J B Chemicals & Pharmaceuticals Ltd (JBCPL) has received United States Food & Drug Authority (US FDA) approval to its Abbreviated New Drug Application (ANDA) for cetirizine hydrochloride (anti-allergic) 5mg and 10 mg tablets. The company's these 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 has sales of about US$ 1.4 billion in USA prior to it became 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 US FDA.
The company is in the process of negotiations with its marketing partners in USA for launch of these products in USA, a JBCPL press release stated.
This approval has potential to further strengthen the company's rest of world business that has shown good growth in the last several years. During 2008-09, the company launched NSAID formulation is USA that met with good success.