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Results For "Shilpa-Medicare"

74 News Found

Shilpa Medicare & mAbTree Biologics win FDA nod for rare blood cancer therapy
Drug Approval | January 30, 2026

Shilpa Medicare & mAbTree Biologics win FDA nod for rare blood cancer therapy

The pioneering monoclonal antibody is for Essential Thrombocythemia (ET) and Polycythemia Vera (PV), rare chronic blood cancers with limited treatment options


Shilpa Medicare aims for US approval of chemo nausea drug
News | January 09, 2026

Shilpa Medicare aims for US approval of chemo nausea drug

Phase 3 study met all primary and secondary endpoints, demonstrating superior convenience, strong efficacy, and excellent safety versus conventional ondansetron injections


Shilpa Medicare receives initial authorization for Rotigotine transdermal patch from Europe
News | December 12, 2025

Shilpa Medicare receives initial authorization for Rotigotine transdermal patch from Europe

This is the first approval of a prescription transdermal dosage Form in the European markets from this facility


Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla
Drug Approval | November 24, 2025

Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla

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


Shilpa Medicare announces positive Phase 3 results for Oeris
Clinical Trials | November 12, 2025

Shilpa Medicare announces positive Phase 3 results for Oeris

OERIS offers extended antiemetic coverage through a single injection that effectively prevents both acute and delayed CINV for up to five days


Briefs: Shilpa Medicare and Medico Remedies
News | October 07, 2025

Briefs: Shilpa Medicare and Medico Remedies

Medico Remedies receives order worth US$ 1,781,000


Shilpa Medicare receives approval of NorUDCA tablets for treatment of NAFLD in India
Drug Approval | August 11, 2025

Shilpa Medicare receives approval of NorUDCA tablets for treatment of NAFLD in India

NorUDCA is the first?in?class treatment for Non?alcoholic Fatty Liver Disease (NAFLD) in India


Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru
Drug Approval | July 17, 2025

Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru

This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms


Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA
Drug Approval | July 11, 2025

Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA

This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product