Bionpharma receives US FDA approval for Etravirine tablets developed in collaboration with STEERLife
Marking a significant milestone in the global effort to expand access to advanced HIV therapies, Bengaluru headquartered STEERLife…
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Browsing Tag
US FDA
Glenmark Pharmaceuticals receives EIR from US FDA for its Monroe facility
Glenmark Pharmaceuticals, a research-led, global pharmaceutical company announced that it has received the Establishment…
Sun Pharma receives US FDA label update approval for UNLOXCYT
Sun Pharmaceutical announced the US Food and Drug Administration (FDA) approved an updated label for UNLOXCYT (cosibelimab-ipdl)…
Zydus receives final approval from US FDA for Verapamil Hydrochloride
Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (US FDA) for Verapamil…
IPA’s 10th Advanced GMP Workshop calls for unified quality vision
Reinforcing its commitment to strengthening global manufacturing and quality benchmarks, the Indian Pharmaceutical Alliance (IPA)…
US FDA conclude Lupin’s Nagpur Unit-1 facility inspection with zero observation
Lupin announced that the United States Food and Drug Administration (US FDA) has completed a product specific Pre-Approval…
A biosimilar boost amid trade barriers
Even as India’s biggest pharma companies pursue biosimilars, product recalls related to manufacturing defects threaten to queer…
Lupin receives EIR from US FDA for its Pithampur unit-3 facility
Lupin announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration…
Lupin receives US FDA approval for Rivaroxaban for oral suspension
Lupin has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug…
Lupin gets tentative US FDA nod for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets
They are indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least…