RL Fine Chem, a leading manufacturer of psychotropic drugs in Karnataka, has invested Rs 3.5 crore to upgrade its existing plant into a US FDA facility at Yelahanka in the outskirts of Bangalore. The company has hired a US consultant for its US FDA approval procedures.

The unit is almost ready in terms of infrastructure facilities and installation of equipments. The plant will be operational in early 2005. It has filed DMF applications for export of active pharmaceutical ingredients to the US. The focus is in the US and European Union markets.

The US FDA compliant plant will manufacture psychotropic and anti depressant APIs. The company is now a second source supplier to the US. Once the production at the US FDA facility commences, it will begin manufacture of a range of products to the region," Anjan K Roy, managing director, RL Fine Chem told Pharmabiz.com

The company received its ISO 9000 certification this year. It has also filed for a Certificate of Suitability (COS) in Europe for psychotropic drugs last month and is expected to get the acceptance within the stipulated time of two months.

Currently, the company has three plants in Yelahanka and one at Hindupur. As a part of its massive expansion programme slated in the next few months, the company will be augmenting its product range and is working towards setting up its second US FDA facility which is expected to be operational in the first half of 2006.

It is also taking contract-manufacturing orders and is working with the several leading foreign companies including Mil Pharma in United Kingdom and Akzo Nobel in Sweden to prepare a Common Technical Document (CTD). "In fact, the filing of COS is the first step towards supply of APIs and intermediaries to the European Union. It is also trying to work with companies like Teva, and Novartis to supply a range of intermediaries and APIs.

The company's regulatory affairs department has been stringent in adhering to the analytical systems. Its research wing is focussing on custom synthesis of intermediaries, which is perceived as a major revenue generator for the company in the future.

RL Fine Chem notched up a turnover of Rs 30 crore with a growth rate of 20 per cent during the year ended March 2004. The international and domestic sales are pegged at 70:30. It allocates five per cent of its total earnings annually for research and development activities.