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...
Tag : USFDA
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,...
Lupin gets approval from USFDA to market generic Tamiflu
Lupin has received final approval from the US health regulator, for its Oseltamivir Phosphate. In a BSE filing the company stated that, it has received final...
Biocon receives 6 observations from USFDA
Biocon has received 6 observations from the US health regulator, after it had inspected its Malaysia manufacturing facility. The company in a regulatory filing stated,...
Natco Pharma’s Mekaguda facility clears USFDA inspection
Natco Pharma’s, Mekaguda facility near Hyderabad, has received zero observations from the US health regulator. The company in its filing stated, “….announce successful completion of regulatory...
Strides Shasun gets USFDA approval for Tenofovir tablets
Strides Shasun’s wholly owned subsidiary Strides Pharma Global Pte. Ltd has got green signal from the US Food and Drug Administration, for Tenofovir Disoproxil Fumarate tablets, 300...
Lupin receives USFDA approval for Tamiflu Capsules
Lupin has received US health regulator’s approval for generic Tamiflu Capsules. The company stated that, it has received final approval for its Oseltamivir Phosphate Capsules...