Corporate Announcement
Security Code : 524652    Company : INDSWFTLTD    
 
Ind Swift gets DCGI approval for unique combination of anti-diarrhoeal drug 
  Exchange Disseminated Time     
Ind Swift Ltd has informed BSE that has announced that the Company has successfully developed a unique combination of the quinoline-derivative, anti-diarrhea plus antibacterial drug. The company has recently received the approval of the Drug Controller General of India (DCGI)for the combination.

The combination which is developed by Company's R&D is a broad spectrum antibiotic drug which besides an effective cure for anti-diarrhea is effective for a number of Infections the major being; infection of Skin and soft tissue; uro-genital Infections; pulmonary infections. The drug also addresses those Infections where Metronidazole is ineffective. During clinical trials the combination has been found to be better than the other drugs in the same category.

"The drug has successfully completed all stages of clinical trials and the company expects to launch it next month," Informs V K Mehta, Managing Director, the Company.

The drug is a combination of 500 mg Nitazoxanide (anti-diarrhea agent) plus 200 mg Oflxacin (quinoline derivative). "The drug is going to be unique in its effectiveness, owing of the combinatorial dose. Its low price will be an added advantage," says Mehta. The drug is also unique in the sense that Worldwide this is the first combination of the Nitazoxanide developed successfully by the Company .

"The market size of the anti-diarrhea segment in India is approximately Rs 5000 million, but most of the existing products in this segment are old molecules" he says. According to Mehta, there have been few product launches in this segment and hence the growth has been slow.

With a brand name that is soon to be finalised, the Company plans to launch the product in both the domestic and the international markets. "The product will be sold through our wide marketing network comprising medical representatives and stockists, in addition to our other strategies, which are still in the pipeline," informs Mehta.

Ind-Swift Laboratories, the other listed entity of the same group, which manufactures active pharmaceutical ingredients and advanced intermediates, had developed the API "Nitazoxanide" which is supplied to the Company, as a backward Integration move . The Company has tied up with number of Companies in India for the co-marketing of the drug Nitazoxanide, the prominent among them are : Lupin, Cipla, Ranbaxy & USV. Company plans to go in for the similar arrangement for this combination also which will provide a better market reach to all the players.

Nitazoxanide is the first molecule approved by the FDA in last 40 years for Gardia and is the only drug approved for the treatment of Diarrhea caused by Cryptosporidium parvum in children aged 12 month to 11 years of age. The molecule was launched in India by the Company within a year of its Global launch by the Originator.

The Company is currently working on developing molecules under the statins, cardiology, diabetology and oncology segments.

The efforts put in by the company in the previous years are now showing results as the Company has received nod for the first US patent for "Controlled Release Macrolide Pharmaceutical Formulations" developed in-house by the Research and Development department of the Company.

The patent has been granted by the US patents and trademarks office. The patent is for the controlled release dosage form of macrolide antibiotic drug to be taken once a day against the conventional dosage form, which is required to be taken twice a day. The Worldwide market of this drug is US$ 1.5 billion and the molecule goes off-patent in 2005 and its expected growth in volume terms would be more than 30% in terms of quantity.

To compete internationally, the Company is focusing on filing patents by developing non infringing process of finished dosage form based on Novel Drug Delivery Systems (NDDS) and developing non-infringing alternate manufacturing processes for active Pharmaceutical Ingredients.
 

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