Aurobindo Pharma added 5.01% to Rs 657.30 after the company said it received final approval from the US drug regulator to manufacture and market Flucytosine capsules in 250 mg and 500 mg strengths.
Flucytosine capsules are generic version of Bausch Health's Ancobon capsules. The product will be launched in June 2020. The announcement was made during trading hours today, 4 May 2020.
As per IQVIA figures, the approved product has an estimated market size of $43 million for twelve months ending March 2020. 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. Aurobindo now has a total of 429 ANDA approvals (401 Final approvals including 23 from Aurolife Pharma LLC and 28 tentative approvals) from the USFDA.
Aurobindo Pharma on 20 April 2020, the US drug regulator had classified the company's Unit IV of Hyderabad plant as VAI (voluntary action indicated).
On a consolidated basis, the drug maker's net profit declined 0.95% to Rs 705.45 crore on a 12.06% rise in net sales to Rs 5,799.44 crore in Q3 December 2019 over Q3 December 2018.
Aurobindo Pharma is engaged in producing oral and injectable generic formulations and active pharmaceutical ingredients (APIs). Its product portfolio is spread over seven therapeutic/product areas, including antibiotics, anti-retrovirals, cardiovascular, central nervous system, gastroenterologicals, anti-allergies and anti-diabetics.
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