Shilpa Medicare bags initial European authorization for Rotigotine Transdermal Patch for Parkinson's disease

Shilpa's Rotigotine patches are indicated for treatment of Restless Legs Syndrome and Parkinson's disease.

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-12-12 09:44 GMT   |   Update On 2025-12-12 09:44 GMT
Advertisement

Karnataka: Shilpa Medicare Limited has received the Initial Authorization from Europe, recommending the grant of the final Marketing Authorization for the company’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.
Advertisement
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," the company stated.
The once-daily, patient-friendly transdermal formulation ensures reproducible, sustained, and controlled release of medication.
This approval has come from the Company’s finished dosage form manufacturing facility, Shilpa Medicare Ltd, Unit VI, located at Dobbaspet, Bengaluru, Karnataka. The facility is involved in manufacturing, packaging, labelling and testing of specialized finished dosage forms as oral dispersible/dissolving Films and Transdermal Patches.
Read also: Shilpa Medicare Telangana facility receives 8 USFDA observations
Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News