In a significant milestone for India's medical technology sector, Vadodara based Mediyant Technologies has secured USFDA 510(k) clearance and a Central Drugs Standard Control Organisation (CDSCO) Class C manufacturing licence for what is being recognized as India's first indigenously manufactured heart lung machine. The achievement
A United States-based subsidiary of Cipla has initiated a recall of certain batches of its generic anti-cancer medication Nilotinib Capsules following a manufacturing issue, according to the U.S. Food and Drug Administration (USFDA). The recall, issued by Cipla USA Inc., involves more than 400 cartons of
Healthium Medtech, a global medtech company with a growing portfolio across surgical, post-surgical, advanced wound care, arthroscopy and infection prevention, announced that it has agreed to acquire a controlling stake in Paramount Surgimed Ltd., one of India’s largest manufacturers and exporters of surgical blades, scalpels
The Association of Indian Medical Device Industry (AiMeD) has raised strong objections to a recent notification issued on March 10, 2025, by the Commissionerate of Health, Medical Services & Medical Education, Government of Gujarat. The notification sets an unjust reimbursement structure, allocating ₹25,000 for USFDA-approved
Cotecna Life Sciences India Private Limited, formerly Geo-Chem Pharma, is proud to announce the inauguration of its new, state-of-the-art laboratory in Mumbai. This development represents a significant step in supporting the rapid growth of India’s pharmaceutical industry and demonstrates Cotecna’s dedication to fostering innovation, quality,
Mumbai, December 17, 2024 – Granules India Limited, a vertically integrated Indian pharmaceutical company, announced today that its wholly-owned foreign subsidiary, Granules Pharmaceuticals, Inc. (GPI), has received approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Lisdexamfetamine
Biocon Biologics, a leading subsidiary of Biocon Ltd., has achieved a significant milestone with the U.S. Food and Drug Administration (USFDA) approval for its biosimilar version of Janssen's Stelara (Ustekinumab). This approval, granted under the rigorous 351(k) regulatory pathway, is poised to address the growing
Revolutionary technology will further boost OneSource’s scientific services offerings OneSource Specialty Pharma Limited, associate company of Strides and India’s first specialty pharma pure-play CDMO (Contract Development and Manufacturing Organization) has entered into a strategic licensing agreement with Bhami’s Research Laboratory (BRL). This partnership will provide OneSource
Gland Pharma Limited (Gland or Company), a generic injectable-focused pharmaceutical company, has received tentative approval from the United States Food and Drug Administration (USFDA) for Latanoprostene Bunod Ophthalmic Solution, 0.024%. The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Vyzulta® Ophthalmic Solution,
Strides’ approval for this product marks the 1st Indian approval from the USFDA for this complex formulation Approval bolsters Strides’ portfolio for the US by adding another differentiated and niche product with limited competition Strides Pharma Science Limited (Strides) today announced that its step-down wholly
