Shilpa Medicare has received the Initial Authorization from Europe, recommending the grant of the final Marketing Authorization for Shilpa Medicare's prescription product, Rotigotine 1, 2, 3, 4, 6, 8 mg/24 h transdermal patch.
This application, submitted as a generic application via Decentralized Procedure in Europe and is a generic version of the innovator product Neupro'. Shilpa's product is pharmaceutical and bioequivalent version of the reference product Neupro'. Shilpa's Rotigotine patches are indicated for treatment of Restless Legs Syndrome and Parkinson's disease.
The total addressable European market for Rotigotine is estimated at ~USD 222 million. Shilpa has on boarded a strategic commercialization partner in Europe, with a targeted launch in FY27.
This authorization represents a significant milestone for the Company, being Shilpa Medicare's First transdermal patch dosage form to receive marketing authorization in the European region.
This approval has come from the Company's finished dosage form manufacturing facility, Shilpa Medicare Ltd, Unit VI, located at Dobbaspet, Bengaluru, Karnataka. This is the first approval of a prescription transdermal dosage Form in the European markets from this facility. The facility is involved in manufacturing, packaging, labelling and testing of specialized finished dosage forms as oral dispersible/dissolving Films and Transdermal Patches.
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