Aurobindo Pharma gains after securing USFDA approval for two generic drugs

Aurobindo Pharma rose 0.89% to Rs 1,371 at 13:53 IST on BSE after the company got final approvals from the USFDA to manufacture and market Azithromycin for injection USP, 500 mg/vial.

The announcement was made during market hours today, 22 June 2015.

Meanwhile, the S&P BSE Sensex was up 355.69 points or 1.3% at 27,671.86

On BSE, so far 66,639 shares were traded in the counter as against average daily volume of 1.36 lakh shares in the past one quarter.

The stock hit a high of Rs 1,380 and a low of Rs 1,360.15 so far during the day. The stock had hit a record high of Rs 1,432.10 on 17 April 2015. The stock had hit a 52-week low of Rs 644.65 on 10 July 2014.

The stock had underperformed the market over the past one month till 19 June 2015, falling 2.05% compared with 1.19% fall in the Sensex. The scrip, however, outperformed the market in past one quarter, gaining 10.84% as against Sensex's 4.05% fall.

The large-cap pharma company has equity capital of Rs 29.20 crore. Face value per share is Re 1.

Azithromycin for Injection USP, 500mg /vial is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Zithromax (Azithromycin for Injection) 500mg/vial of Pfizer, Inc. Azithromycin for injection, USP is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions such as Community-Acquired Pneumonia and Pelvic Inflammatory Disease, Aurobindo Pharma said in a statement.

Separately, Aurobindo Pharma said during market hours today, 22 June 2015, that it has received final approvals from USFDA to manufacture and market Entacapone tablets USP, 200mg. The product will be launched soon, Aurobindo Pharma said. The approved abbreviated new drug application (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Comtan Tablets 200mg of Orion Corporation. Entacapone Tablets are used in the treatment of Parkinson's disease and had estimated market size of $59 million in the United States for the twelve months ended April 2015, according to IMS data, Aurobindo Pharma said.

On 15 June 2015, Aurobindo Pharma said the company has received the final approval from the US Food & Drug Administration to manufacture and market Extended Phenytoin Sodium Capsules USP, 100mg.

Aurobindo Pharma's consolidated net profit dropped 19.5% to Rs 403.80 crore on 36.3% growth in net sales to Rs 3143.97 crore in Q4 March 2015 over Q4 March 2014.

Aurobindo Pharma, headquartered at Hyderabad, manufactures generic pharmaceuticals and active pharmaceutical ingredients (APIs).

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