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Alembic Pharmaceuticals | Udaipur Kiran

Alembic Pharmaceuticals | Udaipur Kiran
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Alembic Pharmaceuticals receives USFDA Final Approval for Fulvestrant Injection

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.

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- BusinessToday

According to the USFDA, the company's US-based unit is recalling the affected lot due to "Failed Impurities/Degradation Specifications".

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Zydus Cadila gets USFDA nod for breast cancer treatment drug

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 Friday said it has received final approval from the US health regulator to market Fulvestrant Injection, used in the treatment of breast cancer.

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Zydus Cadila gets US drug regulator s nod to market Fulvestrant Injection for breast cancer treatment

Zydus Cadila gets US drug regulator s nod to market Fulvestrant Injection for breast cancer treatment
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