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FDA Announces New ANDA Prioritisation Pilot to Support US Generic Drug Manufacturing and Testing
More than half of pharmaceuticals distributed in the US are manufactured overseas. Further, the US is reliant on overseas sources for Active Pharmaceutical Ingredients (APIs). As of 2025, only nine percent of API manufacturers are in the US, compared to 22 percent in China and 44 percent in India.
Generic Drug | 06/10/2025 | By Dineshwori | 104
GSK to submit label update for Wellcovorin at US FDA's request
GSK will file an sNDA with the US FDA to update Wellcovorin’s label to include Cerebral Folate Deficiency, following the agency’s request under its initiative to repurpose older drugs for chronic conditions.
Generic Drug | 24/09/2025 | By Dineshwori | 130
NATCO Launches Tracleer Generic in US with Lupin
NATCO Pharma has announced the launch of Bosentan tablets for oral suspension (TFOS), 32mg, a generic version of Tracleer by Actelion Pharmaceuticals US Inc., in partnership with Lupin.
Generic Drug | 20/08/2025 | By Dineshwori | 218
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