Zydus Matoda facility completes USFDA Remote Regulatory Assessment

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-07-17 05:54 GMT   |   Update On 2025-07-17 05:54 GMT
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Ahmedabad: Zydus Lifesciences has announced that the U.S. Food and Drug Administration (USFDA) has conducted a Remote Regulatory Assessment (RRA) at the Zydus’ formulations manufacturing facility at Matoda in Gujarat for the Prior Approval Supplement (PAS) of Atorvastatin Calcium Tablets USP, 10 mg, 20 mg, 40 mg and 80 mg.

At the closure, there were no observations noted, and the site was recommended for approval. 

Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 27,000 people worldwide, including 1,400 scientists engaged in R & D. Over the last decade, Zydus has introduced several innovative, first-in-class products in the market for treating unmet healthcare needs with vaccines, therapeutics, biologicals and biosimilars.

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