Unichem Labs gets USFDA nod for Montelukast Sodium tablets
Source: IRIS | 09 Oct, 2015, 02.56PM
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Rating: NAN / 5 stars. |
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Unichem Laboratories, a leading pharmaceutical company in India, today announced that it has received ANDA approval from the United States Food and Drug Administration (USFDA) for Montelukast Sodium tablets. The drug is used as a leukotriene receptor antagonist indicated for Prophylaxis and chronic treatment of asthama in adults and adolescents patients.
Montelukast Sodium tablets 10mg are therapeutically equivalent to Singulair tablets 10mg of Merck Sharp & Dohme Corp.
The product will be commercialized from Unichem's Goa plant.
Unichem Laboratories now has total of 19 ANDA approvals including three tentative approvals from USFDA. Shares of the company declined Rs 3.50, or 1.14%, to trade at Rs 310.805 at the BSE (2.55 p.m., Friday).
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