High-Quality (FDA), Speedy & Low Cost CMC Services in India
LSA has chosen Dr. Reddy's Laboratories as its preferred FDA approved service provider for value-added CMC (Chemistry, Manufacturing & Control) services for Israeli companies (from start-ups to mature companies).
Dr. Reddy’s Laboratories Ltd. (NYSE:RDY) (DRL), founded in 1984, is a vertically integrated global pharmaceutical company present across the pharmaceutical value chain.
The company is India’s second largest pharmaceutical company, with revenues of US $546 million, as of fiscal year 2006.
Custom Pharmaceutical Services (CPS) a strategic business unit of Dr. Reddy’s, with world-class pharmaceutical development & manufacturing assets based in India & Mexico, is a rapidly growing provider of customized solutions to established and emerging pharmaceutical companies worldwide.
The main focus is on development and manufacturing of high quality pharmaceutical products cost-effectively and on schedule. CPS’s competitive advantage lies in the fact that it provides all the services that an innovator company would need under one roof.
Services across the pharmaceutical value chain include:
- Discovery Services
- Process Feasibility & Optimization
- Scale up and clinical supplies of NCE APIs & Intermediates
- Development of High potency APIs including Cytotoxic & Hormonal APIs
- Commercial supplies of APIs & Intermediates
- Formulations Research & Development
- Dosage Supplies for clinical studies
- Contract Manufacturing of dosage products
Facilities & Expertise:
- Technology Development Centers (18 Chemistry Labs) & Pilot Plants
- 6 API manufacturing plants & 1 Pilot plant - All USFDA inspected
- 5 Formulations plants – Approved by USFDA, UKMCA, TGA, MCC etc
- Relevant expertise to handle NCEs, matured APIs & Formulations
- Documentation & Regulatory support as required for clinical studies
- Project Management approach with dedicated team members
Formulation Facility – Bachupalli Inspected by USFDA, MCA, MCC, TGA
To sum up, with a strong emphasis on speed and a track record of regulatory compliance, CPS - Dr. Reddy’s is well placed to meet all the requirements of innovator companies.
For further information, please visit www.drreddys.com
top |
|
