Unichem Laboratories receives USFDA approval for Montelukast Sodium Tablets

Unichem Laboratories has received ANDA approval from the United States Food and Drug Administration (USFDA) for Montelukast Sodium Tablets. Montelukast Sodium Tablets 10mg are therapeutically equivalent to Singulair Tablets 10mg of Merck Sharp & Dohme Corp.

Montelukast is a leukotriene receptor antagonist (LTRA). The product will be commercialized from Unichem’s Goa plant. The company now has total of 19 ANDA approvals (Including 3 Tentative Approvals) from USFDA.

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.