Drug Approval | January 16, 2026
Zydus receives final approval from USFDA for Eltrombopag Tablets
Eltrombopag tablets will be produced at the group’s formulation manufacturing facility at SEZ, Ahmedabad
Eltrombopag tablets will be produced at the group’s formulation manufacturing facility at SEZ, Ahmedabad
Gland Pharma receives approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)
WCK 5222 is the first New Chemical Entity (NCE) discovered and developed in India to be submitted for pan-European marketing authorisation
These observations are procedural in nature and the company does not anticipate any impact on supply of its commercial products
USFDA determines Sun Pharma's Baska facility inspection classification as OAI
The EIR was issued following an inspection of the facility from September 8 to September 16, 2025
Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility
The company will respond to the US FDA within the stipulated timelines
Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older
Siponimod Tablets is indicated for the treatment of relapsing forms of multiple sclerosis
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