Amicogen FDA InspectionNews
“Rochem International Inc. is very pleased to announce the successful FDA inspection of Amicogen (China) Biopharm Co Ltd in March of this year.
This was the first FDA inspection of Amicogen and included the APIs Tulathromycin and the Ceftiofur series of products, sterile and non-sterile.
While Amicogen’s products have been sold for a number of years in Europe (also under the former Shandong Lukang Record name), this now opens up their products to users in the USA. Already a number of key customers have started development projects with their non-infringing Tulathromycin API and Rochem as their exclusive partner and regulatory agent, is working towards gaining FDA approvals for these customers’ drug products in the coming years.
“This is an important day in the long term development of Amicogen. We are delighted that our facility has satisfied the inspectors which is also due to the strong compliance support we have enjoyed by partnering with Rochem. We have exciting plans for the future and we and Rochem will work diligently with customers to do all we can to satisfy their every need” says Mr Zhao, General Manager of Amicogen.
Amicogen (China) Biopharm Co Ltd is engaged in the development and sales of Active Pharmaceutical Ingredients (APIs) for animal health products throughout the world.