The Mumbai-based Pearl Organics Limited (POL), India's largest exporter of anti-diabetes bulk active, metformin hydrochloride and anti-inflammatory and analgesic salsalate, has received US FDA approval for its Patalganga bulk drug manufacturing facility in January this year.

The Rs. 11 crore Patalganga factory of the company, which has a production capacity of 85 tonnes of metformin per month, was inspected by US FDA inspectors on January 29, 30 and 31, 2002, and the approval was issued on January 31. The entire facility has been approved for metformin HCL and any new molecules that may be produced in future.

The factory was set up with technological assistance from the US bulk drug major Wykoff Chemicals with whom the company had a joint venture previously. The plant went into operation in December 1995 and production trials of the bulk active commenced in the same month.

The plant will undergo an expansion of capacity by 40 tonnes by March 2002 end, Executive Director K R N Moorthy told www.pharmabiz.com. The POL plant is situated at Patalganga of Raigad district of Maharashtra.

The metformin hydrochloride manufactured here is largely exported to Asian, European, Latin American countries and Canada and the product is receiving good response from international markets, company sources said.

The company sells around 80 tonnes per month of which 45 tonnes is directly exported, 25 tonnes is indirectly exported and 10 tonnes sold to formulators.

A loss-making company for the last there years, POL has turned around by March 31, 2001. The annual turnover by March 31, 2002 is expected to be Rs 16.2 crores of which Rs 12.5 crores are from exports and the remainder comes from domestic supplies including indirect exports. POL will hit a total turnover of Rs 25 crores next year 31.03.2003 , Moorthy hopes.

Moorthy said POL was all set to sign a joint venture agreement next week with a Medicines Control Agency-approved company in the US for selling API to a formulator. The company has already received the certificate of Suitability for Metformin Hcl for three years from the European Department of Quality Medicine. Formulations business in Europe is slated for 2003, he said.

Moorthy says he has shortlisted 20 new molecules, mostly in the segments of cardiovascular, pain management and anti-depressants, of which three will be finalized for production this year. "We have the necessary technological and manufacturing capability. All we need is an ANDA approval."

The salsalate plant, also at Patalganga, has a production capacity of 60 tonnes per annum while the current business is 48 tonnes per annum POL is also contemplating getting registered in Canada and Europe for their two other new products- sertraline hydrochloride and pantoprozole sodium. It has scheduled anti-asthmatic Monteleukast for launch in India in September this year. A handful of formulators like Cipla and Ranbaxy have entered the domestic market with Monteleukast.

The company's 10-member-strong research and development department, also in the same Patalganga premises, is engaged in mainly process development, trouble shooting and introduction of new molecules, Director (Operations) Dr T Balaji informed.