Glenmark dermatology line expands with recent U.S. FDA approval

Date: 25 September 2008

Mumbai, September 25, 2008: Glenmark Generics Limited’s (GGL) US subsidiary has received ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Betamethasone Dipropionate Cream, 0.05% (Augmented) and will soon commence marketing and distribution of this product in the U.S. market. 

Betamethasone Dipropionate is a high-potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses and is the generic therapeutic equivalent of Diprolene AF® cream marketed by Schering.  

This is the eighth steroidal dermatological product in the Company’s marketed product portfolio targeting an overall segment value of USD 60 million. This recent approval aligns with Glenmark’s strategy to continue strengthening its presence in this niche segment. Two ANDA approvals from the Company’s semi-solid pipeline were received in the last quarter - Mometasone Furoate Cream 0.1% and Mometasone Furoate Ointment 0.1%. These products will be manufactured at Glenmark’s U.S. FDA approved state of the art semi-solid facility located in Baddi, India. GGL had earlier licensed the US marketing rights for a line of Clobetasol Propionate dermatology products that include - Cream, Emulsified Cream, Ointment, Gel and Topical Solution through a US based pharmaceutical development company. 

Glenmark’s current portfolio consists of 34 products, translating to 126 SKUs, authorized for distribution in the U.S. marketplace.  The Company has over 35 ANDA’s pending approval with the U.S. FDA of which 20 % fall within the dermatology segment. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio.

About Glenmark Generics Ltd. (GGL) 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, EU and Argentina and maintains marketing front-ends in these countries. GGL has a strong base in Formulations development with teams operating out of laboratories in India and Latin America. The Company has a state-of-the-art manufacturing plant at Goa, India that is approved by US FDA, TPD (Canada), MHRA, UK and many other overseas regulatory authorities. GGL also markets over 45 APIs to more than 80 countries across the world and had over 30 USDMFs filed and/or approved along with several Canadian DMFs, EDMFs and CEPs/CoSs. GGL generated USD 196 Mn in Net Sales in FY08.  [www.glenmark-generics.com] 

About Glenmark Pharmaceuticals Ltd:Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. Its shares are listed on India’s two large stock exchanges, the Bombay Stock Exchange (BSE) and the National Stock Exchange (NSE). It employs over 5000 people across its global operations over 85 countries. The Company is a leader in India in the discovery of new molecules and is focused in the areas of inflammation [Asthma/COPD, etc.], and metabolic disorders [Diabetes, Obesity, etc.]. The Company is in the process of creating marketing front-ends for the launch of its proprietary products in the future. Glenmark’s first Asthma/COPD molecule, Oglemilast [GRC 3886], was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively, in two landmark deals. Oglemilast is presently undergoing Phase II clinical trials in the US. GRC 6211, undergoing Phase II clinical trials in Europe, has been out-licensed to Eli Lilly & company. For more information on GPL, log on to www.glenmarkpharma.com 

*** For further information, please contact: Jason D’Souza | Medha Satam

Glenmark, Mumbai, India Tel: [+91 22] 40189919 / 40189993 Email :  connect@glenmark-generics.com                  

This document is not an offer of securities for sale in the United States or elsewhere. The shares of the Company and its subsidiaries and affiliates are not being registered under 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 shares in the United States.

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