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2025-12-12 02:16:16 pm | Source: Accord Fintech
Shilpa Medicare soars on getting initial authorization for Rotigotine Transdermal Patch from Europe
Shilpa Medicare soars on getting initial authorization for Rotigotine Transdermal Patch from Europe

Shilpa Medicare is currently trading at Rs. 332.65, up by 4.95 points or 1.51% from its previous closing of Rs. 327.70 on the BSE.

The scrip opened at Rs. 329.05 and has touched a high and low of Rs. 339.40 and Rs. 322.50 respectively. So far 16738 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 1 has touched a 52 week high of Rs. 501.60 on 16-Jun-2025 and a 52 week low of Rs. 265.25 on 07-Apr-2025.

Last one week high and low of the scrip stood at Rs. 347.00 and Rs. 322.25 respectively. The current market cap of the company is Rs. 6441.49 crore.

The promoters holding in the company stood at 44.23%, while Institutions and Non-Institutions held 18.57% and 37.20% respectively.

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 around $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. The once-daily, patient-friendly transdermal formulation ensures reproducible, sustained, and controlled release of medication, enhancing patient compliance.

This approval has come from the Company’s finished dosage form manufacturing facility, Shilpa Medicare, 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.

Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.

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