Glenmark Generics Inc USA (GGI), a subsidiary of Glenmark Generics Limited (GGL), has received ANDA approval from the US FDA for lithium carbonate 150mg, 300mg and 600mg 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 one to three weeks.
According to IMS Health, lithium carbonate capsules had annual sales of $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 ANDAs filed with the US FDA
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, and operates in integrated generic and API segments. It 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 GGL laboratories in India and Latin America.
The company has a 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.