Aurobindo Pharma receives USFDA Approval for Flucytosine Capsules

Mohan | Myequity news | Date : 04-05-2020 12:30:00 IST

Aurobindo Pharma Limited is pleased to announce 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 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 forthe 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.


About Aurobindo Pharma Limited

Aurobindo Pharma Limited (www.aurobindo.com) (NSE: AUROPHARMA, BSE: 524804, Reuters: ARBN.NS, Bloomberg: ARBP:IN), headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. The Company’s manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. The Company’s robust product portfolio is spread over major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, Anti-Allergies and AntiDiabetics, supported by an outstanding R&D set-up. The Company is marketing these products globally, in over 150 countries.


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