Dr Reddys Labs gets one USFDA observation for Hyderabad facility
Hyderabad: Pharma major, Dr Reddy's Labs, has recently announced that the United States Food & Drug Administration (USFDA) has issued a Form 483 with one observation at the completion of the inspection at the company's Bollaram facility.The inspection was conducted from 1st May, 2023 to 5th May, 2023."This is to inform you that the United States Food & Drug Administration (USFDA)...
Hyderabad: Pharma major, Dr Reddy's Labs, has recently announced that the United States Food & Drug Administration (USFDA) has issued a Form 483 with one observation at the completion of the inspection at the company's Bollaram facility.
The inspection was conducted from 1st May, 2023 to 5th May, 2023.
"This is to inform you that the United States Food & Drug Administration (USFDA) today completed a routine GMP inspection at our API manufacturing facility (CTO 1) in Bollaram, Hyderabad," the company stated in a BSE filing.
"We have been issued a Form 483 with one observation, which we will address within the stipulated timeline," the company added.
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.
Read also: Dr Reddys Labs concludes acquisition of Mayne Pharma's US generic prescription product portfolio
Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. Established in 1984, 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.
Read also: Eris Lifesciences acquires 9 Dermatology brands from Dr Reddy's Labs for Rs 275 crore
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