The prospective approvals could open up million dollar markets for the Indian company once the two products go off patent. The enalapril maleate patent, held by Merck, expires on February 22, 2000, while the patent on lovastatin, again held by the American giant, expires on June 15, 2001.

Both moves come even as Ranbaxy whole-time director JM Khanna on Wednesday categorically stated that the company has been "in touch" with Bayer AG for the possible licensing of a new drug delivery system (NDDS) for ciprofloxacin. The deal, if it materialises, may see Ranbaxy rake in significant forex inflows.

"I cannot say that it is 100 per cent wrong. There is some truth in that (on talks with Bayer forciprofloxacin). But I don't know why this subject has become so important now. Ranbaxy has been working on NDDS for the last four to five years and there are several products in the pipeline. But we are in touch with them (Bayer)," Khanna said.

On whether negotiations were on concurrently with other international generic firms, Khanna said, "I would not like to disclose anything more at this stage". Ranbaxy is however on course to deliver one NDDS every two years and areas of active interest include anti-infectives, anti-histamines and the cardiovascular segment.

On the progress of the new chemical entity, RBx 2258, a potential treatment for benign prostatic hyperplasia (BPH), Khanna said clinical trials had commenced on June 10 and the results so far were encouraging.

"At this stage we test for the safety of the drug and dose-related effects. But as we evaluate the potential from time to time, the Ranbaxy management feels it may be more appropriate if we license the molecule once stage two (A) ofclinical studies are completed". This stage involves clinical efficacy tests in a small number of patients (say 15-20) and Khanna maintained that no negotiations were currently underway to license RBx 2258.

Ranbaxy has also completed work on a drug delivery system for Keflor (cefaclor) and may market this on its own or even license it out. A cardiovascular drug diltiazem had also been developed through a novel in-house technology. Khanna, however, said: "In both these molecules, we are slightly late, so obviously the business volume reduces to that extent".

On Ranbaxy's new drug discovery research (NDDR) programme wherein an anti-fungal compound showed promise, Khanna said that "at the moment we can only say that by the end of the next year, we could have an investigational new drug application (INDA) for the product".

Insight

The likely approval for its abbreviated new drug application for enalapril maleate and lovastatin will no doubt help Ranbaxy as far as volumes are concerned, but its pasttrack record shows that there is very little effect on its bottomline.

Realising this, Ranbaxy is increasing its focus on other segments of the pharmaceutical industry that has now been opened for Indian players, such as developing new drug delivery systems, chemical synthesis among others. However, it is unlikely that the company will get immediate benefit from any of these. But it is these areas that are likely to provide bottomline growth in the future.