Shares of Alembic Pharmaceuticals Ltd slumped as much as 2.8% on Monday, 10 March, after the company’s Bioequivalence facility in Vadodara was inspected by the US Food and Drug Administration (USFDA), which resulted in a form 483 with one procedural observation. 

In its regulatory filing, the company said, “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 3 March, 2025 to 7 March, 2025. This was a scheduled inspection. The USFDA issued a Form 483 with one procedural observation.”

The document states that the business will respond fully to the findings and submit it to the USFDA within the allotted period. 

Form 483 is a document issued by the USFDA following an inspection of a company’s facility. It outlines observations of conditions or practices that may not comply with FDA regulations.

The document highlights any issues found during the inspection that may raise concerns regarding quality, safety, or rules. The quality of the product, the methods used in production, or the handling of regulated items like food, medicine, and medical equipment are usually the subjects of these observations.

Alembic Pharma, a major pharmaceutical firm with its headquarters in India, manufactures and sells India Formulations, International Generics, and Active Pharmaceutical Ingredients (APIs) all over the world.  One facet of their work profile involves the development of the generic pharmaceutical industry, emphasizing technological innovation.

The company focuses on identifying and addressing gaps in healthcare and life sciences, enhancing the industry by bridging these needs. With strong vertical integration and global recognition, it excels in research, development, manufacturing, and commercialization of a diverse product portfolio. It is known for large-scale production, high-quality standards, and timely delivery to its clients.

At 12:36 pm, the shares of Alembic Pharma were trading 2.26% lower at Rs 825.55 on NSE.

Wondering About Alembic Pharmaceuticals Ltd? The Analyst Has Answers.

Unlock profitable opportunities every day! Unicorn Signals provides actionable intraday trading signals for stocks and futures. Don’t miss out – download Unicorn Signals and start winning now!