Drug Approval | December 20, 2022
USFDA inspection at Alembic Pharmaceuticals’ facility at Jarod
None of the observations are related to data integrity and management believes that they are addressable
None of the observations are related to data integrity and management believes that they are addressable
AUR101, with a good ADME/PK profile and high bioavailability, has demonstrated inhibition of IL-17A in whole blood from psoriasis patients
The company will submit an action plan on the observations and will engage with US FDA for next steps.
The patent also covers the efficacy of the herbal composition in the management of metabolic syndrome disorders
Silodosin capsules treat signs and symptoms of an enlarged prostate gland
As a result, Imago will become a subsidiary of Merck.
The IPO is a complete OFS by existing shareholder Helix Investment Holdings
The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad
Presentations include new data on investigational medicines – favezelimab (MK-4280), zilovertamab vedotin (MK-2140) and nemtabrutinib – as well as KEYTRUDA (pembrolizumab) in multiple blood cancers
Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)
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