Spread over more than 1,05,000 sq. ft. area, Cadila Pharmaceuticals’ R & D facilities, recognized by the Department of Science & Technology, Government of India, are manned by more than 300 scientists. A centralized Quality Control & Analytical Research Laboratory has been set up to meet the domestic and international quality standards. The Company has expanded operations by building further on already existing set-up by investing in new premises, to include modern, state-of-the-art amenities. One of the few companies in the country carrying out collaborative research, Cadila Pharmaceuticals taps the best scientific talent in the country and has collaborations with more than 30 leading Research and Development centers in India. To know more about Cadila Pharmaceuticals visit: http://cadilapharma.com/

2. • USP Products
• Niche Technologies
• Affordable Price
Focus
Since inception in 1951

3. Formulation
Development
Pre-Clinical &
Clinical Research
Biotechnology
R&D Divisions
Chemical SBU - API
Herbal Product
Development

4. 1 2 3 4
Rugged new
product
Identification
process
Integration
with API /
Chemical
SBU
Niche Generic /
Innovative
dosage forms
(NDDS)
Strong IP
portfolio
Domestic – Generics
(Me-too)
Export for Me-Too &
Value-added Generics
Exports & Domestic
NDDS
NDDS, US ANDA &
ROW Dossier
2010 2015
New Drug Products /
NDDS – First-time
launch in India
Generic
opportunities in
Regulated Export
markets
R&D
Model
Growth Drivers

5. Research & Development
Intellectual
Property
Phyto-
chemistry
Pharma
Development
Pre Clinical
Clinical
Research
Chemical
SBU
Biotechnology
Regulatory
RQA
R&D Framework

6. Divisions
1. PROCESS CHEMISTRY
2. ANALYTICAL DEVELOPMENT
3. REGULATORY AFFAIRS
4. INTELLECTUAL PROPERTY CELL
5. PROCESS SCALE-UP
• Development of Non-
Infringing Process
• Multi-scale synthesis -
from gm to kilo level
• Eco-friendly and cost
effective process
Capabilities
• Gastroenterology
• Cardiovascular System
• Central Nervous
System
• Antiemetic
• Anti-allergic
Focus Areas
Chemical R&D

7. Pharma Formulation Development
Formulation
Development
Packaging
Development
Technology
Transfer
Analytical
Research
Stability
Intellectual
Property
• Research-friendly
environment
• Participative
leadership
• Range of product
formulations
covering
therapeutic
groups in human
& animal
healthcare

8. Novel Drug Delivery System
THERAPY
1. Gastroenterology
2. Cardiovascular System
3. Diabetic
4. Anti-viral & Ant-Tubercular
Fixed Dose Combinations
Biotechnology Formulations
Herbal Products
Liquid OralsOphthalmic Topical
Soft Gelatin
Capsules
Solid Orals Parenteral
Research Pipeline
Dosage Forms
Markets
• India-Domestic
• International
• Semi-regulated
(Latin America, SE Asia,
CIS region)
• Regulated Markets
( USA-EU )
Formulation: Scope

9. Novel & Innovative Dosage Forms
Capabilities
• Liposome-based drug delivery
system
• Oral controlled release
formulations
• Improved Bioavailability: Anti
Viral, Paclitaxel, Cur cumin
o Micro emulsions,
o Nano-emulsions
o SMEDDS
o Bio-enhancer
• Nano-crystal
dispersions
• Lyophilized
formulations
• Taste Masking

10. Define Research Design Develop Implement
IPM / Literature Search Pre – Formulations Bench Scale Lab Scale PE Batch
Exhibit
Batch
Stability /
BioStudies
Stage 0 Stage 1 Stage 2 Stage 3 Stage 4
• Product identified
• Bulk supplier identified
& committed
• Literature search
• IPM strategy
finalization
• Packaging
development initiated
• Development strategy
finalization
• Analytical method
development started
• Prototype developed
and stability study
• AR&D Methods
developed
• In Vitro Dissolution
profiling
• Formulation / process
finalized
• Taste / Trade Dress
approval for Market
Launch
• Prototype scaled up to
Lab scale
• AR&D methods firmed
up and validated
• Pre-Exhibit batch
execution
• Pilot BE studies
• Exhibit batch
execution
• Stability study as per
ICH requirement.
• Pivotal BE studies
• Technical Dossier
compilation
• Commercial scale
Process Validation
post Regulatory
approval
Drug Development Process

11. EQUIPMENT
• HPLC
• UPLC
• GC
• DS
• Dissolution Testing Apparatus
• USP Type I and II
• USP Type III
• UV-Visible Spectrometer
• Franz diffusion cell
Analytical Research Lab

12. ACTIVITIES
• API Characterization
• Pre-formulation studies
• Forced degradation studies
• Analytical method development
validation & transfer to QC
• Stability studies as per ICH guidelines
• Specialized analytical tools to support
biotech formulations, NDDS products
Analytical Research Lab

13. • Selection and testing of
primary / secondary /
tertiary packaging
materials
• Innovative packaging
solutions
• Art work development
• Master Manufacturing
Docket, Specifications,
Standard Testing
Procedures
• Review of Technology
Transfer Docket, Product
Development Report
• Process optimization and
scale-up
• Integration of
Formulation
Development with
Production, QA, QC etc.
• Trouble-shooting at
manufacturing
Packaging Development Technology Transfer

14. Pre-Clinical
• Experimental
Pharmacology
• Regulatory Toxicology -
US FDA also
Clinical Pharmacology
• Two separate identical 46 bedded units
(total 92 beds)
• Data pool of approx. 6,000 healthy volunteers.
(500 female volunteers and 400 geriatric volunteers )
Clinical Research
• Clinical Trials Submission
for
o DCGI
o US FDA
Clinical Research Organization

15. Africa FW Africa SE Asia CIS Latin MENA EU/Aus/NZ/WHO USA
Global Registrations: An Update
A total of
1223 Registrations
Globally

16. Thank you