Unichem Laboratories has received tentative ANDA approval from the United States Food and Drug Administration (USFDA) for Unichem's Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets USP, 5 mg/120 mg (OTC) to market a generic version of Johnson and Johnson Consumer Inc's Zyrtec-D 12 Hour (Cetirizine Hydrochloride/Pseudoephedrine Hydrochloride, 5mg/120 mg) Extended Tablets.
The product will be commercialized from Unichem’s Goa Plant on receipt of final approval.
Unichem Laboratories is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world.
