USFDA approves Strides Shasun generic Ibuprofen capsules
The United States Food & Drug Administration (USFDA), has given approval to Strides Shasun generic Ibuprofen capsules, 200 mg, which is used for relieving pain. The company...
Tag : USFDA
USFDA isssues 13 observations to Alkem’s Daman plant
The US health regulator has issued 13 observations, to Alkem Laboratories Daman facility and 1 to US plant. The inspection was conducted by the regulator,...
Glenmark Pharma gets USFDA nod for Clobetasol Propionate Spray
Glenmark Pharmaceuticals Inc. USA has been given final approval by the United States Food & Drug Administration (USFDA), for Clobetasol Propionate Spray, 0.05%, the generic version...
Cadila Healthcare gets USFDA approval for Metoprolol Succinate tablets
Cadila Healthcare has received final approval to market Metoprolol Succinate extended-release tablets, from USFDA in the strengths of 25mg, 50mg, 100mg and 200mg. The tablet will be manufactured...
Sun Pharma gets USFDA nod for psoriasis drug Ilumya
Sun Pharmaceuticals Industries has received approval from USFDA, for its psoriasis drug Ilumya. Ilumya is generically known as tildrakizumab-asmn and comes under specialty drugs –...
USFDA issues 3 observations to Alembic Pharma for Gujarat plant
The US health regulator has issued 3 observations to Alembic Pharmaceuticals Ltd, after inspecting its formulation facility in Panelav, Gujarat. In a regulatory filing the...
USFDA issues observations to Cipla’s Goa unit
Cipla has received observations for its Goa unit, from the US health regulator. The USFDA conducted a product specific pre-approval inspection, at Goa plant in...
Strides Shasun gets USFDA nod for Efavirenz Tablet
Strides Shasun’s wholly owned subsidiary, Strides Pharma Global Pte has received approval from Unites States Food and Drug Administration (USFDA), for Efavirenz Tablets USP, 600 mg....
Lupin gets USFDA approval for Tydemy tablets
Lupin has launched Tydemy tablets, which is suggested to be used by women for contraception. The company in a statement said that, the launch follows the...
Cadila Healthcare gets USFDA nod to market Tizanidine tablets
Cadila Healthcare has received final approval from USFDA, to market Tizanidine tablets USP in strengths of 2 mg and 4 mg. The tablets will be manufactured...