Shilpa Medicare Receives Initial Authorisation for Rotigotine Transdermal Patch from Europe
DSIJ Intelligence-1 / 12 Dec 2025/ Categories: Mindshare, Trending
From Rs 141.20 per share to Rs 339.40 per share, the stock gave multibagger returns of 140.4 per cent in just3 year whereas the BSE Sensex Index is 37 per cent.
Shilpa Medicare Limited has received Initial Authorisation from Europe recommending the grant of final Marketing Authorisation for its generic Rotigotine 1, 2, 3, 4, 6, 8 mg/24 h transdermal patch. Submitted via a Decentralised Procedure, this product is the bioequivalent version of the innovator drug Neupro, and is indicated for treating Restless Legs Syndrome and Parkinson's disease. This authorisation is a significant achievement as it is Shilpa Medicare's first transdermal patch dosage form to receive such clearance in the European region. The company has already secured a strategic commercialisation partner and is targeting a launch in Fiscal Year 2027 for a total addressable European market estimated at approximately USD 222 million.
The approval for this once-daily, patient-friendly transdermal formulation, which ensures reproducible, sustained, and controlled release of medication, came from the company's specialised finished dosage form manufacturing facility located at Unit VI, Dobbaspet, Bengaluru, Karnataka. This specific facility specialises in manufacturing specialised finished dosage forms such as oral dispersible/dissolving films and transdermal patches, and this authorisation marks its first approval of a prescription transdermal dosage form in the European markets. This milestone highlights the company's capabilities in developing and manufacturing complex, high-compliance drug delivery systems.
About the Company
Shilpa Medicare Ltd is an Indian pharmaceutical company that specialises in the development, manufacturing, and marketing of active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs). The company has a global presence, with exports to over 65 countries.
According to the financials, Shilpa Medicare has a market cap of over Rs 6,500 crore. The shares of the company saw a Spurt in Volume by more than 1.70 times on the BSE. From Rs 141.20 per share to Rs 339.40 per share, the stock gave multibagger returns of 140.4 per cent in just3 year whereas the BSE Sensex Index is 37 per cent.
Disclaimer: The article is for informational purposes only and not investment advice.