Ranbaxy Labs gains after USFDA OKs generic drug

Ranbaxy Laboratories rose 2.45% to Rs 656.85 at 15:11 IST on BSE after the company said that it received approval from the US drug regulator to manufacture and sell generic version of Antara capsules in the US market.

The announcement was made during trading hours today, 5 November 2014.

Meanwhile, the BSE Sensex was up 111.54 points, or 0.40%, to 27,971.92.

On BSE, so far 1.61 lakh shares were traded in the counter, compared with an average volume of 1.43 lakh shares in the past one quarter.

The stock hit a high of Rs 663.50 and a low of Rs 642 so far during the day. The stock hit a 52-week high of Rs 667.30 on 3 November 2014. The stock hit a 52-week low of Rs 306.05 on 27 January 2014.

The stock had underperformed the market over the past one month till 3 November 2014, rising 0.45% compared with 4.86% rise in the Sensex. The scrip had, however, outperformed the market in past one quarter, rising 13.49% as against Sensex's 9.34% rise.

The large-cap company has an equity capital of Rs 212.29 crore. Face value per share is Rs 5.

Ranbaxy Laboratories announced that it received approval from the US Food and Drug Administration (USFDA) to manufacture and market Fenofibrate Capsules USP, 43 milligram (mg) and 130 mg. The Office of Generic Drugs, USFDA, has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Antara Capsules, 43 and 130 mg, respectively, of Lupin Atlantis (Lupin).

Total annual market sales for Fenofibrate Capsules USP, 43 mg and 130 mg were $56 million (IMS - MAT: September 2014). Fenofibrate Capsules are indicated for Primary Hypercholesterolemia and Mixed Dyslipidemia. In addition, it is indicated for Severe Hypertriglyceridemia.

"We are pleased to receive approval for these two strengths of Fenofibrate Capsules, which represents a welcome addition to our generic portfolio of products and offer an alternative in strengths and dosage forms for this molecule to patients and healthcare professionals. The product will be manufactured at Ohm Laboratories, in our U.S. facility located in New Brunswick, New Jersey and launched immediately thereafter," according to Dan Schober, Vice President, Trade Sales, Ranbaxy Inc.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

Ranbaxy Laboratories reported a consolidated net profit of Rs 477.75 crore in Q2 September 2014 compared with net loss of Rs 454.16 crore in Q2 September 2013. Total income rose 15.91% to Rs 3277.87 crore in Q2 September 2014 over Q2 September 2013. Sales rose 17% to Rs 3218 crore in Q2 September 2014 over Q2 September 2013, primarily due to exclusivity sales of Valsartan in the US during Q2 September 2014.

Ranbaxy Laboratories is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies.

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