Alembic Pharma down 3% on getting USFDA observation for its Vadodara plant

Alembic Pharmaceuticals shares slipped 2.8 per cent on BSE, logging an intraday low at Rs 821.65 per share. The selling pressure on the counter came after the US Food and Drugs Administration (US FDA) conducted an inspection at the company's Bioequivalence facility at Vadodara and issued a form 483 with one procedural observation. 

 

Around 9:39 AM, Alembic Pharmaceuticals share price was down 2.84 per cent at Rs 821.65 per share on BSE. In comparison, the BSE Sensex was up 0.31 per cent at 74,563.29. The market capitalisation of the company stood at Rs 16,150.61 crore. The 52-week high of the stock was at Rs 1,296.15 per share and the 52-week low was at Rs 725.6 per share. 

 

"We would like to inform the exchange that the United States Food and Drug Administration (USFDA) has conducted an inspection at our Bioequivalence Facility located at Vadodara from March 3, 2025 to March 7, 2025. This was a scheduled inspection. The USFDA issued a Form 483 with one procedural observation," the filing read.  

 

The filing further read the company will provide a comprehensive response to US FDA for the observations within the stipulated period. 

 

Form 483 is a document issued by the USFDA to a company after an inspection of its facility. The form lists observations of conditions or practices that may not be in compliance with FDA regulations.

 

The form highlights any issues found during the inspection that could potentially lead to safety, quality, or regulatory concerns. These observations are usually related to manufacturing practices, product quality, or the handling of regulated products like drugs, medical devices, and food.

 

Alembic Pharma is an Indian pharmaceutical major that manufactures and markets India Formulations, International Generics, and Active Pharmaceutical Ingredients (APIs) across the globe. Their work profile includes advancing generic pharma industry with an emphasis on technology and innovation.

 

The company is in the business of identifying new and existing gaps and strengthening healthcare and life science by meeting them. Vertically integrated and globally recognised for strength in research and development, manufacturing as also commercialisation of a wide range of products, they offer large-scale, quality and on-time delivery to the clients.

 

In the past one year, Alembic Pharmaceuticals shares have lost 14  per cent against Sensex's rise of 1 per cent.