JB Chemicals & Pharmaceuticals Ltd has received final approval from the Office of Generic Drugs, Food and Drug Administration (US FDA), to manufacture and market Fluconazole tablets in the US market. JB is the third Indian company to receive such approval for this product.

Fluconazole (Antifungal) is indicated for the treatment of vaginal candidiasis, Oropharyngeal and Oesophageal candidiasis, Cryptococcal meningitis, Prophylactic treatment of patients with bone marrow transplantation to decrease incidences of candidiasis. The total market size of Fluconazole tablets in the USA is about US $ 610 million.

The company already has US FDA approval to manufacture and market ciprofloxacin tablets 250 mg, 500 mg, 750 mg in the US market. The company plans to file more ANDAs in the years to come, according to a company release.