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...
Tag : USFDA
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...
Zydus gets USFDA approval for anti-obsessional drug
Cadila Healthcare’s US subsidiary has received approval for anti-obsessional drug, from the US health regulator. In a filing the company stated that, Zydus Pharmaceuticalst (USA) Inc,...
Lupin gets USFDA nod for Calcipotriene Topical Solution
Lupin has received final approval for Calcipotriene Topical Solution, 0.005% (Scalp Solution), from USFDA. The company has received approval to market a generic version of Dovonex...
Dr Reddy’s receives USFDA approval for Sapropterin Dihydrochloride
Dr Reddy’s Laboratories has received approval from the US health regulator for drug that reduces blood phenylalanine concentrations in patients. It has received tentative approval from...
Aurobindo receives USFDA approval for Fondaparinux Sodium injection
The US health regulator has given approval to Aurobindo Pharma, for manufacturing and marketing generic version of Fondaparinux Sodium injection, which is used to prevent deep vein...
Glenmark receives USFDA approval for generic version of Minastrin tablet
The US health regulator has given final approval to Glenmark Pharmaceuticals for a generic version of Minastrin 24 tablets, which is used to prevent pregnancy....