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.
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.
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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.
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.
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