The United States Food and Drug Administration (USFDA) issued Form 483 with an observation after an inspection at Glenmark Pharmaceuticals’ formulation manufacturing facility based in Aurangabad, India, between June 27, 2022 and July 1. 2022.
The Aurangabad site focuses on manufacturing formulations (OSD, inhaler and foam). This factory spans 30 acres and serves domestic and international markets.
The company stated that it undertakes to take all necessary measures to respond to its observations as soon as possible. “The company is committed to maintaining the highest quality manufacturing standards at all of its facilities around the world,” he added.
Glenmark Pharmaceuticals is a global pharmaceutical company with operations in the specialty, generic and over-the-counter sectors.
The pharmaceutical company’s consolidated net profit fell by 33.5% to Rs 155.59 crore on a 4.6% increase in net sales to Rs 2,961.15 crore in Q4 FY22 compared to Q4 FY21.
Shares of Glenmark Pharmaceuticals gained 1.81% to settle at Rs 394 on Friday, July 1, 2022.
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