Tag: USFDA

Mumbai: India’s largest drugmaker Sun Pharmaceutical has received a nod from the US Food and Drug Administration (USFDA) to expand the therapeutic use of its innovative drug Ilumya for ...

Glenmark Pharmaceuticals on Wednesday said its subsidiary, Glenmark Specialty SA, has received final approval from the United States Food and Drug Administration for its inhaler fluticasone propionate inhalation aerosol ...

New Delhi: Zydus Lifesciences on Friday said the US health regulator has granted Orphan Drug Designation to Desidustat, a novel oral product medication for the treatment of Sickle Cell ...

Drugmakers Glenmark and Dr Reddy's Laboratories are recalling products in the US due to manufacturing issues, according to the US Food and Drug Administration (USFDA). As per its latest ...

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 tentative ...

Drug major Sun Pharmaceutical Industries aims to bolster compliance across its manufacturing operations and work towards achieving full regulatory resolution at the three facilities facing USFDA action, according to ...

Dr Reddy's Laboratories has received Form 483 with two observations after the US health regulator inspected its API manufacturing plant in Telangana. The US Food & Drug Administration (USFDA) ...

NEW DELHI: Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to manufacture the generic version of cholesterol lowering Niacin extended-release tablets.The ...

Alembic Pharmaceuticals on Thursday said it has received approval from the US health regulator to market a generic anticonvulsant medication. The company has received approval from the US Food ...

The US health regulator has pulled up Granules India for failing to maintain buildings for drug storage and avoiding adequate procedures regarding cleaning and maintenance of equipment at its ...