JB Chemicals & Pharmaceuticals has received approval for its Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (US FDA) 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 commercialize this product in Q3 of this financial year and is expected to boost the Company's US sales.
JB Chemicals & Pharmaceuticals is engaged in manufacturing of pharmaceutical specialties in various dosage forms, herbal remedies, diagnostics, generic drugs, active pharmaceutical ingredients (APIs).
