Aurobindo Pharma rose 0.32% to Rs 769 at 11:16 IST on BSE after the company said it received US drug regulator's approval for Isosulfan Blue injections.
The announcement was made during trading hours today, 3 February 2016.Meanwhile, the BSE Sensex was down 278.82 points, or 1.14%, to 24,260.18.
On BSE, so far 80,000 shares were traded in the counter, compared with an average volume of 1.14 lakh shares in the past one quarter. The stock hit a high of Rs 774.45 and a low of Rs 751.60 so far during the day. The stock hit a record high of Rs 891.50 on 30 December 2015. The stock hit a 52-week low of Rs 490.50 on 26 February 2015. The stock had underperformed the market over the past one month till 2 February 2016, sliding 13.12% compared with 6.20% decline in the Sensex. The scrip had also underperformed the market in past one quarter, falling 9.44% as against Sensex's 7.61% fall.
The large-cap company has an equity capital of Rs 58.48 crore. Face value per share is Re 1.
Aurobindo Pharma announced that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Isosulfan Blue injection, 1% (50 mg/5 ml) single-dose vials in the US market. The product is expected to be launched in Q4 March 2016. The approved abbreviated new drug application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Lymphazurin Injection, 1%, of Covidien.
Isosulfan Blue injection, under cardio vascular therapeutic group, is used in a lymphography procedure. Isosulfan Blue Injection upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. The approved product has an estimated market size of $57 million for the twelve months ending December 2015 according to IMS.
This is the 24th ANDA (including two tentative approvals) to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing general injectable products. Aurobindo now has a total of 237 ANDA approvals (205 final approvals including 10 from Aurolife Pharma LLC and 32 tentative approvals) from USFDA.
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Aurobindo Pharma's consolidated net profit rose 21.4% to Rs 451.76 crore on 14.6% rise in net sales to Rs 3280.11 crore in Q2 September 2015 over Q2 September 2014.
Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company's manufacturing facilities are approved by several leading regulatory agencies like US FDA, UK MHRA, Japan PMDA, WHO, Health Canada, MCC South Africa, ANVISA Brazil. The company's robust product portfolio is spread over 6 major therapeutic/product areas encompassing antibiotics, anti-retrovirals, cvs, cns, gastroenterologicals, and anti-allergies, supported by an outstanding research and development (R&D) set-up. The company is marketing these products globally, in over 150 countries.
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