3. • Exports to over 100 countries.
• 9th largest pharma exporter from India.
• Forbes “Best under a Billion” outside USA award in
2003, 2004 and 2005
• One of the largest manufacturer of APIs, viz. Atenolol,
Amodiaquine, Artemisinin derivatives, Chloroquine,
Furosemide, HCQS, Propranolol
• Approved API suppliers to MNCs like AstraZeneca,
BASF, GSK, Merck, Pfizer, and Sanofi-Aventis
• Contract manufacturing of formulations for EU customers,
viz. Almus ,Crescent, Hexal, Stada, Ranbaxy UK, and others
Highlights
2003
2004
2005
Forbes Global - Best Under a Billion
4. We aspire to be US$ 400 Mln Company by 2010 by
• Becoming world leaders in 25 APIs
• Consolidating our global leadership
in Antimalarial therapies
• Establishing key partnerships
with innovator companies & MNCs
• Being a competent and competitive supplier
of generic formulations
• Expanding presence to 170 countries
Aspirations
5. 48, Kandivili Industrial Estate
Kandivili (West), Mumbai – 400 067
All markets, all divisions.
Area: 10,000 sq feet.
Research & Development (Formulations)
6. • Good knowledge skills
• Experienced scientists
• Multidimensional exposure
Developm
ent
Analytical Regulatory Total
Ph.D 2 4 0 6
M.Pharm 16 0 3 19
M.Sc 6 20 4 30
B.Pharm 19 4 13 36
B.Sc 3 17 0 20
Others 23 2 2 27
Total 69 47 22 138
Research & Development (Formulations)
Personnel strength
7. Major Equipment at R&D facility
Activity Major equipments
Granulation • Fluid Bed Processor- Single pot operation
• High Shear Granulators
• Extruder & Spheroniser- pellet technology
• Roll Compactor-dry granulation
• Tray dryers, Fluidized Bed Dryers
• Low RH- effervescent tablets (< 20% RH)
Compression • Double layered compression machine
• Press cota
• Double rotary/ Single rotary compression machine
Coating • Auto Coater- Sugar, Film & Pellet coating.
• Manually operated conventional coating pan.
Packing • Blister Packing machine- with Alu Alu packing facility
• Strip packing machine.
Capsules • Manually operated Capsule Filling Machines-
Tab-IN-Cap / Pellets, all sizes
Liquids/
Ointments/
Creams
• Suitable equipments for liquids, ointments & creams
(Planned in future for Regulated Markets)
Stability
study
• Walk-in stability chambers (ICH guidelines)
Fluid Bed Processor
Autocoater
8. Analytical Instruments
Instruments Nos
Nuclear Magnetic Resonance Spectrometer (NMR) 1
Liquid Chromatograph Mass Spectrometer (LCMS) 1
Gas Chromatograph Mass Spectrometer (GCMS) 1
X – Ray Diffraction (XRD) 1
HPLC with PDA and UV – VIS Detector 21
Head Space Gas Chromatography 2
Dissolution Tester with UV Visible Spectrophotometer 1
UV Visible Spectrophotometer 1
Dissolution Tester 8
FTIR 1
High Performance Thin Layer Chromatography 1
Particle Size Analyzer (Malvern) 1
Autotitrator 1
Differential Scanning Calorimeter 1
9. Dosage Forms Expertise
Solid Oral Dosage Forms • Tablets
• Capsules
Liquid Formulations • Syrups, Suspensions
• Emulsions & Dry Syrups
Semisolid Formulations • Ointments, Gels & Creams
(Planned in future for
regulated markets)
Sterile Dosage Forms • Liquid Injectables
• Dry Powder Vials
Novel Drug Delivery
Systems
• Microemulsions
• Geomatrix Systems
• Bilayer Systems
• Tab-in-Tab technology
10. • Stability Indicating Assay
• Related Compounds
• Dissolution Profile
• Content Uniformity
• OVI / Residual Solvents
• Impurity profile study
• Drug : Excipients compatibility study
• Characterization of impurities
Analytical Expertise
11. In-House Regulatory Expertise
• Advises Ipca’s scientists on legislations,
pharmaceutical law frames and developing
regulatory strategies
• Preparation and filing of dossiers
• Liaisoning with different regulatory bodies
DESIGN
ANALYTICAL
PKG. DESIGN
TECHNOLOGY
STABILITY
STUDIES
PROCESS /
SCALE UP
NEW
PRODUCT
Administrative
1
3 4 5
CTD
2
Quality Non
Clinical
Clinical
Quality
Summary
13. Pre-formulation Establish Drug : Excipients
compatibility.
Development lots Mini experimental trials to decide the
formula / process.
Process optimization Fine tuning to avoid scale-up problem.
Process qualification To define critical processing steps
(Scale-up batch) and test parameters usually mimics
production conditions.
Pivotal batch Samples are used to perform the bio-
equivalence study / clinical trials.
Product development For PAI visit.
report & Submission
Development Program Timelines
3
4
2
4
2
Stability
Studies
Around 15 Months for Product Development, by Following ICH Guidelines
Months Stages Activities
14. The starting formulation may be based on
INTUITION
but the ending formulation must be based on
SCIENCE
15. • Dedicated areas attached to manufacturing sites
Two at Athal for EU generics
One at Piparia for ANDAs (US)
• cGMP compliance
• Flexibility 6.5 Kg – 50 Kg
• Equipment with similar principle
• Technology transfer team on-site
Applications :
• Manufacturing pivotal/clinical batches
• Stability batches (100,000 minimum)
• Scaling up 10 x
Pilot Plant
Capabilities for Oral Solids:
16. Technology Transfer
R&D Development
More effective as we move
point of intersection to the left
Manufacturing
& Quality
0
100
Launch / Commercialization
Early Development
• Master Manufacturing Document
• Development Report
• Specifications
• Validation Protocols/SOPs
• Onsite training & technical Presentation
18. EU Generics
Generic Products
US ANDAs
Status EU US
Approvals 23 2
Submissions 15 6
Pivotal Batches 9 9
Under
Development
21 19
Total 68 36
23
15
9
21
2
6
9
19
19. Research & Development (Formulations)
Summary of generic fillings
# Country
Cumulative
dossier
approvals recd.
Dossier filed-
awaiting
approvals
Total
dossiers
1 UK 23 15 38
2 New Zealand 5 14 19
3 Australia 5 - 5
4 US 2 6 8
5 Portugal 12 7 19
6 South Africa 27 19 46
7 Hungary 5 - 5
Grand Total 79 61 140
20. Product development since last 3 years
Research & Development (Formulations)
Dosage form No. of products
Tablets
IR 119
NDDS 24
Bilayered 08
Matrix based 11
Delayed release 05
Hard gelatin Caps 10
Liquid orals 10
Dry powder for
reconstitution 06
Sterile preparation 10
Liquid injs. 05
Dry powder for inj. 05
Semi solids 02
Total
Domestic 108
162 Products
ANDA 20
EU 34
21. Top 100 drugs - U.S. market value
Orals 76%
Non - orals 24%
Technology and product focus
drug delivery systems
Source: IMS America - products
Oral CR
60% Inhalation
27% Tablet in tablet
Bi-layer tablet
22. Bilayered approach – why?
• Release of both drugs starts immediately
• Ease of manufacturing
• Elegance to the product
A
+
L
=
A
L
Technology & product focus
23. A’sunate
A’quine
Why?
• Elegance to the product
• Improved product stability
• Minimal incompatibility
Tab in tab technology
Technology & product focus
24. Unique Products*
Physical and /or chemical
incompatible drugs
• Cefadroxil + Lactobacillus
• Artesunate + Amodiaquine
Drugs with different
biological half lives
• Loratidine + Pseudoephedrine
Dual release formulations • Antidiabetic drug combinations
To prevent side effects • Lamotrigene MR tablets
Mumps – multiple unit
particulate system
• Filled in hard gelatin capsule
• Compressed within a tablet
(Diameter about 800 - 1000µ)
(Metoprolol Succinate XL)
*For Indian Market
27. Eminent Indian Academic Institutes
BITS, Pilani, Rajasthan
Central Drug Research Institute
(CDRI), Lucknow (UP)
Bombay College of Pharmacy
(BCP), Mumbai
PERD Center, Ahmedabad
Bombay University, Mumbai
Sponsored Ph.D fellowship
R & D Partnerships: Industry & Academia Interface
Tapping into India’s best & brightest technical pool for collaborative research
Working together to achieve our goals.
28. • Pharmacopoeias
• Freedom of Information (FOI)
• Orange Book/BNF
• Physicians Desk Reference (PDR)
• Generally Recognized Safe Excipients
(GRSE)
• ICH Guidelines
• CDER Guidelines
• Literature Search
Sources of Information
29. Project Management
• We offer dedicated project managers
• Periodic status reports – as per client requirements
• Regular conference calls
• Meetings (at least twice a year or more as needed)
30. R&D investment (% to sales)
Year
%
To
sales
1.87%
2.80%
4.40%
4.97%
5.05% 5.52%
Research & Development (Formulations)
Both formulation & chemical R&D
0
1
2
3
4
5
6
2001-02 2002-03 2003-04 2004-05 2005-06 2006-07
32. • Our aim is to develop stable, safe & efficacious products
• Optimal utilization of resources
• State of the art latest equipments and instruments
• Infrastructure & technical capabilities for first mover advantage
• Multi-dimensional dosage formulations NDDS/CR & SR
innovative approach to have USP over the competitors
• Analytical competency inline with International regulatory
requirements
• Accrediation -- ISO 9000 and DST (Dept. of Science &
Technology, Govt. of India)
In Summary
34. Dr. V. K. Jadhav
Vice President – Analytical Development
& Regulatory Affairs
Phone : + 91 22 6647 4406
Mobile : + 91 93241 15111
E-mail : vivek@ipca.co.in
Mr. Hasit Bhatt
President, Ipca Pharmaceuticals, Inc.
Phone : 908-412-6561
Mobile : 908-432-3028
E-mail : hasit@ipcausa.com
Mr. Y. K. Bansal
President – R & D (F)
Phone : + 91 22 6647 4450
Mobile : + 91 98211 33026
E-mail : ykbansal@ipca.co.in
Ipca India Contacts
Ipca US Contact
Mrs. Kavita Sehwani
General Manager – Regulatory Affairs
Phone : + 91 22 66474344
Mobile : + 91 93231 91467
E-mail : kavita@ipca.co.in
