Aurobindo Pharma rose 2.40% to Rs 786.10 at 13:34 IST on BSE after the company said it received US drug regulator's approval for Esomeprazole Magnesium delayed-release capsules.
The announcement was made during trading hours today, 22 April 2016.
Meanwhile, the BSE Sensex was down 8.19 points, or 0.03%, to 25,872.19 .
On BSE, so far 1.28 lakh shares were traded in the counter, compared with an average volume of 2.46 lakh shares in the past one quarter. The stock hit a high of Rs 789 and a low of Rs 759 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 582 on 25 February 2016. The stock had outperformed the market over the past one month till 21 April 2016, rising 3.32% compared with 2.35% rise in the Sensex. The scrip had, however, underperformed the market in past one quarter, falling 1.08% as against Sensex's 8% rise.
The large-cap company has an equity capital of Rs 58.52 crore. Face value per share is Re 1.
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Aurobindo Pharma is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Esomeprazole Magnesium delayed-release capsules USP, 20 milligram (mg) and 40 mg, used in the treatment of gastroesophageal reflux disease.
The launch of this product is based on the settlement terms/litigation outcome with AstraZeneca. The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Nexium delayed-release capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP.
The approved product has an estimated market size of $4.2 billion in the US market for the twelve months ended February 2016 according to IMS.
This is the 70th 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 253 ANDA approvals (217 Final approvals including 10 from Aurolife Pharma LLC and 36 tentative approvals) from USFDA.
Aurobindo Pharma's consolidated net profit rose 39.2% to Rs 534.95 crore on 9.2% growth in net sales to Rs 3432.08 crore in Q3 December 2015 over Q3 December 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 7 major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, Anti-Allergies and Anti-Diabetics, supported by an outstanding R&D set-up. The company is marketing these products globally, in over 150 countries.
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