Tag: USFDA

Torrent Pharmaceuticals on Wednesday said the US health regulator has issued a Form 483 with five observations after inspecting its Gujarat-based manufacturing plant. The US Food and Drug Administration ...

Drug maker Lupin, on Monday, said it has launched a generic medication used to treat or prevent bacterial infections in the US market.Also read:Lupin settles lawsuit over diabetes drug ...

New Delhi: Natco Pharma on Tuesday said it has received a warning letter from the US health regulator for its Telangana-based manufacturing plant. The US Food and Drug Administration ...

Gland Pharma on Monday said it has received approval from the US health regulator to market a generic medication used to treat breast cancer. The company has received approval ...

New Delhi, Leading drugmakers Sun Pharma and Lupin are recalling products in the US market over manufacturing issues, as per the US Food and Drug Administration (USFDA). Mumbai-based Sun ...

Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulatory for its generic version of cancer treatment drug Cyclophosphamide capsules. The approval by ...

New Delhi: Pharma major Lupin Ltd on Monday said it has received approval from the US health regulator to market its generic Fluconazole tablets used in the treatment of ...

New Delhi: The US health regulator has pulled up Intas Pharmaceuticals for manufacturing lapses, including failure of its quality control unit to ensure CGMP compliance, at its Sanand-based manufacturing ...

Zydus Lifesciences Ltd on Thursday said it has received final approval from the US health regulator to manufacture and market its generic Indomethacin suppositories indicated for moderate to severe ...

Glenmark Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic diabetes drug in the American market. The company has received final ...