Glenmark Generics Inc., USA (GGI), the United States subsidiary of Glenmark Generics Limited (GGL), announced they have been granted final approval for their Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration (US FDA) for levocetirizine dihydrochloride 5 mg tablets, the generic version of UCB Inc.’s Xyzal tablets.
Glenmark’s levocetirizine dihydrochloride tablets are currently available and shipping will commence immediately from the company’s New Jersey facility. Total US sales as reported by IMS Health for the 12 month period ending December 2010 were approximately USD 231 million. Levocetirizine Dihydrochloride is an antihistamine indicated for the relief of symptoms associated with allergic rhinitis.
The company’s current portfolio consists of 69 generic products authorized for distribution in the US market and approximately 40 ANDA’s filed with the US FDA pending approval. 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.
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.