Piramal Pharma has said the US health regulator has issued it a Form 483 with four observations after inspecting its Telangana-based manufacturing plant. The US Food and Drug Administration (USFDA) conducted an inspection of the company’s Digwal plant from February 9, 2026, to February 13, 2026. These observations are related to enhancement in procedures and not related to data integrity and indicated to be classified as a VAI (voluntary action indicated), it added.
Alkem Laboratories informed the exchanges that the drug regulator USFDA has completed a Pre-Approval Inspection at its subsidiary Enzene Biosciences’ manufacturing facility in India, resulting in Form 483, with six procedural observations. Enzene is preparing its response and has initiated corrective actions to address the procedural observations.
Generic drugmaker Zydus Lifesciences has received final approval from the US Food and Drug Administration for Ammonium Lactate Cream, 12 per cent. The product will be manufactured at the group’s topical manufacturing site in Ahmedabad and distributed by Viona Pharmaceuticals Inc. Ammonium lactate cream had annual sales of $15 million in the US, Zydus said citing IQVIA MAT December 2025 numbers.
Natco Pharma has received the Central Drugs Standard Control Organization’s (CDSCO) approval to manufacture and market generic Semaglutide injection in India. Semaglutide is indicated for treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. The company will launch the product in the India market in March, Natco said
Published on February 16, 2026