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USFDA inspection ends with ‘Zero’ observations: Alkem

Drug firm Alkem Laboratories yesterday said the US health regulator has conducted an inspection of its Taloja facility in Maharashtra, and it...

Granules Pharma clears USFDA audit

Granules India yesterday announced that Granules Pharmaceuticals, a wholly-owned foreign subsidiary of the company located in Chantilly, Virginia, USA, has cleared a...

Zydus Cadila gets USFDA nod for Ibrutinib tablets

Zydus Cadila has received tentative approval from the US Food and Drug Administration (USFDA) to market Ibrutinib tablets, in the strengths of...

Lupin gets USFDA nod for generic Antifungal drug

Global pharma major Lupin Limited announced the US launch of tavaborole topical solution, 5% having received an approval from the United States...

Unichem gets tentative USFDA nod for drug to treat Diabetes

Unichem Laboratories has received tentative approval for ANDA of Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg from the United...

Alembic gets USFDA final nod for Erlotinib Tablets

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug...

Alembic gets USFDA nod for drug for the treatment of Depression

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug...

Viona Pharma recalls 21,240 bottles of this Diabetes drug

Viona Pharmaceuticals Inc is recalling over 21,000 bottles of metformin hydrochloride extended-release tablets manufactured by Ahemdabad-based Cadila Healthcare, the latest enforcement report of the US Food...

Zydus Cadila gets USFDA nod for drug to treat HIV infection

Zydus Cadila has received final approval from US Food and Drug Administration (USFDA) to market emtricitabine and tenofovir disoproxil fumarate tablets, 100...

Alembic gets USFDA nod for Nitrofurantoin Capsules USP

Alembic Pharmaceuticals announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug...

Axio Biosolution gets USFDA nod for Patch for bleeding control

Axio Biosolutions, an integrated wound care company has received the USFDA 510(k) clearance of its hemostatic product Axiostat Patch, which helps control...

Lupin launches generic drug to treat HIV 1 infection

Global pharma major Lupin Limited announced the launch of emtricitabine and tenofovir disoproxil fumarate tablets 200 mg/300 mg, having received an approval...

Indian Pharma: Cost effective alternative to batch processing

Indian pharma could consider continuous flow processing technology which is a cost-effective alternative to batch processing. This is because consistency in manufacture...

Glenmark gets USFDA nod for generic Lung cancer drug

Glenmark Pharmaceuticals yesterday said it has received approval from the US health regulator to market Nintedanib capsules, used in the treatment of...

Pfizer stops distribution of Anti Smoking Drug

Pfizer Inc said recently that it is pausing the distribution of its anti-smoking treatment, Chantix, after finding elevated levels of cancer-causing agents...

USFDA okays Tocilizumab for treatment of Covid-19

Washington: The US Food and Drug Administration (USFDA) has issued an emergency use authorisation (EUA) for the drug Actemra (tocilizumab) -- used for arthritis -- for...

Zydus Cadila gets tentative nod from USFDA for Pemetrexed for Injection

Zydus Cadila has received tentative approval from the USFDA to market Pemetrexed for Injection in the strengths of 100mg/vial, 500 mg/vial, and...

USFDA approves this drug for emergency use for severe C-19

The US health regulators have approved Roche’s arthritis drug Actemra for emergency use to treat hospitalised C-19 patients, giving an extra boost...

Cipla gets USFDA nod for Inhalation product

Cipla yesterday said that it has received final approval from the US health regulator for Arformoterol Tartrate Inhalation Solution, used to treat...

Zydus Cadila gets tentative nod from USFDA for Fingolimod Capsules

Zydus Cadila has received tentative approval from the United States US (USFDA) to market Fingolimod capsules in the strength of 0.25 mg...

Dr. Reddy’s Labs launches Icosapent Ethyl Capsules

Dr Reddy's Laboratories Ltd announced the launch of the US Food and Drug Administration (USFDA) approved icosapent ethyl capsules, 1 gram

Alkem gets two observations from USFDA for USA plant

Alkem Laboratories on Saturday said the US health regulator has issued two observations after inspection of its St Louis-based manufacturing facility. The US Food...

Lupin gets USFDA nod for treatment of Kidney patient

Global pharma major Lupin Limited announced that it has received approval for its sevelamer hydrochloride tablets, 400 mg and 800 mg from...

Aleor gets USFDA nod for Testosterone Topical Solution

Alembic Pharmaceuticals announced that its joint venture Aleor Dermaceuticals has received final approval from the US Food & Drug Administration (USFDA) for...

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