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USFDA issued a warning letter to Glenmark Pharmaceuticals for significant CGMP violations at its Pithampur plant, including ...
Lupin receives USFDA approval for generic Liraglutide Injection and Glucagon, expanding access to diabetes treatments.
Ibrutinib tablets had annual sales of $2,148.9 million in the United States, as per the IQVIA data dated May 2025, Zydus Life ...
Mumbai: Global pharma major Lupin Limited has received approval from the United States Food and Drug Administration (USFDA) ...
London: GSK plc has announced the extension of the US Food and Drug Administration (FDA) review period for the Biologics ...
Pharmaceutical company Lupin has received approval from the US Food and Drug Administration (USFDA) to market generic diabetes drugs.
A Form 483 is issued at the conclusion of an inspection when USFDA investigators observe conditions that may be in violation ...
Zydus Lifesciences got USFDA approval for Celecoxib capsules (50–400 mg) to treat arthritis, JIA, and AS. Made in Ahmedabad, ...
Zydus Lifesciences Ltd on Thursday said it has received tentative approval from the US health regulatory agency for its generic version of cancer treatment drug Ibrutinib tablets.
The US health regulator has pulled up Glenmark Pharmaceuticals for manufacturing lapses, including failure to establish laboratory controls, at its Pithampur-based plant. In a warning letter, the ...
Dr Reddy’s received a Form 483 with seven USFDA observations after inspecting its Srikakulam manufacturing plant in Andhra ...
Biocon Biologics receives USFDA approval for Kirsty, an interchangeable biosimilar to NovoLog, expanding their insulin ...
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