The Hindu Business Line : JB Chem lines up hectic schedule for coming year

IT looks like an active year ahead for the Mumbai-based JB Chemicals and Pharmaceuticals (JBCPL), which is poised to file up to six Abbreviated New Drug Applications (ANDAs) per year in the US market. And this, even as the company expects to get an approval from the US regulatory authority for its ciprofloxacin.

An antibiotic used to treat bacterial infections, ciprofloxacin is a blockbuster drug (grossing $1 billion) and Bayer is the original patent-holder. The patent is slated to expire in June 2004, when the innovator company's paediatric exclusivity period comes to an end.

"We expect to get the US Food and Drug Administration's (FDA) approval by the time the exclusivity period ends and would be ready to ship our first consignment by then. Cipro is one of the two ANDAs that have been filed and the others would be in the anti-depressant and central nervous system (CNS) therapeutic areas," said Mr Shirish B. Mody, Director.

Giving a preview into the company's road ahead, he told Business Line that filing a single ANDA would cost the company about Rs 2 crore, products have already been lined up for the first year and the required budgetary allocations have already been made.

Only in January this year the company had received USFDA approvals for its manufacturing facilities at Panoli, Gujarat.

Armed with these regulatory approvals for both its plants that manufacture the finished drug form and the active pharmaceutical ingredients respectively, the company looks set to increase its activities in the global regulated markets.

Elaborating on how the company would sell in the US, he said that its drugs would be marketed by NeoJB LLC, which would in turn place it with Lannett Company Inc, a distribution company.

NeoJB LLC is an 80:20 joint venture company between research-based company, Spectrum Pharmaceutical and JB Life Science Overseas Ltd, a JBCPL subsidiary.

The company expects the return on its investments to come this year.

According to Mr Mody, JBCPL is expected to end the current fiscal with sales of about Rs 310 crore, a top-line growth of about 10 per cent. The company expects a bottom-line growth of about 17 per cent.

More Stories on : Outlook | Health | Pharmaceuticals

Article E-Mail :: Comment :: Syndication :: Printer Friendly Page