The U.S. Food and Drug Administration (USFDA) has issued Form 483 with one observation after an inspection at Glenmark Pharmaceuticals' formulation manufacturing facility based out of Aurangabad, India between 27 June 2022 and 1 July 2022.
Aurangabad site is focused in the manufacturing of formulations (OSD, Inhaler & Foam). This plant is spread over 30 acres and it serves to both domestic and international markets.
The company said that it is committed to undertake all necessary steps required to address their observations at the earliest. "The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe," it added.
Glenmark Pharmaceuticals is a global pharmaceutical company with a presence across specialty, generics, and OTC businesses.
The pharmaceutical company's consolidated net profit slumped 33.5% to Rs 155.59 crore on a 4.6% rise in net sales to Rs 2,961.15 crore in Q4 FY22 over Q4 FY21.
Shares of Glenmark Pharmaceuticals gained 1.81% to settle at Rs 394 on Friday, 1 July 2022.
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