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Latest Articles in usfda

Aurobindo Pharma Gets Sebi's Warning On Ongoing USFDA Audit

The letter is in regards to certain disclosures made by the company on the ongoing USFDA audit of company's Unit-1 and observations made by the USFDA between the period 2019 to 2022, Aurobindo Pharma Ltd (APL) said in a regulatory filing

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Alembic Arm Recieves Final USFDA Approval For Generic Fever Blisters Drug

Alembic has received a cumulative total of 166 ANDA approvals (142 final approvals and 24 tentative approvals) from the USFDA

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Alembic Gets USFDA Nod To Market Ivabradine Used In Treating Heart Failure

Alembic said it has now received a cumulative total of 164 ANDA approvals (140 final approvals and 24 tentative approvals) from the USFDA till date

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USFDA Rejects Biocon, Viatris Application For Insulin Aspart

The USFDA has issued a complete response letter (CRL) for the biologics licence application (BLA) for Insulin Aspart filed by our partner Viatris (Mylan),

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Granules India Gets USFDA Nod For Its Generic Amphetamine Mixed Salts

Citing IQVIA Health data, the company said Amphetamine mixed salts 5mg, 7.5mg, 10mg, 12.5mg, 15mg, 20mg and 30mg immediate release tablets had US sales of approximately USD 335 million for the most recent twelve months ending in October 2021.

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Torrent Pharma Recalls Over 27,000 Bottles Of Blood Pressure Drug In US

The affected lot has been produced in India and later the company has supplied to its US-based subsidiary for distribution in the US, the world's largest market for generic drugs.

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USFDA Inspection Of Company’s US Plant Completed Successfully: Torrent Pharmaceuticals

The plant was inspected by USFDA (United States Food and Drug Administration) between December 6 and December 15, 2021

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Lupin Recalls 4,113 Cartons Of Oral Contraceptive Medicine In US Market

The affected lot has been produced at the company's Pithampur-based manufacturing facility in Madhya Pradesh and distributed in the US by Baltimore-based Lupin Pharmaceuticals, Inc.

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Dr Reddy's Launches Drug In US To Treat High Blood Pressure, Heart Failure

Dr Reddy's Valsartan Tablets are available in 40 mg in bottle count size of 30, and 80 mg, 160 mg and 320 mg tablets in bottle count sizes of 90

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Alembic Pharma Gets USFDA Nod For Formoterol Fumarate Inhalation Solution

The approval for the abbreviated new drug application (ANDA) for formoterol fumarate inhalation solution is for 20 mcg/2 ml per unit-dose vial.

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Sun Pharma Recalls Products In US Market

The US arm of the domestic pharma major is recalling Tadalafil tablets in the American market, according to the latest enforcement report of the USFDA.

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Zydus Cadila Gets USFDA Green Signal For Cancer Drug With 180 Days Exclusivity

The company has received approval from the US Food and Drug Administration (USFDA) for the Nelarabine injection 250 MG/50ML, a generic version of Arranon injection.

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Sun Pharma, Lupin Recall Products In US Market, Says USFDA

New Jersey-based Sun Pharmaceutical Industries Inc, a unit of the company, has initiated the Class III nationwide (US) recall of the 10-count blister packs on October 12 this year.

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USFDA Issues 6 Observations After Inspection Of Biocon's Malaysian Arm Mfng Facility

At the conclusion of the inspection, the agency has issued a Form 483 with a total of 6 observations across Drug Substance, Drug Product and Devices Facilities

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Zydus Cadila Gets USFDA Nod To Market Depression Treatment Drug In US Market

The drug will be manufactured at the group''s formulation manufacturing facility at the SEZ, Ahmedabad, Zydus Cadila noted.

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