J B Chemicals Gujarat unit gets EIR from USFDA Medical Dialogues Bureau12 Feb 2020 1:03 PM ISTThe company has received EIR from the United States Food and Drug Administration (USFDA) for its newly set up and commissioned solid oral dosage forms...
Zydus Cadila gets USFDA nod for Fluocinonide cream to treat skin conditions Medical Dialogues Bureau12 Feb 2020 12:51 PM ISTFluocinonide cream USP, 0.1 per cent, approved by USFDA is indicated to treat a variety of skin conditions such as psoriasis, eczema, dermatitis,...
Cadila Healthcare Ahmedabad facility gets EIR from USFDA Medical Dialogues Bureau11 Feb 2020 12:09 PM IST The company's topical manufacturing facility at Ahmedabad has received an EIR from the United States Food and Drug Administration (USFDA) signifying...
JB Chemicals Gujarat unit passes USFDA inspection with one observation Medical Dialogues Bureau10 Feb 2020 8:04 PM ISTNEW DELHI: JB Chemicals and Pharmaceuticals on Monday said its Gujarat unit has passed the US health regulator's periodical inspection with one minor...
Dr Reddys launches generic version of Syprine in US Farhat Nasim9 Feb 2020 10:45 AM IST In a regulatory filing, Dr Reddy's Laboratories announced the launch of Trientine Hydrochloride capsules USP, 250 mg, a therapeutically equivalent...
Alkem Labs St Louis facility gets 3 USFDA observations Medical Dialogues Bureau8 Feb 2020 4:13 PM ISTNew Delhi: Drugmaker Alkem Laboratories (Alkem Labs) recently informed that the company has received three observations from the US health...
Granules Pharma gets USFDA nod for genetic disorder drug Colchicine Medical Dialogues Bureau8 Feb 2020 10:30 AM IST "The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc, a...
Strides Pharma arm inks pact with Pharmaceutics International to acquire 18 ANDA Farhat Nasim7 Feb 2020 3:34 PM IST "Strides...announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte Ltd, Singapore, has entered into a definitive asset...
Lupin gets USFDA nod for generic version of Arava Tablets Medical Dialogues Bureau6 Feb 2020 1:08 PM IST Leflunomide Tablets USP is a generic equivalent of Arava Tablets, 10 mg and 20 mg, of Sanofi- Aventis, Lupin said.Mumbai: Pharma major Lupin Limited...
Granules India arm gets USFDA nod for generic version of Valcyte Medical Dialogues Bureau5 Feb 2020 3:13 PM IST Valganciclovir hydrochloride oral solution is bioequivalent to the reference listed drug product (RLD), Valcyte for Oral Solution, 50mg/mL, OF Roche...
Sun Pharma unveils acne drug Absorica LD in US Medical Dialogues Bureau5 Feb 2020 11:41 AM IST "The launch of Absorica LD - which offers the proven efficacy and safety of Absorica at a lower dose - underscores our commitment to making a...
Cadila Healthcare Ahmedabad facility clears USFDA inspection Farhat Nasim5 Feb 2020 9:15 AM IST United States Food and Drug Administration (USFDA) inspected the manufacturing facility of Alidac Pharmaceuticals, the company's wholly-owned...
