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Alembic Pharma's Vadodara facility gets one Form 483 observation from US FDA

08-Mar-2025 | 12:53
Alembic Pharmaceuticals stated that the United States Food and Drug Administration (US FDA) had conducted an inspection at the company?s bioequivalence facility located at Vadodara from 3rd to 7th of March 2025.

Post the conclusion of this scheduled inspection, the US FDA issued a Form 483 with one procedural observation the company?s aforementioned unit.

?The company will provide comprehensive response to US FDA for the observations within the stipulated period,? Alembic Pharmaceuticals said in a statement.

The announcement was made after market hours on Friday.

Alembic Pharmaceuticals is in the business of the development, manufacturing, and marketing of pharmaceutical products, i.e., formulations and active pharmaceutical ingredients.

The company?s consolidated net profit tumbled 23.29% to Rs 138.42 crore in Q3 FY25, compared with Rs 180.45 crore posted in Q3 FY24. Revenue from operations was at Rs 1,692.74 crore in the third quarter of FY25, up 3.81% year on year (YoY).

The scrip had jumped 4.26% to end at Rs 845.65 on the BSE on Friday.

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