Aurobindo Pharma has received final approval from US Food and drug administration to manufacture and market Flucytosine capsules, 250mg and 500mg.
Aurobindo now has a total of 429 ANDA approvals (401 Final approvals including 23 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA.
The approved product has an estimated market size of $ 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 third ANDA to be approved out of APL Healthcare formulation facility in Hyderabad, India used for manufacturing oral products.
About Aurobindo Pharma:
Founded in 1986 by Mr. P. V. Ramprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born of a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry.
A fully integrated pharma company, Aurobindo Pharma features among the top 2 companies in India in terms of consolidated revenues. Aurobindo exports to over 150 countries across the globe with more than 90% of its revenues derived from international operations.
Aurobindo Pharma became a public company in 1992 and listed its shares on the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillins, it has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and anti-biotics, among others.
The Centre is capable of developing, scaling up and commercializing various dosage forms spread across tablets, capsules, soft gels, oral liquids, injectables (solutions, suspensions, lyophilized, etc.), and ophthalmic (three piece and BFS) and nasal delivery systems.The focus is to develop products for the US and EU followed by other international markets, including specialized markets like Japan.