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Results For "USFDA"

1345 News Found

Zydus receives final approval from USFDA for Eltrombopag Tablets
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


Bengaluru’s STEERLife  and Bionpharma secure USFDA nod for generic HIV drug
Drug Approval | January 14, 2026

Bengaluru’s STEERLife and Bionpharma secure USFDA nod for generic HIV drug

Developed using STEERLife’s proprietary FragMelt continuous processing platform, the approval marks a major breakthrough in pharmaceutical manufacturing


Strides Pharma Inc's Chestnut Ridge facility gets 4 observations from USFDA
Drug Approval | December 26, 2025

Strides Pharma Inc's Chestnut Ridge facility gets 4 observations from USFDA

These observations are procedural in nature and the company does not anticipate any impact on supply of its commercial products


Briefs:  APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem
Drug Approval | December 20, 2025

Briefs: APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem

USFDA determines Sun Pharma's Baska facility inspection classification as OAI


Alembic announces USFDA final approval for Travoprost Ophthalmic Solution USP, 0.004%
Drug Approval | December 20, 2025

Alembic announces USFDA final approval for Travoprost Ophthalmic Solution USP, 0.004%

Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension


Lupin receives EIR from USFDA for Nagpur injectable facility
Drug Approval | December 17, 2025

Lupin receives EIR from USFDA for Nagpur injectable facility

The EIR was issued following an inspection of the facility from September 8 to September 16, 2025


Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga
News | December 15, 2025

Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga

Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility


Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension
News | December 12, 2025

Alembic receives USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic suspension

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb


Granules Life Sciences facility receives EIR from USFDA
News | December 12, 2025

Granules Life Sciences facility receives EIR from USFDA

This approval confirms the facility's compliance with FDA quality standards and regulatory requirements