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Tag: usfda

You Searched For "usfda"
Glenmark gets USFDA approval for Dimethyl Fumarate Delayed-Release Capsules

Glenmark gets USFDA approval for Dimethyl Fumarate Delayed-Release Capsules

Ruchika Sharma7 Oct 2020 3:13 PM IST
Mumbai: Glenmark Pharmaceuticals Inc., USA today announced that the company has been granted final approval by the United States Food & Drug...
Lupin gets USFDA nod to generic equivalent of Tecfidera Delayed-Release Capsules

Lupin gets USFDA nod to generic equivalent of Tecfidera Delayed-Release Capsules

Ruchika Sharma7 Oct 2020 12:31 PM IST
Mumbai, Baltimore: Pharma major, Lupin Limited, has recently announced that the company has received approval for its Dimethyl Fumarate...
Panacea Biotec Baddi plant fails to establish laboratory controls, gets USFDA warning letter

Panacea Biotec Baddi plant fails to establish laboratory controls, gets USFDA warning letter

Farhat Nasim5 Oct 2020 3:11 PM IST
"Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and...
Sun Pharma

Patent Infringement: Sun Pharma sued by Orexo over generic opioid dependence drug Zubsolv

Farhat Nasim4 Oct 2020 11:15 AM IST
New Delhi: In a major setback to Sun Pharmaceutical Industries Limited, Swedish drugmaker Orexo recently filed a patent infringement action in the...
Dr Reddys launches generic version of Sensipar tablets in US

Dr Reddys launches generic version of Sensipar tablets in US

Ruchika Sharma3 Oct 2020 1:30 PM IST
Dr. Reddy's Cinacalcet Tablets are available in 30 mg, 60 mg, and 90 mg tablets in a bottle count size of 30.
AstraZeneca discontinues Phase 3 trial of prostate cancer drug Truqap

AstraZeneca COVID vaccine under USFDA safety inquiry

Ruchika Sharma2 Oct 2020 10:30 AM IST
Washington: The U.S. Food and Drug Administration has broadened its investigation of a serious illness in AstraZeneca Plc's Covid-19 vaccine study and...
Panacea Biotec Baddi unit gets USFDA warning letter

Panacea Biotec Baddi unit gets USFDA warning letter

Ruchika Sharma1 Oct 2020 12:00 PM IST
New Delhi: Drug firm Panacea Biotec on Wednesday said it has received a warning letter from the US health regulator for its pharmaceutical formulation...
Lupin unveils generic equivalent of Tykerb Tablets

Lupin unveils generic equivalent of Tykerb Tablets

Ruchika Sharma1 Oct 2020 11:45 AM IST
Mumbai, Baltimore: Pharma major, Lupin Limited, has recently announced the launch of Lapatinib Tablets, 250 mg, after Lupin's alliance partner Natco...
Lupin bags tentative USFDA nod for rare autoimmune disorder drug Amifampridine

Lupin unveils generic version of Lipitor Tablets

Ruchika Sharma29 Sept 2020 12:30 PM IST
Mumbai, Baltimore: Pharma major, Lupin Limited, has recently announced the launch of Atorvastatin Calcium Tablets USP, 10 mg, 20 mg, 40 mg, and 80...
Dr Reddys unveils multiple sclerosis drug Dimethyl Fumarate Delayed-Release Capsules

Dr Reddys unveils multiple sclerosis drug Dimethyl Fumarate Delayed-Release Capsules

Ruchika Sharma28 Sept 2020 3:30 PM IST
Hyderabad and Princeton: Dr. Reddy's Laboratories Ltd. has recently announced the launch of Dimethyl Fumarate Delayed-Release Capsules, a therapeutic ...
Dr Reddys launches Dexmedetomidine Injection in US

Dr Reddys launches Dexmedetomidine Injection in US

Ruchika Sharma27 Sept 2020 10:30 AM IST
Hyderabad and Princeton: Drugmaker, Dr. Reddy's Laboratories Ltd., has recently announced the launch of Dexmedetomidine Hydrochloride in 0.9%...
Granules India gets USFDA green flag for sleep aid drugs Naproxen Sodium, Diphenhydramine Hydrochloride Tablets

Granules India gets USFDA green flag for sleep aid drugs Naproxen Sodium, Diphenhydramine Hydrochloride Tablets

Ruchika Sharma27 Sept 2020 10:15 AM IST
Naproxen Sodium and Diphenhydramine Hydrochloride Tablets are used for relief of occasional sleeplessness associated with minor aches and pains and to...
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