Zydus Lifesciences gets zero USFDA observations for Ahmedabad facility
Ahmedabad: Zydus Lifesciences Ltd. has announced that the United States Food and Drug Administration (USFDA) has concluded the cGMP inspection with nil observations at the group’s injectables manufacturing facility at Zydus Biotech Park in Changodar, Ahmedabad.
The facility underwent inspection from 5 th June to 13 June, 2023.
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Medical Dialogues team had earlier reported that the company had received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Varenicline Tablets, 0.5 mg and 1 mg (USRLD: Chantix Tablets) and Diclofenac Sodium and Misoprostol Delayed-Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg.
Read also: Zydus Lifesciences wins USFDA nod for Diclofenac Sodium and Misoprostol Delayed Release Tablets
Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian Pharmaceutical company headquartered in Ahmedabad. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals. It is primarily engaged in the manufacture of generic drugs.
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