Dr Reddy gets EIR for Cuernavaca plant in Mexico from USFDA
Dr Reddy’s Laboratories has received establishment inspection report for its Cuernavaca facility in Mexico, from the US health regulator. In a filing to BSE the company...
Tag : USFDA
Lupin gets EIR for Pithampur unit, from USFDA
Lupin has received the establishment investigation report (EIR) for the successful inspection of its Pithampur, Unit 1, from USFDA. The inspection was carried out during July...
Galaxy Surfactants receives 13 observations from USFDA, for Tarapur unit
Galaxy Surfactants has received Form 483, for two of its facilities situated at Tarapur, Maharashtra. The company’s two of the facilities (M3 & N46) at...
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...
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...