Glenmark Generics Inc., USA (GGI), a subsidiary of Glenmark Generics, has received tentative approval from US FDA for pramipexole dihydrochloride tablets, the generic version of Boehringer Ingelheim’s Mirapex tablets and Atomoxetine hydrochloride capsules, the generic version of Lilly’s Strattera.
The tentative approval for pramipexole dihydrochloride tablets is for the 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg strengths. Pramipexole dihydrochloride tablets generated sales of USD 487 million for the 12 month period ending September 2009, according to IMS Health. Atomoxetine hydrochloride capsules is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) and generated USD 498 million in sales for the 12 month period ended September 2009, according to IMS Health.
Based on the tentative approval for pramipexole dihydrochloride tablets, Glenmark Generics should be able to launch the product in October 2010 or earlier in certain circumstances.
The significance of these tentative approvals exemplifies Glenmark’s rapid success over a relatively short period of time. The company has received ten final and five tentative approvals this calendar year and has well over 40 ANDAs pending approval with the US FDA.
Glenmark’s current marketing portfolio consists of 49 products authorized for distribution in the United States. The company remains focused on strategic planning and development and continues its aggressive filing schedule for new ANDA submissions.
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. It primarily sells its FDF products in the United States and the European Union EU, as well as its oncology FDF products in South America. The company supplies APIs to customers in approximately 65 countries, including the US, various countries in the EU, South America and India.