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Alembic Pharmaceuticals Ltd has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Carbidopa, Levodopa and Entacapone Tablets, 12.5 mg/50 mg/200 mg, 18.75 mg/75 mg/200 mg, 25 mg/100 mg/200 mg, 31.25 mg/125 mg/200 mg, 37.5 mg/150 mg/200 mg, and 50 mg/200 mg/200 mg. Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson’s disease. 

IPCA Laboratories informed the exchanges that manufacturing facility at Tarapur (Maharashtra) has now received Establishment Inspection Report classifying the manufacturing facility as “Voluntary Action Indicated (VAI) and that this facility is considered to be in a minimally acceptable state of compliance with regard to current good manufacturing practice (CGMP) from the US FDA. Earlier, it 

Zydus Lifescience, a leading, discovery-based, global pharmaceutical company has announced that the USFDA has granted Orphan Drug Designation (ODD) to Desidustat, a novel oral HIF-PHI, for the treatment of Sickle Cell Disease (SCD). The USFDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States.

Published on February 9, 2026

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