Ajanta Pharma’s subsidiary -- Ajanta Pharma USA, has launched 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 the company 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 the company has developed for the US market. To date, the US FDA has granted the company’s five ANDA final approvals and two ANDA tentative approvals. An additional 19 ANDAs are pending approval from the US FDA.
Ajanta Pharma 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.
