Aurobindo Pharma rose 1.69% to Rs 826.65 at 12:33 IST on BSE after receiving final approval from the US Food & Drug Administration to manufacture and market Tramadol Hydrochloride Extended-release Tablets USP, 100 mg, 200 mg and 300 mg.
The company made the announcement during market hours today, 23 October 2015.
Meanwhile, the S&P BSE Sensex was up 225.17 points or 0.83% at 27,512.83.
On BSE, so far 61,615 shares were traded in the counter as against average daily volume of 1.85 lakh shares in the past one quarter.
The stock hit a high of Rs 828.95 and a low of Rs 816 so far during the day. The stock had hit a record high of Rs 832.50 on 20 August 2015. The stock had hit a 52-week low of Rs 467.50 on 21 October 2014.
The stock had outperformed the market over the past one month till 21 October 2015, rising 14.2% compared with 4.18% rise in the Sensex. The scrip had also outperformed the market in past one quarter, gaining 8.63% as against Sensex's 3.17% decline.
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The large-cap company has equity capital of Rs 58.40 crore. Face value per share is Rs 1.
Aurobindo Pharma said that Tramadol Hydrochloride Extended-release Tablets USP, 100 mg, 200 mg and 300 mg will be launched in the US by Q4 March 2016. The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) ULTRAM ER (Tramadol Hydrochloride) Extended-Release Tablets 100 mg, 200 mg and 300 mg of Valeant INTL.
Tramadol Hydrochloride Extended-release Tablets are used in the treatment of moderate-to-severe pain in adults who require around-the-clock treatment for an extended period of time. The approved product has an estimated market size of $56 million in the US, for the twelve months ending August 2015 according to IMS.
This is the 50th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 217 ANDA approvals (189 Final approvals including 10 from Aurolife Pharma LLC and 28 Tentative approvals) from USFDA.
Aurobindo Pharma's consolidated net profit rose 4.1% to Rs 432.44 crore on 12.8% growth in net sales to Rs 3263.72 crore in Q1 June 2015 over Q1 June 2014.
Aurobindo Pharma, headquartered at Hyderabad, manufactures generic pharmaceuticals and active pharmaceutical ingredients (APIs).
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