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
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.
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