Intimation under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015 - Approval of Shilpa Medicare Limited, Unit VI, Dabaspet, Bengaluru by SFDA, Saudi Arabia

Shilpa Medicare's Unit VI facility in Dabaspet, Bengaluru has received GMP certification from the Saudi Food and Drug Authority (SFDA), Saudi Arabia. The approval follows a full on-site GMP inspection conducted from 18-20 February 2025, which was closed with zero observations. The facility focuses on manufacturing oral films and transdermal patches, with the inspection specifically covering the Ondansetron Oral Film drug product. This opens the Saudi market for the company, adding to its existing export footprint in the US, Australia, and other emerging countries. The facility is also already approved by the European Medicine Agency (EMA) following a recent inspection by Finnish regulators.