Glenmark Generics Inc. USA (GGI), a subsidiary of Glenmark Pharmaceuticals, has received approval from the US FDA for lithium carbonate 150 mg, 300 mg and 600 mg capsules and will immediately commence marketing and distribution of these products in the US market.

Lithium is indicated in the treatment of manic episodes of bipolar disorder. It is also indicated as a maintenance treatment for individuals with a diagnosis of bipolar disorder. Maintenance therapy reduces the frequency of manic episodes and diminishes the intensity of those episodes which may occur. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, elation, poor judgment, aggressiveness, and possibly hostility. When given to a patient experiencing a manic episode, lithium may produce a normalization of symptomatology within 1 to 3 weeks.

According to IMS Health, lithium carbonate capsules had annual sales of US$ 10 million for the period ending September 2008.

Glenmark's current portfolio consists of 38 generic products authorized for distribution in the US market. The company currently has over 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.