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Shilpa Medicare's Unit VI facility, located at Dabaspet, Bengaluru, Karnataka, has received Saudi Food and Drug Authority (SFDA), Saudi Arabia, GMP certification.
This follows the on-site inspection of this Site from 18 – 20th Feb 2025. This was a full GMP inspection of entire facility with specific focus on Ondansetron Oral Film drug product.
The inspection was closed with ZERO observations.
This facility of Shilpa Medicare Ltd is engaged in the manufacture, testing, storage and release of finished dosage forms in the category of Oral Films and Transdermal Patches. Oral Films are currently being supplied from this Site to US, Australia and other Emerging countries. The Site is approved by European Medicine Agency, Europe following a recent inspection by Finnish regulators.
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.