Latest News for: usfda
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USFDA issues Form 483 with 6 observations to Alkem subsidiary's Chakan plant
Business Line 16 Feb 2026
The company has achieved zero ...
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Alkem Labs' Chakan facility gets six observations in USFDA inspection, no data integrity issues
The Times of India 16 Feb 2026
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USFDA issues Form 483 with 4 observations to Piramal Pharma's Telangana unit
Business Line 14 Feb 2026
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DifGen Pharmaceuticals LLC Receives USFDA Approval for Fluorometholone Ophthalmic Suspension, 0.1% - Expanding Its Complex Generic Portfolio
PR Newswire 12 Feb 2026
Food and Drug Administration (USFDA) for its Fluorometholone Ophthalmic Suspension, 0.1% - a complex generic formulation used to treat eye inflammation. This is only the second generic USFDA approval of this complex suspension product.
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Zydus’ Desidustat gets USFDA orphan drug status for sickle cell disease
The Economic Times 06 Feb 2026
Zydus Lifesciences announced a significant development today ... .
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Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets
The Economic Times 06 Feb 2026
... for Parkinson's disease, has been cleared by the USFDA.
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Strides Pharma's Chestnut Ridge unit in New York classified as voluntary action indicated by USFDA
The Times of India 05 Feb 2026
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Natco Pharma gets USFDA nod for cancer generic drug
Business Line 03 Feb 2026
Natco’s Erdafitinib is approved for ...
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Indoco Remedies gets USFDA nod to sell generic epilepsy medicine
The Economic Times 30 Jan 2026
This medication is used to treat epilepsy in adults and children ... .
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Sun Pharma, Cipla recall products in US market: USFDA
Business Line 26 Jan 2026
As per its latest Enforcement Report, the ...
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Sun Pharma, Cipla recall products in US over manufacturing issues: USFDA
The Economic Times 26 Jan 2026
These recalls align with the oversight of the U.S. .
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Zydus Lifesciences gets USFDA nod for generic blood disorder drug
The Times of India 15 Jan 2026
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Bionpharma Inc. Receives USFDA Approval for Etravirine Tablets Developed in Collaboration with STEERLife
Canada Newswire 13 Jan 2026
today announced that Bionpharma has received Abbreviated New Drug Application (ANDA) approval from the United States Food and Drug Administration (USFDA) for its generic Etravirine tablets.
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Alembic Pharmaceuticals gets USFDA tentative nod for generic cancer treatment drug
The Times of India 12 Jan 2026
Alembic Pharmaceuticals has secured tentative approval from the USFDA for its ...
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