Aurobindo Pharma gets USFDA nod for Flucytosine Capsules

Hyderabad: Aurobindo Pharma Limited has announced that the Company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Flucytosine Capsules, 250 mg and 500 mg.

Flucytosine Capsules are a generic version of Bausch Health's Ancobon® Capsules. The product will be launched in June 2020.

The approved product has an estimated market size of US$ 43 million for the twelve months ending March 2020, according to IQVIA. Flucytosine Capsules are indicated for the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus

This is the 3 rd ANDA to be approved out of APL Healthcare formulation facility in Hyderabad, India used for manufacturing oral products. Aurobindo now has a total of 429 ANDA approvals (401 Final approvals including 23 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.

Aurobindo Pharma Limited is a pharmaceutical manufacturing company headquartered in Hyderabad, India. The company manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company's area of activity includes six major therapeutic/product areas: antibiotics, anti-retrovirals, cardiovascular products, central nervous system products, gastroenterological, and anti-allergics.

The company markets these products in over 150 countries. 

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