USFDA issues 12 observations for three Biocon units in Malaysia
The inspection across these three units concluded with 12 observations issued on the Form 483
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Browsing Tag
USFDA
Alembic Pharma gets USFDA nod for seizure treatment drug
The approval from is for the company’s abbreviated new drug application (ANDA) for Clonazepam orally disintegrating tablets, in…
Lupin receives tentative US FDA approval for Mirabegron ER Tablets
Lupin’s Mirabegron ER Tablets, 25 mg and 50 mg, is a generic version of Myrbetriq Extended Release Tablets, 25 mg and 50 mg, of…
US group says Novartis MS drug price out of line with benefit
The Boston-based Institute for Clinical and Economic Review (ICER), which has been reviewing Mayzent for months, recommended that…
Aurobindo Pharma gets warning letter from US FDA for Andhra Pradesh unit
The company received a warning letter from the United States Food and Drug Administration (US FDA) related to their unit XI,…
Zydus settles patent case over Aptalis’ drug Canasa
Canasa is indicated to treat mildly to moderately active ulcerative colitis
Natco gets US FDA nod to market renal disease drug
The product, as the first generic, will be launched shortly in the US market
Lupin receives FDA approval for Rosuvastatin Calcium tablets
The medicine is indicated for the treatment of adult patients with hypertriglyceridemia
Zydus receives US FDA approval for Temozolomide capsules and Nadolol tablets
Both drugs to be manufactured at the company’s formulations manufacturing facility at the Pharma SEZ, Ahmedabad
Torrent Pharma gets establishment nod from US FDA
The plant located at Dahej SEZ, in Gujarat, has also received approval from EU Germany Torrent Pharma said its third…