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SteinCares, a leading specialty healthcare company in Latin America, and Shilpa Biologicals, a fully integrated biopharmaceutical company and subsidiary of Shilpa Medicare, announce a strategic licensing agreement to commercialize a biosimilar across Latin America.
Under the agreement, SteinCares will hold exclusive rights to register, commercialize, and distribute the biosimilar across the region while Shilpa Biologicals will complete product development and provide long-term commercial manufacturing from its facility in Dharwad, India. The partnership brings together Shilpa Biologicals' expertise in biologics development and high quality commercial manufacturing with SteinCares' integrated regional platform, combining regulatory capabilities, market access, and deep understanding of Latin American healthcare systems.
SteinCares is a leading specialty pharmaceutical company dedicated to expanding patient access to innovative and cost-effective treatments across Latin America.
Shilpa Biologicals is a fully integrated biopharmaceutical company with a therapeutic focus on immunology, oncology, and ophthalmics. As a hybrid CDMO/pharma company, Shilpa offers both development and manufacturing services alongside ready-to-license novel formulations.
Under the agreement, SteinCares will hold exclusive rights to register, commercialize, and distribute the biosimilar across the region while Shilpa Biologicals will complete product development and provide long-term commercial manufacturing from its facility in Dharwad, India.
The partnership brings together Shilpa Biologicals’ expertise in biologics development and high-quality commercial manufacturing with SteinCares’ integrated regional platform, combining regulatory capabilities, market access, and deep understanding of Latin American healthcare systems.
Shilpa Medicare is a manufacturer of API, formulation, and development services.
The company's consolidated net profit jumped 40.28% to Rs 44.58 crore on a 28.32% increase in revenue to Rs 409.73 crore in Q3 FY26 as compared with Q3 FY25.
The scrip fell 1.33% to currently trade at Rs 322.95 on the BSE.
This application submitted as an ANDA with USFDA 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 US market for Rotigotine is estimated at USD 112 million.
This Filling represents a significant milestone for the Company, being Shilpa Medicare's First transdermal patch dosage form, which is a complex dosage form to be filed in the US market. The once-daily, patient friendly transdermal formulation ensures reproducible, sustained, and controlled release of medication, enhancing patient compliance. This submission 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.
Shilpa Medicare Ltd, Global Health Ltd, PNC Infratech Ltd and RattanIndia Power Ltd are among the other gainers in the BSE's 'A' group today, 01 February 2026.
Easy Trip Planners Ltd spiked 8.12% to Rs 6.79 at 11:46 IST. The stock was the biggest gainer in the BSE's 'A' group. On the BSE, 6.02 lakh shares were traded on the counter so far as against the average daily volumes of 9.86 lakh shares in the past one month.
Shilpa Medicare Ltd surged 7.09% to Rs 310.5. The stock was the second biggest gainer in 'A' group. On the BSE, 2.84 lakh shares were traded on the counter so far as against the average daily volumes of 9958 shares in the past one month.
Global Health Ltd soared 5.82% to Rs 1116.45. The stock was the third biggest gainer in 'A' group. On the BSE, 12552 shares were traded on the counter so far as against the average daily volumes of 10062 shares in the past one month.
PNC Infratech Ltd added 5.65% to Rs 229. The stock was the fourth biggest gainer in 'A' group. On the BSE, 80853 shares were traded on the counter so far as against the average daily volumes of 13406 shares in the past one month.
RattanIndia Power Ltd advanced 5.52% to Rs 8.98. The stock was the fifth biggest gainer in 'A' group. On the BSE, 31.07 lakh shares were traded on the counter so far as against the average daily volumes of 16.07 lakh shares in the past one month.
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.
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.
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.