USFDA clears Indoco’s Goa Plant II and III
The inspection was held from 27th May, 2019 to 4th June, 2019, where the company had received four observations (483s)
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Browsing Tag
USFDA
Indoco Remedies gets warning letter from USFDA for oral dosages plant in Goa
The company has received a warning letter from the United States Food and Drug Administration (USFDA) as a result of the…
USFDA inspection at Chennai facility ends with zero observations: Natco Pharma
The inspection was conducted during the period July 8-12, 2019
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
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