JB Chemicals receives USFDA approval for Cetirizine

JB Chemicals & Pharmaceuticals (JBCPL) has received USFDA approval for its Abbreviated New Drug Application (ANDA) for Cetirizine 5 mg and 10 mg tablets. The company’s formulations have been found to be bioequivalent to the innovator McNeil Consumer Healthcare’s product Zyrtech.

Cetirizine tablets are now sold over-the counter (OTC) in USA. It had sales of about $1.4 billion in USA prior to it becoming an OTC product.

The company would manufacture these formulations at its state-of-the-art manufacturing facility at Panoli (Gujarat), which has already been classified as acceptable and GMP compliant by USFDA.

JB Chemicals is in the process of negotiations with its marketing partners in the US for launching these products.

This approval has potential to further strengthen the company’s rest of the world (RoW) business that has shown good growth in the last several years. During 2008-09, the company launched NSAID formulations in USA that met with good success.

JBCPL manufactures and markets a diverse range of pharmaceutical formulations, herbal remedies and APIs. It has strong presence in Russia, Ukraine, CIS countries and South Africa.