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J B Chemicals gets USFDA approval for Carbamazepine ER Tablets

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The product is a generic version of Tegretol XR tablet in the same strength of Novartis Pharma

US FDA has approved J.B Chemicals’ Abbreviated New Drug Application (ANDA) for Carbamazepine Extended-Release Tablets USP 100 mg, 200 mg and 400 mg. (for treatment of Epilepsy and Trigeminal Neuralgia).

The product is a generic version of Tegretol XR tablet in the same strength of Novartis Pharmaceuticals Corp.

According to IQVIA, US sales were approximately USD 128 million. The Company plans to commercialise this product in Q3 of this financial year and is expected to boost the Company’s US sales.

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