The Hindu Business Line : JB Chemicals gets USFDA nod to market ciprofloxacin

The company announced here on Monday that it has received final approval from the United States Food and Drug Administration (USFDA), to manufacture and market ciprofloxacin (an anti-infective drug) — in tablet strengths 250 mg, 500 mg and 750 mg — in the US market.

JB Chemicals is reportedly only the third Indian company to receive such an approval, following Ranbaxy and Dr Reddy's who got their US regulatory approvals in June this year. However, according to analysts tracking the sector, at least 14 global generic companies are in the fray to make copycat versions of cipro, after its patent expired on June 9.

German drug maker Bayer is the original patent holder for cipro and the company had a pact with Ranbaxy for a once-a-day version of the drug that the Indian company had developed.

Meanwhile, JB Chemicals said that it would market ciprofloxacin tablets through its joint venture NeoJB LLC, of the US. The company expects to receive USFDA approval to manufacture and market anti-fungal drug fluconazole tablets in strengths of 50 mg, 100 mg and 200 mg by December 2004.

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