Glenmark Generics receives approval from USFDA for Mometasone Furoate Topical Solution USP, 0.1%

Date: 10 August 2010

Glenmark Generics receives approval from USFDA for Mometasone Furoate Topical Solution USP, 0.1% 

August 10, 2010: Glenmark Generics Inc., USA, the subsidiary of Glenmark Generics Limited, has been granted final approval from the United States Food and Drug Administration (U.S. FDA) for Mometasone Furoate Topical Solution USP, 0.1% and will immediately commence marketing and distribution of this product in the U.S. market.  

Mometasone Furoate is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Like other topical corticosteroids, Mometasone Furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. Total market sales for the Company’s Mometasone Furoate product line is approximately USD 25 million for the 12 month period ending June 2010 as reported by IMS Health. 

Today’s approval compliments Glenmark’s growing portfolio of semi-solid dosage products and enhances their established line of Mometasone Furoate which includes the cream and ointment preparations.  Glenmark has received nine final and two tentative approvals to date in their fiscal year 2011. The Company is currently authorized to distribute 61 products in the U.S. marketplace and has over 45 applications pending with the U.S. FDA. 

About Glenmark Generics limited.

Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark) and aims to be a global integrated Generic and API leader.  GGL has an established presence in North America, a developing EU presence and Argentina and maintains marketing front-ends in these countries. It primarily sells its FDF products in the United States ("US") and the European Union ("EU"), as well as its oncology FDF products in South America. The Company supplies APIs to customers in approximately 63 countries, including the US, various countries in the EU, South America and India.  

Disclaimer

“Glenmark Generics Limited (“Company”) is proposing, subject to market conditions and other considerations, a public issue of its equity shares and has filed a Draft Red Herring Prospectus with SEBI. The Draft Red Herring Prospectus is available on the website of SEBI at www.sebi.gov.in and the respective websites of the BRLMs at www.enam.com and www.kmcc.co.in.   Investors should note that investment in equity shares involves a high degree of risk and for details relating to the same, see the section titled “Risk Factors” of the aforementioned Draft Red Herring Prospectus.” 

This press release is not an offer of securities for sale in the United States or elsewhere.  The shares of Glenmark Generics Limited are not being registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), and may not be offered or sold in the United States unless registered under the Securities Act or pursuant to an exemption from such registration.  There will be no public offering of the shares in the United States. 

NOT FOR PUBLICATION OR DISTRIBUTION IN THE UNITED STATES, CANADA, JAPAN OR AUSTRALIA

Download PDF