Glenmark Pharma Says USFDA Issues Comments on Form 483 for Co Formulation Facility


The drugmaker announced on Wednesday that the US drug regulator issued Form 483 with six observations at the company’s formulation manufacturing plant in Baddi, Himachal Pradesh, India.

The United States Food and Drug Administration (USFDA) issued Form 483 with six observations after an inspection at Glenmark Pharmaceuticals’ formulation manufacturing facility based in Baddi, Himachal Pradesh, India between June 13, 2022 and June 22, 2022.

The facility caters for the production of oral solids and oral liquids, external preparations like lotions, creams and respiratory segment products.

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 and compliant 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 rose 0.25% to Rs 367.75 on BSE.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

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