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Glenmark gets US FDA nod to market lithium carbonate capsules

Glenmark gets US FDA nod to market lithium carbonate capsules
PTI
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First Published: Wed, Feb 04 2009. 06 24 PM IST
Updated: Wed, Feb 04 2009. 06 24 PM IST
Mumbai: Drug maker Glenmark Pharmaceuticals on Wednesday said it has received US regulatory approval for marketing Lithium Carbonate capsules, used in the treatment of bipolar disorder.
In a filing to the Bombay Stock Exchange, the company said that Glenmark Generics, a subsidiary of the company, has received US Food and Drug Administration (USFDA) approval and would immediately start marketing and distribution of Lithium Carbonate capsule in the US.
The capsule is available in the strength of 150 mg, 300 mg and 600 mg. It is used for treatment of bipolar disorder, wherein a person goes through one or more episodes of abnormally elevated mood clinically referred to as mania.
Glenmark’s current portfolio consists of 38 generic products authorised for distribution in the US market. The company currently has over 40 Abbreviated New Drug Application (ANDA)s filed with the USFDA pending approval.
Glenmark Generics is a subsidiary of Glenmark Pharmaceuticals and has established presence in North America, EU and Argentina and maintains front-ends in these countries, the filing added.
Shares of the Glenmark Pharmaceuticals settled at Rs121.15, down 7.55% on the BSE.
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First Published: Wed, Feb 04 2009. 06 24 PM IST
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