USFDA approval for JB Chem's Panoli unit

The Bharuch-based J B Chemicals & Pharmaceuticals Ltd (JBCPL) on Monday said the company has received the approval from the United States Food and Drug Administration (USFDA) for its pharmaceutical manufacturing facility at Panoli in Bharuch district of Gujarat for manufacturing tablets dosage forms for the US market.

The USFDA conducted an inspection of the facility in October last year and based on this inspection, USFDA has classified the facility as acceptable, the company said.

"This state-of-the-art manufacturing facility at Panoli is equipped to manufacture various tablets dosage forms to cater to the growing global generics market. The facility approval endorses JBCPL's sustained commitment to compliance to current good manufacturing practices and this approval is a major milestone and will enable the company to explore the inexhaustible reservoir of the US market more effectively and speedily," said a company official. This will pave way for the company's future ANDA submissions.

Commenting on the approval, J B Mody, chairman and managing director, JBCPL, said, "This will help our company deliver our commitment to bring generics to the US market and speaks volumes of the company's strong research and development and regulatory skills. To expand the overseas network of the company's export business, it is aggressively exploring certain high growth potential regulated markets like Europe, the UK and Latin American countries in addition to the USA."

Looking at the increasing export opportunities in the global market, JBCPL has been eyeing American and European generics markets and has begun scouting for overseas partners to market drugs that are currently patented.

"The company has already provided exclusive marketing rights of its ciprofloxacin to Larnett Company Inc, to market the drug in the United States, and is in the process of looking at prospective partners in Europe. Although JBCPL has not fixed up revenues it aims to generate out of the deals with the US and European partners, the worldwide generics market is worth $80 billion," JBCPL's executive director (production) Kamlesh Udani said.

"Having given Larnett Company the exclusive rights to market ciprofloxacin in the US, the company is now scouting for similar partners in Europe as well," he said.

JBCPL has formed a joint-venture company, NeoJB LLC, with the US-based Spectrum Pharmaceuticals Inc.

Larnett will receive ciprofloxacin, widely used to treat bacterial infections, and market and supply it exclusively in the US. NeoJB LLC is a 80:20 joint venture company between Spectrum and J B Life Science Overseas Ltd, a subsidiary of JBCPL.

The worldwide sales of ciprofloxacin per year is about $1 billion.