Zydus Lifesciences’ arm gets USFDA’s final approval for Efinaconazole Topical Solution

18 Jul 2022 Evaluate

Zydus Lifesciences’ subsidiary -- Zydus Worldwide DMCC has received final approval from the United States Food and Drug Administration (USFDA) to market Efinaconazole Topical Solution, 10%. (US RLD: Jublia).

Efinaconazole is an azole antifungal used for the topical treatment of Onychomycosis of the toenails due to Trichophyton rubrum and Trichophyton mentagrophytes. The drug will be manufactured at the group’s topical manufacturing facility at, Ahmedabad, India. Jublia (Efinaconazole) topical solution, 10% had annual sales of $292 million in the United States according to IQVIA data (IQVIA MAT May 2022). The group now has 317 approvals and has so far filed over 420 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as 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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