Pork Belies: Will traceability regs see China lose dominance of global heparin market?

By Gareth Macdonald contact

- Last updated on GMT

Will trace
Will trace

Related tags: Crude heparin, Heparin

Heparin production may be moving back to Europe according to the EFCG, which cited the opening of Pharma Action’s processing plant as an indication that API buyers value quality and compliance throughout the supply chain.

Despite some fluctuations China is still the single largest pork product supplier according to the US Department of Agriculture (USDA), which estimated in an October report that the country produces 56m tons of pig meat every year​.

China is also a major supplier of crude heparin, which is a material derived from pig intestines that is used to produce the active pharmaceutical ingredient (API) that is vital to blood thinning medications used in surgery.

This reliance was acknowledged as a potential problem by US CDER director Janet Woodcock in June​ who said: “market share analysis indicates the majority of crude heparin [used by US drugmakers] remains to be sourced from China​,” which she described as “risky”.

Crude heparin used by API manufacturers in China is suspected to have been the cause of more than 100 deaths in 2008, with the allegation being that suppliers bulked up the raw materials they produced with a highly allergenic substance called oversulfated chondroitin sulphate (OSCS).

Despite this scandal, which has resulted in neither prosecution of suspected suppliers​ nor any Chinese investigation of the quality of the 15% of crude heparin used to make blood thinners for domestic consumption, China still dominates the global market.

China's continued dominance?

Drugmakers are under increasing pressure from regulators in the US​ and Europe​ to do more to ensure the quality of the raw materials they use throughout the supply chain, which is already prompting non-Chinese suppliers to invest in traceability.

Earlier this month​ German API supplier Pharma Action and parent company Toennies opened a crude heparin production plant making a virtue of the facility’s “total traceability​.”

The plant in Rheda-Wiedenbrueck in Western Germany will source pig intestinal mucosa only from slaughterhouses operated by Toennies, whose core business is meat production, and process this material into crude heparin. The plant will supply Pharma Action’s API production lab in Berlin.

One plant with capacity to produce 15 tonnes of crude heparin a year is a drop in the ocean compared with the millions of tons exported from China, but the owners’ emphasis on traceability could indicate a change in market dynamics according to the European Fine Chemicals Group (EFCG).

A spokesman for the organisation, which is part of the European chemical industry association CEFIC, said: “It may be interpreted as a sign that the pendulum is swinging back – and that production that had moved to the East is now finding its way back to Europe.​ 

That this green field site will be making heparin may be an indicator that quality and compliance is attributed a high value and that Western sites may deliver such soft attributes in spades​.” 

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