The certification follows an on-site inspection conducted from 18 February to 20 February 2025. It was a full GMP inspection of the entire facility, with a specific focus on the Ondansetron Oral Film drug product. Notably, the inspection concluded with zero observations.
Shilpa Medicare’s Unit VI is engaged in the manufacturing, testing, storage, and release of finished dosage forms, specifically oral films and transdermal patches. The facility currently supplies oral films to markets including the United States, Australia, and other emerging countries.
In addition to the SFDA certification, the site has also been approved by the European Medicines Agency (EMA), following a recent inspection by Finnish regulators.
Shilpa Medicare is a manufacturer of API, formulation, and development services. Shilpa Medicare (SML) started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka, India.
The company's consolidated net profit fell 40.77% to Rs 14.51 crore, while revenue from operations rose 13.40% to Rs 330.80 crore in Q4 FY25 over Q4 FY24.