USFDA

By Tushar Sharma , 9 March 2026

An American subsidiary of pharmaceutical major Cipla has initiated a voluntary recall of certain batches of its generic anti-cancer medication in the United States after manufacturing specifications were not met. The recall, classified as a Class III action by U.S. health regulators, affects more than 400 cartons of Nilotinib capsules available in two dosage strengths. The decision was taken as a precautionary measure following the identification of quality inconsistencies during manufacturing checks.

By Tushar Sharma , 4 September 2025

Caplin Point Laboratories has secured approval from the U.S. Food and Drug Administration (USFDA) for its Milrinone Lactate Injection, a critical drug used in treating patients with severe heart failure. The regulatory clearance represents a significant step for the Chennai-based pharmaceutical company as it seeks to expand its footprint in the U.S. generics market.