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. |
