Zydus Lifesciences bags USFDA okay for Fungal infection treatment
Ahmedabad: Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Micafungin for Injection, 50 mg/vial, and 100 mg/vial, single-dose vials (USRLD: Mycamine).
Micafungin for Injection is indicated to treat variety of fungal infections. It is also used to prevent fungal infections in patients who are having a stem cell transplant. Fungal infection is a disease caused by fungi. It is also known as mycosis.
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The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India.
Micafungin for Injection had annual sales of USD 99 mn in the United States, according to IQVIA data (IQVIA MAT Aug 2022). The group now has 329 approvals and has so far filed over 428* ANDAs since the commencement of the filing process in FY 2003-04.
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Zydus group is headquartered in Ahmedabad, India. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim in India and in the US and Brazil.
Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain), and in the high-profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.
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