The US Food and Drug Administration (USFDA) has given its final approval to Glenmark Generics Inc. USA (GGI), the US arm of Glenmark Generics Limited (GGL), to market lithium carbonate capsules in variable strengths.

GGI will market the capsules in dosages of 150 mg, 300 mg and 600 mg.

Lithium is used for treating patients suffering from manic episodes of Bipolar Disorder. Bipolar Disorder, Manic (DSM-III) is equivalent to Manic Depressive illness, Manic, in the older DSM-II terminology.

Lithium 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.

Total annual market for these capusules stood at $10 million for the period ending September 2008.

Presently, Glenmark markets 38 generic products in the US market. The company currently has over 40 Abbreviated New Drug Application (ANDA)s filed with the USFDA pending approval.
 
Glenmark Generics Limited (GGL) is a division of Glenmark Pharmaceuticals Limited (GPL) that aims to be a global integrated generic and API leader. GGL has established its strong presence in North America, EU and Argentina and maintains marketing front-ends in these countries.

The Company also has a high-tech manufacturing plant at Goa, India that is sanctioned by US FDA, TPD (Canada), MHRA, UK and many other overseas regulatory authorities.