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Alembic Pharmaceuticals Limited (Alembic) today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dronedarone Tablets USP, 400 mg. The tentatively approved ANDA is therapeutically equivalent to the reference listed drug

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According to an official statement on Friday, India has granted homegrown drugmaker Biological E permission to begin midtage studies of its COVID-19 vaccine in children and adolescents. The Drugs Controller General of India (DCGI) gave the approval to the Hyderabad-based pharmaceutical company on Sept. 1, the statement said. The

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Zydus, an innovation driven global pharma major and TLC, a specialty pharmaceutical company in Taiwan, today announced the signing of a license supply and commercialization agreement to commercialize AmphoTLC™ (Amphotericin B Liposome for Injection 50mg) in India. AmphoTLC™ is a critical drug to treat Mucormycosis

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