief of mildnervous tension and difficulty in fallingasleep. - Traditional Use: Traditional herbalmedicinal product used for the temporaryrelief of sleep disturbances due to symptomsof mild anxiety.
Coated tablet
Dossier
All European countries
OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Siberian ginseng root 120 mg
Convalescence
Traditional herbal medicinal product for symptomsof asthenia such as fatigue and weakness,exclusively based upon long-standing use
Capsule
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medical Device
Medical device
Simethicon 125mg
Treatment of gastro-intestinal disorders
De-foaming agent for the symptomatictreatment of flatulence and gastrointestinalcomplaints, e.g. Meteorism
Chewable Soft Gelatin Capsule
CE mark
All European countries (except UK, IRE)
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Plantain herb 300 mg
Cough and cold
Catarrh of the respiratory tract, inflammations ofthe oral and pharyngeal mucosa.
Effervescent tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Red vine leaf 180 mg
Circulatory function
Symptomatic relief of venous relief to helpmaintain healthy leg vein circulation.
Capsule
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
St. John´s Wort herb 300 mg, Black cohoshrhizome 6.4 mg
Climacteric symptoms, menstrual disturbances
Traditional herbal medicinal product for the reliefof neurovegetative disorders and low mood inconnection with menopausal symptoms,exclusively based upon long-standing use.
Coated tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
St. John´s Wort herb 120 mg, Valerian root 56 mg
Low mood
Traditional herbal medicinal product for therelief of slightly low mood and mild anxiety,sleep disturbances due to symptoms of mildanxiety, exclusively based upon long-standinguse.
Coated tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
St. John´s Wort herb 250 mg
Low mood
Well-established use: Psychovegetativedisorders, mild depressive moods. - TraditionalUse: Traditional herbal medicinal product used torelieve the symptoms of slightly low mood andmild anxiety.
Film-coated tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
St. John´s Wort herb 425 mg
Low mood
Well-established use: Psychovegetativedisorders, mild depressive moods. -Traditional Use: Traditional herbal medicinalproduct used to relieve the symptoms ofslightly low mood and mild anxiety.
Coated tablet
Dossier
All European countries
OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Valerian root 300 mg
Mild nervous tension, sleep disorder
Herbal medicinal product for the relief of mildnervous tension and sleep disorders. (Also forchildren over 6 years old)
Coated tablet
Marketing authorization
DE
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Valerian root 300 mg
Mild nervous tension, sleep disorder
Herbal medicinal product for the relief of mildnervous tension and sleep disorders. (Alsofor children over 6 years old)
Coated tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)MedicinalMedicinal product (WEU/THMP)
Valerian root 150 mg
Mild nervous tension, sleep disorder
Herbal medicinal product for the relief of mildnervous tension and sleep disorders. (also forchildren over 6 years old)
Coated tablet
Marketing authorization
DE, UK, PL, PT
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Valerian root 150 mg
Mild nervous tension, sleep disorder
Herbal medicinal product for the relief of mildnervous tension and sleep disorders. (Alsofor children over 6 years old)
Coated tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Valerian root 425 mg, Melissa leaf 220 mg
Mild nervous tension, sleep disorder
For the relief of mild nervous tension anddifficulty in falling asleep.
Coated tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Valerian root 125 mg, Melissa leaf 112.5 mg,Passionflower herb
Mild nervous tension, sleep disorder
For the relief of mild nervous tension anddifficulty in falling asleep.
Coated tablet
Marketing authorization
UK, AT
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Valerian root 450 mg
Mild nervous tension, sleep disorder
Well-established Use: Herbal medicinal productfor the relief of mild nervous tension and sleepdisorders.
Coated tablet
Dossier
All European countries
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Medicinal product (WEU/THMP)
Medicinal product (WEU/THMP)
Valerian root 425 mg, Melissa leaf 220 mg
Mild nervous tension, sleep disorder
For the relief of mild nervous tension anddifficulty in falling asleep.
Coated tablet
Marketing authorization
DE
OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement
EMS is the leader of the pharmaceutical market in Brazil, both in revenue and in units- even considering all the multinationals. It has two GMP production sites in Sao Paulo,where operates a modern industrial complex, including one of the largest R&D centers.The drugs are distributed in Brazil and in our subsidiaries, in Italy, Portugal and Spain,and exported to more than 30 countries.
Contact Preson: José Piccolotto ([email protected])Contact Telephone Number: 55 - 19 - 3887.9934
OTC PRODUCTS
Name
Form
Strength
Indication
Status
Ambroxol Hydrochloride
Syrup Pediatric Without Sugar
3mg/Ml
Expectorants
Ctd-Eu
Name
Form
Strength
Indication
Status
Terbinafine Hydrochloride
Cream
10mg/G
Topical Dermatological Antifungals
Ctd-Eu
Name
Form
Strength
Indication
Status
Acetylsalicylic Acid
100mg, 300mg, 500mg
Tablet (+Fc)
Analgesics And Antipyretics
Anvisa/Br
Name
Form
Strength
Indication
Status
Aceclofenac
Cream
15mg/G
Anti-Inflammatories
Anvisa/Br
COMPANY NAMEEMS
CITYSao Paulo
COUNTRYBrazil
OTC & Biosimilar Directory Supplement
COMPANY PROFILE
PACK SHOTS
Name
Form
Strength
Indication
Status
Acetylcysteine
Granulated Powder (Sachet)
200mg, 600mg
Expectorants
Anvisa/Br
Name
Form
Strength
Indication
Status
Carbocysteine
Syrup & Suspension
20mg/Ml (Pediatric) 50mg/Ml
Mucolytics
Anvisa/Br
Name
Form
Strength
Indication
Status
Clobutinol Hydrochloride
Syrup
4mg/Ml
Cough Suppressants
Anvisa/Br
Name
Form
Strength
Indication
Status
Ketoconazole
Shampoo
20mg/G
Topical Scalp Antifungals
Anvisa/Br
Name
Form
Strength
Indication
Status
Bromhexin Hydrochloride
Syrup Pediatric
4mg/5ml
Mucolytics
Anvisa/Br
Name
Form
Strength
Indication
Status
Naphazoline Hydrochloride
Nasal Solution
0,50mg/Ml
Nasal Decongestants
Anvisa/Br
Name
Form
Strength
Indication
Status
Neomycin Sulfate + Bacitracin
Ointment
5mg/G + 250 Ui/G
Antibacterials Topics
Anvisa/Br
Name
Form
Strength
Indication
Status
Diclofenac Diethylammonium
Gel
10mg/G
Anti-Inflammatories
Anvisa/Br
OTC & Biosimilar Directory Supplement
Name
Form
Strength
Indication
Status
Aluminum Hydroxide
Oral Suspension
61,5mg/Ml
Antacids
Anvisa/Br
Name
Form
Strength
Indication
Status
Dexchlorpheniramine Maleate
Cream
10mg/G
Antihistamines
Anvisa/Br
Name
Form
Strength
Indication
Status
Mebendazole
Tablet & Oral Suspension
100mg & 20mg/Ml
Benzimidazole Derivatives
Anvisa/Br
Name
Form
Strength
Indication
Status
Nimesulide
Gel
20mg/G
Anti-Inflammatories And Antirheumatics
Anvisa/Br
Name
Form
Strength
Indication
Status
Nystatin + Zinc Oxide
Ointment
100.000 Ui/G + 200mg/G
Wound-Healing Agents
Anvisa/Br
Name
Form
Strength
Indication
Status
Miconazole Nitrate
Cream & Lotion
20mg/G & 20mg/Ml
Plain Topical Corticosteroids
Anvisa/Br
Name
Form
Strength
Indication
Status
Tiabendazole
Ointment
50mg/G
Antihelminthics
Anvisa/Br
Name
Form
Strength
Indication
Status
Apevitin Bc
Syrup
Thiamine Hydrochloride + Riboflavin +Pyridoxine Hydrochloride + Nicotinamide +Ascorbic Acid
Appetite Stimulants
Anvisa/Br
Name
Form
Strength
Indication
Status
Diclofenac Sodium
Gel
10mg/G
Anti-Inflammatories
Anvisa/Br
Name
Form
Strength
Indication
Status
Dimethicone
Drops
75mg/Ml
Antiflatulents
Anvisa/Br
Name
Form
Strength
Indication
Status
Dimethicone + Homatropine Methylbromide
Drops
80 + 2,5mg/Ml
Antiflatulents And Anticholinergics
Anvisa/Br
Name
Form
Strength
Indication
Status
Dimethicone
Capsule / Tablet
125mg / 40mg
Antiflatulents
Anvisa/Br
Name
Form
Strength
Indication
Status
Dipyrone Sodium
Drops & Oral Solution & Tablet
500mg/Ml
Analgesics And Antipyretics
Anvisa/Br
Name
Form
Strength
Indication
Status
Dipyrone Sodium + Isometheptene + Caffeine
Drops
300 + 50 + 30mg/Ml
Functional Bowel Disorders
Anvisa/Br
Name
Form
Strength
Indication
Status
Dipyrone Sodium + ScopolamineHydrobromide
Oral Solution
6,67 + 333,4mg/Ml
Analgesics And Antiemetics
Anvisa/Br
Name
Form
Strength
Indication
Status
Guaifenesin
Syrup (Honey)
200mg/12,5ml
Expectorants
Anvisa/Br
OTC & Biosimilar Directory SupplementOTC & Biosimilar Directory Supplement
Name
Form
Strength
Indication
Status
Cystex
Coated Tablet
Acriflavine Hydrochloride + Methenamine +Methylthioninium Chloride + Belladonna Powder15 + 250 + 20 + 15mg
Antiseptics, Urinary
Anvisa/Br
Name
Form
Strength
Indication
Status
Complexo B
Syrup & Tablet & Drops
Thiamine Hydrochloride + Riboflavin +Pyridoxine Hydrochloride + Cyanocobalamin+ Nicotinamide + Calcium Pantothenate (3mg + 1mg + 1mg + 1,5mcg + 2,5mg +1,5mg)/Ml
Multivitamins
Anvisa/Br
Name
Form
Strength
Indication
Status
Gripen F
Capsule
Paracetamol + Phenylephrine Hydrochloride +Chlorpheniramine
400 + 4 + 4 Mg
Analgesics, Descongestants And Antihistamines
Anvisa/Br
Name
Form
Strength
Indication
Status
Stilux
Ophthalmic Solution
Zinc Sulfate + Naphazoline Hydrochloride +Boric Acid + Sodium Borate
0,15 + 0,30 + 15 + 0,70mg/Ml
Ophtalmic Aseptic Adstringent
Anvisa/Br
OTC & Biosimilar Directory Supplement OTC & Biosimilar Directory Supplement
COMPANY PROFILEFarmalider, S.A. is a private company of Madrid, Spain, specialized in the developmentand licensing out of products in the following areas: OTC - including food supplements with a medical claimValue-added - new presentations and combinationsInnovative - registered as novelty products with preferred pricingBranded Generics - specific to individual market requirementsContact Preson: Susanna El-Armale ([email protected])Contact Telephone Number: +34 93 447 39 58
PACK SHOTS
OTC PRODUCTS
Product Name
Strength
Presentation
Use/Claim
Status
BENZOCAINE
5%
Gel
Toothache relief
2011
Product Name
Strength
Presentation
Use/Claim
Status
BENZOCAINE/ TETRACAINE
14%/ 2%
Spray
Toothache relief
Q2 2011
Product Name
Strength
Presentation
Use/Claim
Status
BIPxine®/ ALOE VERA/ ROSE RUBIGINOSA
N/A
Cream
Repair cream post-laser in large areas (legs, back)
Available
Product Name
Strength
Presentation
Use/Claim
Status
BIPxine®/ ALOE VERA/ ROSERUBIGINOSA/CENTELLA ASIATICA
N/A
Cream
Repair cream post-laser in sensitive areas(armpits, bikini area, face)
Available
COMPANY NAMEDiapharm UK
CITYMadrid
COUNTRYSpain
Product Name
Strength
Presentation
Use/Claim
Status
FOLIC ACID/ IODINE/ VITAMIN B12
400 mg/ 294 mg/ 2 mg
Tablets
Indicated for the prevention of deficiencydisorders in pregnant women
Available
Product Name
Strength
Presentation
Use/Claim
Status
FOLIC ACID/ IODINE/ VITAMIN B12/ IRON
400 mg/ 294 mg/ 2 mg
Tablets
Products formulated to meet nutritional needsin pregnant women or those trying to getpregnant. Prophylaxis of neural tube defects,prevention of neurological disorders in thefetus and preventing anemia caused by irondeficiency
Q42010
Product Name
Strength
Presentation
Use/Claim
Status
HYALURONIC ACID/ HORSE-CHESTNUT/CAFFEINE/ MENTHOL
N/A
Crackling gel
Relief for heavy and tired legs
Available
Product Name
Strength
Presentation
Use/Claim
Status
IBUPROFEN
200 mg, 400 mg, 600 mg
Tablets
Analgesic, antipyretic, anti-inflammatory
Available
Product Name
Strength
Presentation
Use/Claim
Status
IBUPROFEN (2%)
20 mg/ml
Oral suspension (multidose bottles)
Analgesic, antipyretic (paediatric)
Available
Product Name
Strength
Presentation
Use/Claim
Status
IBUPROFEN (4%)
40 mg/ml
Oral suspension (multidose bottles)
Analgesic, antipyretic (paediatric)
Available
Product Name
Strength
Presentation
Use/Claim
Status
CHLORHEXIDINE/ BENZOCAINE
5 mg/ 2 mg
Lozenges
Oral antiseptic
Q4 2010
Product Name
Strength
Presentation
Use/Claim
Status
DEXTROMETHORPHAN HBr
10 mg/5 ml
Oral solution (multidose bottles)
Cough relief
Available
Product Name
Strength
Presentation
Use/Claim
Status
DEXTROMETHORPHAN HBr
15 mg
Soft-gel capsules
Cough relief
Q42010
Product Name
Strength
Presentation
Use/Claim
Status
DEXTROMETHORPHAN HBr
10 mg
Lozenges
Cough relief
Q32010
Product Name
Strength
Presentation
Use/Claim
Status
DEXTROMETHORPHAN HBr
5 mg/ml, 10 mg/5 ml
Oral solution (unidose sticks)
Cough relief
Q32010
Product Name
Strength
Presentation
Use/Claim
Status
ELEUTEROCOCCUS/ MINERALS/ VITAMINS
N/A
Capsules
Vitamin and mineral supplement for womentaking the contraceptive pill
Available
OTC & Biosimilar Directory SupplementOTC & Biosimilar Directory Supplement
Product Name
Strength
Presentation
Use/Claim
Status
IBUPROFEN
100 mg, 200mg, 400mg, 600mg
Oral suspension
Analgesic, antipyretic, anti-inflammatory
Available
Product Name
Strength
Presentation
Use/Claim
Status
IBUPROFEN (arginine)
200mg, 400mg, 600mg
Granules for oral solution (unidose sachets)
Analgesic, antipyretic, anti-inflammatory
Available
Product Name
Strength
Presentation
Use/Claim
Status
IBUPROFEN
200 mg, 400mg
Orodispersible powder
Antipyretic and pain mild to moderate
Q22011
Product Name
Strength
Presentation
Use/Claim
Status
LIGNANS/ RESVERATROL/ GREEN TEA/RED CLOVER/ MINERALS/ VITAMINS
N/A
Capsules
Relief of climacteric symptoms for women inmenopause
Available
Product Name
Strength
Presentation
Use/Claim
Status
LORATADINE
10 mg
Soft – gel capsules
Antihistamine
Available
Product Name
Strength
Presentation
Use/Claim
Status
PARACETAMOL
250 mg, 325 mg, 500mg
Orodispersable granules (unidose sticks)
Analgesic, antipyretic (paediatric)
Available
OTC & Biosimilar Directory Supplement
Product Name
Strength
Presentation
Use/Claim
Status
PARACETAMOL
500 mg, 650 mg, 1g
Tablets
Analgesic, antipyretic
Available
Product Name
Strength
Presentation
Use/Claim
Status
PARACETAMOL/ PSEUDOEPHEDRINESULPHATE/ DEXTROMETHORPHAN Hbr
500 mg/ 30 mg/ 15 mg
Powder for oral solution (unidose sticks)
Cough and cold
Available
Product Name
Strength
Presentation
Use/Claim
Status
VITAMINS / MINERALS/ OMEGA-3/ OMEGA-6
N/A
Capsules
Indicated to meet the nutritional needs of amother during breastfeeding period
Available
OTC & Biosimilar Directory Supplement
Helvetia Pharma is a Czech - Swiss company established in 2005 and focused onresearch, development, manufacturing and marketing of immunostimulants and dietarysupplements. We manufacture our own private label products under our manufacturingarm, using the latest technologies. Our factory holds EU GMP certification. VaxinHPproducts are intended for prevention and treatment of most common diseases usingmicrobial immunomodulators.Contact Preson: Mona Sandescu ([email protected])Contact Telephone Number: 00 420 222 511 878
OTC PRODUCTS
COMPANY NAMEHelvetia Pharma
CITYPrague
COUNTRYCzech Rebublic
OTC & Biosimilar Directory Supplement
COMPANY PROFILE
PACK SHOTS
OTC & Biosimilar Directory Supplement
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
FemiVaxinum NEO
Dietary Supplement
*Candida Albicans *Candida Glabrata, *CandidaKrusei, *Gardnerella Vaginalis, *CandidaTropicalis, *Propionibacterium Acnes Lysatum,*Beta Glucan
*Suitable for women with recurrent vaginalinflammation caused by yeasts or bacteria,*Improvement of vaginal mucosa conditions
Gynecology
30 capsules
Approved
Czech Republic, Slovakia, Azerbaijan, Poland
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
NefroVaxin HP
Dietary Supplement
*Klebsiella Pneumonia,*PseudomonasAeruginosa, *Enterococcus Faecalis,*Escherichia coli, *Proteus Mirabilis,*Propionibacterium Acnes Lysatum, *Beta Glucan
*Suitable for women and men with recurrenturinary system inflammation caused by bacteria,*Improves urinary system conditions, *Additionagent to the decreased immunity treatment
Urology
30 capsules
Approved
Czech Republic, Slovakia, Azerbaijan, Poland
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
RespiVaxin HP
Dietary Supplement
*Streptococcus Pneumonia, *KlebsiellaPneumoniae, *Staphylococcus Aureus,*Streptococcus Pyogenes, *Escherichia Coli,*Bovinní Kolostrum, *Beta Glucan
*Suitable for everybody with recurrentrespiratory system inflammation caused bybacteria, *Improves respiratory mucosaconditions, *Represents the most commonbacteria which cause respiratory infections
ORL
30 capsules
Approved
Czech Republic, Slovakia
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
DentalVaxin HP and DentalVaxin HP Kids
Dietary Supplement
*Streptococcus Mutans, *StreptococcusSanguis, *Streptococcus Mitis, *ActinomycesViscosus, *Erythritol, *Coenzime Q10,*Manitol*Treatment and prevention of dental caries,*Improves condition of mouth mucosa,*Strong non specific immunomodulatoryeffect, *Product for adults, *Product for kids(6+ years)
Stomatology
30 capsules
Approved
Czech Republic, Slovakia,
Oystershell is a specialized developer of over-the counter health products. Sinceseveral years the company has been dedicated to the research and development oflow risk and soft claim health products such as dietary supplements and medicaldevices. This strategy has led to the international launch of several new-generationproducts in OTC sub domains such as head lice treatment, oral care, burnsmanagement and others.Contact Preson: André Janssens ([email protected])Contact Telephone Number: 32 9 377 24 85
OTC PRODUCTS
COMPANY NAMEOystershell
CITYDrongen
COUNTRYBelgium
OTC & Biosimilar Directory Supplement
COMPANY PROFILE
PACK SHOTS
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Flamozil
OTC
Carbomere
Paraben-free hydrogel spray for woundtreatment
Superficial burns, grazed skin, bedsores,open leg sores
Spray can 50g – Spray can 75g - Spray can285g - Tube 50g
Medical device
TBD
Product name
Category
Ingredients
Use/Claim
Main Indication
Unit Size
Status
Sold In (Countries)
Tixozin
OTC
Zinc oxide
Prevention of diaper rash
Prevention of diaper rash
Pump spray 100ml
Medical device
TBD
OTC & Biosimilar Directory Supplement
COMPANY PROFILEProgressare Medinvest is a group of companies that offer innovative productdevelopment in a healthcare industry. Progressare offers innovative producttechnologies with a focus on medical devices. Our focus is aimed at establishing nichemarkets in which we launch new brands to extend the complete product categoriesrather than compete with existing products.All our products are patented, validated,clinically evaluated,registered and licensed. Contact Preson: Maikel Hendriks ([email protected])Contact Telephone Number: +31 (0)20 345 95 05
PACK SHOTS
COMPANY NAMEProgressare
CITYAmsterdam
COUNTRYNetherlands
OTC PRODUCTS
Product name
Category
Ingredients
Use/Claim
Status
Sold In (Countries)
Dry Mouth Spray
Medical Device
Patented Rye Extract
Treats symptoms of Xerostomia, Treats fungusinfections, Treats and prevents gingivitis and badbreath. Balances mouth flora. For moderate tosevere Dry Mouth; Long lasting relief;
Class I
Nordics
Product name
Category
Ingredients
Use/Claim
Status
Sold In (Countries)
Bladder Infection Capsule
Medical Device
Patented Rye Extract
Treats and prevents bladder infection. Helpsthe bladder clean. Increases the resistance inthe bladder. Good for urinary tract. Has abeneficial effect on the acidity of urine. Workspreventatively during stress or othermedication
Class Iia
The Nederlands
OTC & Biosimilar Directory Supplement
Product name
Category
Ingredients
Use/Claim
Status
Sold In (Countries)
Vaginal Capsule
Medical Device
Patented Rye Extract
Prevents and treats Bacterial Vaginosis (BV);Reduces unpleasant odor and discharge;Optimizes the vaginal flora and condition of thetissues. Counters yeast.
Class IIa
The Nederlands
Product name
Category
Ingredients
Use/Claim
Status
Sold In (Countries)
Nail Fungus Pen
Medical Device
Patented Rye Extract
Treats and prevents nail fungus. Revitalizesyour damaged nails. Fast results.
Class IIa
Most European Markets
Product name
Category
Ingredients
Use/Claim
Status
Sold In (Countries)
Cold Sore Prevention
Medical Device
Zinc Particles
Treats and prevents the symptoms of cold sores.Relieve dryness and flaking. Revitalizing tosupport natural healing.
Class I
The Nederlands
Product name
Category
Ingredients
Use/Claim
Status
Sold In (Countries)
Fissure Wipes
Medical Device
100% natural extracts of witch hazel, Sweetbroom, horse-chestnut and vitamins.
Treat and provide relief from hemorrhoidalirritation.Cooling sensation and soothingeffect to calm inflamed tissues immediatelyupon contact. Temporary relief of irritationand burning. Effective astringent andantiseptic medical properties to acceleratethe anal skin healing process.
Class I
The Nederlands, UK
Product name
Category
Ingredients
Use/Claim
Status
Sold In (Countries)
Wart Pen
Medical Device
Patented Rye Extract
Painless treatment and removal of warts andcorns.
Class IIa
Most European Markets
Product name
Category
Ingredients
Use/Claim
Status
Sold In (Countries)
Wound Healing Spray
Medical Device
Patented Rye Extract
For external treatment of small cuts, burnsand insect bites. Aids in the natural healingprocess. Revitalizing to support naturalhealing. Prevent scarring. Stimulates skinregeneration. Provides soothing effect oncontact. Prevents bacterial infections.Relieves pain and discomfort (infection risks).
Class IIa
The Nederlands
OTC & Biosimilar Directory Supplement
OTC & Biosimilar Directory Supplement
BIOSIMILAR COMPANY LISTFEATURED COMPANYIntas
3S
Bharat Biotech
Bioton
Emcure
Interlong
MJ Biopharm
Pharmaclon
Reliance
Shantha
Shreya
OTC & Biosimilar Directory Supplement
COMPANY PROFILEIBPL is an integrated biopharmaceutical company with in house facility fordevelopment, manufacturing of bulk and finished formulation. GMP certifications fromEurope, South-Africa, and GCC. Peg GCSF, GCSF, EPO and IFN and seven morebiosimilar molecules under development. Celestial Biological, a subsidiary of IBPL isactively engaged in marketing of plasma proteins – Albumin and IVIG under the brand‘Albucel’,‘Globucel’ and factocel in India.Contact Preson: Dr. Subir Basak ([email protected])Contact Telephone Number: 00-917966112501
PACK SHOTS
COMPANY NAMEIntas
CITYAhmedabad
COUNTRYIndia
BIOSIMILAR PRODUCTS
Product name Main Indication Unit Size Status Sold In (Countries)
NEUKINE (GCSF)
ERYKINE(rHu EPO)
INTALFA(rHu IFN Alfa 2b)
NEUPEG / PEGASTA(rHu Peg GCSF)
Febrile Neutropenia
Chronic renal failureAnemia associated with Cancer
Hepatitis B&C, Multiple myeloma
Febrile Neutropenia
150 mcg/1 ml,300 mcg/1ml,480 mcg /0.5 mlavailable in PFS
2000 iu,4000 iu,10000iu,40000 iu/1 mlvailable inPFS
3 miu, 5 miu /1 mlavailable inb PFS
6 mg/1 ml & 6 mg /0.6 mlavailable in PFS
Commercial
Commercial
Commercial
Commercial
SE Asia, LATAM,MENA, CIS-Russia.Under registrationin US and Europe
SE Asia, LATAM,MENA, CIS-Russia
SE Asia, LATAM,MENA, CIS-Russia
SE Asia, LATAM,MENA, CIS-Russia
FEATURED COMPANY: Intas
OTC & Biosimilar Directory Supplement
COMPANY PROFILEShenyang Sunshine Pharmaceutical Company Limited (SUNSHINE) is an integratedbiopharmaceutical company engaged in research/development, manufacture andmarketing/sales of biopharmaceutical products in China. Our recombinant, orgenetically engineered, protein-based products and product candidates are designedto address large markets with significant unmet medical needs in nephrology, oncology,supportive cancer care, inflammation and infectious disease.Contact Preson: Dr. Yingfei Wei ([email protected])Contact Telephone Number: +86 24 2538 6060
PACK SHOTS
COMPANY NAME3S
CITYShenyang
COUNTRYChina
BIOSIMILAR PRODUCTS
Product name Main Indication Unit Size Status Sold In (Countries)
Recombinant Human Erythropoietin Injection
Recombinant Human Thrombopoietin Injection
Recombinant Interferon ·-2a
Recombinant Human Interleukin-2
Heparin Sodium
Anemia associated withrenal failure
Thrombocytopenia
Lymphatic or haemopoietictumor. Hepatitis B & C
Metastatic renal cellcarcinoma
Anticoagulant
2000IU/vial, 3000IU/vial,4000IU/vial, 10000IU/vial
7500U/1ml , 15000U/1ml
1MIU, 3MIU, 5MIU
100,000 200,000 500,000,1M IU
1000, 5000 and 25000 IU
Approved
Approved
Approved
Approved
Approved
China
China
China
China
China
Product name Main Indication Unit Size Status Sold In (Countries)
ALBUCEL(Human albumin)
FACTOCEL (Factor VIII)
GLOBUCEL(Human immunoglobulin G)
Peg IFN
PTH
FSH
Etanercept
Rituximab
Bevacizumab
Restores blood volume
For the treatment ofHaemophlia
Primary immunodeficiency,Kawasaki syndrome,Idiopathic thrombocytopenic purpura,B-cell chronic lymphocytic leukemia,Allogenic bonemarrow transplantation,CIPD, Gullaine barre syndrome,Paediatric HIV1 Infection
20g/100 ml
250 iu /vial
5gm/100 ml
Commercial
Commercial
Commercial
Dev. Phase
Dev. Phase
Dev. Phase
Dev. Phase
Dev. Phase
Dev. Phase
India
India
India
OTC & Biosimilar Directory Supplement
OTC & Biosimilar Directory Supplement
COMPANY PROFILEBIOTON S.A., a biotechnology company, produces recombined human insulin andother protein substances based on gene recombination and protein processingtechniques. It produces drug pharmaceutical forms for injections, includingbiotechnological drugs. The company sells its products primarily in Russia, Belarus,Lithuania, Georgia, Azerbaijan, Ukraine, and Vietnam. BIOTON was founded in 1989and is based in Warsaw, Poland.Contact Preson: Radosaw Romanczuk ([email protected])Contact Telephone Number: 48 (22) 721 40 00
PACK SHOTS
COMPANY NAMEBioton
CITYWarsaw
COUNTRYPoland
BIOSIMILAR PRODUCTS
Product name Main Indication Unit Size Status Sold In (Countries)
Somatropin rDNA origin
Regular Insulin Injection Soluble EP , Biosynthetic,dervived by Human rDNA Technology
Insulin Injection, Isophane EP , Biosynthetic, derived byHuman rDNA Technology
Mixture of Insulin Injection Soluble (10%) and InsulinInjection Isophane (90%) , Biosynthetic, derived byHuman rDNA Technology
Mixture of IIS (20%) and III (80%)
Mixture of IIS (30%) and III (70%)
Mixture of IIS (40%) and III (60%)
Mixture of IIS (50%) and III (50%)
Hormone
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
5mg
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
Approved
Approved
Approved
Approved
Approved
Approved
Approved
Approved
EU
Poland
Poland
Poland
Poland
Poland
Poland
Poland
Bharat Biotech, Hyderabad, India, is a multidimensional biotechnology companyspecialising in product-oriented research, development and manufacturing of vaccinesand biotherapeutics; established in the year 1996. BBIL's state-of-the-artmanufacturing plant is the largest of its kind in Asia-Pacific. Built with an investment ofover INR 1000 million, the Manufacturing, Control Procedures and Protocols, conformto the internationally recognized institutions such as USFDA, UKMCA and WHO.Contact Preson: Mr Sai Prasad ([email protected])Contact Telephone Number: +91 40 2348 0567
PACK SHOTS
COMPANY NAMEBharat Biotech
CITYHyderabad
COUNTRYIndia
BIOSIMILAR PRODUCTS
Product name Main Indication Unit Size Status Sold In (Countries)
Recombinant Hepatitis-B Vaccine
Vi Capsular polysaccharide of Salmonellatyphi (Ty2 strain)
Recombinant Human Epidermal GrowthFactor Gel
Enoxaparin
Heparin Sodium
Hepatitis-B
Typhoid fever
Diabetic Foot Ulcers
Anti-thrombotic
Anticoagulant
10mcg, 20mcg
25 μg / 0.5ml
150 μg / gm
20mg, 40mg, 60mg
1000, 5000 and 25000 IU
Approved
Approved
Approved
Approved
Approved
India
India
India
India
India
OTC & Biosimilar Directory Supplement
COMPANY PROFILE
OTC & Biosimilar Directory Supplement
COMPANY PROFILEShenzhen Neptunus Interlong Bio-Technique Co, a hi-tech enterprise, covers researchand development, production, sales and distribution. Due to many years of excellentmanagement, it keeps its leading status in domestic market and pursues the strategyof internationalization.
Contact Preson: Zhang Simin ([email protected])Contact Telephone Number: 86 755 26411869
PACK SHOTS
COMPANY NAMEInterlong
CITYShenzhen
COUNTRYChina
BIOSIMILAR PRODUCTS
Product name Main Indication Unit Size Status Sold In (Countries)
Recombinant Human Interleukin-2
Recombinant Human Interferon ·-2b
Influenza vaccine
Oncologic. Hepatitis B
Lymphatic or haemopoietic tumor.Hepatitis B & C
A1/New Caledonia/20/99 (H1N1)A3/Wisconsin/67/2005 (H3N2)B/Malaysia/2506/2004
0.2 MIU/vial, 0.5 MIU/vial,1 MIU/vial, 2 MIU/vial
1 MIU/vial, 3 MIU/vial, 5 MIU/vial
1MIU, 3MIU, 5MIU
Approved
Approved
Approved
China
China
China
Established in 1983, Emcure has a commitment and drive, propelled growth from asingle manufacturing facility , to a range of world class manufacturing facilities spreadacross API, formulations and biotechnology. In 2006, it received US FDA approval forits solid dosages facility at Hinjwadi, Pune. With this approval, the facility hasaccreditation from US FDA, UK MHRA, WHO Geneva and MCC South Africa.
Contact Preson: Ramesh Souri ([email protected])Contact Telephone Number: 91 20-30610000
COMPANY NAMEEmcure
CITYGujarat
COUNTRYIndia
BIOSIMILAR PRODUCTS
Product name Main Indication Unit Size Status Sold In (Countries)
Filgrastim
Recombinant Human GranulocyteMacrophage Colony Stimulating factor(r-hu-GMCSF)
R Human Erythropoietin
Allergens
Allergens
Anemia
150 mcg, 300 mcg
250 mcg, 300 mcg
10,000 IU, 20,000 IU, 40,000 IU
Approved
Approved
Approved
India
India
India
OTC & Biosimilar Directory Supplement
COMPANY PROFILE
OTC & Biosimilar Directory Supplement
COMPANY PROFILEEstablished in 2002 NPP FARMAKLON, in 2006 obtained a license for the productionand sale of the first and only in Russia currently patented gamma-interferon: INGARON® (interferon-gamma human recombinant) in two dosage forms - lyophilisates forsolution for intramuscular and subcutaneous injection and lyophilisates for solution forintranasal administration.
Contact Preson: Skalyga Maria ([email protected])Contact Telephone Number: 495- 621-69-68
PACK SHOTS
COMPANY NAMEPharmaclon
CITYMoscow
COUNTRYRussia
BIOSIMILAR PRODUCTS
Product name Main Indication Unit Size Status Sold In (Countries)
Interferon gamma
Interferon alfa-2b
Interferon gamma
Interferon alfa-2b
Chronic viral hepatitis B and C, HIV / AIDSinfection and TB in the lungs
Acute viral hepatitis B; acute prolonged hepatitis B,chronic active hepatitis B and D, hepatitis C
Influenza
Preventing and treating influenza and other acuterespiratory viral infections
100 000 IU, 500 000 IU,1,000,000 IU, 2,000,000 IU
500000 ME, 1000000 IU,3000000 ME, 5000000 ME
100 000 IU
50 000 IU
Approved
Approved
Approved
Approved
Russia, Pakistan
Russia, Pakistan
Russia, Pakistan
Russia, Pakistan
MJ Biopharm, Biotechnology initiatives are focused on development of biology, the innovative“bio-pharmaceuticals”. With excellent facilities and expertise of human recombinant DNAhuman insulin Formulations, the efforts are to develop ”Key Knowledge” based on BiologicalEntities, leading to manufacture and market of high value bio-therapeutics with globalbenchmarks.MJ Biopharm is actively engaged in collaborative development efforts withknown biotechnology groups working on “Peptides” leading to “Key Biological Products”Contact Preson: Dilip Ghosh ([email protected])Contact Telephone Number: 91 22 22020644
COMPANY NAMEMJ Biopharm
CITYGujarat
COUNTRYIndia
BIOSIMILAR PRODUCTS
Product name Main Indication Unit Size Status Sold In (Countries)
Regular Insulin Injection Soluble EP, Biosynthetic, dervived byHuman rDNA Technology
Insulin Injection, Isophane EP, Biosynthetic, derived by HumanrDNA Technology
Mixture of Insulin Injection Soluble (30%) and Insulin InjectionIsophane (70%), Biosynthetic, derived by Human rDNATechnology
Long acting Insulin Zinc Injectable Suspension EP,Biosynthetic, derived by Human rDNA Technology
Regular Insulin Injection Soluble derived from monocomponentInsulin of Porcine Origin USP
Insulin Isophane Susp Injection derived from monocomponentInsulin of Porcine Origin USP
Long acting Insulin Injection derived from monocomponentInsulin of Porcine Origin USP
Mixed 30:70 Insulin Injection derived from monocomponentInsulin of Porcine Origin USP
Regular highly purified Insulin Injection of Bovine Origin USP
Isophane Susp highly purified Insulin Injection Bovine Origin USP
Long acting highly purified Insulin Injection Bovine Origin USP
Mixed 30:70 highly purified Insulin Injection Bovine Origin USP
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
Approved
Approved
Approved
Approved
Approved
Approved
Approved
Approved
Approved
Approved
Approved
Approved
India
India
India
India
India
India
India
India
India
India
India
India
OTC & Biosimilar Directory Supplement
COMPANY PROFILE
OTC & Biosimilar Directory Supplement
COMPANY PROFILEA pioneer in the field of biotechnology, Shantha Biotechnics is the first Indian company todevelop, manufacture and market a recombinant human healthcare product in India. We arecommitted to breaking new ground in modern biotechnology to address critical healthcareneeds of the developing world. Shantha is currently focusing its R&D efforts in thedevelopment of generic biologicals, novel therapeutic antibodies, proteins and vaccines.
Contact Preson: Srinivas Rao ([email protected])Contact Telephone Number: 1 516 859 3010
PACK SHOTS
COMPANY NAMEShantha
CITYHyderabad
COUNTRYIndia
BIOSIMILAR PRODUCTS
Product name Main Indication Unit Size Status Sold In (Countries)
r-DNA Hepatitis B Vaccine
Recombinant interferon Alfa 2b
Recombinant human erythropoietin
DPT +H vaccine
Hepatitis B
Hepatitis B and C
Anemia
Diphtheria, Pertussis, Tetanusand Hepatitis B
20mcg
3M IU, 5M IU
2000 IU, 4000 IU
D: 25 Lf, P:15 IU, T: 5Lf,HBsAg 10mcg
Approved
Approved
Approved
Approved
India
India
India
India
Reliance GeneMedix will initially strive to gain marketing approval in territories wherepatents have expired or never existed. Our aim is to register our products in the EU, wherethe legal and regulatory pathway for our main products has been set. We are also ultimatelyaiming at registering our products in the US, once patents have expired and the legal andregulatory pathway is in place. To achieve our aims, we are working proactively with therelevant regulatory authorities. Contact Preson: Conor O'Dea ([email protected])Contact Telephone Number: +353 5793 23572
PACK SHOTS
COMPANY NAMEReliance
CITYTullamore
COUNTRYIreland
BIOSIMILAR PRODUCTS
Product name Main Indication Unit Size Status Sold In (Countries)
Recombinant Human Interferon ·-2b
Erythropoietin (EPO)
human recombinant GranulocyteColony Stimulating Factor (G-CSF)
Reteplase-Recombinant TissuePlasminogen Activator
Recombinant follitropin betastimulating hormone (r-FSH)
Lymphatic or haemopoietic tumor.Hepatitis B & C
Anemia
Reversing neutropenic conditions
Acute myocardial infarction
Fertility hormone
3 MIU/vial, 5 MIU/vial
2000, 3000, 4000, 6000,10,000 and 40,000 IU
300 mcg/0.5 ml
18mg
300 IU, 900 IU and 1200 IU
Approved
Approved
Approved
Approved
Approved
India
India
India
India
India
OTC & Biosimilar Directory Supplement
COMPANY PROFILE
Shreya Group origins go back to Moscow, Russia, where Shreya Corporation, the parentcompany, was established in 1995. Once a one-man trading company, Shreya is today thethird largest Marketing & Distribution Company in Russia. Shreya Group has interests inboth pharmaceutical and biopharmaceutical products in key therapeutic segments.Currently, Shreya operates in Russia, CIS, India, South East Asia and African countries. TheGroup turnover for the year 2006 was US $ 581 million including US $ 85 million in India.Contact Preson: Sujit Kumar Singh ([email protected])Contact Telephone Number: 91 22 66938222
PACK SHOTS
COMPANY NAMEShreya Group
CITYMumbai
COUNTRYIndia
BIOSIMILAR PRODUCTSProduct name Main Indication Unit Size Status Sold In (Countries)Recombinant DNA human insulin buccal spray
Regular Insulin Injection Soluble EP, Biosynthetic, dervivedby Human rDNA Technology
Insulin Injection, Isophane EP, Biosynthetic, derived byHuman rDNA Technology
Mixture of Insulin Injection Soluble (30%) and InsulinInjection Isophane (70%), Biosynthetic, derived by HumanrDNA Technology
Long acting Insulin Zinc Injectable Suspension EP,Biosynthetic, derived by Human rDNA Technology
Purified Human Urofollitropin
Purified Human Chorionic Gonadotropin
Purified Human Menopausal Gonadotropin
Recombinant human growth hormone (somatropin)
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
Hypoglycaemia
Hormone
Hormone
Hormone
Hormone
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
40 IU/ml, 100 IU/ml, 100 IU/m
75 IU, 150 IU
2000 IU, 5000 IU, 10000 IU
75 IU, 150 IU
12 IU / 4mg
OTC & Biosimilar Directory Supplement
COMPANY PROFILE
Approved
Approved
Approved
Approved
Approved
Approved
Approved
Approved
Approved
India, Ecuador
India
India
India
India
India
India
India
India