Lupin gets tentative US FDA approval for Valbenazine capsules
Valbenazine is indicated for the treatment of tardive dyskinesia (uncontrollable movement of face, tongue, or other body parts)
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US FDA
US FDA accepts Glenmark’s IND application for GRC 54276 to proceed with Phase 1/2 clinical study for…
GRC54276 is an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor developed by Glenmark
Glenmark gets ANDA approval for Clindamycin Hydrochloride Capsules
Glenmark Pharmaceuticals has received final approval from the United States Food & Drug Administration (US FDA) for…
Cingulate and Indegene sign agreement for lead ADHD candidate CTx-1301
The agreement spans cross-functional services through an omnichannel marketing approach designed to manage pre-commercial support…
Glenmark, Cediprof partner to alleviate US amphetamine shortage
Announce exclusive US distribution pact, distribution expected to start during the second half of 2023
Strides’ Bangalore facility gets EIR from USFDA
The company’s flagship facility was inspected by the USFDA between December 5 and 9, 2022, and a form 483 listing three…
Glenmark gets second tentative ANDA approval for Saxagliptin Tablets, 2.5 mg and 5 mg
Glenmark’s first tentative approval letter for Saxagliptin Tablets, 2.5 mg and 5 mg was received on June 12, 2017
NATCO announces ANDA filing for generic olaparib tablets in US
Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic and prostrate cancer
Sun Pharma gets US FDA nod for generic lenalidomide capsules
The respective product approval is based on Revlimid Capsules, 5 mg, 10 mg, 15 mg, 25 mg and 2.5 mg, 20 mg as a reference product
Lupin gets US FDA approval for Brivaracetam Tablets
The product will be manufactured at Lupin’s facility in Nagpur, India