The imminent ban on Rofecoxib formulations in India has come as a set back to the Chennai-based Shasun Chemicals and Drugs Ltd's growth plans, especially in the US market, it is learnt.

Shasun had filed Drug Master File (DMF) in USA (16617/19th May 2003) for Rofecoxib and is considered to be the first company to register details with US FDA for this drug. The company was planning to export the API to the US market once the Merck's patent expired.

The Rs 275-crore odd Shasun, which manufacturers eight APIs, including Rofecoxib from its world class Cuddalore facility, is in the process of tapping potential APIs in the global markets as part of its overall growth strategy to become a major Indian pharma company. Shasun is also planning to export its major APIs in finished dosage forms to the US market and is setting up a Rs 30-crore formulation facility in Pondicherry, besides a Rs 125-crore knowledge management centre.

However, at present the APIs which contribute major revenues to Shasun are ibuprofen, ranitidine and nizatidine. SCDL is also the largest ibuprofen manufacturer in the world.

The company is yet to come out with its comments on the impact and damage of the ban and subsequent developments related to Rofecoxib in India, according to various sources. Top-level company officials declined to comment on the new developments despite repeated efforts of Pharmabiz to contact them.

Shasun sources had indicated a few months ago to this paper that with the launch of its Cox 2- Inhibitor, an analgesic and pain management molecule, Shasun would become the only manufacturer globally to manufacture and market this product. DMF was filed by adopting the non-infringing process and the drug would reach the pre-generic or generic mode within one and a half to two years.

Soon after the Merck's decision to withdraw Vioxx, Shasun had informed the stock exchanges that the Merck's action would not have a material impact on the operational performance of the company. The company's share prices fell by four per cent during the first week of October.

Ranbaxy, Juggath Pharma and Micro Labs have already announced to withdraw their Rofecoxib brands.