Lupin gets tentative US FDA approval for Valbenazine capsules EP News Bureau Mar 27, 2023 Valbenazine is indicated for the treatment of tardive dyskinesia (uncontrollable movement of face, tongue, or other body parts)
US FDA accepts Glenmark’s IND application for GRC 54276 to proceed with Phase 1/2 clinical study for… EP News Bureau Mar 16, 2023 GRC54276 is an orally available, small molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor developed by Glenmark
Glenmark gets ANDA approval for Clindamycin Hydrochloride Capsules EP News Bureau Mar 14, 2023 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 EP News Bureau Mar 14, 2023 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 EP News Bureau Mar 9, 2023 Announce exclusive US distribution pact, distribution expected to start during the second half of 2023
Strides’ Bangalore facility gets EIR from USFDA EP News Bureau Feb 24, 2023 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 EP News Bureau Feb 17, 2023 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 EP News Bureau Feb 13, 2023 Olaparib is indicated primarily for certain forms of ovarian, breast, pancreatic and prostrate cancer
Sun Pharma gets US FDA nod for generic lenalidomide capsules EP News Bureau Feb 10, 2023 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 EP News Bureau Dec 21, 2022 The product will be manufactured at Lupin’s facility in Nagpur, India