Jagsonpal Pharma receives USFDA warning letter, shares impacted

Jagsonpal Pharmaceuticals (BSE: JAGSNPHARM) announced it received a warning letter from the USFDA on February 5, 2025, regarding observations made during an inspection of its contract manufacturing facility. The company disclosed the warning letter in compliance with Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The USFDA's concerns relate to CGMP (Current Good Manufacturing Practice) deviations, specifically regarding Establishment Registration and Drug listing violations. Jagsonpal estimates the impact on current fiscal year sales to be INR 3.5 crore, representing approximately 1.46% of total sales till date. The company currently supplies only one over-the-counter (OTC) Active Pharmaceutical Ingredient (API) to the U.S. market and has no other products in the pipeline to the US.