USFDA Inspection: Alembic Pharma gets form 483 with 5 procedural observations for Gujarat plant
The US Food and Drug Administration (USFDA) conducted inspection at Jarod-based solid oral formulation facility.
New Delhi: Alembic Pharmaceuticals on Saturday said the US health regulator has issued Form 483 with five observations after inspecting its Gujarat-based manufacturing plant.
The US Food and Drug Administration (USFDA) conducted inspection at Jarod-based solid oral formulation facility from November 14-22, 2024, the drug firm said in a regulatory filing.
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The USFDA issued a Form 483 with five procedural observations, reports PTI.
The company will provide a comprehensive response to the USFDA for the observations within the stipulated period, it said.
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Alembic Pharmaceuticals is engaged in the development, manufacturing, and marketing of a wide range of pharmaceutical products. Founded in 1907 and headquartered in Vadodara, Gujarat, Alembic specializes in generic drugs, active pharmaceutical ingredients (APIs), and over-the-counter (OTC) products. The company has a global presence, with operations in over 75 countries, including the U.S., Europe, and emerging markets. Alembic is known for its medicines across therapeutic segments such as cardiovascular, anti-infective, pain management, and oncology.
