JB Chemicals gets USFDA approval for Tinidazole

22 Oct 2013 Evaluate

JB Chemicals & Pharmaceuticals (JBCPL) has received US Food and Drug Administration (USFDA) 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. The company would manufacture these formulations at its state-of-the-art manufacturing facility at Panoli in 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 USFDA. The company also plans to file more ANDAs to support its US business. 

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