The drug maker on Wednesday announced that the US drug regulator has issued Form 483 with six observations to the company's formulation manufacturing facility in Baddi, Himachal Pradesh (India).
The U.S. Food and Drug Administration (USFDA) has issued Form 483 with six observations after an inspection at Glenmark Pharmaceuticals' formulation manufacturing facility based out of Baddi in Himachal Pradesh (India) between 13 June 2022 and 22 June 2022.
The facility caters to the production of oral solids and liquid orals, external preparations like lotions, creams and respiratory segment products.
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 and compliant 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.
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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 rose 0.25% to Rs 367.75 on the BSE.
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