USFDA nod for J B Chem drug master file

The US Food and Drug Administration (USFDA) has accepted the drug master file (DMF) of J B Chemicals and Pharmaceuticals Ltd for ciprofloxacin hydrochloride USP, an active pharmaceutical ingredient (API).

USFDA has assigned a DMF number for the API, JBCPL announced on Wednesday.

The DMF has been filed in the name of Unique Chemicals, a division of J B Chemicals and Pharmaceuticals. The acceptance reiterates the company's focus to bring quality formulations and API's to the fast growing US markets in addition to strengthening its API business globally, a statement said.

Ciprofloxacin hydrochloride is an anti-bacterial molecule which had gone off patent in the US earlier this year.

JBCPL also holds the abbreviated new drug application (ANDA) for ciprofloxacin tablets and has already started marketing ciprofloxacin tablets in the US generic market.

JBCPL will be the third Indian company having both ANDA and DMF approvals for ciprofloxacin. This will give it an edge over other companies marketing cipro in the international markets, particularly in the US.

"The USFDA has assigned a DMF number for ciprofloxacin hydrochloride USP and this will give a fillip to our strategy of backward integration and help in consolidating our presence in the US generic market," J B Mody, chairman and managing director said in a statement.

The company already has five more DMFs filed with USFDA and has plans to file few more DMFs in 2005. JBCPL's tablets and API manufacturing facilities at Panoli in Bharuch district have been approved by US FDA earlier this year.