Ranbaxy jumps on buzz US plant gets FDA clearance

Ranbaxy Laboratories rose 3.93% to Rs 408.60 at 11:50 IST on BSE on reports that the company's US-based facility, Ohm Laboratories Inc, have got a clean chit from the US drug regulator.

Meanwhile, the BSE Sensex was up 242.29 points, or 1.20%, to 20,515.20.

On BSE, 7.78 lakh shares were traded in the counter compared with average volume of 8.35 lakh shares in the past one quarter.

The stock hit a high of Rs 435 and a low of Rs 406.55 so far during the day. The stock hit a 52-week high of Rs 559.80 on 8 November 2012. The stock hit a 52-week low of Rs 253.95 on 2 August 2013.

The stock had underperformed the market over the past one month till 10 October 2013, sliding 12.99% compared with the Sensex's 1.38% rise. The scrip had, however, outperformed the market in past one quarter, rising 13.78% as against Sensex's 5.07% rise.

The large-cap company has an equity capital of Rs 211.56 crore. Face value per share is Rs 5.

According to reports, the US Food and Drug Administration (USFDA) is satisfied with the manufacturing practices at Ranbaxy's US facility, Ohm Laboratories, which produces solid dosage forms of analgesics, antibiotics, anti-diarrhoeal, laxatives, antacids and cough & cold remedies.

The facility, in December last year, received an FDA Form 483 (observations after an inspection), with a listing of deviations from US 'good manufacturing norms'.

However, earlier this month, the FDA issued an Establishment Inspection Report (EIR) to Ohm Laboratories. An EIR signals satisfactory resolution of issues related to good manufacturing practices raised by FDA.

Reports suggested that the clearance will allow Ranbaxy to continue supplying products from this unit. Ranbaxy could also shift some pending applications to Ohm from its Mohali unit in India, which is under an FDA import alert, to avoid delays in product launches. The clearance will also allow Ranbaxy to file applications for approvals for generics (or off patent drugs) from Ohm, reports added.

Ranbaxy's factories located at Paonta Sahib in Himachal Pradesh and Dewas in Madhya Pradesh were banned by US regulator in 2009, and its plant in Mohali in Punjab also received an import alert in September 2013.

In May 2013, Ranbaxy agreed to pay $500 million penalty to the US government to settle criminal and civil charges related to drug safety.

As per recent media reports, Ranbaxy has close to 30 generic drug filings in facilities like Ohms in the US and Mohali, with Mohali having the maximum filings. The Mohali plant manufactures oral solids for export to the US, the European Union and other geographies.

Ranbaxy Laboratories reported consolidated net loss of Rs 524.24 crore in Q2 June 2013, lower than net loss of Rs 585.72 crore in Q2 June 2012. Net sales declined 17.8% to Rs 2633.20 crore in Q2 June 2013 over Q2 June 2012.

Ranbaxy Laboratories is an integrated, research based, international pharmaceutical company producing a wide range of generic medicines. Ranbaxy serves its customers in over 150 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 43 countries and manufacturing operations in 8 countries. Ranbaxy is a member of the Daiichi Sankyo Group.

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