|Erol Thomas Isim, founder of Pharma Action|
After tainted Chinese heparin in 2008 led to dozens of deaths of dialysis patients in the U.S., global regulators started preaching loud and clear on the need for heparin makers to be able to track back sources to ensure they were safe. German meat company Tönnies saw an opportunity there, bought a German heparin API maker and started building a brand-new plant. That facility was dedicated this week and will start producing heparin intermediates this year.
Pharma Action, the company Tönnies bought in 2012, says its new €25 million ($31.2 million) German facility will be able to manufacture 30 metric tons of product, which is about 60% of Europe's demand for traceable heparin raw material. Erol Thomas Isim, founder of Pharma Action and now its managing director, said the "Made in Germany" logo its products will carry and the company's "closed loop supply chain" will be a big attraction.
Crude heparin is extracted from pig intestines, and the raw ingredients will come from a Tönnies plant where the animals are slaughtered and dissected under one roof, with their origins completely traceable. The ingredients will then go to the new 3,500-square-meter (37,600-square-foot) Pharma Action plant for processing, Isim explained. "Both Tönnies and Pharma Action will do everything to ensure that these assumptions are justified, and continue to introduce measures to further enhance product safety," he said.
Pharma Action expects global demand for the products and will sell them outside of Europe, focusing on Japan and the U.S. Given FDA efforts to ensure safe heparin is being used by companies manufacturing finished product, the U.S. is a good bet. In 2008, contaminated heparin marketed by Baxter International ($BAX) was tied to the deaths of 80 patients. The FDA found the heparin was tainted with OSCS in crude heparin that came from Chinese suppliers. Six years later, fallout from the incident continues.
Just last month the FDA posted a warning letter it sent to a Chinese crude heparin maker that it banned in July from selling into the U.S. The letter said that Beijing Shunxin Meihua Bio-technical would not allow inspectors to get a good look at its plant and records. The FDA said in the letter the company appears to be getting some of its raw materials from a supplier who is on an FDA watch list of suspect companies that don't carefully monitor the source of their materials. Results of tests done for the FDA confirmed the presence of ruminant DNA in one of two samples of porcine crude heparin produced by Shunxin and obtained from one of its Chinese customers.
- here's the Pharma Action announcement (PDF)