USFDA issues 9 observations for Dr Reddy's Labs Hyderabad facility
Hyderabad: Pharma major, Dr Reddy's Labs, has announced that the United States Food & Drug Administration (USFDA) has concluded a product specific Pre-Approval Inspection (PAI) with nine observations at the Company's biologics manufacturing facility in Bachupally, Hyderabad.
The inspection was conducted from October 4, 2023 to October 12, 2023.
"We have been issued a Form 483 with nine observations, which we will address within the stipulated timeline," the Company stated in a BSE filing.
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.
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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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