Unichem Laboratories receives ANDA approval for Montelukast Chewable Tablets, 4 mg and 5 mg from USFDA
Myequity news service | Date : 04-07-2018 14:30:00 IST
Unichem Laboratories Limited, announced that it has received final ANDA appioval for its Montelukast Chewable Tablets, 4 mg and 5 mg from the United States Food and Drug. Administration (USFDA) to market a generic version of Merclc Sharp & Dohme Ccrporation's Singulair Tablets,4 mg and 5 mg.
Unichem's Montelukast Chewable Tablets, 4 mg and 5 mg are the AB rated generic equivalent of Merck sharp & Dohme Corporation's Singulair Tablets, 4 mg and 5 mg. They are indicated for:
• the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older.
• the prevention of exercise-induced broncho construction in patients 15 years of age and older and the relief of symptoms of allergic rhinitis (seasonal allergic rhinitis in adults and pediatric patients 2 years of age and older, and perennial allergic rhinitis and pediatric patients 6 months of age and older).
The Product will be commercialized from Unichem's Goa Plant.About Unichem Laboratories Limited:
Unichem Laboratories Limited 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 several markets across the world. In India, The company has strong skills in product development, process chemistry and manufacturing complex API as well as dosage forms.
Unichem Laboratories Limited closed 2.55% up at Rs 242.95