- Active Pharma Ingredients (API)
- Custom Pharma Services (CPS)
- Generics
- Generic Biopharmaceuticals
- New Chemical Entities & Differentiated Formulations
- Contact Us
Regulatory:
Dr. Reddy's is committed to the manufacture of premium quality products in compliance with all regulatory requirements and customer expectations. We operate in accordance with cGMP requirements and the USFDA and ICH guidelines & regulations. All our manufacturing facilities are successfully inspected for several products by the USFDA and various other Agencies.
We are aided by a Best-in-Class Regulatory Affairs Team and we support our customers with DMFs for their dosage form approvals / ANDA filings. We have filed several DMFs in US, Canada (PMFs), Europe, Turkey, Korea, CIS and many more in other parts of the world. Some of our products have also recieved the Certificate of Suitability (COS) from European Pharmacopoeia
Our Customer support on Technical and Regulatory queries with constant focus on responsiveness, reliability, customization, and confidentiality set us apart from others. Continuous adaptation to the latest developments in global regulatory procedures and active partnership with Pharmacopoeial bodies give us cutting edge in this area.
Intellectual Property:
Competent and well equipped Intellectual Property Management Cell of Dr. Reddy’s facilitates the creation of intellectual wealth by navigating the Research and Development work and honoring others intellectual property. A team of well qualified IP experts comprising specialists from diverse fields of science are involved in evaluating techno-legal and techno-commercial aspects of the products, strategic product development, competitive IP generation and patenting, leveraging the intellectual property across the globe. This is a continuous process aimed at providing generic medicines at affordable prices to the mankind. IPM cell in Dr Reddy's also facilitates P-IV challenges leading to early generic launch of the products in the US market.
