Shilpa Medicare Limited's 100% subsidiary, Shilpa Pharma Lifesciences Limited's Active Pharmaceutical Ingredient (API) manufacturing facility, Unit II, situated at Raichur in Karnataka state has undergone a GMP inspection by ANVISA-Brazil from April 15-April 19, 2024.
Shilpa Medicare Limited's (SML) CDMO customer, Unicycive Therapeutics has reported positive results from pivotal clinical trial of Oxylanthanum Carbonate (OLC), a NCE molecule with potential treatment for hyperphosphatemia in chronic kidney disease patients which has several benefits for various patients in this chronic disease. Unicycive is expected to file the New Drug Application for OLC by mid-2024 with potential approval by mid-2025.
Shilpa Biologicals, a wholly owned subsidiary of Shilpa Medicare has filed its first Drug Master File of recombinant Human Albumin 20% with USFDA.
Shilpa Medicare’s marketing partner, Amneal Pharmaceuticals, has launched PEMRYDI RTU (Pemetrexed injection 10 mg/mL), the first ready-to-use pemetrexed formulation in the US market. The product has already been granted permanent J-code (J9324) by U.S. Centers for Medicare & Medicaid Services (CMS).
Shilpa Medicare Limited, headquartered at Raichur, Karnataka, India, has received closure of Decentralized Procedure for Varenicline Tablets, 0.5 mg and 1 mg. Commercial supplies shall be started after the approval of National Procedure.
An award has been passed by an Arbitral Tribunal consisting of Sole Arbitrator on January 22, 2024, which has been received on January 23, 2024 in the matter of Arbitration between Shilpa Medicare Limited (SML) and Celltrion (Claimant) towards supply and distribution agreement.
Shilpa Medicare shares up 2% on acquiring US-based Pilnova Pharma
Shilpa Medicare Limited has received approval from the Office of the Directorate of Ayurveda and Unani Services (division of the Ministry of Aayush) for the manufacture and sale of Oral Mucositis Spray a treatment option made available for the first time in India under the brand name ORAAL.
Shilpa Medicare Limited, headquartered at Raichur, Karnataka, India, has received Marketing Authorization from MHRA, UK, for Betahistine Dihydrochloride Orodispersible Films, 24 mg. Shilpa is the first company to receive approval for the 24 mg strength as a Film formulation in UK. Shilpa's approval is a hybrid product application, which is bioequivalent to the reference product.
Shilpa Medicare has received approval from CDSCO, New Delhi for manufacturing and sale of Lenvatinib Capsules, 12, 18 and 24 mg in India. Shilpa will commercialize the product under the brand name Lenshil. Lenshil 12 mg and Lenshil 18 mg will be launched immediately followed by Lenshil 24 mg.