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...
Tag : USFDA
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...
Aurobindo Pharma receives 9 observations from USFDA
Aurobindo Pharma has received 9 Form 483 observations from USFDA, for its Unit IV injectable facility. Unit IV is situated in Pashamailaram near Hyderabad, where it...
Laurus Labs gets zero observations from USFDA
Laurus Labs has received Form 483 with zero observations for Unit 2 (the formulations unit). The United States Food and Drug Administration (USFDA) has successfully...
Natco Pharma seeks USFDA nod for hepatitis drug
Natco Pharma has filed an abbreviated new drug application (ANDA) for Sofosbuvir Tablets, 400mg, with the United States Food and Drug Administration (USFDA). The company...
Zydus Cadila receives USFDA approval for sedative injection
Zydus Cadila, has received final approval from US health regulator to market Dexmedetomidine Hydrochloride injection. The company in a regulatory filing stated that, the approval is...
Granules India receives establishment inspection report from USFDA
Granules India has received EIR from US Food and Drug Administration (USFDA), for Chantilly unit. USFDA has issued establishment inspection report (EIR) for Granules Pharmaceuticals,...