Granules India Limited saw its stock price decline by 2.75% to ₹458.65 on the NSE after the U.S. Food and Drug Administration (FDA) issued a warning letter related to its Gagillapur unit.
Key Details of the FDA Warning Letter
- Date of Warning Letter: February 26, 2025
- Facility Inspected: Granules India’s Gagillapur facility in Telangana
- Inspection Period: August 26 – September 6, 2024
- Major Violations Noted:
- Data integrity and contamination concerns
- Failure to follow adequate cleaning procedures
- Presence of microbial contamination
- Bird droppings and facility maintenance issues
- Deficiencies in equipment calibration and performance monitoring
Regulatory Concerns & Response
The FDA warning letter outlines violations of Current Good Manufacturing Practices (CGMP) and deems the company’s products adulterated under the U.S. Federal Food, Drug, and Cosmetic Act.
The FDA’s observations highlight:
- Cross-contamination issues due to ineffective cleaning of manufacturing equipment and air handling units (AHUs).
- Bird infestation in critical manufacturing areas, leading to potential contamination.
- Failure to maintain records properly, with torn CGMP records found in waste bags.
- Lack of adequate equipment calibration and oversight, increasing the risk of contamination in drug products.
Granules India submitted an initial response on September 27, 2024, addressing some of the concerns. However, the FDA deemed the response inadequate, urging stronger corrective and preventive actions (CAPAs).
Impact on Stock & Market Reaction
- Investors reacted negatively to the regulatory warning, leading to a decline in the stock price.
- The warning letter could impact Granules India’s U.S. exports, raising concerns over potential regulatory action or product recalls.
- The company is expected to submit a comprehensive compliance plan to the FDA to prevent further regulatory consequences.
Disclaimer: The information provided is for informational purposes only and should not be considered financial or investment advice. Stock market investments are subject to market risks. Always conduct your research or consult a financial advisor before making investment decisions.
