JB Chem to enter US market, eyes overseas acquisitions

To introduce products in the UK, plans to file up to six ANDAs every year

The Bharuch-based JB Chemicals and Pharmaceuticals Ltd is all set to enter the US market with its range of products this fiscal year.

The Rs 300 crore company is also planning to take its tablets and intravenous fluids to the UK market.

The company's exports contributed 52 per cent to its total sales of Rs 314.55 crore in the last fiscal year. JBCPL will focus on potential export markets and is also looking for acquisition of small and medium size pharma companies in the UK, other European countries, Latin America and the US.

The company has finalised a plan to file four to six abbreviated new drug applications (ANDAs) each year from this year.

It will also make aggressive submissions of drug master files and take necessary measures to expedite product registration and filing of additional dossiers in the regulated markets such as the US, Europe and Latin America.

Kamlesh Udhani, director (production), said, "We have already filed two ANDAs with the USFDA for our anti-ineffective product ciprofloxacin and anti-fungal product fluconazole. Also, we expect to get approval for ciprofloxacin in three different dosage forms. With these, we are all set to launch the product in the US upon expiry of product patent in this June."

"We have received clearance for ciprofloxacin. Only brief formalities on part of USFDA are pending for fluconazole.

"We are gearing up to storm the US market with these two products to start with," Udhani said.

The company has recently received approval from the Columbian drug regulatory authority, Invima, the National Institute for the Surveillance of Drugs and Food designated by the Columbian ministry of social protection, for supply of its pharmaceutical specialities to the Columbian market.

The company has tablets and active pharmaceutical ingredient manufacturing facilities at Panoli near Bharuch.

The facilities are approved by the USFDA.

The company's bulk metronidazole facility in the Thane-Belapur industrial area in Maharashtra also has USFDA approval.

Udhani said, "We will market our products in the US through Neo JB LLC, a joint venture between JB Chemicals and Spectrum Pharmaceuticals, USA. Neo JB has a tie-up with Lanett Inc, a generic company in the US. We are looking for acquisitions in various countries including the US.

"We will also concentrate on selling products in the overseas markets through our own subsidiaries. We want the products manufactured in our plants to be sold there."

JBCPL holds a 20 per cent stake in Neo JB LLC while the rest is held by Spectrum Pharma Inc. Ciprofloxacin and fluconazole products will be sold by Neo JB under JB Chemicals and Pharmaceuticals' brand name.

Officials of the UK Medicinal and Health Regulatory Agency had visited JBCPL's manufacturing facilities located in Gujarat.

"The process of product registration has been completed. Recently, the Medicinal and Health Regulatory Agency has appointed a document reviewer for the final process of getting approval for JBCPL to sell its products in the UK. We are expecting to get the approval during the current fiscal year, Udhani said.