Dr Reddy's Hyderabad API Plant Gets Seven Observations From USFDA

Dr. Reddy’s Laboratories Ltd. received seven observations from the US Food & Drug Administration on its Hyderabad plant on Tuesday. The agency conducted a GMP inspection from Nov. 13 to 19 at the drugmaker's API manufacturing facility (CTO-2) in Bollaram, Hyderabad.

It received a Form 483 with seven observations, which the company will address within the stipulated timeline, according to an exchange filing.

The USFDA Form 483 notifies the company’s management of objectionable conditions at the reviewed facility. At the conclusion of an inspection, the Form 483 is presented and discussed with the senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.

A GMP inspection is a regulatory process designed to ensure that a facility adheres to good manufacturing practices standards, guaranteeing the safety and quality of its products.

Dr. Reddy's Labs operates six active pharmaceutical ingredient (API) plants in Hyderabad and Vishakhapatnam. It develops and manufactures complex APIs such as steroids, peptides, complex long-chain molecules, and highly potent APIs.

API is the biologically active component of a drug product like a tablet, capsule, cream, or injectable that produces the intended effects.