USFDA
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Franchise India Bureau Jul 05 2018 - 2 min readWockhardt Ltd, the Mumbai-based pharmaceutical company which has been under the US FDA scanner over regulatory issues, is set to raise about $300 million through sale of dollar-denominated bonds. It has hired UBS, Barclays, Nomura and Standard Chartered to manage the fundraising process, according to two people aware of the development. Wockhardt plans to raise ...
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Franchise India Bureau Jun 08 2018 - 1 min readGlenmark Pharmaceuticals has received final approval from the US health regulator for generic versions of Loestrin tablets, used to prevent pregnancy. "Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food & Drug Administration (USFDA) for Hailey 1.5/30 (Norethindrone Acetate and Ethinyl Estradiol tablets USP, 1.5 mg/30 mcg) and Hailey Fe ...
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Franchise India Bureau May 28 2018 - 1 min readZydus Cadila has received final nod from the US health regulator to market Nystatin ointment and Omeprazole and Sodium Bicarbonate capsules. Nystatin ointment is used to treat fungal skin infections. Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market Nystatin ...
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Franchise India Bureau May 14 2018 - 1 min readPharma major Lupin has confirmed the completion of the inspection by US health regulator for its Nagpur facility without making any observations. In a BSE filing, Lupin "announced the successful completion of an inspection carried out by the United States Food and Drug Administration (USFDA) at its Nagpur facility. The inspection ...
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Franchise India Bureau May 08 2018 - 1 min readDrug firm Suven Life Sciences has confirmed that its Pashamylaram facility near Hyderabad has undergone successful inspection by the US health regulator. The facility has undergone renewal inspection from February 5-18 by the United States Food and Drug Administration (USFDA), Suven Life Sciences said in a filing to BSE.