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.
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