alyante introduction presentation
DESCRIPTION
Alyante is a custom research services organisation that delivers quality research to help improve your research efficiencies. It provides comprehensive end-to-end solutions ranging from chemical and pharmaceutical development to product supply, including complete regulatory support for filing. To enhance your product portfolio, Alyante offers innovative services including NDDS. Alyante’s array of innovation-based services and commitment to excellence will help you create new value. Alyante is an assurance of an alliance that strives to keep your research always ahead of the competition through innovation and trust.TRANSCRIPT
Trusted Partners for Innovation and Business EdgeA Wockhardt InitiativeWockhardt Business InitiativeA Wockhardt InitiativeWockhardt Business Initiative
Wockhardt India & RoW
Wockhardt USWockhardt UK &
IrelandWockhardt
France
R&D Center8 API Plants
8 Formulation Plants
Finished Dosage Plant @ Morton Grove
Finished Dosage Plant @ Wrexham, UK & Pinewood, Ireland
1 API Plant @ Quimper, France
1 Finished Dosage Plant @ Mazal, France
40 yrs of Experience & World class Capabilities
Wockhardt Business Initiative
Pharma Value Chain
Contract ResearchContract Research Clinical DevelopmentClinical DevelopmentContract ManufacturingContract Manufacturing
time
Pro
duct
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fita
bili
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Alyante’s Service Area• Clinical Supply• Chemical and Pharma Development• Polymorph Studies & Impurity Synthesis• Metabolite Studies• BA / BE Studies• IP & Patent Protection Strategies• Complete filing support
• Clinical Supply• Chemical and Pharma Development• Polymorph Studies & Impurity Synthesis• Metabolite Studies• BA / BE Studies• IP & Patent Protection Strategies• Complete filing support
• Commercial Supply• BA / BE Studies• IP & Patent Protection Strategies• Complete filing support
• Commercial Supply• BA / BE Studies• IP & Patent Protection Strategies• Complete filing support
Wockhardt’s Services
Target Identification & Validation
Target Identification & Validation
Compound Generation, Screening & Lead
Optimization
Compound Generation, Screening & Lead
OptimizationPreclinical BA / BEPreclinical BA / BE Human
Trials
Human Trials API MfgAPI Mfg Formulation
Mfg
Formulation Mfg
Manufacturing & Marketing
Wockhardt Business Initiative
Alyante Advantage
Lead Finalizatio
n
Pre Clinic
alClinical Trials Commercialize
d
Growth Mature
$
Costs
Revenues
Cost Reduction
1st Alyante Adv
Patent Extension
2nd Alyante Adv
Early to Market
On Patent Off Patent
Early to
marketLate to market
Wockhardt Business Initiative
N
O
V
E
L
T
Y
Chiral Resolution
Stable & Novel Polymorphs
Non Infringing Process
NDDS Development
Modified Release forms
Dose Reduction / Optimization Strategies
Targeted Drug Delivery Systems
Creating a Patent Portfolio
Maximize Innovations
Patent Extension Services
Isolation, Characterization & Synthesis of Impurities
Wockhardt Business Initiative
Asymmetric synthesis / Chiral Separation
Peptide synthesis
Biocatalytic reactions
Varied Temperature range (-80°C to 120°C)
High pressure reactions (Up to 2Kg/cm2 in SS reactors)
Polymorph Preparation (Spray dryer facility available)
High Temperature & Pressure, Cryogenic and Organometalic Reactions
Dedicated GMP Pilot-plant facility to cater 50-100 Kg of APIs
Chemical Capabilities
Wockhardt Business Initiative
Development, Scale-up and Technology Transfer of all type of Dosage forms
Injectable dosage forms with delivery devices such as Pens, PFS, Cartridges
Ophthalmic & OTIC dosage forms
Quick development of Immediate Release Solid and Liquid Orals
Developing and commercializing Modified, Dual, Delayed Release Products
Formulations Diversity
Wockhardt Business Initiative
Bi-layer, Multi-layer, Tablet-in-tablet technologies
Effervescent, Orally Dissolving, Chewable, Sublingual Tablets
Platform Technologies for complex products
Regulatory and IP Support for all Filing activities
Formulations Diversity
Wockhardt Business Initiative
Instrumentation support for NCEs and Formulations development
State-of-the-art instruments such as UPLC, HPLC, GC, NMR, XRD, DSC, LC-MS, GC-MS, FTIR, Malvern Particle Size Analyzer and Dissolution Apparatus
Analytical Excellence
Wockhardt Business Initiative
Dedicated teams for method development, validation and routine analysis
Walk-in Stability chambersMicrobiological Testing
Analytical Excellence
Wockhardt Business Initiative
Bulk Active’s ManufacturingManufacturing from India50 L to 1500 L reaction volumeSS, GL and MSGL reactorsPressure upto 2 kg / cm2
Filteration Equipment• Centrifuges of 14” and 24” Φ• Nutsch Filter (Dia 16”) / Pressure Nutcsh filter (Dia
18”)• Sparkler filter (8.5” ΦX 8 plates)
Drying Equipment• VTD ; FBD ; RCVD ; Spray dryer (Glass)
Wockhardt Business Initiative
Commercial API List
Wockhardt Business Initiative
Commercial APIs USDMF EDMF CEP
Dextromethorphan Hydrobromide
Dextropropoxyphene Hydrochloride
Dextropropoxyphene Napsylate
Cefuroxime Axetil Amorphous
Sterile Ceftriaxone Sodium
Sterile Ceftriaxime Sodium
Ceftazidime for Injection
Oxybutynine Hydrochloride
Octreotide Acetate
Granisetron
Zoledronic Acid
Clopidogrel Bisulphate Form 1
Clopidogrel Hydrochloride
Commercial API List (contd.)
Wockhardt Business Initiative
Commercial APIs USDMF EDMF CEP
Tamsulosin HCl
Captopril
Felodipine
Nicardipine
Adenosine
Zolpidem
Zonisamide
Ziprasidone HCl
Donepezil
Duloxetine
Epinephrine
D-Oxyphene Base
API List Under Development
Wockhardt Business Initiative
APIs under development
Armodafinil
Aripiprazole
Cefepime
Des venlafaxine
Dronedarone
Fexofenadine
Fesoterodine
Olanzapine
Palonosetron
Prasugrel
Ropinirole
Tolterodine Tartrate
Finished Dosage Manufacturing @ India
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Bhimpore, Daman
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Kadaiya, Daman
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Cephalosporin
Controlled Drug
Inj Dry Powders
Cartridges
Lyophilize
Opth.Solu
PFS
LVP
SVP
Gels
Ointments
Creams
Susp.
Liquids
Sachets
Powders
Capsules
Tablets
Conventional
Dosage
Form
Sites
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SEZ
(In-Progress)
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RA
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FD
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US
FD
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MH
RA
US
FD
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RA
US
FD
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US
FD
A
Wockhardt Business Initiative
Finished Dosage Manufacturing ex-India
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UK
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France
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USA
Controlled Drug
Injectable Dry Powders
Cartridges
Lyophilization
Opthalmic Solution
SVP
Gels
Ointments
Creams
Drops
Suspensions
Liquids
Sachets
Powders
Capsules
Tablets
Conventional
Dosage
Form
Sites
Fac
ilit
y
MH
RA
US
FD
A
Fac
ilit
y
MH
RA
US
FD
A
Fac
ilit
y
MH
RA
IMB
Fac
ilit
y
MH
RA
US
FD
A
Wockhardt Business Initiative
Biopharmaceutical Value Chain
Manufacturing
Established facilities for meeting global
requirements- Pilot plant
- Biotech Plant
- Biopharmaceutical facility
Regulatory
Registrations
- 69 Product
Registrations received
- 94 registrations in
pipeline
Commercial
SBU established
- Marketing in ~30 countries
Concept to Commercialization Capabilities
R & D
6 Biotech products developedrhu Insulin,
r Erythropoeitin, rhu ins Glargine
Wockhardt Business Initiative
Receiving RFP post CDA execution Evaluation and Proposal submission Proposal Discussion Project Awarded
The Project Philosophy
BD
BD & Team
Customer Contact Point
Setting up the project team Project kick-off telecon Continuous Updates Prompt & Transparent reporting Customer sign-off post completion Final Report submission
Wockhardt Business Initiative
Alyante is…beyond profits…
an Assurance…
about unlocking greater value in your research…
…about Trust and Commitment
Excellence in Execution…
Wockhardt Business Initiative
… it’s about relationships
…and an alliance beyond projects
… and keeps you always ahead of the competition
Excellence with Alyante!
Committed Service
- Quick and timely development
- Ensured Quality Work- Excellent Cost Management
Customized Service
- Tailor made, specific solutions for your needs
- Flexibility in development- Quick resolution of issues- Complete confidentiality and active support in case of any IP issue
Alyante is To Serve our Partners
Wockhardt Business Initiative
Why ?
SeasonedTeam to address all requirements
Active IngredientsFinished DosagesAnalytical Support
Clinical SuppliesPatent ServicesNDDS
BroadestSpectrum ofInfrastructure
Extensive RegulatoryExpertise
Commercial SuppliesExclusive MfgOwn Clinical Research
Organization
In – House IP and RA team> 45 DMFs > 150 ANDAs
End to End Drug Development Partner
Wockhardt Business Initiative
Thank You
Contact us @Wockhardt LtdWockhardt Towers, 6th Floor(Near National Stock Exchange)Bandra – Kurla ComplexBandra (E)Mumbai – 400 051Maharashtra, India
Phone: +91 22 2653 4444
Fax: +91 22 2653 4242
+91 22 6692 1196
www.wockhardt.com