Shilpa Medicare Ltd Share Price – NSE  / BSE

Pharmaceuticals, Small Cap

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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According to an exchange filing, the ten-day inspection of the facility, conducted from 12 November to 21 November 2025, concluded with the issuance of the Form 483 with eight observations. None of the observations have been categorized as repeat observations.

The facility is capable of manufacturing, packaging, testing, storing, and distributing sterile injectables, oral tablets, and capsules, supplying products to the US, Europe, and other global markets. The company said US sales from this plant accounted for less than 1% of its total business in H1 FY25-26 and less than 5% in FY24-25.

The unit is approved by major regulatory authorities, including EMA (Europe), Health Canada, Anvisa (Brazil), and TGA (Australia). Shilpa Medicare added that it will respond comprehensively to the inspectional observations within the stipulated timeline.

Shilpa Medicare is a manufacturer of API, formulation, and development services. The company's consolidated net profit surged 145.7% to Rs 44.07 crore in Q2 FY26 as against Rs 17.94 crore recorded in Q2 FY25. Revenue rose 7.6% YoY to Rs 369.97 crore in the quarter ended 30 September 2025.

The counter rose 0.57% to Rs 352.80 on the BSE.

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Shilpa Medicare announced that USFDA Inspection of Shilpa Medicare, Unit IV, Jadcherla, Telangana, India has been completed on 21 November 2025. The ten day inspection ended with the issuance of FDA Form 483 with eight inspectional observations none of which has been categorized as a repeat observation.

This facility is capable of manufacturing, packaging, testing, storage and distribution of sterile injectables, oral tablets and Capsules, and is supplying to US, Europe and other markets across the globe. The US sales of products manufactured at this plant was less than 1% of the total business of the company for the first half year of FY25-26 and less than 5% of the total business of the company for FY24-25.

The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia.

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Shilpa Medicare announced the launch of NODUCA™ (Nor Ursodeoxycholic Acid (NorUDCA)), a first-in-class therapy for the first time in India or anywhere in the world, following the historic approval granted in August 2025 by the Central Drugs Standard Control Organisation (CDSCO), India. The drugs ushers in a new line of treatment for patients suffering from metabolic dysfunction-associated fatty liver disease (MAFLD), previously referred to as non-alcoholic fatty liver disease (NAFLD).

NorUDCA offers three major therapeutic benefits for MAFLD and associated liver disorders:

- Anti-inflammatory action: Actively reduces hepatic and ductular inflammation, limiting progression to cirrhosis and liver failure.

- Anti-fibrotic effect: Promotes reversal of liver scarring (fibrosis) and stabilizes liver architecture, as proven in Phase 3 studies, with 83.3% of patients showing fibrosis reversal and 90% achieving normal liver enzyme levels within 3 months.

- Choleretic protection: Encourages toxin clearance via enhanced bile secretion and protects cholangiocytes, minimizing risk of advanced disease.

NODUCA™ (norursodeoxycholic acid), a novel bile acid therapy designed to treat metabolic dysfunction associated fatty liver disease (MAFLD), offers a first-in-class approach to improving liver health by reducing inflammation, fibrosis, and cholestasis through unique mechanisms distinct from conventional therapies.

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