Ranbaxy figured among the gainers today after the company got a tentative approval from USFDA for manufacture and marketing of an anti-infection  drug in the US.

The scrip of the exports-focussed drugs major edged up 1% to Rs 726 on BSE. It hit a high of Rs 727.90 earlier in the day. Around 10,900 Ranbaxy Laboratories (RLL) shares were traded on BSE so far. The stock has been on a sustained rise on the bourses over the last two years.

<P>But over the past few months, the rally has seen intermittent corrections. The stock gained 48% from Rs 491.80 on 7 November 2002 to the current Rs 727.90. It achieved a 52-week closing high of Rs 739.55 on 17 June 2003.
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A broad-based rally in pharma shares due to dissipating fears over the imminence of VAT and revised USFDA rules announced by the George Bush administration last week have boosted RLL of late. RLL has been focussing on the US generics markets. The new USFDA rules announced by the US government last week augur well for Indian drug companies since they limit a patent-holder's ability to delay the introduction of cheaper generic versions of drugs, according to pharma analysts.
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A host of drugs are going off patent over the next five years. The litigation costs for local pharma companies will also come down. In addition, with the favourable approach adopted by U.S. president George Bush towards outsourcing from India, the concern that there could be IT-like curbs on the pharma sector seems diminished, say analysts.
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Today's firmness in the Ranbaxy stock stems from company's announcement that it has got a tentative approval from the US Food and Drug Administration (FDA) for manufacture and marketing Ofloxacin Tablets 200mg, 300mg and 400mg. In 2002, sales for Ofloxacin Tablets totaled $ 31.30 million (IMS-MAT, April 2003). The product is one of the first oral quinolones experiencing patent expiration having the most extensive clinical record of safety and efficacy in the quinolone class of antibiotics.
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Ofloxacin Tablets (Floxin) are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the designated microorganisms for infections such as acute bacterial exacerbations of chronic bronchitis, community acquired pneumonia, uncomplicated skin and skin structure infections, acute, uncomplicated urethral and cervical gonorrhea, nongonococcal urethritis and cervicitis, mixed infections of the urethra and cervix, acute pelvic inflammatory disease, uncomplicated cystitis, complicated urinary tract infections and Prostatitis.
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Recently, RLL secured a tentative approval from the US FDA to market a generic form of Bristol-Myers Squibb's anti-depressant Serzone (Nefazodone Hydrocholride tablets) in 50 mg, 100 mg, 150 mg, 200 mg and 250 mg dosages. Earlier, the export-focused Indian drugs maker announced that it received tentative approval from US FDA to manufacture and market Fluconazole tablets, 50mg, 100 mg, 150mg and 200 mg, therapeutically equivalent to the reference listed drug Diflucan tablets of Pfizer Central Research. Diflucan is indicated for the treatment of vaginal candidiasis, oropharyngeal and esophageal candidiasis and cryptococcal meningitis.
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RLL had recently said it would set up a research and development (R&D) facility in North America. The R&D facility is essentially being put in place to complement the company's strengths, particularly for carrying out phase-III clinical trials. However, it did not give further details.
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Last month, RLL announced that it entered into an agreement with Medicines for Malaria Venture (MMV) Geneva for the development of the synthetic peroxide anti-malarial drug. Besides pharmaceutical and clinical development, RLL will have worldwide rights for the registration and commercialisation of the product. RLL's team of scientists will work in collaboration with scientists and researchers from the University of Nebraska Medical Centre, Monash University and the Swiss Tropical Institute in identifying a candidate for development.
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For Q1 ended 31 March 2003, on a standalone basis, RLL registered a massive 195% rise in net profit to Rs 279.8 crore compared to Rs 94.9 crore in the corresponding period in the previous year. Net sales increased by 94% to Rs 1,024.9 crore from Rs 528.9 crore.
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