Dr Reddy's Labs gets 4 USFDA observations for Srikakulam facility
Hyderabad: Through a recent BSE filing, Dr Reddy's Labs has informed that the United States Food & Drug Administration (USFDA) has completed a GMP inspection with 4 observations at the Company's API manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh.
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Established in 1984, Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. The Company offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology.
Dr Reddy's Labs major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe.
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