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Tag: usfda

You Searched For "usfda"
USFDA issues 6 observations for Jubilant Pharmova Roorkee facility

USFDA issues 6 observations for Jubilant Pharmova Roorkee facility

Ruchika Sharma3 Aug 2022 12:15 PM IST
Noida: Jubilant Pharmova Limited has announced that the United States Food and Drug Administration (USFDA) has recently concluded audit of the Solid...
Casper Pharma Hyderabad facility concludes USFDA inspection with zero observations

Casper Pharma Hyderabad facility concludes USFDA inspection with zero observations

Ruchika Sharma31 July 2022 1:00 PM IST
Hyderabad: Suven Pharmaceuticals Ltd has announced that the US Food and Drug Administration (USFDA) has completed a pre-approval inspection at Casper...
Aleor Derma gets USFDA approval for Diclofenac Sodium Topical Gel

Aleor Derma gets USFDA approval for Diclofenac Sodium Topical Gel

Rahul Verma31 July 2022 11:55 AM IST
Alembic Pharmaceuticals Limited today announced that its wholly owned subsidiary, Aleor Dermaceuticals Limited has received final approval from the US...
Alembic Pharma arm bags USFDA nod for Diclofenac Sodium Topical Gel

Alembic Pharma arm bags USFDA nod for Diclofenac Sodium Topical Gel

Ruchika Sharma29 July 2022 1:23 PM IST
Diclofenac Sodium Topical Gel, 3% is indicated for the topical treatment of actinic keratoses.
GSK Nucala application for COPD accepted for review in China

GSK gets USFDA nod for Benlysta for children with active lupus nephritis

Ruchika Sharma29 July 2022 11:39 AM IST
London: GSK plc has announced that the US Food and Drug Administration (USFDA) has approved Benlysta (belimumab) for the treatment of children aged 5...
Dr Reddys Labs unveils Bortezomib for Injection in US

Dr Reddy's Labs unveils Bortezomib for Injection in US

Ruchika Sharma28 July 2022 11:15 AM IST
Hyderabad: Drugmaker, Dr Reddy's Laboratories Ltd., has announced the launch of Bortezomib for Injection 3.5 mg, the generic equivalent of Velcade...
Zydus Lifesciences bags USFDA nod for BP drug Bisoprolol Fumarate

Zydus Lifesciences bags USFDA nod for BP drug Bisoprolol Fumarate

Ruchika Sharma27 July 2022 11:25 AM IST
The drug will be manufactured at the group's formulation manufacturing facility at, SEZ, Ahmedabad, India.
Lupin secures USFDA nod for Azilsartan Medoxomil Tablets

Lupin secures USFDA nod for Azilsartan Medoxomil Tablets

Ruchika Sharma25 July 2022 5:46 PM IST
The product will be manufactured at Lupin’s facility in Nagpur, India.
Sun Pharma, Glenmark recall products in US

Sun Pharma, Glenmark recall products in US

Rahul Verma25 July 2022 5:28 PM IST
Leading drug makers Sun Pharma and Glenmark are recalling products in the US, the world's largest market for medicines, due to lapses in the...
Dr Reddys Labs launches generic version of Allegra in US

Dr Reddy's Labs launches generic version of Allegra in US

Rahul Verma25 July 2022 1:04 PM IST
Drugmaker, Dr Reddy's Laboratories Ltd., has announced the first-to-market launch of over-the-counter (OTC) Fexofenadine HCl 180 mg and...
Natco partner bags USFDA nod for Cabazitaxel Intravenous Powder

Natco partner bags USFDA nod for Cabazitaxel Intravenous Powder

Ruchika Sharma25 July 2022 12:15 PM IST
Hyderabad: Natco Pharma Limited today announced that the U.S. Food and Drug Administration (USFDA) has granted approval to its partner Breckenridge...
Glenmark, Sun Pharma recall products in US over manufacturing issues

Glenmark, Sun Pharma recall products in US over manufacturing issues

Ruchika Sharma25 July 2022 11:33 AM IST
New Delhi: Leading drug makers Sun Pharma and Glenmark are recalling products in the US, the world's largest market for medicines, due to lapses in...
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