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Latest Articles in usfda

Jubilant Pharmova Arm Completes Studies Using Novel Oral Formulation Of Remdesivir

Shares of Jubilant Pharmova were trading at Rs 775.30 per scrip on BSE, up 7.07 per cent from its previous close.

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Sun Pharma, Alembic Recall Products In The US Market

Princeton (New Jersey) based Sun Pharmaceutical Industries Inc is also recalling 2,520 bottles of diabetes drug, Metformin HCl Extended-Release tablets, in the US market.

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Zydus Cadila Gets USFDA Nod For Cancer And High Blood Pressure Treatment Drug

Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Ibrutinib Capsules in the strengths of 70 mg and 140 mg, Cadila Healthcare said in a regulatory filing.

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Dr Reddy's Gets 3 Observations From USFDA For US-Based API Plant

The audit of the company's active pharmaceutical ingredients (API) manufacturing plant at Middleburg, New York has been completed by the US Food and Drug Administration (USFDA), the Hyderabad-based drug major said in a regulatory filing.

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Natco's Marketing Partner Gets USFDA Nod For Cancer Treatment Drug

Natco's partner BPI plans to launch 2.5 mg, 5 mg and 7.5 mg strengths of the product shortly within the next few weeks.

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Lupin Gets USFDA Nod For Generic Diabetes Drug

As per IQVIA MAT November 2020 data, Empagliflozin and Metformin Hydrochloride ER Tablets had estimated annual sales of USD 357 million in the US.

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Glenmark Pharma Gets USFDA Nod For Generic Drug

The company's US-based subsidiary has received final approval from the US Food and Drug Administration (USFDA) for the product which is a generic version of PF Prism CV's Rapamune tablets

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Top drug regulator suspends import license of 19 firms for their COVID-19 test kit

Top drug regulator suspends import license of 19 firms for their COVID-19 test kit

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Alembic Pharma Gets EIR From USFDA For Its Panelav Facility

Shares of Alembic Pharmaceuticals were trading at Rs 940.05 per scrip on the BSE, up 3.50 per cent from its previous close.

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Glenmark Pharmaceuticals Gets USFDA Nod For Fingolimod Capsules

Shares of Glenmark Pharmaceuticals were trading at Rs 411.20 a piece on BSE in morning trade, up 1.44 per cent from their previous close.

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Remdesivir included in 'investigational therapy' for restricted emergency use on COVID-19 patients: Health Ministry

Remdesivir included in 'investigational therapy' for restricted emergency use on COVID-19 patients: Health Ministry

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Dr Reddy's Labs In Licensing Pact With Gilead Sciences For Remdesivir

Gilead Sciences has signed similar non-exclusive voluntary licensing agreements with Cipla, Hetero Labs, Jubilant Lifesciences, Mylan and Zydus Cadila.

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Cipla Receives USFDA’s Green Flag For Generic Inhaler

Leading pharmaceutical firm Cipla has received final approval for a generic version of Proventil HFA Inhalation Aerosol used to treat acute bronchospasm or asthmatic symptoms

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Granules Pharmaceuticals, Inc Hets USFDA Nod For Colchicine Tablets

Shares of Granules India were trading at Rs 159.55 a piece on BSE, up 3.74 per cent from the previous close.

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Glenmark Pharma Gets Tentative Nod From USFDA For Multiple Sclerosis Drug

Glenmark's said its current portfolio consists of 161 products authorised for distribution in the US market and 49 abbreviated new drug applications (ANDAs) pending approval with the USFDA.

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