Ranbaxy Labs slips after US FDA withdraws approval for 2 generic drugs

Ranbaxy Laboratories fell 1.90% to Rs 641.75 at 10:20 IST on BSE after the US drug regulator revoked tentative approval for the company's generic versions of the heartburn tablet Nexium and antiviral medicine Valcyte.

The company made the announcement on Thursday, 6 November 2014, when the market was shut for a public holiday.

Meanwhile, the BSE Sensex was down 109.37 points, or 0.39%, to 27,806.51.

On BSE, so far 1.52 lakh shares were traded in the counter, compared with an average volume of 1.46 lakh shares in the past one quarter.

The stock hit a high of Rs 642.40 and a low of Rs 623 so far during the day. The stock hit a record high of Rs 667.30 on 3 September 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 5 November 2014, rising 2.48% compared with 5.07% rise in the Sensex. The scrip had, however, outperformed the market in past one quarter, rising 14.61% as against Sensex's 7.75% 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 communication from the US Food and Drug Administration (FDA) wherein FDA has determined that Ranbaxy's Abbreviated New Drug Applications (ANDAs) of concern did not have any data integrity issues. However, FDA has rescinded the previously granted tentative approvals for Ranbaxy's ANDAs for esomeprazole magnesium delayed-release capsules, 20 milligram (mg) and 40 mg and for valganciclovir hydrochloride tablets USP, 450 mg.

FDA has said that its original decisions granting tentative approvals were in error because of the compliance status of the facilities referenced in the ANDAs at the time the tentative approvals were granted. As a consequence, in FDA's view, Ranbaxy has forfeited its eligibility for 180-day exclusivity for its ANDA for valganciclovir hydrochloride tablets USP, 450 mg.

Ranbaxy said it is disappointed with this development and is actively evaluating all available options to preserve its rights.

On Wednesday, 5 November 2014, Ranbaxy announced that it received approval from the US drug regulator 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.

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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