Unichem laboratories shines on getting US FDA approval for Memantine Hydrochloride Tablets

29 Oct 2012 Evaluate

Unichem laboratories is currently trading at Rs. 185.60 up by 0.05 points or 0.03% from its previous closing of Rs. 185.55 on the NSE.

The scrip opened at Rs. 187.95 and has touched a high and low of Rs. 187.95 and Rs. 184.50 respectively. So far 6,018 shares were traded on the counter.

The NSE stock of face value Rs. 2 has touched a 52 week high of Rs. 203.40 on 25-Sep-2012 and a 52 week low of Rs. 100.35 on 13-Dec-2011.

The promoters holding in the company stood at 49.53% while Institutions and Non-Institutions held 13.95% and 36.52% respectively.

Unichem laboratories has received ANDA tentative approval from the United States Food and Drug Administration (US FDA) for Memantine Hydrochloride Tablets. Final approval for the roduct will be received by the company after the patent expires on April 11, 2015. 

Memantine Hydrochloride Tablets 5mg and 10mg are therapeutically equivalent to NAMENDA Tablets 5mg and 10mg of Forest Laboratories Inc. Memantine Hydrochloride is used to treat moderate to severe dementia of the Alzheimer's type. Further, it reduces the actions of chemicals in the brain that may contribute to the symptoms of Alzheimer's disease.

The product will be commercialized from Unichem’s GOA plant. Active pharmaceutical ingredient i.e. Memantine Hydrochloride used for this ANDA is also made in house at Pithampur plant

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