J B Chemicals & Pharmaceuticals Ltd announced on October 21, 2013, that it has received US FDA approval for its Abbreviated New Drug Application (ANDA) for tinidazole (for treatment of bacterial infection) 250 mg and 500 mg tablets. The company plans to launch this prescription product in Q4 this year.
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The company would manufacture these formulations at its state-of-the-art manufacturing facility at Panoli (Gujarat). The company’s US business has shown good growth in the last two years. The approval for tinidazole has potential to further strengthen this business. In addition, the company expects approval of few more ANDAs already filed with US FDA. The company also plans to file more ANDAs to support its US business.
ALSO READ: Anand Sharma seeks greater market access for Indian pharma products in Russia
The company would manufacture these formulations at its state-of-the-art manufacturing facility at Panoli (Gujarat). The company’s US business has shown good growth in the last two years. The approval for tinidazole has potential to further strengthen this business. In addition, the company expects approval of few more ANDAs already filed with US FDA. The company also plans to file more ANDAs to support its US business.