As part of its efforts to enter the regulated markets, Bangalore-based Ray Laboratories (RL) Fine Chemicals has received approval from the US FDA for its psychiatry drugs namely Amitriptyline Hydorchloride and Lorazepam. The company has filed Drug Master Files (DMF) and it is expecting to receive Abbreviated New Drug Application (ANDA) status shortly.

The company also received approvals from the Japanese Drug Authorities for various central nervous systems (CNS) related products. It is also expected to get its Certificate of Suitability (COS) for Amitriptyline Hydrochlride.

In the wake of these approvals RL Fine has chalked out an expansion plan at an investment of $ 9 million to set up a state-of-the-art facility as per the US FDA guidelines, which would be operational in 2008.

In order to strengthen its global presence, the company has registered its products in Russia, Iran, Canada and many Latin American countries.

The Rs 35-crore company , has 70 per cent of its turnover from exports. "It was our perseverance to go global which saw us through the stringent US FDA approval," stated Anjan K Roy, managing director, RL Fine Chem.

The psychotropic bulk drug major has several long-term partnerships with multinational companies for supply of its range of anti-psychotropic products. The major players in the segment are Lundbeck, Novartis, Roche, Abbot, and Pfizer who have a wide range of formulations.

In the international arena it is the highest product quality and cost competitiveness which would allow to companies to operate, stated Roy.
On the Chinese threat in the bulk drug segment, Roy stated that RL Fine had an exclusive product profile. "China focused on intermediates and Indian companies had a name for their APIs.

The company today is the largest manufacturer of amitriptyline hydrochloride in the world. The other bulk drugs in the range of psychotropics are butriptyline hydrochloride, chlorpromazine hydrochloride, citalopram, and clomipramine hydrochloride to name a few. It also manufactures APIs used in muscle relaxants, antihistamines, antispasmodics, vasodilators, anti diarrhoeas etc.

The company has four units in Yehalanka in the outskirts of Bangalore. It annually invests around five per cent of its turnover into R&D activities. In 1997, it received the export excellence award from the Government of Karnataka and in 1999 it received the Quality Assurance award from Spain.