Unichem Lab gains on ANDA approval for antihistamine tablet

Mumbai-based pharmaceutical products manufacturer, Unichem Laboratories made a public announcement that it received tentative ANDA approval from USFDA, on Tuesday.

Unichem Labs informed that USFDA gave tentative ANDA approval for its Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride tablets USP, 5 mg/120 mg (OTC) to market a generic version of Johnson and Johnson Consumer's Zyrtec-D 12 Hour (Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride, 5mg/120 mg) extended tablets. The medicinal indication is given for antihistamine and nasal decongestant. Further, the company informed that it will commercialise the products from its Goa plant, for which final approval is still pending.

Abbreviated New Drug Approval (ANDA) is an application for a US generic drug approval for an existing licensed approved drug. Once approved, the company may manufacture and market generic drug products.

Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. It is engaged in the manufacturing and marketing of pharmaceutical formulations as branded generics as well as generics in several markets across the world.

At 2.10 pm, the stock traded with flat gains of 0.15 per cent at Rs. 186.35 per share on BSE.