In an exclusive interview to The Financial Express, Zydus Cadila President Ganesh Nayak said that the pharma major was working towards the filing of 10 ANDAs (Abbreviated New Drug Applications) as well as European Product Licences by the end of December 2001. Zydus has decided to apply for 10 ANDAs every year therafter as well. According to Nayak, while these registrations were a "very costly and time- consuming affair, the effort is justified in view of the fact that the market potential is tremendous once these are acquired."

Moreover, with the pharmaceuticals industry headed for a major shakeout within the near future with the coming in of the post-GATT era and the introduction of product patents and exclusive marketing rights from 2005, Nayak maintained that filing of ANDAs and DMFs (Drug Master Files) would become imperative for "companies who want to become truly global players." It may be mentioned that some of the domestic pharma majors which are also working towards filing ANDAs and DMFs are Ranbaxy, Dr Reddy's, Sun, Wockhardt and Cipla.

Elaborating on the market potential of the products for which ANDAs and DMFs were required, Nayak said the current US and European market for these products was around a whopping $20 billion.

It may be mentioned that all these products belong to the blockbuster drugs category which rank among the top 20 products in the US and European pharmaceutical market. These products are under various stages of development and a few of them are at an advanced stage of bioequivalence study.Apart from filing for these registrations, Zydus Cadila is also utilising its potential for backward integration into bulk active manufacturing capability and has sent a European Certificate of Suitability submission for a bulk active while another application is under process. In addition, Nayak said that Zydus has also already sent a US Drug Master File this month itself. Well-defined schedules and time plans are in place for submission for 12 DMFs for US and European submissions by December 2001.

As part of its strategy for going global, Zydus has also set up a subsidiary in New Zealand and registration process for four products in New Zealand and Australia are underway. Regulatory evaluation for another product is under way, while three more are under advanced stages of bioequivalence study.

Meanwhile, on the domestic front, in a bid to maximise capacity utilisation of its state-of-the-art plant at Moraiya near Ahmedabad, Zydus is bullish on co-marketing arrangements with other domestic pharmaceutical companies. The company has recently entered into such an arrangement with the Mumbai-based Thermis Chemicals for the co-marketing of Atorvastatin - the latest blockbuster for high cholestrol launched by Zydus less than two years ago. A similar co-marketing tie-up for the same molecule with two other pharma majors is in the offing, Nayak added.

"We feel that co-marketing is definitely better than mere contract manufacturing, since if good companies are in the market for the marketing of a particular molecule, it will only expand the use of the molecule and thereby increase the market. And the companies inventing the molecule like us also stand to gain, as not only does this ensure more capacity utilisation, but also additional revenue generation," Naik said.