Zydus Cadila gets nod from USFDA for Doxorubicin Hydrochloride Liposome Injection

11 Sep 2020 Evaluate

Zydus Cadila has received final approval from the USFDA to market Doxorubicin Hydrochloride Liposome Injection (US RLD: Doxil Liposome Injection) in the strengths of 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials. This is the group’s first approval for a complex injectable which has been developed in-house and will be manufactured at group’s facility located in SEZ. The Company’s injectable portfolio has 39 products under development with an addressable market size of $20bn. U.S. sales for Liposomal Doxorubicin Injection were approximately $124 million for the 12 months ending July 2020, according to IQVIA.

Cadila Healthcare is an India-based pharmaceutical company. The company's subsidiaries include Zydus Wellness, Liva Pharmaceuticals, Biochem Pharmaceutical Industries, Zydus Technologies, German Remedies, Dialforhealth India, Dialforhealth Unity and Dialforhealth Greencross, among others.

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