JB Chemicals receive USFDA nod for Carbamazepine tablets

JB Chemicals & Pharmaceuticals Limited has received an approval from USFDA for its abbreviated new drug application (ANDA) for Carbamazepine extended-release tablets USP 100 mg, 200 mg and 400 mg.

The drug is used for the treatment of epilepsy and trigeminal neuralgia. Epilepsy is a group of neurological disorders characterized by recurrent epileptic seizures. Epileptic seizures are episodes that can vary from brief and nearly undetectable periods to long periods of vigorous shaking. Meanwhile, Trigeminal neuralgia is a long-term pain disorder that affects trigeminal nerve thereby, resulting in the episodes of severe, sudden, shock-like pain in one side of the face that may lasts for a few seconds to minutes. Whereas, atypical form results in a constant burning pain that is comparatively less severe.

The product is a generic version of Tegretol XR tablet in the same strength of Novartis Pharmaceuticals Corp. According to IQVIA data, US sales were approximately USD 128 million.

JB Chemicals & Pharmaceuticals manufacture & market a range of pharmaceutical formulations, herbal remedies and active pharmaceutical ingredient (APIs). The company's business segments include domestic formulation business, exports and API business.

On Monday, the stock of JB Chemicals surged 1.9 per cent to Rs 562.95 from its previous close of Rs 552.65 on BSE.