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Latest Articles in us fda

Covaxin's Clinical Trials Can Resume In US As FDA Lifts Hold

The FDA's earlier decision, in April, to put on hold the trials was based on the US firm's decision to voluntarily implement a temporary pause in dosing participants of the jab, following the World Health Organisation's observations on Covaxin manufacturing plants in India

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Granules Pharmaceuticals Inc., Concludes FDA Audit

GPI is a US FDA & DEA approved facility which spreads over 100,000 sq ft area, with established R&D & Manufacturing capabilities for low volume, oral solid dosage forms.

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Glenmark launches SUTIB (Sunitinib) - priced 96% lower than the innovator brand- Reduces the risk of kidney cancer progression by 58%

Glenmark launches SUTIB (Sunitinib) - priced 96% lower than the innovator brand- Reduces the risk of kidney cancer progression by 58%

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Glenmark's consolidated net profit rises by 30.05% to Rs. 2481.79 Mn. in Q3 FY 2020-21

Glenmark's consolidated net profit rises by 30.05% to Rs. 2481.79 Mn. in Q3 FY 2020-21

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Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Phosphate Gel

Glenmark Pharmaceuticals receives ANDA approval for Clindamycin Phosphate Gel

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Glenmark Pharmaceuticals receives ANDA approval for Sirolimus tablets, 0.5 mg, 1 mg and 2 mg

Glenmark Pharmaceuticals receives ANDA approval for Sirolimus tablets, 0.5 mg, 1 mg and 2 mg

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Glenmark Pharmaceuticals receives ANDA approval for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg

Glenmark Pharmaceuticals receives ANDA approval for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg

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Cipla Receives Final Approval For Generic Version Of Shire’s Firazyr®

Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

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Glenmark Stock Up After US Approval To Its Savella Generic

Shares of drug maker Glenmark Pharmaceuticals rose 0.52 per cent to Rs 868. 45 a unit on BSE on Friday, a day that saw the benchmark Sensex down by at least 50 points

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US Bans Divi's Factory, Shares Hit 3-year Low

US health regulators have banned a drug production site in India belonging to Divi's Laboratories Ltd due to manufacturing violations, sending the company's shares down to a near three-year low on Wednesday

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Sun Pharma Says FDA To Lift Ban On Mohali Drug Plant

Sun Pharmaceutical Industries said on Tuesday that US regulators plan to lift a ban on its Mohali plant in Punjab, allowing the company to restart supplies from there after four years

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US FDA Finds Quality Control Problems At Sun Pharma's Halol Plant

The US Food and Drug Administration has again raised concerns about the quality control process at Indian drugmaker Sun Pharmceutical Industries' Halol factory, an inspection report obtained by Reuters shows

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FDA Halts Sale Of Some Antibacterial Hand, Body Wash Products

Johnson & Johnson, Procter & Gamble Co and Colgate-Palmolive Co have said they have either reformulated or are reformulating their products to delete the most common of the 19 ingredients

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FDA Warns Former Sun Pharma US Drug Factory Over Quality Concerns

The plant was sold to Frontida in June by Sun, India's No. 1 drugmaker, which said the move was 'a part of its manufacturing consolidation in the US'

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Indoco Remedies Q1 Net Marginally Down At Rs 19.8 Crore

Indoco Remedies on Friday reported a marginal decline in net profit at Rs 19.8 crore for the June quarter against Rs 20.8 crore in the corresponding period last fiscal

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