BRIDGEWATER, N.J., Dec. 3, 2015 /PRNewswire/ -- Ajanta Pharma USA Inc., a subsidiary of Ajanta Pharma Limited, India, announced today the launch of Montelukast Sodium IR Tablets (10mg) and Montelukast Sodium Chewable Tablets (4mg & 5mg), generic versions of SINGULAIR® Tablets and SINGULAIR® Chewable Tablets, respectively. The United States Food & Drug Administration (US FDA) approval extends the breadth of the Montelukast offerings from Ajanta Pharma into three dosage forms (Immediate-Release Tablets, Chewable Tablets, and Oral Granules).
Montelukast IR Tablets and Chewable Tablets are part of an ever-growing portfolio that Ajanta Pharma has developed for the US market. To date, the US FDA has granted Ajanta Pharma five ANDA final approvals and two ANDA tentative approvals. An additional 19 ANDAs are pending approval from the US FDA.
About Ajanta Pharma
Ajanta Pharma Limited is a fully-integrated pharmaceutical company with global headquarters in Mumbai, India. Over 6,000 employees are engaged in developing, manufacturing and marketing of quality finished dosages across 35 countries. Its mission is to serve global healthcare needs through empathy, innovation and technology.
For more details about Ajanta Pharma USA Inc., please visit us at www.ajantapharmausa.com.
SINGULAIR® is a registered trademark of Merck & Co., Inc.
SOURCE Ajanta Pharma USA Inc.