MUMBAI, India -- Ajanta Pharma gets approvals for 3 ANDA’s
(Montelukast Tablets, Chewable Tablets and Oral Granules)
Mumbai – (August 4, 2015) – Ajanta Pharma Limited, a specialty focused pharmaceutical formulation company, has received final approval for its 3 ANDAs (Abbreviated New Drug Application) by US FDA (United States Food and Drug Administration)
1. Montelukast Tablets, 10mg
2. Montelukast sodium chewable tablets, 4mg & 5mg and
3. Montelukast oral granules
Montelukast Sodium Tablets, 10 mg, the generic version of Singulair® tablets by Merck, is indicated for treatment of prophylaxis and chronic treatment of asthma and to relieve symptoms of seasonal and perennial allergic rhinitis in patients two years of age and older.
Montelukast 4mg chewable tablets are suitable for 2 to 5 year old patients while Montelukast 5mg chewable tablets are available for patients from 6 to 14 years of age. Montelukast oral granules are specially appropriate for patients of 12 months of age and older.
For the 12 months ending June 2015, Montelukast Tablets, Chewable Tablets and Granules had sales of approximately $237 million, $87 million and $31 million respectively, according to IMS Health*. Ajanta intends to launch these products shortly.
The approval of the Montelukast product family is part of an ever-growing portfolio that Ajanta Pharma has developed for the US market. Including these 3 ANDA approvals, Ajanta now has 5 approved ANDAs and another 20 ANDAs under approval with FDA.
About Ajanta Pharma Limited
Ajanta Pharma is an established pharmaceutical formulation company with clear focus on fast growing therapeutic segments of Cardiology, Ophthalmology, Dermatology, & Pain Management in the Indian market and is among the fastest growing in the country. Many of company’s products are first in the market place and are leading in their sub therapeutic segments. In the Emerging Markets company has presence in more than 35 countries across Africa, Philippines, Rest of Asia, Middle East, CIS and Latin America. For each of these markets company has customised product basket with wider therapeutics presence. The company has a portfolio of ANDAs for the regulated markets of USA and has recently entered this market with its maiden product. Company’s state of the art R&D centre for formulation development is located at Mumbai, having a team of 400+ people. Company has world class manufacturing facilities - 5 located in India and 1 at Mauritius. One of the manufacturing facilities in India is approved by US FDA, UK MHRA, pre-qualification from WHO, apart from having approval from FDAs of many other countries. The Recently completed new formulation manufacturing facility (oral solids) at Dahej is undergoing qualification and will be dedicated for Regulated Markets.
For more details on the company please visit our website www.ajantapharma.com .
*IMS Health, National Sales Perspectives, June 2015
SINGULAIR® is a registered trademark of Merck & Co., Inc.
