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Every OneSource Specialty Pharma regulatory approval announcement on NSE and BSE, newest first, each with its own page.
Time
5 announcements
OneSource Specialty Pharma received Karnataka government approval for its Unit II expansion project. The facility expansion enhances manufacturing capacities to service global partners and support growth.
OneSource Specialty Pharma's partner, Orbicular, received Health Canada approval for a generic version of Ozempic (semaglutide). This marks the second generic semaglutide approval in Canada, the world's second-largest market for the drug. OneSource will support commercial supply from its FDA-approved Bengaluru facility, strengthening its global CDMO position in complex injectables.
OneSource Specialty Pharma's partner, Dr. Reddy's Laboratories, received Health Canada approval for its generic Semaglutide injection (Ozempic® generic). OneSource will serve as the CDMO partner providing scale-up and commercial manufacturing from its US-FDA approved Bengaluru facility. This regulatory milestone strengthens the partnership and leverages OneSource's specialty manufacturing capabilities.
OneSource Specialty Pharma Limited received an EU GMP Certificate for its Sterile Product Division in Bangalore from German authorities. The certification follows an October 2025 inspection and covers aseptic liquids, secondary packing, and quality control. This approval complements existing US-FDA, Health Canada, ANVISA, and TGA clearances, strengthening the facility's global sterile manufacturing capabilities.
OneSource Specialty Pharma Limited received the renewal of EU-GMP certification for its flagship Unit II manufacturing facility in Bengaluru. The certification follows a successful inspection by European regulatory authorities. This renewal validates the site's capabilities in biologics drug-substance and sterile injectable manufacturing for the European market.