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.