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Welcome to the latest issue of Microbioz India. As
Microbioz India, August 13th, 2024– Dr. Reddy’s Laboratories has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its formulations manufacturing facility in Duvvada, Visakhapatnam, a remarkable regulatory achievement. The issuance of the EIR indicates that an earlier inspection has been completed and the factory is meeting strict regulatory standards.
This is a positive outcome for Dr. Reddy’s as it shows that they are committed to maintaining high standards when it comes to making pharmaceutical formulations. In addition, Duvvada site forms part of the global manufacturing network at Dr.Reddy’s which makes formulations for the US market.
The EIR from USFDA is very important for any pharmaceutical manufacturing facility intending to supply the US market. It also means that this establishment addressed all issues raised by FDA during their inspections hence adheres to Good Manufacturing Practices (GMP).
Keeping up high quality and regulatory excellence is important not only for sustaining operations but also establishing firm foot in the fiercely competitive American pharmaceutical market according to them.
This update on regulations speaks volumes about efforts made by the company towards matching international levels positioning it further as globally trusted drug manufacturer.
For more details and further updates, visit our newsstand at Microbioz India.
