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
Developed using STEERLife’s proprietary FragMelt continuous processing platform, the approval marks a major breakthrough in pharmaceutical manufacturing
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
Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
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 approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb
This approval confirms the facility's compliance with FDA quality standards and regulatory requirements
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