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Alembic Pharmaceuticals Ltd has received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application, Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per SingleDose Prefilled Syringe.
According to the USFDA, the company's US-based unit is recalling the affected lot due to "Failed Impurities/Degradation Specifications".
Zydus Cadila gets USFDA nod for breast cancer treatment drug SECTIONS Last Updated: Jul 30, 2021, 01:07 PM IST Share Synopsis Fulvestrant injection is used alone or in combination with other drugs to treat a certain type of hormone receptor positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) or breast cancer that has spread to other parts of the body in women who have experienced menopause. AP Zydus Cadila said the drug will be manufactured at the group's formulation manufacturing facility at Zydus Biologics, Ahmedabad. Drug firm Zydus Cadila on ...
Sino Biopharmaceutical 2021 First Quarterly Profit attributable to Owners of the Parent Soars 118.5% to RMB1.91 Billion Contribution of Sales of New Products to Revenue Rises to 47.4% Driving Revenue Up by 16.4% HONG KONG, May 24, 2021 - (ACN Newswire) - Sino Biopharmaceutical Limited ("Sino Biopharmaceutical" or the "Company", together with its subsidiaries, the "Group") (HKEX:1177), a leading and innovation-driven pharmaceutical conglomerate in the PRC, has announced its unaudited first quarterly results for the three months ended 31 March 2021. Development Highlights -- Chia Tai - Tianqin...