"These draft guidances are aimed at ensuring that we provide as much scientific and regulatory clarity as possible with respect to complex generic drugs," US FDA Commissioner Scott Gottlieb in a ...
MIRAMAR, Fla., Feb. 12, 2026 /PRNewswire/ -- DifGen Pharmaceuticals, a leading US based generic pharmaceutical company, today announced that it has received approval from the U.S. Food and Drug ...
Future Outlook With ANDA approval secured, Bionpharma will lead the commercialization and distribution of Etravirine tablets in the United States. Both organizations view this achievement as a solid ...
The recent guidance from the USFDA on complex generics is expected to provide more clarity to US-focused Indian pharmaceutical formulators The recent guidance from the US Food & Drug Administration ...
AHMEDABAD, India--(BUSINESS WIRE)--Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received final approval from the United States Food and ...
Mumbai: US health regulator's observations are "unmistakably" beneficial in the long run and have helped the company accelerate the pace of quality reforms, pharma major Dr Reddy's Laboratories has ...
JM Financial said in a note that Cipla and Lupin have multiple inhalers in their pipelines, while injectables form a significant portion of the portfolio at Dr. Reddy's Laboratories, Aurobindo Pharma ...
The move is part of a broader push to onshore pharmaceutical production and reduce reliance on foreign suppliers, particularly from India and China. The US Food and Drug Administration (FDA) has ...
Mumbai, November 5, 2008: Sun Pharmaceutical Industries Ltd. (Reuters:SUN.BO, Bloomberg:SUNP IN, NSE:SUNPHARMA, BSE:524715) announced that USFDA has granted approval for the Abbreviated New Drug ...
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