Dr Reddy's Labs gets 10 USFDA observations for Bachupally facility
Hyderabad: Dr Reddy's Labs has recently announced that the United States Food & Drug Administration (USFDA) has competed an inspection with ten observations at the company's formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad."This is to inform that the United States Food & Drug Administration (USFDA) completed a routine cGMP inspection at our formulations...
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Hyderabad: Dr Reddy's Labs has recently announced that the United States Food & Drug Administration (USFDA) has competed an inspection with ten observations at the company's formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad.
"This is to inform that the United States Food & Drug Administration (USFDA) completed a routine cGMP inspection at our formulations manufacturing facility (FTO-3) in Bachupally, Hyderabad," the Company informed in a BSE filing.
The inspection was conducted from October 19, 2023 to October 27, 2023.
"We have been issued a Form 483 with ten observations, which we will address within the stipulated timeline," Dr Reddy's Labs further informed.
Medical Dialogues team had earlier reported that the USFDA had concluded a product specific Pre-Approval Inspection (PAI) with nine observations at the Company's biologics manufacturing facility in Bachupally, Hyderabad.
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 Reddys major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe.
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