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Valacyclovir (Valtrex) generic windfall sales in US bolster Ranbaxy’s Q1 2010 revenues to Rs 961 cr

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Wednesday, May 12, 2010, 20:12 This news item was posted in Industry category and has 0 Comments so far.

Daiichi-controlled Ranbaxy Laboratories has posted strong bottom line during the first quarter ended March 2010, thanks to winfall revenues from generic valacyclovir (Valtrex).

Ranbaxy has earned a consolidated net profit of Rs 960.58 crore during the first quarter of 2010 as against a net loss of Rs 767.33 crore in the corresponding period of last year. The earnings per share worked out to Rs 22.84 as compared to negative Rs 18.25 in the last period.

Its consolidated net sales went up sharply by 59.9 per cent to Rs 2,487 crore from Rs 1,555 crore. The company launched valacyclovir, a first-to-file (FTF) product in last quarter of 2009 and has achieved a market share of over 60 per cent in US market.

It also launched an authorised generic of Oxycodone ER tablets in Q1 of 2010. Its sales in emerging markets were US$ 212 million, a growth of 15 per cent, and contributed 39 per cent to sales. Developed markets recorded sales of US$ 304 million, a growth of 145 per cent, primarily on account of FTF revenues in USA. Sales in North America improved by 222 per cent to Rs 1,211 crore. Its sales in Europe improved by 10 per cent to Rs 310 crore.

“Solid growth in key geographies, along with optimal delivery value from FTF opportunities in the USA, ensured that we achieved yet another quarter of strong operations performance,” stated Atul Sobti, CEO and managing director, Ranbaxy.

Ranbaxy also launched project Viraat, a comprehensive program aimed at India leadership, in January, he added.

The company’s domestic sales increased by 6 per cent to Rs 345 crore. Excluding a large government tender in Q1’09, the growth was 15 per cent. Sales in the consumer healthcare business were at Rs 43.6 crore, a growth of 50 per cent. Revital is now the sixth largest product in the Indian Pharmaceutical market.

The company’s sales in CIS region recovered by 26 per cent to Rs 110 crore and that in Africa improved by 30 per cent to Rs 177 crore. The sales in Latin America also improved by 40 per cent to Rs 90 crore during the quarter under review.

Ranbaxy’s other operating income, including export benefits and income arising out of milestone payments, and patent exclusivity settlements, went up to Rs 280.32 crore from Rs 22.30 crore in the similar period of last year. Further, its foreign exchange gains amounted to Rs 319.47 crore as against a loss of Rs 1130.60 crore in the last period. These items impacted its bottom line favourable during the first quarter of 2010. The R&D expenditure increased by 44.4 per cent to Rs 155.79 crore from Rs 107.90 crore.

Ranbaxy’s standalone net sales increased by 105 per cent to Rs 1,649 crore from Rs 802 crore in the corresponding quarter of last year. It earned a standalone net profit of Rs 872 crore as against net loss of Rs 778 crore.

In March, US FDA denied approval for Daiichi-Ranbaxy’s generic tamsulosin hydrochloride tablets to treat  enlarged prostate due to the ongoing controversy on good manufacturing practice norms violations, reports said.

Ranbaxy has been denied the approval for tamsulosin generic because of its failure to address the manufacturing violations in some of its facities in India and US.

Recently, US FDA has asked Ranbaxy to undertake concrete steps to ensure that all of the company’s facilities involved in manufacturing products to US market confirm with the regulator’s cGMP requirements.

Ranbaxy has been issued warnings for manufacturing violations at least thrice during the last four years by USFDA.

During inspections carried out in Ohm Laboratories,Inc., located at 34 West Fulton Street, Gloversville, NY. in July 13 through August 12, 2009 the US FDA investigators identified significant violations from cGMP regulations for finished pharmaceuticals.

The US market accounted for about a quarter of Ranbaxy’s $1.6-billion revenues for the year ended 2008.

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