Aurobindo Pharma gained 0.8% to Rs 771.60 at 12:10 IST on BSE after the company received final approval from the USFDA to manufacture and market Amlodipine and Valsartan Tablets USP, 5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg and 10 mg/320 mg.
The announcement was made during market hours today, 26 April 2016.Meanwhile, the BSE Sensex was up 11.72 points, or 0.05%, to 25,690.65.
On BSE, so far 34,194 shares were traded in the counter, compared with an average volume of 2.47 lakh shares in the past one quarter. The stock hit a high of Rs 778 and a low of Rs 758.95 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 25 April 2016, gaining 1.63% compared with 1.35% rise in the Sensex. The scrip had, however, underperformed the market in past one quarter, dropping 6.43% as against Sensex's 4.87% rise.
The large-cap company has an equity capital of Rs 58.52 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 Amlodipine and Valsartan Tablets USP, 5 mg/160 mg, 10 mg/160 mg, 5 mg/320 mg and 10 mg/320 mg. This product is expected to be launched in Q1 June 2016.
The approved Abbreviated New Drug Application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Exforge Tablets of Norvartis Pharmaceuticals Corporation. Amlodipine and Valsartan Tablets are used in the treatment of hypertension to lower blood pressure. The approved product has an estimated market size of $123 million in US for the twelve months ending February 2016, according to IMS.
This is the 71st 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 254 ANDA approvals (218 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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