list of registered drugs for january – december 2013 · web viewvee pak inc., illinois, usa...

DRUGS REGISTERED IN JANUARY 2013

DATE PRODUCT GENERIC DESIGNATION

MANUFACTURER LOCAL AGENT

CLASSIFICATION STATUS

37) 14.01.13

Health 2000 Enalapril 10mg Tablets

Enalapril maleate USP 10mg

S Kant Healthcare Limited, India

Health Brands Limited

Antihypertensive List 4

38) 14.01.13

X’tor 10 film coated tablets

Atorvastatin 10mg Ipca Laboratories Limited, India

Servi-Care Distributors Limited

Antihyperlipidemic agent

List 4

39) 18.01.13

Cloprez 75mg Film-Coated Tablets

Clopidogrel 75 mg MSN Laboratories Limited, Andhra Pradesh, India

Medical Products Limited

Antiplatelet Agent List 4

40) 18.01.13

Xiomida 300mg Film Coated Tablets

Oxcarbazepine 300mg

Jubilant Life Sciences Limited, Uttarakhand, India


Anticonvulsants List 4

41) 18.01.13

Glemont-CT4 Chewable Tablets

Montelukast Sodium equivalent to Montelukast 4mg)

Glenmark Pharmaceuticals Limited, India

T. Geddes Grant Distributors Ltd

Leukotriene modifiers

List 4

42) 18.01.13

Valsaden 320mg/25mg Film Coated Tablets

Valsartan 320mg & Hydrochlorothiazide 25mg

Krka dd Novo Mestro, Slovenia

Servi-Care Distributors Ltd


43) 31.01.13

Valsacor 320mg Film Coated Tablets

Valsartan 320mg Krka dd Novo Mestro, Slovenia



44) 31.01.1 Valsacor Valsartan 160mg Krka dd Novo Servi-Care Antihypertensive List 4

3 160mg Film Coated Tablets

Mestro, Slovenia Distributors Ltd

14.01.13

Boostrix suspension for injection in prefilled Syringe-preservative free monodose

Each dose (0.5ml) contains:Diphtheria toxoid not less than 2IU, Tetanu toxoid not less than 20IU, Prtussis toxoid 8mcg, Filamentous haemagglutinin 8mcg, Pertactin 2.5mcg, Adsorbed on aluminium hydroxide (ALCOH3) 0.3mg A13+, and aluminum phosphate (ALPO4) 0.2MG A13+

GlaxoSmithKline Biologicals S.A., Belgium

GlaxoSmithKline Caribbean Limited

Toxoid List 4

45) 31.01.13

Valsacor 80mg Film Coated Tablets

Valsartan 80mg Krka dd Novo Mestro, Slovenia



DRUGS REGISTERED IN JANUARY 2013DATE PRODUCT GENERIC

DESIGNATIONMANUFACTURER LOCAL AGENT CLASSIFICATIO

NSTATUS

1)

28.01.13

Prostatin Premium Male Formula Capsules

Each capsule contains vitamin B12 3mcg, Zinc 7.5mg, selenium 50mcg, proprietary blend 250mg

Alfa Vitamins Laboratories Inc, USA

Facey Commodity Company Ltd

Vitamins & Minerals

List 2

2)

28.01.13

Vision Support Capsules

- Alfa Vitamins Laboratories Inc, USA


Vitamins & Herbs List 2

3)

28.01.13

Sleep Nice Capsules Passion flower 100mg, chamomile flowers 100mg St. john’s wort herb 60mg



Herbal List 2

4)

28.01.13

Osteo X-1 tablets Each tablet contains 100mg ipriflavone, VitaminD3 equivalent to 133.33IU Vitamin D



Vitamins List 2

DRUGS REGISTERED IN FEBRUARY 2013

DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION

STATUS

5) 05.02.13

Vitabiotics PregnaCare His and Her Conception-Wellman Conception Tablets

Each tablet contains:Vitamin A, as Dry Vitamin A Acetate type 250CWS/A 750ug, Vitamin D3 100 CWS/AM {100,00iu/g} 15ug, Vitamin C as L-Ascorbic acid DC 97% gran starch free 90mg, Thiamin (vitamin B1) as Thiamin Mononitrate DC 97% 12mg, Vitamin B6 as Pyridoxine Hydrochloride 97% 19mg, Riboflavin (vitamin B2) as Riboflavin 5mg, Vitamin B12 as Cyanocobalamin {vitamin B12} Crystalline 75ug, Biotin as D-Biotin 150ug, Folacin as Folic Acid 400mg, Niacin {Vitamin B3} as Nicotinamide 18mg, Pantothenic as Calcium D-Pantothenate 10mg, Vitamin E as Alpha Tocopheryl Acid Succinate 30mg, L-Arginine as L-Arginine Mono Hydrochloride 10mg, Iron as Ferrous Fumanate 6mg, Magnesium as Magnesium Oxide 60mg, Zinc as Zinc Sulphate Monohydrate 15mg, Manganese as Manganese Sulphate Monohydrate 0.50mg, Copper

Thompson & Copper Ltd, Cheshire United Kingdom

Cari-Med Limited Vitamins & Minerals

List 2

as Copper Sulphate Dried 1mg, Chromium as Chromium Trichloride 6H20 50ug, Selenium as Sodium Selenate Anhydrous 150ug, Siberian Ginseng Extract as Siberian Ginseng Extract 4:1 30mg, CoQ10 as Co-Enzyme Q10 2mg, L-Carnitine Tartrate as L-Carnitine Tartrate 50mg, Citrus Bioflavonoids 60% as Citrus Bioflavonoids 60% 10mg, L-Glutathione as L-Glutathione 2.50mg, Maca as Maca Extract 250mg, Pine Bark Extract as Pine Bark Extract 95% Proanthocyanidins 30mg, Octacosanol as Rice Bran 3mg, Inositol as Inositol 40mg, Lycopene Extract 5% as Lycopene (Standardized Extract 5%) 1.5mg


DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT

CLASSIFICATION

STATUS

6)

05.02.13

Vitabiotics Wellteen Plus Omega 3-Wellteen Tablets

Each tablet contains:Vitamin A as VitaminA acetate (dry type325) 400ug, Natural Mixed Cartenoids as carocare nat. betacarotene 20% V 2mg, Thiamin {vitamin B1} as thiamin mononitrate DC 97% 6mg, Riboflavin (vitamin B2) as Riboflavin 3mg, Vitamin D3 as vitamin D3 100 CWS/AM {100,00IU/g}20ug, Folacin (Flolic Acid) as folic acid 400ug, Vitamin B12 as Cyanocobalamin {vitamin B12} crystalline 15ug, Vitamin B6 as pyridoxine hydrochloride 97% 8mg, Patothenic Acid as Calcium D-Pantothenate 6mg, Biotin as D-Biotin 75ug, Vitamin C as Ascorbic Acid {vitamin C} DC 97% 80mg, Vitamin E as D Alpha Tocopheryl Acid Succinate 8mg, Niacin {vitamin B3} as Nicotinamide 18mg, Zinc as Zinc Sulphate Monohydrate 15mg, Iron as Ferrous Fumarate 12mg, Selenium as Sodium Selenate Decahydrate 55ug, Magnesium as Magnesium Oxide, granulated USP 94mg, Manganese as Manganese Sulphate Monohydrate


Cari-Med Limited

Vitamins & Herbs List 2

2mg, Copper as Copper Sulphate Dried 1mg, Iodine as Potassium Iodide 130ug, Chromium as Chromium Trichloride 6H20 50ug, L-Carnitine Tartate as L-Carnitine Tartrate 50mg, Green Tea Extract {equivalent {as Green Tea Extract 8:1 40mg, Cranberry {as Cranberry Extract 15:1 CRA-STD 100mg, CoQ10 {as Co-Enzyme Q10 2mg


DATE PRODUCT

GENERIC DESIGNATION MANUFACTURER

LOCAL AGENT


7)

05.02.13

Vitabiotics Osteocare Tablets

Each tablet contains: Calcium {as magnesium hydroxide) 800mg, magnesium {as magnesium hydroxide) 150mg, zinc (as zinc sulphate monohydrate} 5mg, vitamin D {as vitamin D3 (500IU/mg) EC) 5mcg


Cari-Med Limited

Minerals List 2

8)

05.02.13

Health 2000 Diclofenac Gel B.P.

Each gel contains:Diclofenac diethylamine B.P., 1.16% w/v (equivalent to diclofenac sodium B.P. 1% w/w) in a gel base

M/S Tuton Pharmaceuticals, Gujarat, India

Health Brands Ltd

Analgesic List 2

9)

06.02.13

Pectylin-C Expectorant

Each tablet contains:Diphenhydramine hydrochloride B.P., 14mg, Ammonium Chloride B.P., 135mg, Sodium Citrate P.p., 1.1mg.

Ipca Laboratories Ltd, Sejavta, India

Servi-Care Distributors Ltd,

Antihistamine, Expectorant

List 2

10) 06.02.13

Clean and Clear Advantage 3-in-1 Foaming Acne Wash

Contains: Salicylic Acid 2% Vee Pak Inc., Illinois, USA

Cari-Med Limited

Keratolytic,bacteriocidal & comedolitic agent

List 2


DPRODUCT

GENERIC DESIGNATION

MANUFACTURER

LOCAL AGENT

CLASSIFICATION

STATUS

0Neutrogena

Contains: Sa

Neutrogena Co

Kirk Distri

Keratolytic,bacterioc

List 2

Oil-Free Acne Stress Control Powe

licylic Acid 2%

rporation, California, USA

butors Limited

idal & comedolitic agent

r-Cream0Vitabiotics PregnaCa

Each tablet contains:N

Thompson & Copper Ltd, C

Cari-Med Limited

Vitamins & Minerals

List 2

re His and Her Conception-Pregnac

atural Mixed Carotenoids as Carocare N

heshire United Kingdom

are Conception Tablets

at. Betacarotene 20% V 36mg, Thiamin

(vitamin B1) as Thiamin Mononitrate 8mg,

Riboflavin (vitamin B2) as Riboflavin 5mg

, Vitamin D3 as Vitamin D3 100 CWS/AM {100

,000 IU/g} 15ug, Folacin as (Folic Acid)

as Folic Acid 400ug, Vitamin B12 as Vitamin

B12 0.1% WS {Cyanocobalamin Prep.} 20

ug, Vitamin B6 as Pyridoxine Hydrochlor

ide 10mg, Pyridoxine Hydrochloride as

Calcium D-Pantothenate 6mg, Biotin as

D-Biotin 150ug, Vitamin C as Coated Asco

rbic Acid Type FC 90mg, Vitamin E as D Al

pha Tocopheryl Acid Succinate 30mg, Ni

acin {Vitamin B3} as Nicotinamide 20mg, Z

inc as Zinc Sulphate Monohydrate 15mg,

Iron as Ferrous Fumarate 14mg, Seleniu

m as Sodium Selenate Anhydrous 50ug,

Magnesium as Magnesium Oxide Granul

ated USP 60mg, Copper as Copper Sulphat

e Dried 1mg, Iodine as Potassium Iodid

e 140ug, Inositol as Inositol 50mg, L-Arg

inine as L-Arginine Mono Hydrochlorid

e {Veggie} 100mg, N-Acetyl Cysteine as

N-Acetyl Cysteine IP 50mg



STATUS

13) 05.02.13

Lergi Tablets Cetirizine Hydrochloride B.P. Tablets 10mg

Aurochem Laboratories (India), Pvt. Ltd., India

Inter Commercial Distributors Limited

Antihistamine List 2

14) 27.02.13

CO Q-10 30mg Softgels

Coenzyme Q10 Alfa Vitamins Laboratories Inc, USA


Vitamins List 2

15) 27.02.13

Aurovite-M Syrup

Vitamin A Palmitate BP 3000IU, Vitamin D³ BP 500IU, Vitamin B¹ BP 2mg, Riboflavin Sodium Phosphate BP 1.2mg, Nicotinamide BP 10mg, Vitamin B¹² BP 2.5mcg, Vitamin C BP 40mg, Vitamin B6 BP 1mg, Flavoured Syrup Base q.s., per 5ml



Vitamins List 2

16) 27.02.13

Vitamin C 1000mg Tablets

Vitamin C 1000mg (Ascorbic acid)



Vitamins List 2

17) 27.02.13

Ultra B Complex Tablets

Vitamin B¹ 100mg, Vitamin B² 100mg, Vitamin B³ 100mg, Vitamin B6 100mg, Folic Acid 800mcg, Vitamin B¹² 100mcg, Biotin 500mcg, Vitamin B5 100mg.



Vitamins List 2





18) 27.02.13

Triple Alflexil Triple Strength Tablets

Two tablets contain: Glucosamine HCI 1500mg,Chondroitin Complex 800mg, MSM 750mg)



Herbal List 2

19) 27.02.13

Ginkgo Biloba Capsules

Ginkgo biloba leaves powder 300mg,Ginkgo biloba leaves extract 60mg, 24%/6% standardized



Herbal List 2

20) 27.02.13

Ginseng with Ginkgo Biloba Tablets

Ginseng root 150mg, ginkgo biloba leaves powder 50mg, ginkgo biloba leaves extract 30mg



Herbal List 2

21) 27.02.13

Relaxin Capsules

Each capsule contains: Valerian root 100mg,Passion flower 100mg, chamomile flower 100mg)



Herbal List 2

22) 27.02.13

Senna Leaves High Potency Capsules

Senna leaves 235mg Alfa Vitamins Laboratories Inc, USA


Herbal List 2





23) 27.02.13

Calcium 600 +D Tablets

Calcium carbonate 600mg,equivalent to 240mg of calcium} Vitamin D 200IU



Vitamin & Mineral List 2

24) 27.02.13

Black Cohosh 250mg Capsules

Black Cohosh 250mg Alfa Vitamins Laboratories Inc, USA


Herbal List 2

25) 27.02.13

Vitamin B¹² 1000mcg Tablets

Vitamin B¹² 1000mcg Alfa Vitamins Laboratories Inc, USA


Herbal List 2

26) 27.02.13

Aminopep Forte Liquid

Amino Acid, Multivitamins & Mineral Syrup

Indus Pharmaceuticals, Chennai, India

UniMed Health Care Limited

Vitamins & Minerals

List 2

27) 27.02.13

Alcof-C Cough Syrup

Dextromethorphan Hydrobromide BP 10mg, Cetirizine Hydrochloride BP 5mg, Phenylephrine Hydrochloride BP 5mg, Menthol BP 1.5mg per 5ml.



Cough suppresant, Nasal Decogestant, Antihistamine

List 2


DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS

28)

27.02.13

Alcof-D Cough Syrup

Chlorpheniramine Maleate BP 4mg, Phenylephrine Hydrochloride BP 5mg, Dextromethorphan Hydrobromide BP 10mg, Menthol BP 0.5mg per 5ml



Antihistamine, Nasal Decogestant, Cough Suppressant

List 2

29)

27.02.13

Capsitop Gel

Capsaicin USP {as capsicum oleoresin} 0.025% w/w, Diclofenac diethylamine BP 1.160% w/w, Levomenthol BP 1% w/w, Methyl Salicylate BP 3% w/w.

Stedman Pharmaceuticals, Pvt. TamilNadu, India

UniMed Health Care Limited

Topical Anesthetic List 2

30)

27.02.13

Sanidex Solution (Activator Powder)

Activated Glutaraldehyde Solution 2% w/v & Activator Powder

Sirmaxo Chemicals, Pvt. Ltd., Thane, India

Lasco Distributors Limited

Sterilant List 2



CLASSIFICATION

STATUS

31)

27.02.13

Herbal Life Formula 2 Multivitamin Complex

Each tablet contains:Calcium Carbonate (37% CA} with Maltodextrin FG 302.58mg, Potassium Gluconate 189.8mg, Microcrystallin Cellulose NF/PH EUR/JP 173.55mg, Magnesium Oxide DC, Granular 125.06mg, Ascorbic Acid {97%} DC 64.43mg, Niacinamide USP/FCC 43.73mg, Zinc Gluconate Granular 41.34mg, Croscarmellose Sodium NF- NON-GMO 24mg, DL-Alpha Tocopheryl Acetate {50%} 23mg, Potassium Glycerphosphate 40% on rice {10%K} 17mg, Magnesium Gluconate Dihydrate 16.23mg, Beta Carotene Beadlets {7.5%} 16mg, Pyridoxine Hydrochloride USP 14.38mg, Biotin {1% TRIT} in Microcrystalline Cellulose 12mg, Stearic Acid {Vegetable grade} NF 12mg, Tocopherols, natural mixed {30%} 12mg, D-Calcium Pantothenate 10.12mg, Silicon Dioxide NF 10mg, Magnesium Stearate NF 10mg, Riboflavin 95%, fine granular on HPMC 10.5mg, Betaine Hydrochloride 10mg,

Manhattan Drug Company Inc., New Jersey

Herbalife International of America Inc

Vitamins, Minerals & Herbs

List 2

Hydoxypropyl Methlcellulose 8.95mg, Thiamine Mononitrate 8.55mg, Lycopene Beadlets 5% VBAF 7.92mg, Ferrous Fumarate Powder 7.06mg, Xangold Lutein 10% GFB 3.96mg, Chromium Chloride {1% CR} on DCP 3.8005mg, Copper Gluconate 3.78mg, L-Selenomethionine {0.5% SE on Calcium Phosphate Dibasic} Kosher 3.57mg, Vanadium Amino Acid Chelate {0.1% Vanadium} 2mg, Inositol 2mg, Choline Bitartrate Coated 2mg, Vitamin D³ GFP {100.000 IU/G} 1.93mg, Potassium Iodide 3% TRIT on Calcium Phosphate Dibasic 1.92mg, Folic Acid {10% TRIT.} 1.66mg, Carrot Powder 1mg, Vegetable Powder 1mg, Soinach Powder 1mg, Glycerine USP {99%}, Kosher 0.99mg, Grape Skin Powder 1mg, Pomegranate Polyphenol Extract Blend 1mg, Citrus Bioflavonoids Powder {25%} 1mg, Cyanocobalamin {1% TRIT. IN DCP} 0.29mg



MANUFACTURER LOCAL AGENT CLASSIFICATION

STATUS

32) 27.02.13

Male Factor 1000 Capsules

Each tablet contains:Calcium Carbonate (37% CA} with Maltodextrin 0.125 258mg, Green Oat PE 5:1 150mg, Nettle Leaf Extract 5:1 75mg, Ascorbic Acid {99%} 55mg, Sea Buckthorn Powder 50mg, Eleutherococcus Hydroalcoholic Spray-Dried 0.5% 2.5mg, Ginseng Leaf Extract Ginsenosides 30% 2.5mg.

Manhattan Drug Company Inc., New Jersey

Herbalife International of America Inc

Herbal List 2

33) 27.02.13

Green Tea 300mg Capsules

Green tea leaves 300mg per capsule



Herbal List 1



MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS

27.02.13 Alcof Cough Expectorant

Chlorpheniramine Maleate BP 2.2mg, Ammonium Chloride BP 110mg, Sodium Citrate BP 50mg, Menthol BP 1.1mg per 5ml.



Expectorant,Antihistamine,

List 1

27.02.13 Benefibre Wheat Dextrin Powder

Wheat Dextrin 100% Powder 3g per serving

Novartis Consumer Health Inc., Nebraska, USA

Cari-Med Limited Dietary Fibre List 1

19.02.13 Incivo Film-Coated Tablets 375mg

Telaprevir 375 mg Janssen_Cilag S.p.A., Via C. Janssen, Latina, Italy

Cari-Med Ltd Antiviral Agent List 4

19.02.13 Valsaden 80mg/12.5mg Film-coated Tablets

Valsartan 80mg, hydrochlorothiazide 12.5mg

Krka d.d., Novo Mesto, Slovenia

Servi-Care Distributors Ltd.


27.02.13 Valsaden 160mg/12.5mg Film-coated Tablets

Valsartan 160mg, hydrochlorothiazide 12.5mg




DRUGS REGISTERED IN MARCH 2013




13.03.13

Roswera 5mg Film-coated Tablets

Rosuvastatin Calcium 5mg




List 4

13.03.13

Health 2000 Simvastatin 40mg Tablets

Simvastatin 40mg USP

Skant Healthcare Ltd., India



List 4

14.03.13






List 4

14.03.13






List 4

14.03.13






List 4

15.03.13

Apo-Rosuvastatin 10mg Tablets


Apotex Incorporated, Canada

Cari-Med Limited


List 4

55) 15.03.13

Apo-Rosuvastatin 20mg Tablets


Apotex Incorporated, Canada

Cari-Med Limited


List 4

56) 18.03.13

Lopinavir and Ritonavir 200/50mg Tablets

Lopinavir 200mg, Ritonavir 50mg

Cipla Limited, India Lasco Distributors Limited

Antiviral Agent List 4

57) 18.03.13

Lamivudine and Tenofovir Disoproxil Fumarate Tablets 300mg/300mg

Lamivudine USP 300mg, Tenofovir Disoproxil Fumarate 300mg {equivalent to Tenofovir Disoproxil 245mg})



58) 18.03.13

Abacavir Sulfate and Lamivudine Tablets

Each uncoated tablet contains:Abacavir sulfate {equivalent to abacavir 60mg, Lamivudine USP 30mg})



59) 19.03.13

Levo-Denk 250 Film-Coated Tablets

Each film-coated tablet contains:250mg Levofloxacin {equivalent to 256.23mg levofloxacin hemihydrate})

Rottendorf Pharma GmbH, Germany

H.D. Hopwood and Co. Ltd.

Antibiotic List 4



STATUS

60) 19.03.13

Lancer 30 Delayed Release Capsules

Lansoprazole 30mg USP Aurochem Pharmaceuticals (India), Pvt. Ltd.

Inter Commercial Distributors, Ltd

Proton Pump Inhibitor

List 4

61) 25.03.13

Saphris 5mg Sublingual Tablets

Contains: Asenapine maleate 7.03mg equivalent to asenapine 5mg

Catalent UK Swindon Zydis Ltd., UK


Antipsychotics List 4

62) 25.03.13

Saphris 10mg Sublingual Tablets

Contains: Asenapine maleate 14.06mg equivalent to 10mg asenapine

Catalent UK Swindon Zydis Ltd., UK


Antipsychotics List 4

63) 25.03.13

Cortiflow Inhaler CFC Free

Each actuation delivers Anhydrous Beclometasone Dipropionate B.P., 50mcg, suspended in propellant HFA 134a (1,1,1,2 Tetrafluoroethane)

M/S Midas-Care Pharmaceticals, Pvt., Ltd., Aurangabed, India

Unimed Limited Steroid-inhaled List 4

64) 25.03.13

Sodium Chloride Intravenous Infusion B.P

.9% w/v) NS (Each 100ml contains: Sodium Chloride B.P., 900mg

Ahlcon Parenterals (India) Ltd., Rajasthan, India


Parental Nutrition List 4

65) 25.03.13

Cadigrel Tablets 75mg

Each film-coated tablet contains: Clopidogrel Bisulfate USP {equivalent to Clopidogrel 75mg

Cadila Pharmaceuticals Ltd., Gujarat, India

New Vision Distributors Limited

Antiplatelet Agent

List 4



CLASSIFICATION

STATUS

66) 25.03.13

Intacape 500 Tablets

Each contains: Capecitabine USP 500mg Intas Pharmaceuticals Ltd., India

Lascelles Laboratories Ltd

Anitneoplastics List 4

67) 26.03.13

Implanon Implant 68mg

Each implant contains: 68mg of etonogestrel

N.V. Organon, OSS, The Netherlands


Contraceptive-Progestins

List 4

68) 27.03.13

Posicaine 100 Injection

Contains: Articaine HCI 4% with Epinephrine 1:100,000)

Novocol Pharmaceutical of Canada Inc., Ontario, Canada

Glenn Logan Anaesthetic List 4

69) 27.03.13

Posicaine 200 Injection

Contains:Articaine HCI 4% with Epinephrine 1:200,000

Novocol Pharmaceutical of Canada Inc., Ontario, Canada

Glenn Logan Anaesthetic List 4

70) 27.03.13

Broncochem Flu Remedy Caplets

Acetaminophen 500mg, Bromhexine HCL 8mg, Phenylephrine 5mg, Chlorphenirmine

Magnachem International Laboratory, San Cristobal, Dominican Rep.

Qualcare Limited

Antihistamine,Pain reliever,Mucolytic Agent

List 4

71) 27.03.13

Apo- Escitalopram 10mg Tablets

Contains: Escitalopram Oxalate 10mg Apotex Research Private Ltd., Bangalore, India

Cari-Med Limited

Antidepressant List 4

28.03.13

Cisplatin Injection B.P., 50ml for I.V. Infusion

Each 50ml vial contains: Cisplatin, B.P.50mg

Naprod Life Sciences PVT. Ltd., Dist. Thane, India

Inter Commercial Distributors Ltd.

Antineoplastics List 4

72) 28.03.13

Etoposide Injection U.S.P. 100mg/5ml

Each 5ml vial contains: Etoposide U.S.P,100mg

Naprod Life Sciences PVT. Ltd., Dist. Thane, India

Inter Commercial Distributors Ltd

Antineoplastics List 4

DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS

FOR USE5-4-13 Zoteon

Podhaler 28mg Inhalation Powder Hard Capsules

Tobramycin Novartis Pharmaceuticals Corporation, USA

Cari-Med Limited

Respiratory List 4 Adult use; children age 6 and over

5-4-13 Ribomustin 25mg powder for concentrate for solution for infusion

Bendamustine Hydrochloride

Thissen Laboratories SA, Belgium

Cari-Med Limited

Alkylating Agents List 4 Adult use only

5-4-13 Ribomustin 100 mg powder for concentrate for solution for infusion

Bendamustine Hydrochloride

Thissen Laboratories SA, Belgium

Cari-Med Limited

Alkylating Agents List 4 Adult use only

5-4-13 Triben Plus Ear Drops

Overleaf not seen Jenburkt Pharmaceuticals Ltd, India

Pulse Medicine and Surgicals

Otic Antibiotic List 4 Adult use only

5-4-13 Apo-Letrozole 2.5 mg tablets

Letrozole USP Apotex Inc, Canada Cari-Med Limited

Anti-Cancer Agent

List 4 Adult use only

12-4-13 Telma 20 tablets

Telmisartan BP 20 mg Glenmark Pharmaceuticals Limited, India

T. Geddes Grant Distributors Limited

Anti-hypertension List 4 Adult use only

12-4-13 Telma 40 tablets

Telmisartan BP 40 mg Glenmark Pharmaceuticals Limited, India



DRUGS REGISTERED IN APRIL 2013



FOR USE12-4-13 Telma 80

tabletsTelmisartan BP 80 mg Glenmark

Pharmaceuticals Limited, India



12-4-13 Multiplex Syrup Vitamin A Palmitate USP 1500 IU, Vitamin D3 USP 200 IU, Vitamin B1 BP 1.5mg, Vitamin B2 5’ Phos. Sod. BP 1.75mg, Vitamin B6 BP 0.5mg, Vitamin B12 BP 2.5mcg, Vitamin C BP 25mg, Niacinamide BP 12.5mg, L.Lysine mono Hydrochloride USP 100mg, Zinc Sulphate USP 8.25mg, Vitamin E USP 0.5mg, Dexpanthenol USP 1.00mg

Indus Pharmaceuticals Arlab (India) Pvt, Ltd, Alathur, India

Unimed Health Care Limited

Nutritional List 2 Adult use only

12.4.13 Ardyss-LeVine Green Dietary Supplement

Aloe vera juice (from concentrate) 7.5g, milk thistle extract 180mg, alfalfa herb extract 120mg, artichoke extract 120mg, senna leaf extract 120mg, gamma oryzanol 120mg, licorice extract deglycyrrihizinated 60mg, schizandra berry extract 60mg, ginger root extract 1.5mg, sodium copper chlorophyllin (mulberry leaf extract) 1.2mg; per 30ml

Aseptic Solutions, California, USA

Uni-Med Health Care Limited


12.4.13 Ardyss-Multiplus Dietary

Vitamin A (50% as beta carotene and 50% as vitamin A palmitate) 5,000 IU, vitamin C (as ascorbic

Aseptic Solutions, California, USA

Uni-Med Health Care Limited


Supplement acid) 500mg, vitamin D (as cholecalciferol) 200 IU, vitamin E (as d-alpha tocophreyl acetate) 30 IU, vitamin K (as phytonadione) 40mcg, thiamin (as thiamine phytonadione) 1.5mg, riboflavin (as riboflavin-5 phosphate) 1.7mg, niacin (as niacinamide) 20mg, vitamin B6 (as pyridoxine hydrochloride) 2mg, biotin (as d-biotin) 150mcg, pantothenic acid (as calcium Pantothenate) 10mg, calcium (as calcium chloride) 50mg, magnesium (as magnesium sulfate) 20mg, zinc (as zinc sulfate) 15mg, selenium (as sodium selenite) 70mcg, copper (as cupric sulfate) 1mg, manganese (as manganese chelate) 2mg, chromium (as chromium polynicotinate) 120mcg, potassium (as potassium citrate) 75mg; per 30ml

18-4-13 Ciprocip 500 tablets

Ciprofloxacin hydrochloride equivalent to ciprofloxacin BP 500mg

Flagship Biotech International, India

Uni-Med Distributors Limited

Antibiotic List 4 Age 17 and over

18-4-13 Ranitidine 300mg tablets (BP)

Ranitidine hydrochloride 336 mg equivalent to ranitideine 300 mg



H2RB List 4 Adult use only

18-4-13 Ranitidine 150mg tablets (BP)

Ranitidine 150 mg Flagship Biotech International, India


H2RB List 4 Adult use only



FOR USE19-4-13 Flogrel 75 mg

tabletsClopidogrel bisulphate 97.87 mg equivalent to clopidogrel 75 mg



List 4 Adult use

17-4-13 Thycarzole 5 mg tablets

Carbimazole 5mg BP Unicure Remedies PVT. Ltd India


Anti-Hyperthyroidism


17-4-13 Air-o-vent Inhaler CFC Free

Overleaf not seen M/S Midas-Care Pharmaceuticals, Aurangabad, India

UniMed Distributors Limited

Respiratory List 4 Adult and children use

19-4-13 Aprovasc 150mg/5mg film coated tablets

Irbesartan 150mg/Amlodipine besilate 5 mg

Sanofi Aventis De Mexico, SA De CV Ocayoacac, Mexico

H.D. Hopwood Anit-hypertension List 4 Adult use only









19-4-13 Aprovasc 150mg/10mg

Irbesartan 150mg/Amlodipine besilate

Sanofi Aventis De Mexico, SA De CV


film coated tablets

10 mg Ocayoacac, Mexico



FOR USE19-4-13 Intelence

200mg tabletsEtravirine 200 mg Janssen-Cilag S.p.A.

Latina, ItalyCari-Med Limited

Anti-viral List 4 Age 6 and over

19-4-13 Doxorubicin Hydrochloride for injection BP 10mg/vial

Doxorubicin hydrochloride BP 10 mg

Naprod Life Sciences Pvt Ltd Dist Than India

Inter-Commercial Distributors Limited

Anti-Cancer List 4 Adult use only

19-4-13 Doxorubicin Hydrochloride for injection BP 50mg/vial

Doxorubicin hydrochloride BP 50 mg

Naprod Life Sciences Pvt Ltd Dist Than India



22-4-13 Afinitor 5mg tablets

Everloimus 5mg Novartis Pharma Stein AG Switzerland

Cari-Med Limited


24-4-13 Flucosyst-150 capsule

Fluconazole 150 mg USP Medicamen Biotech Limited Rojasthan, India

Indies Pharma Anti-Fungal List 4 Adult use only

23-4-13 Bioprist Atenolol-50 tablets

Atenolol 50 mg BP Medicamen Biotech Limited Rojasthan, India

Indies Pharma Anti-hypertension List 4 Adult use only

23-4-13 Neutrogena Oil-Free Acne Wash Redness Soothing Facial

Salicylic Acid 2% w/w Vee Pak Inc, USA Cari-Med Limited


Cleanser LiquidDRUGS REGISTERED IN APRIL 2013


FOR USE18-4-13 Moxflag 500

CapsulesAmoxicillin trihydrate BP 599.37mg equivalent to amoxicillin 500mg BP



Antibiotic List 4 Age 6 and over

23-4-13 Health 2000 Fexophen 180 tablets

Fexofenadine hydrochloride 180 mg BP

Unicure Remedies PVT LTD, India


Antihistamine List 4 Adult use only

29-4-13 Pantoking Injection; for IV use; 40 mg per vial; lyophilized

Pantoprazole sodium USP equivalent to pantoprazole 40mg

M/S Flagship Biotech International, Gujarat, India

Unimed Distributors Limited

Proton pump inbitor


25-4-13 Health 2000 Doxorubicin Hydrochloride for Injection 10 mg

Doxorubicin hydrochloride USP 10mg

M/S Health Biotech Ltd, Dist Solan, India



15.04.13

Zoteon Podhaler 28mg Inhalation Powder

Contains: Tobramycin Novartis Pharma Schweiz, AG Switzerland

Cari-Med Limited

Antibiotic List 4

DRUGS REGISTERED IN MAY 2013


FOR USE1-5-13 Efcure-600

tabletsEfavirenz 600 mg M/S Emcure

Pharmaceuticals Ltd, Pun, India

Servi-Care Distributors Limited

Anti-viral List 4 Adult use only

1-5-13 Meropenem for injection USP 500mg; vials for IV use

Meropenem USP equivalent to meropenem (anhydrous) 500 mg

Mepromax Life Sciences Private Ltd, Selaquil India

T.Geddes Grant Distributors Limited

Antibiotic List 4 Adult use only

1-5-13 Dextrose injection BP 5% w/v (50g/1) for IV use; 500ml plastic bags

Dextrose anhydrous BP 5gm; water for injection BP QS

Ahlcon Parenterals (I) Ltd Rajasthan, India


Parenteral List 4 Adult use only

1-5-13 Sodium chloride (0.9%w/v) and Dextrose (5%w/v) injection BP for IV use; 500ml plastic bags

Overleaf not seen Ahlcon Parenterals (I) Ltd Rajasthan, India


Parenteral List 4 Adult use only

3-5-13 Famy-Depo Contraceptive Injection 1ml vial; IM use only

Medroxyprogesterone acetate USP 150mg

Famy Care Ltd, Ahmedabad, India

Qualcare Limited

Contraceptive List 4 Adult use only



FOR USE3-5-13 Pirsec

20mg/1100mg capsules

Omeprazole 20mg; sodium bicarbonate 1100mg

Norwich Pharmaceuticals Inc, USA

GSK Caribbean Limited


3-5-13 Pirsec 40mg/1100mg capsules

Omeprazole 40mg; sodium bicarbonate 1100mg

Norwich Pharmaceuticals Inc, USA

GSK Caribbean Limited


3-5-13 Edurant 25 mg Film-coated tablets

Rilpivirine Janssen Cilag S.p.A. Italy

Cari-Med Limited

Anti-viral List 4 Adult use only

3-5-13 Inlyta 1mg Film-coated tablets

Axitimib 1mg Pfizer Manufacturing Deutschland, GmbH, Germany

H.D. Hopwood Biologic List 4 Adult use only

3-5-13 Inlyta 5mg Film-coated tablets

Axitimib 5mg Pfizer Manufacturing Deutschland, GmbH, Germany

H.D. Hopwood Biologic List 4 Adult use only

7-5-13 ZincOra Oral Rehydration Salts BP 20.8g, sodium chloride 2.6g, potassium chloride 1.5g, sodium citrate 2.9g, anhydrous glucose 13.5g, orange flavor (dry) 0.3g per sachet

Medicamen Biotech Limited, Rajasthan, India

Indies Pharma Jamaica Limited

Oral Rehydration Salts


7-5-13 Zinc Ora Zinc sulphate 57 mg USP as monohydrate equivalent to elemental zinc 20 mg tablets

Medicamen Biotech Limited, Rajasthan, India


Oral Rehydration Salts



FOR USE7-5-13 L-Montus

tabletsLevocetirizine dihydrochloride 5mg and Montelukast sodium equivalent to Montelukast 10mg

Fourrts (India) Laboratories Pvt. Ltd, Chehnai India


Respiratory List 4 Adult use only

7-5-13 Infen-25 tablets Dexketoprofen trometamol equivalent to Dexketoprofen 25 mg tablets

Emcure Pharmaceuticals Ltd, Maharashtra, India

Servi-Care Distributors limited

NSAID List 4 Adult use only

9-7-13 Kudose 0.4mg Prolonged Release Capsules

Tamsulosin hydrochloride as modified release pellets 0.4 mg BP

Genpharma International PVT Ltd, India


α- blocker List 4 Adult use only

10-5-13 Firmagon 120mg Powder and Solvent for Solution for injection

Degarelix 120mg as acetate Rentschler Biotechnolagie GmbH, Germany

New Vision Distributors

Anti-Neoplastic Agent



DRUGS REGISTERED IN JUNE 2013

DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENT

S FOR USE25-6-13 Jarrow Formulas

Choless Optimizer Tablets

Jarrow Formulas, Inc., California, USA

Leading Brands Jamaica Limited

List 2

25-6-13 Jarrow Formulas Pressure Optimizer Tablets



List 1

25-6-13 Sav-Laton Antiseptic Liquid

Cetrimide BP 3% w/v, Chlorhexidine gluconate Solution BP 1.5% equivalent to Chlorehexidine Gluconate 0.3% w/v, Isopropyl Alcohol BP 2.84% w/v)

Shirlome Chemical Corporation Ltd., 63 Hagley Park Rd., Kgn

10, Jamaica

Ayrtons Distributors (Ja.) Co. Ltd.

List 1

25-6-13 Jarrow Formulas Skin Optimizer

Capsules



List 1

25-6-13 Jarrow Formulas Bone-Up Capsules



List 2

25-6-13 Jarrow Formulas


Leading Brands Jamaica

List 2

Vision Optimizer Capsules

Limited


DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMNTS FOR USE

25-6-13 Jarrow Formulas Neuro Optimizer

Capsules



List 2

25-6-13 Systane Gel Drops Lubricant Eye Gel (Sterile)

Polyethylene Glycol 400 NF, 0.4% w/v,Propylene Glycol USP 0.3% w/v.

Alcon Laboratories, Inc., Texas, USA

Cari-Med Limited

List 2

25-6-13 Health 2000 Fexophen 120 Tablets

(Fexofenadine Hydrochloride 120mg USP)

Unicure Remedies Pvt. Ltd., Baroda, India


Histamine blocker List 2

25-6-13 Relcer Gel Vanilla Flavour

Glenmark Pharmaceuticals Limited, Mumbai, India

T. Geddes Grant Limited

List 2

25-6-13 Diabetes Formula Capsules

First Priority Manufacturer’s, Washington, USA

BioTech R&D Institute Ltd.

List 2

25-6-13 Nature’s Pearl Premium Muscadine Grape Seed Capsules

Ground Muscadine Grape Seed 100% [vitis rotundifolia] 650mg

Nature’s Pearl Corporation, North Carolina, USA

Nature’s Pearl Corporation

List 1



MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS FORUSE

25-6-13 Vidatox 30CH Homeopathic Product Sublingual Drops

Venom of rhopalurus junceus 30CH/0.01ml

Business Groups for Biopharmaceutical and Chemical Production,LABIOFAM Vimang Laboratory for Herbal Medicine, Havana, Cuba

Business Groups for Biopharmaceutical and Chemical Production, Havana, Cuba.

List 4

6-6-13 Zelboraf 240mg film-coated

tablets

Vemurafenib Roche S.p.A., Italy Facey Commodity Co. Ltd.

Anti-Neoplastic Agent

List 4

10-6-13 Esmeron 10mg/ml; 10mls solution for IV injection or IV infusion – vials

Each 10ml vial contains: rocuronium bromide 100mg

Hameln Pharmaceuticals, Germany

MSD Sharp & Dohme, GmbH C/o Health Brands

Muscle Relaxant List 4

7-6-13 Apo-Rosuvastatin 5mg Tablets

Rosuvastatin calcium Apotex Incorporated, Canada

Car-Med Limited Anti-Hypercholesterolemic Agent

List 4

11-6-13 Veltam 0.4 modified release tablets

Tamsulosin hydrochloride USP 0.4mg

Intas Pharmaceuticals, India

Lascelles Limited α- blocker

List 4

11-6-13 Olanzapine Sandoz 5mg film-

coated tablets

Olanzapine Sandoz Ilac, Turkey Qualcare Limited Anti-psychotic Agent

List 4

11-6-13 Olanzapine Olanzapine Sandoz Ilac, Turkey Qualcare Limited Anti-psychotic List 4

Sandoz 10mg film-coated

tablets

Agent


DATE PRODUCT GENERIC DESIGNATION MANUFACTURER

LOCAL AGENT CLASSIFICATION

STATUS REQUIREMENTS FOR USE

12-6-13 Beclate 250 inhaler CFC

Free

Beclometasone dipropionate BP 250mcg per actuation

Cipla Limited, India


Respiratory Agent List 4

10-6-13 Singulair 4mg Oral Granules

Montelukast sodium DSM Pharmaceuticals Inc, NC, USA


Respiratory Agent/Leukotrien

e Receptor Antagonist

List 4

14-6-13 Flagmine 60mg Film-

Coated Tablets

Pyridostigmine bromide BP 60mg

Bharat Parenterals

Limited, India


Acetylcholinesterase Inhibitor

List 4

14-6-13 Moxflag Oral Suspension 250mg/5ml;

100ml

Each 5ml of suspension contains Amoxicillin trihydrate BP equivalent to Amoxicillin 250mg

Flagship Biotech International Ltd.,

India


Anti-biotic List 4

17-6-13 Carbimazole 5mg Tablets

Carbimazole BP 5mg Alvita Pharma Private Limited,

India


Anti-thyroid Agent List 4

14-6-13 Neagel Sterile Ophthalmic

Gel

Ganciclovir 0.15% 150mg/100g

Laboratories Poen S.A.C.I.F.I.,

Bermudez, Argentina

T. Geddes Grant Distributors

Limited

Anti-viral Agent List 4

20-6-13 Health 2000 Losartan

Losartan Potassium USP 50mg

Brussels Laboratories Pvt.,


Anti-hypertensive Agent

List 4

Potassium 50mg Tablets

Ltd., India





20-6-13 Health 2000 Ciprofloxacin

250mg Tablets

Ciprofloxacin hydrochloride USP equivalent to Ciprofloxacin 250mg

S Kant Healthcare Ltd., India


Anti-biotic List 4

20-6-13 Health 2000 Ciprofloxacin

500mg Tablets

Ciprofloxacin hydrochloride USP equivalent to Ciprofloxacin 500mg

S Kant Healthcare Ltd., India


Anti-biotic List 4

25-6-13 Clinex Lotion 1%

Each 1ml contains: Clindamycin phosphate USP equivalent to Clindamycin 10mg

Aristopharma Limited, Dhaka, Bangladesh

R.A. Williams Distributors Limited

Anti-biotic List 4

25-6-13 Haloperidol Injection BP; Ampoules; IV/IM use

Each 1ml contains: Haloperidol BP, 5mg

M/S Flagship Biotech

International, Maharashtra State, India

UniMed Distributors

Limited

Anti-psychotic List 4

26-6-13 Health 2000 Nifedipine Sustained Release Tablets 20mg

Nifedipine USP, 20mg M/S Brussels Laboratories Pvt. Ltd., Gujarat State, India



List 4

26-6-13 Health 2000 Amlodipine 5mg Tablets

Amlodipine besylate BP, 5mg S Kant Healthcare Ltd., Gujarat India



List 4

Health 2000 Amlodipine 10mg Tablets

Amlodipine besylate BP, 10mg

S Kant Healthcare Ltd., Gujarat India



List 4





26-6-13 Efavirenz 600mg/Lamivudine 300mg, Tenofovir Disoproxil Fumarate 300mg Tablets

Aurobindo Pharma Limited,

India

Intercommercial Distributors Ltd

Anti-Retroviral Agent (ARV)

List 4

26-6-13 Pepguard Injection

(Lyophilized); vials; for I.V. use

Each vial contains: Esomeprazole sodium equivalent to Esomeprazole, 40mg

M/S. Flagship Biotech International, Gujarat State, India

Unimed Distributors Ltd.

Proton Pump Inhibitor (PPI)

List 4

28-6-13 Teicobact-400 Injection; vials; for IV/IM use

Each vial contains: Teicoplanin, 400mg

M/S. Flagship Biotech International, Gujarat State, India

Unimed Distributors Ltd.

Anti-biotic List 4

28-6-13 Amoxiclav-Denk 1000/125 Powder for Oral Suspension

Pencef Pharma GmbH, Berlin, Germany

H.D Hopwood Anti-biotic List 4

DRUGS REGISTERED IN JULY 2013




01-7-13 Apo-Lansoprazole 15mg Delayed-Release Capsules

Lansoprazole U.S.P., 15mg

Apotex Inc., Ontario, Canada

Cari-Med Limited


List 4

01-7-13 Apo-Lansoprazole 30mg Delayed-

Release Capsules

Lansoprazole U.S.P., 30mg

Apotex Inc., Ontario, Canada

Cari-Med Limited


List 4

01-7-13 Gonapeptyl Depot 3.75mg Powder & Solvent For Suspension for Injection; S.C. or I.M use; Pre-filled syringes

Ferring GmbH, Wittland, Kiel, Federal Republic of Germany

New Vision Distributors Ltd.

Leutinizing Hormone Releasing Hormone(LHRH) analogue

List 4

10-7-13 Arcoxia 30mg Tablets

Etoricoxib 30mg Frosst Iberica, Madrid, Spain


COX II Inhibitor List 4

11-7-13 Health 2000 Dispersible Aciclovir 800mg Tablets

Aciclovir BP 800mg Unicure Remedies PVT Ltd., India


Anti-viral Agent List 4

12-7-13 Glemont – CT5 Montelukast Sodium Glenmark T. Geddes Grant Respiratory List 4

Chewable Tablets {equivalent to Montelukast 5mg}

Pharmaceutical Ltd., India

Ltd. Agent/Leukotriene Receptor Antagonist

DRUGS REGISTERED IN AUGUST 2013




07-8-13 Health 2000 Captopril 25mg Tablets

Captopril USP 25mg Skant HealthCare Ltd., India

Health Brands Ltd.


List 4

09-8-13 Panto-Denk 20 Gastro-Resistant Tablets

Pantoprazole Sodium Sesquihydrate 22.6mg Equivalent to Pantoprazole 20mg

Advance Pharma GmbH, Germany

H.D. Hopwood & Co., Ltd.


List 4

09-8-13 Panto-Denk 40 Gastro-Resistant Tablets

Pantoprazole Sodium Sesquihydrate 45.1mg Equivalent to Pantoprazole 40mg

Advance Pharma GmbH, Germany

H.D. Hopwood & Co., Ltd.


List 4

12-8-13 Simponi Solution for Injection in

Pre-filled Syringes

Golimumab 50mg/0.5ml Baxter Pharmaceuticals Solution, LLC, Indiana

Cari Med Ltd. Human Monoclonal Antibody

List 4

12-8-13 Carvedi-Denk 25 Tablets

Carvedilol 25mg Artesan Pharma GmbH, Germany

H.D. Hopwood Company Ltd.

Anti-hypertensive Agent/β-blocker

List 4

12-8-13 Carvedi-Denk 6.25 Tablets

Carvedilol 6.25mg Artesan Pharma GmbH, Germany

H.D. Hopwood Company Ltd.

Anti-hypertensive Agent/β-blocker

List 4

DRUGS REGISTERED IN SEPTEMBER 2013


LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS FOR USE

09-9-13 Quetiapine 200mg Sandoz film-coated tablets

Quetiapine hemifumarate 230.26mg equivalent to Quetiapine 200mg

Sandoz Ilac Sanayi Ve Ticaret, Turkey

Qualcare Limited

Anti-psychotic Agent

List 4

09-9-13 Quetiapine 300mg Sandoz film-coated tablets

Quetiapine hemifumarate 345.39mg equivalent to Quetiapine 300mg

Sandoz Ilac Sanayi Ve Ticaret, Turkey

Qualcare Limited


List 4

09-9-13 Health 2000 Ibuprofen 600mg Tablets

Ibuprofen BP 600mg Skant HealthCare Ltd., India

Health Brands Ltd.

NSAID List 4

17-9-13 Health 2000 Glidon 30 modified release tablets

Gliclazide BP 30mg Unicure Remedies PVT Ltd., India

Health Brands Ltd.

Anti-Hyperglycaemic

Agent

List 4

17-9-13 Health 2000 Glidon 60 modified release tablets

Gliclazide BP 60mg Unicure Remedies PVT Ltd., India

Health Brands Ltd.

Anti-Hyperglycaemic

Agent

List 4

25-09-13

Health 2000 Metformin HCL Extended Release 500mg Tablets.

Metformin hydrochloride USP 500mg

Skant Healthcare Ltd., India

Health Brands Ltd.

Anti-Hyperglycaemic

Agent

List 4

20-9-13 Allocol with Aloe Supreme Allo Products List 1

Vera Chemicals Ltd., Weymouth Close, Kingston 20

Mandeville, Manchester, Jamaica

DRUGS REGISTERED IN OCTOBER 2013

DATE PRODUCT GENERIC DESIGNATION MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS FOR USE

14-10-13

Organo Gold Organic Ganoderma Lucidum Spore Powder Capsules

Reiishi Mushroom {Ganoderma lucidum, spore} 250mg

Reena Enterprise Ltd., o/a Total Health Centre, Ontario, Canada

Organo Gold International (Jamaica) Limited

List 2

14-10-13

Organo Gold Organic Ganoderma Mycelium Capsules

Reiishi Mushroom {Ganoderma lucidum, mushroom 400mg



List 2

14-10-13

Organo Gold Organic Ganoderma Lucidum Capsules

Reiishi Mushroom {Ganoderma lucidum, whole} 250mg



List 2

8-10-13 Fluarix Vaccine Northern Hemisphere2013-2014 Strain Update

GlaxoSmithKline Biologicals, Dresden, Germany

GlaxoSmithKline Caribbean Ltd.

List 4

8-10-13 Xalkori 200mg Capsules

Crizotinib 200mg Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany

H.D. Hopwood Anti-Neoplastic Agent

List 4

8-10-13 Xalkori 250mg Capsules

Crizotinib 250mg Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany

H.D. Hopwood Anti-Neoplastic Agent

List 4



MANUFACTURER



10-10-13

Opavia 5 Film-coated Tablets

Olanzapine Ph. Eur 5mg Jubilant Life Sciences Ltd., India



List 4

10-10-13

Opavia 10 Film-coated Tablets

Olanzapine Ph. Eur 10mg Jubilant Life Sciences Ltd., India



List 4

11-10-13

Telmimark 20 Tablets

Telmisartan BP 20mg Marksans Pharma Ltd., India

Health Brands Ltd.


List 4

11-10-13



Health Brands Ltd.


List 4

11-10-13



Health Brands Ltd.


List 4

14-10-13

Simponi Solution for Injection in Pre-filled Injector (Pen) (Single use SmartJect Auto-injector) For Subcutaneous Injection.

Golimumab 50mg/0.5ml Baxter Pharmaceuticals Solution, LLC, Indiana, USA

Cari-Med Ltd. Human Monoclonal Antibody

List 4

14-10-13

Tenoretic 50–12.5mg Tablets

Atenolol 50mg, Chlorthalidone 12.5mg

AstraZeneca, S.A de C.V., Fracc. Lomas Verdes, Naucalpan de Juárez, Mexico

Cari-Med Ltd. Anti-hypertensive Agent

List 4

15-10-13

Efavirenz 600mg/Emtricitabine 200mg/Tenofovir Disoproxil fumarate 300mg tablets

Each film coated tablets coantains efavirenz 600mg, Emtricitabine 200mg, Tenofovir disoproxil fumarate 300mg

Aurobindo Pharma Ltd., India

Inter-Commercial

Distributors Ltd.


List 4



MANUFACTURER



15-10-13

Auropan Plus Tablets

Hyoscine butylbromide BP 10mg, Paracetamol BP 500mg

Aurochem Laboratories (India) Pvt. Ltd.

Inter-Commercial Distributors Ltd.

List 4

15-10-13

Otrimar Sea Water with Aloe Vera Nasal Spray

5% aloe vare extract, 30% sea water, purified water

SPPH Impasse des Boussenots, Quetigny Cedex, France

Cari-Med Ltd. List 4

15-10-13

Epiduo Gel Pump 0.1%/2.5%

Adapalene 0.1%, Benzoyl Peroxide 2.5%)

G Production Inc., Canada

Cari-Med Ltd. Dermatologic Agent

List 4

16-10-13

Anzavir R 300mg/100mg Tablets

Atazanavir (as sulfate) equivalent to Atazanavir 300mg, Ritonavir USP 100mg per film coated tablet

Mylan Laboratories Limited, India

Recharged Distributors Limited


List 4

17-10-13

Nexoz 20 delayed release tablets

Each enteric coated tablet contains

Ind-Swift Limited, India



List 4

Esomeprazole Magnesium Trihydrate equivalent to Esomeprazole to 20mg

17-10-13

Nexoz 40 delayed release tablets

Each enteric coated tablet contains Esomeprazole Magnesium Trihydrate equivalent to Esomeprazole to 40mg

Ind-Swift Limited, India



List 4

23-10-13

Health 2000 Digilan 125mcg

Tablets

Digoxin, B.P., 125mcg M/S. Unicure Remedies Pvt. Ltd., Baroda, India

Health Brands Ltd.

Cardiac Glycoside List 4



MANUFACTURER



24-10-13

Diovan 320mg Tablets

Valsartan 320mg Novartis Farmacéutica S.A., Barcelona, Spain

Cari-med Limited


List 4

30-10-13

Benefix 250 IU powder and solvent for solution for injection – IV use

Each vial contains 250IU nonacog alfa {recombinant coagulation factor IX}; 1 vial + 1 prefilled syringe + 1 injection set

Powder Manufacturer: Wyeth Farma S.A., Spain; Manufacturer of solvent/ diluent: Vetter Pharma-Fertigung GmbH & Co KG., Germany

H.D. Hopwood List 4

30-10-13

Benefix 500 IU powder and solvent for solution for injection – IV use.

Each vial contains 500IU nonacog alfa {recombinant coagulation factor IX}; 1 vial + 1 prefilled syringe + 1 injection set

Powder Manufacturer: Wyeth Farma S.A., Spain; Manufacturer of solvent/ diluent: Vetter Pharma-Fertigung GmbH & Co KG., Germany

H.D. Hopwood List 4

30-10-13

Irlara 35mg modified release film-coated tablets.

Trimetazidine dihydrochloride BP 35mg

Genpharma International Pvt. Ltd., India


Anti-anginal Agent

List 4

DRUGS REGISTERED IN NOVEMBER 2013


MANUFACTURER



12-11-13

Prantel Suspension Each 1 ml contains: Pyrantel embonate Ph. Eur., 14.4mg equivalent to Pyrantel 5mg; Febantel, 15mg

For M/S. Cipla Ltd., Maharashtra, India by M/S. Mistair Health & Hygiene Ltd., Kolhapur, India

Lasco Distributors Ltd.

Anthelmintic Agent

List 2

12-11-13

Cofenac Gel Diclofenac diethylamine, B.P., 1.16% w/w

M/S. Cipla Ltd., Verna, Goa, India

Lasco Distributors Ltd.

Analgesic Agent (Rub)

List 2

equivalent to Diclofenac sodium, B.P., 1% w/w

26-11-13

KomeFast Super Toning Cream

Hydroquinone 1.9% Orion Sales Limited, Delisser Avenue, Yallas,

St. Thomas

Orion Sales Limited

Dermatologic Agent

List 2

12-11-13

Febuday 80 Tablets

Febuxostat 80mg M/S. MSN Laboratories Ltd., Bollaram, India


List 4

12-11-13

Febuday 40 Tablets

Febuxostat 40mg M/S. MSN Laboratories Ltd., Bollaram, India


List 4

12-11-13

Otibact Ear Drops Each 1ml contains: enrofloxacin 5mg; silver sulfadiazine, U.S.P., 10mg

M/S. Cipla Ltd., Bhiwandi, India, by M/S. Vardhaman Remedies Pvt. Ltd., Maharashtra, India


Anti-biotic List 4 For Veterinary Use Only



MANUFACTURER


13-11-13

Pantonex DR-20 Delayed-Release Tablets

Pantoprazole sodium sesquihydrate EP equivalent to pantoprazole 20mg

IPCA Laboratories Ltd., Silvassa, India



List 4

13-11-13

Pantonex DR-40 Delayed-Release

Pantoprazole sodium sesquihydrate EP

IPCA Laboratories Ltd., Silvassa,



List 4

Tablets equivalent to pantoprazole 40mg

India

13-11-13

Simvastatin Tablets 10mg

Simvastatin EP 10mg Jubilant Life Sciences Ltd., Uttarakhand, India

Medical Products Ltd.

Anti-Hypercholesterolemic Agent

List 4

13-11-13

Simvastatin Tablets 20mg

Simvastatin EP 20mg Jubilant Life Sciences Ltd., Uttarakhand, India



List 4

13-11-13

Losartan Potassium Tablets

25mg

Losartan potassium Ph. Eur. 25mg

Jubilant Life Sciences Ltd., Uttarakhand, India



List 4

13-11-13

Losartan Potassium Tablets

50mg

Losartan potassium Ph. Eur. 50mg




List 4

13-11-13

Valtan-80 Tablets Valsartan Ph. Eur. 80mg Jubilant Life Sciences Ltd., Uttarakhand, India



List 4

13-11-13

Valtan-320 Tablets Valsartan Ph. Eur. 320mg




List 4



MANUFACTURER LOCAL AGENT CLASSIFICATION STATUS REQUIREMENTS FOR USE

14-11-13

Pleniva-20 Gastro-Resistant Tablets

Pantoprazole sodium sesquihydrate Ph. Eur. equivalent to pantoprazole 20mg




List 4

14-11-13

Pleniva-40 Gastro-Resistant Tablets

Pantoprazole sodium sesquihydrate Ph. Eur. equivalent to pantoprazole 40mg




List 4

13-11-13

Dorzopt Eye Drops Solution

Each 1ml contains 22.3mg (2%) Dorzolamide hydrochloride equivalent to Dorzolamide 20mg

M/S. Indoco Remedies Ltd., Verna, Goa, India

Indies Pharma Ja. Ltd.

Anti-glaucoma Agent

List 4

13-11-13

Dorzotim Eye Drops Solution

Each 1ml contains 22.26mg (2%) Dorzolamide hydrochloride equivalent to Dorzolamide 20mg Timolol maleate 6.83% (0.59%) equivalent to 5mg Timolol



Anti-glaucoma Agent

List 4

15-11-13

Latanopt 0.005% Sterile Eye Drops

Each 1ml contains Latanoprost 50mcg



Anti-glaucoma Agent/Intra-ocular

Hypertension

List 4

15-11-13

Simvast 10mg Tablets

Simvastatin Ph. Eur. 10mg




List 4

15-11-13





Anti-Hyperlipidemic Agent

List 4



MANUFACTURER


15-11-13






List 4

12-11-13

LH 5000 (Softec III) Posterior Chamber Intraocular Lens

Lenstec (Barbados) Inc., Christ Church, Barbados

Clear Horizon Ltd.

List 4

21-11-13

Biograst Injection 300mcg in a Pre-filled Syringe; Biograst Injection 300mcg in a Pre-filled Syringe;

Recombinant Human Granulocyte Colony Recombinant Human Granulocyte Colony

Beijing Four Pharmaceutical Co. Ltd., Beijing City, China

Indies Pharma Ja. Ltd

List 4

21-11-13

Complera 200mg/25mg/300mg Tablets

Emtricitabine 200mg; rilpivirine 25mg; tenofovir disoproxil fumarate 300mg

Patheon Inc., Mississauga, Canada

H.D. Hopwood Anti-Retroviral Agent (ARV)

List 4

21-11-13

Des’ Air Tablets Desloratadine INN 5mg Incepta Pharmaceuticals Ltd., Dhaka, Bangladesh


Histamine Blocker List 4

21-11-13

Des’ Air Syrup Desloratadine INN 25mg/5ml

Incepta Pharmaceuticals Ltd., Dhaka, Bangladesh


Histamine Blocker List 4



MANUFACTURER


22-11- Biosporine oral Cyclosporine U.S.P., Incepta Indies Pharma Immunosuppressan List 4

13 solution 100mg/1ml Pharmaceuticals Ltd., Dhaka, Bangladesh

Ja. Ltd. t

22-11-13

Fusitop – H Cream Each 1gm contains: Fusidic Acid, B.P., 20mg; Hydrocortisone acetate, B.P., 10mg



Topical Anti-biotic List 4

22-11-13

Budison Nebules Nebuliser Suspension 1mg/2ml

Each 2ml ampoule conatins Budesonide B.P., 1mg




22-11-13

Budinase Nasal Spray, 120 metered sprays

Each actuation delivers budesonide, B.P., 100mcg




22-11-13

Curinac 0.1% Cream

Adapalene INN 1mg per gram



Dermatological Agent

List 4

25-11-13

Amloval 5/160 Tablets

Amlodipine besilate, B.P., equivalent to Amlodipine 5mg; Valsartan, U.S.P., 160mg

Popular Pharmaceuticals Ltd., Dhaka, Bangladesh



List 4



MANUFACTURER


25-11-13

Amloval 10/160 Tablets

Amlodipine besilate, B.P., equivalent to

Popular Pharmaceuticals



List 4

Amlodipine 10mg; Valsartan, U.S.P., 160mg

Ltd., Dhaka, Bangladesh

25-11-13

Acarbay 25 Tablets

Acarbose, B.P., 25mg IND-Swift Ltd., Samba (Jammu), India


Anti-Hyperglycaemic

Agent

List 4

25-11-13

Acarbay 50 Tablets

Acarbose, B.P., 50mg IND-Swift Ltd., Samba (Jammu), India


Anti-Hyperglycaemic

Agent

List 4

26-11-13

Prezista 800mg film coated tablets

Darunavir ethanolate 867.28mg corresponding to 800mg Darunavir

Janssen Ortho LLC, Gurabo, Puerto Rico

Cari-Med Limited


List 4

26-11-13

Pantosec 20mg tablets

Each tablet contains Pantoprazole sodium sesquihydrate USP 22.55mg equivalent to Pantoprazole 20mg

Incepta Pharmaceuticals Ltd., Bangladesh



List 4

26-11-13

Pantosec 40mg tablets

Each tablet contains Pantoprazole sodium sesquihydrate USP 45.1mg equivalent to Pantoprazole 40mg

Incepta Pharmaceuticals Ltd., Bangladesh



List 4

27-11-13

Biocaltrol 0.25 Capsules

Calcitriol, B.P., 0.25mcg Incepta Pharmaceuticals Ltd., Bangladesh


List 4



MANUFACTURER


27-11-13

Biopofol Emulsion for IV Administration

Each 20ml vial contains propofol, B.P., 200mg

Popular Infusions Ltd., Tongi, Bangladesh


General Anaesthetic

List 4

28-11-12

Venalon 500 Tablets

Each tablet contains Diosmin (micronized) BP

Incepta Pharmaceuticals


Venotropic Agent List 4

450mg; Hesperidin BP 50mg

Ltd., Bangladesh

22-11-13

Softec HD Posterior Chamber Intraocular Lens

Ethoxy 2 Hydrox Benzo 1%, Azo Iso Butyronitrile 0.11%, Ethylene Glyco Dimethacrylate0.42%, 2-Hydroxy Ethyl Methacrylate 85.58%, Methyl Methacrylate 14%


Clear Horizon Ltd.

List 4

22-11-13

Softec 1 Posterior Chamber

Intraocular Lens

Acryloxy Ethoxy 2 Hydrox Benzo 1%, Azo Iso Butyronitrile 0.11%, Ethylene Glyco Dimethacrylate0.42%, 2-Hydroxy Ethyl Methacrylate 85.58%, Methyl Methacrylate 14%


Clear Horizon Ltd.

List 4

DRUGS REGISTERED IN DECEMBER 2013


MANUFACTURER


3-12-13 Barzithro 500 Tablets

Azithromycin 500mg USP Flamingo Pharmaceuticals Ltd., India

Supreme Chemicals Limited

Anti-biotic List 4

3-12-13 Cozaar XQ Amlodipine camsylate Hanmi Pharma Health Brands Anti-hypertensive List 4

5/100mg Tablets 7.84mg; Losartan potassium100mg

Co. Ltd., (Paltan site), Gyeonggi-do, Republic of Korea (manufacturer

Limited Agent

3-12-13 Cozaar XQ 5/50mg Tablets

Amlodipine camsylate 7.84mg; Losartan potassium50mg

Hanmi Pharma Co. Ltd., (Paltan site), Gyeonggi-do, Republic of Korea (manufacturer



List 4

5-12-13 Health 2000 Alpramark 0.25mg Tablets

Alprazolam EP 0.25mg Marksans Pharma Ltd., India


Anti-anxiety Agent List 4

5-12-13 Health 2000 Alpramark 0.50mg Tablets

Alprazolam EP 0.50mg Marksans Pharma Ltd., India


Anti-anxiety Agent List 4

5-12-13 Mycon Oral Gel 2% w/w

Miconazole BP 2% w/w {miconazole 20mg per gram

Aristopharma Ltd., Bangladesh

R.A. Williams Distributors

Anti-fungal Agent List 4

10-12-13

Bronculair 10mg Tablets

Montelukast sodium 10.4mg equivalent to Montelukast IH 10mg

Marksans Pharma Ltd., India


Respiratory Agent/Leukotriene Receptor Antagonist

List 4

11-12-13

Baramlo 5 Tablets Amlodipine besilate 6.93mg equivalent to Amlodipine BP 5mg

Flamingo Pharmaceuticals Limited, India



List 4

DRUGS REGISTERED IN DECEMBER 2013


MANUFACTURER


11-12-13

Baramlo 10 Tablets

Amlodipine besilate 13.87mg equivalent to

Flamingo Pharmaceuticals

Supreme Chemicals


List 4

Amlodipine BP 10mg Limited, India Limited11-12-

13Renvela 800mg Film-Coated Tablets

Sevelamer carbonate 800mg

Genzyme Ireland Ltd., Waterford, Ireland

H.D. Hopwood Phosphate binding Agent

List 4

12-12-13

Stelara 45mg/0.5ml Solution for injection in pre-filled syringe – for SC use.

Ustekinumab 45mg/0.5ml

Cilag AG, Switzerland

Cari-Med Limited

Human monoclonal anti-body

List 4

13-12-13

Fusidate H Cream Fusidic acid 2%, hydrocortisone acetate BP 1%

Aristopharma Limited, Bangladesh

R.A. Williams Distributors Ltd.,

Anti-biotic List 4

13-12-13

Barfurox 250mg Tablets

Cefuroxime axetil USP 315mg equivalent to cefuroxime 250mg

Flamingo Pharmaceuticals Ltd., India


Anti-biotic List 4

list of registered drugs for january – december 2013 · web viewvee pak inc., illinois, usa...

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