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Aurobindo Pharma spurts on receiving USFDA Approval for Lacosamide Tablets

02 May 2016 Evaluate

Aurobindo Pharma is currently trading at Rs 769.45, up by 8.50 points or 1.12% from its previous closing of Rs 760.95 on the BSE.

The scrip opened at Rs. 770.25 and has touched a high and low of Rs. 770.25 and Rs. 761.00 respectively. So far 22680 shares were traded on the counter.

The BSE group 'A' stock of face value Rs. 1 has touched a 52 week high of Rs. 891.50 on 30-Dec-2015 and a 52 week low of Rs. 582.00 on 25-Feb-2016.

Last one week high and low of the scrip stood at Rs. 786.00 and Rs. 756.00 respectively. The current market cap of the company is Rs. 44859.10 crore.

The promoters holding in the company stood at 53.79% while Institutions and Non-Institutions held 34.67% and 11.54% respectively.

Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg. Aurobindo was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification, therefore, Aurobindo is eligible for 180 days of generic drug shared exclusivity. The launch of this product will be based on the outcome of the litigation in the United States Court with UCB.

The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Vimpat Tablets, 50 mg, 100 mg, 150 mg and 200 mg of UCB, Inc. Lacosamide Tablets is indicated for adjunctive therapy in the treatment of partial-onset seizures. The approved product has an estimated market size of $ 782 million for the twelve months ending February 2016 according to IMS.

This is the 73rd ANDA (including 15 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 257 ANDA approvals (221 Final approvals including 11 from Aurolife Pharma LLC and 36 tentative approvals) from USFDA.

Aurobindo Pharma Share Price

1488.50 9.95 (0.67%)
08-May-2026 16:59 View Price Chart
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