USFDA issues Form 483 with 6 observations to Enzene Biosciences’ Chakan plant following PAI
The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.
The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.
It is the only biopharmaceutical company in India to offer all three dosage strengths of the drug (125mcg, 250mcg, and 500mcg)
He will lead the final stages of work to commission the 54,000-square-foot facility and then lead ongoing operations at the site
An amount of Rs. 70.9 crore has been earmarked for funding capital expenditure for the proposed expansion
This is Enzene Biosciences third biosimilar to be approved
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