Glenmark Pharma submits drug application for Ryaltris with USFDA
Glenmark Pharmaceuticals has submitted a new drug application for its nasal spray Ryaltris, with the US health regulator. In a BSE filing the company stated,...
Tag : USFDA
Glenmark gets USFDA approval for Colesevelam Hydrochloride tablets
Glenmark Pharma has received final approval for Colesevelam Hydrochloride tablets, 625 mg, the generic version of Daiichi Sankyo’s Welchol tablets, 625 mg, from the US...
USFDA completes inspection of Indoco Remedies, Navi Mumbai facilities
The USFDA has completed the inspection of Indoco Remedies, API manufacturing facilities at Patalganga and Rabale, Navi Mumbai. In a release the company stated that, the inspection...
Granules India receives USFDA nod for Methylergonovine tablets
Granules India has received USFDA’s approval for Methylergonovine 0.2 mg tablets. The abbreviated new drug applications (ANDA) was filed by Granules Pharmaceuticals Inc., a wholly...
USFDA concludes inspection of Divis Labs unit-I at Choutuppal
The USFDA has completed inspection of Divis Laboratories unit-I at Choutuppal, Telangana with no 483 observations. The inspection was a general cGMP inspection by the FDA and...
Granules India gets EIR from USFDA for Jeedimetla facility
Granules India has received Establishment Inspection Report (EIR), from the US health regulator for facility in Telangana. The US Food and Drug Administration inspected Jeedimetla facility...
USFDA concludes inspection of J B Chemicals Panoli facility
The US health regulator has completed inspection of J B Chemicals and Pharmaceuticals Panoli facility, in Gujarat with two minor observations. In a BSE filing the...
Glenmark Pharma gets approval for skin treatment cream from USFDA
Glenmark Pharmaceuticals has received final approval for the generic version of Temovate cream used to treat inflammation and itching caused by a number of skin conditions,...
Cadila Healthcare gets final approval from USFDA for Carbidopa tablets
Cadila Healthcare has received final approval to market Carbidopa tablets,25 mg from USFDA. The drug is used with a combination levodopa/carbidopa product to treat symptoms of...
USFDA issues 7 observations to Biocon’s Bengaluru facility
The US health regulator, has issued 7 observations to Biocon’s sterile drug product manufacturing facility in Bengaluru, after inspection. In a filing to the BSE the...