Simvastatin

It takes a special type of bond to produce simvastatin reliably

Hovione and CKD Bio will jointly produce and market simvastatin on a worldwide basis, offering the market with the most competitive integrated manufacturing platform for the supply of simvastatin API for the generic industry (not offered where such constitutes an infringement of third parties’ patent rights).

• Integrated supply of simvastatin API under cGMP to FDA and ICH requirements.
• Registration dossiers for simvastatin tablets for the European and United States markets.
• Independently developed process patent for the manufacture of simvastatin API.
• Process validation batches for simvastatin API concluded.
• Worldwide registration filings ready in Spring 2003.

Hovione and CKD Bio enjoy a long and fruitful business relationship, having collaborated in several projects involving semi-synthetic active ingredients over the last 30 years. The simvastatin project demonstrates the unique synergies which the two companies benefit from. One with an unparalleled excellence in fermentation and the other with a long history of success in building synthetically on natural products and scaling the processes to industrial manufacture. This strategic integration puts Hovione and CKD Bio in a unique position to guarantee reliability of supply, competitive terms and complete customer support.

Hovione Press Release (3 Sept. 2002): Hovione and CKD announce joint collaboration to produce and market Simvastatin

For further information please contact Carla Vozone at