Shilpa Medicare has informed that Shilpa Medicare, headquartered at Raichur, Karnataka, India, 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.
The above information is a part of company’s filings submitted to BSE.
