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Alembic Pharma secures USFDA tentative nod for generic Darolutamide prostate cancer tablets

Alembic Pharma secures USFDA tentative nod for generic Darolutamide prostate cancer tablets

Alembic Pharmaceuticals has received USFDA tentative approval for its generic Darolutamide tablets used in prostate cancer treatment. The approval applies to the 300 mg strength, positioning Alembic’s product as a generic equivalent to Nubeqa Tablets. With significant demand expected for this category, the company could gain momentum as it moves toward final commercialization.

Summarised by Beize from a story on The Economic Times on 14 May 2026
Zydus Biologics Ahmedabad facility faces seven USFDA observations but data integrity stays clean

Zydus Biologics Ahmedabad facility faces seven USFDA observations but data integrity stays clean

Zydus Lifesciences says its Zydus Biologics injectable plant in Ahmedabad was inspected by the USFDA from April 27 to May 5, 2026. The audit resulted in seven observations, though the company emphasized that there were no data integrity issues. Zydus is now in discussions with the USFDA to address the findings promptly and maintain compliance.

Summarised by Beize from a story on The Economic Times on 6 May 2026

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Alembic Pharma wins USFDA nod for generic methotrexate injection for cancer and arthritis

Alembic Pharma wins USFDA nod for generic methotrexate injection for cancer and arthritis

Alembic Pharmaceuticals has received USFDA final approval for its generic methotrexate injection, a widely used medicine for multiple cancers and inflammatory conditions. The regulator greenlit key dosage formats and confirmed therapeutic equivalence to the reference Hospira product, clearing the way for Alembic to market the injectable in the US for cancers and conditions like rheumatoid arthritis and severe psoriasis.

Summarised by Beize from a story on The Economic Times on 24 Apr 2026
USFDA scrutiny on Indian plants is rising but pharma is more prepared than a decade ago

USFDA scrutiny on Indian plants is rising but pharma is more prepared than a decade ago

USFDA inspections in India have accelerated recently, raising concerns about potential adverse observations. But industry insiders say today’s pharma firms are better positioned than a decade ago, thanks to tech upgrades and de-risking strategies. Analysts expect limited impact on earnings and stock prices, as companies can better cushion regulatory actions.

Summarised by Beize from a story on The Economic Times on 24 Apr 2026
Cipla gets USFDA nod for generic albuterol inhalation aerosol for respiratory relief

Cipla gets USFDA nod for generic albuterol inhalation aerosol for respiratory relief

Cipla has received final approval from the USFDA for its generic albuterol sulfate inhalation aerosol, a key medicine used for respiratory conditions. The clearance strengthens Cipla’s US portfolio and provides a therapeutic equivalent to a widely used branded drug, underlining its momentum in the respiratory segment.

Summarised by Beize from a story on The Economic Times on 24 Apr 2026
USFDA flags five observations at Ajanta Pharma Paithan facility after inspection

USFDA flags five observations at Ajanta Pharma Paithan facility after inspection

Ajanta Pharma said the US FDA issued Form-483 with five observations following an inspection of its Paithan manufacturing facility in Maharashtra from April 13–21, 2026. The company said it will file its response within the required timeframe, adding that Form-483 is issued when inspectors identify potential regulatory violations that may need corrective action.

Summarised by Beize from a story on The Economic Times on 24 Apr 2026

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