Financial Daily from THE HINDU group of publications
Thursday, Dec 09, 2004
Financial Daily from THE HINDU group of publications Thursday, Dec 09, 2004 |
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Corporate
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Announcements JB Chemicals gets FDA nod for anti-bacterial molecule Our Bureau
Mumbai , Dec. 8 J.B. Chemicals & Pharmaceuticals Ltd on Wednesday announced that the US Food & Drug Administration has accepted its Ciprofloxacin Hydrochloride USP, an Active Pharmaceutical Ingredient (API). USFDA has accepted the Drug Master File and assigned a DMF number for it. The DMF is filed in the name of Unique Chemicals, a division of the company. "This acceptance reiterates the company's strong focus and commitment to bring quality formulations and APIs to the fast growing US markets in addition to strengthening company's API business globally," J.B. Chemicals said in a statement to the BSE. Ciprofloxacin Hydrochloride is an antibacterial molecule, which had gone off-patent in the US earlier this year. J.B. Chemicals also holds ANDA for Ciprofloxacin tablets and has already started marketing Ciprofloxacin tablets in the US generic market. "J.B. Chemicals will be the third Indian company having both ANDA (abbreviated new drug approval) and DMF approvals for Ciprofloxacin. This will give an edge to JBCPL over other companies marketing cipro in the international markets particularly in the US," it said. The company already has five more DMFs filed with USFDA and has plans to file few more DMFs in 2005. The authority had approved the company's tablets and API manufacturing facilities at Panoli earlier this year.
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