Indoco Remedies received final approval of its abbreviated new drug application (ANDA) for Febuxostat tablets 40 mg and 80 mg, which is therapeutically equivalent to Uloric tablets of Takeda Pharmaceuticals U.S.A., Inc.
The market size of Febuxostat tablets in USA is over $500 million.
Febuxostat is used for the treatment of gout caused by excessive levels of uric acid in the blood (Hyperuricemia). Febuxostat prevents the production of uric acid by blocking the activity of the enzyme (xanthine oxidase) that converts purines to uric acid. Uric acid forms crystals in joints and tissues, causing inflammation and pain. Hyperuricemia can cause kidney disease and kidney stones as well. The announcement was made during market hours today.
On a consolidated basis, Indoco Remedies reported net profit of Rs 7.81 crore in Q2 September 2019 compared with net loss of Rs 7.45 crore in Q2 September 2018. Net sales rose 21.1% to Rs 286.21 crore in Q2 September 2019 from Rs 236.26 crore in Q2 September 2018.
Indoco Remedies is a fully integrated, research-oriented pharma company with presence in 55 countries. The company has 9 manufacturing facilities, 6 of which are for FDFs and 3 for API.