Alembic Pharma Falls 3% After USFDA Observation on Vadodara Facility

Alembic Pharmaceuticals share price dropped 2.8% on the BSE, hitting an intraday low of ₹821.65. The decline followed an inspection by the US Food and Drug Administration (USFDA) at the company’s Bioequivalence facility in Vadodara. As of 9:39 AM, the stock was trading at ₹821.65, down 2.84%, while the BSE Sensex was up 0.31% at 74,563.29.

Alembic Pharma’s market capitalisation stood at ₹16,150.61 crore. The stock’s 52-week high is ₹1,296.15, while the 52-week low is ₹725.6.

USFDA Inspection and Observation

Alembic Pharma confirmed in a regulatory filing that the USFDA inspected its Vadodara Bioequivalence facility from March 3 to March 7, 2025. The inspection was pre-scheduled, and the USFDA issued a Form 483 with one procedural observation.

The company assured that it will submit a detailed response to the USFDA within the required timeframe.

What is Form 483?

Form 483 is a document issued by the USFDA when an inspection identifies practices or conditions that may not comply with regulatory standards. These observations typically relate to manufacturing practices, product quality, and regulatory compliance.

About Alembic Pharmaceuticals

Alembic Pharma is a leading Indian pharmaceutical company involved in manufacturing and marketing Indian Formulations, International Generics, and Active Pharmaceutical Ingredients (APIs). The company focuses on R&D, innovation, and large-scale production to meet global healthcare needs.

Stock Performance Over the Past Year

In the last 1 year, Alembic Pharma’s stock has declined by 14%, whereas the Sensex has gained 1%.

Conclusion

Despite short-term pressure from regulatory observations, Alembic Pharma remains an important player in the pharmaceutical industry with a strong focus on R&D and global expansion.

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