USFDA nod may boost Unichem Laboratories

Updated - September 21, 2019 at 05:00 AM.

 

Unichem Laboratories on Friday said inspection of its unit in Kolhapur, Maharashtra, by the US health regulator has been completed without any observations. The company’s newly-commissioned active pharmaceutical ingredients (API) facility was inspected by the United States Food and Drug Administration from September 16 to 20, Unichem Labs said. The CGMP surveillance and pre-approval inspection was successfully concluded without issue of Form 483, it added.

Published on September 20, 2019 23:30