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...
Tag : USFDA
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...
Zydus Cadila gets USFDA approval to market 2 drugs
Zydus Cadila has received final approval to market two drugs, from the US health regulator. The company stated that, it has received approval to market Methylprednisolone tablets USP...
Lupin gets USFDA approval to market Tetrabenazine tablets
Lupin has received final approval to market its Tetrabenazine tablets, from the US health regulator. It is used for treating involuntary movements associated with Huntington’s disease....
USFDA completes Unichem’s Ghaziabad plant inspection
The US health regulator has completed the inspection of Unichem’s Laboratories, Ghaziabad facility in Uttar Pradesh and the regulator has not issued any observation to it....
Glenmark gets USFDA nod for generic version of Temovate Topical
Glenmark Pharmaceuticals has received final approval for generic version of Temovate Topical Solution, from the US health regulator. It is used to treat certain scalp and skin...