Li Li, a drug industry veteran, spent almost five years getting his heparin plant ready for U.S. regulatory approval.
It was an arduous process, he said, displaying thick black binders with detailed documentation of his operations here. And his timing couldn't have been better.
Heparin, a widely used blood thinner, was once made from cow lungs. Drug makers shifted to pig intestines as concerns over mad cow disease heightened in the 1990s, and no place has more hogs than China. In October 2005, Li's company made its first shipment to the U.S. Since then, Shenzhen Hepalink Pharmaceutical Co. has become the world's largest producer of heparin's main ingredient.
Now Li and his staff of 370 are watching to see what will happen to their main Chinese rival for the U.S. market.
That company is under intense scrutiny in the wake of four deaths in the U.S. that were linked to heparin made by Baxter International Inc. Baxter has said that tests detected irregularities in samples of the drug processed with ingredients from China. Baxter's Chinese supplier, Changzhou SPL -- a joint venture with a Wisconsin company -- was never inspected by the Food and Drug Administration, nor was it registered with Chinese drug regulators as required.
FDA inspectors last week arrived at the Changzhou SPL plant. On Monday, an FDA spokeswoman said the investigation was continuing.
The Chinese heparin-materials industry is under a spotlight as foreign drug makers and others in the health field wonder about the quality of its products. Since 2005, Li said, his plant has been inspected on nine occasions by Chinese and foreign authorities and audited 25 times by Hepalink's customers, including five times by its U.S. client, APP Pharmaceuticals Inc. of Schaumburg, Ill.
This week APP is paying an outside drug regulatory affairs specialist to visit Hepalink. Li said he didn't know what the two representatives from Drug Source Co. would focus on. "It is an unannounced random audit," Li said.
Hepalink is the biggest of some 50 Chinese exporters that rake in more than $100 million in sales and dominate the global market for heparin products. But only 32 companies are listed with China's drug regulatory agency as qualified makers of heparin ingredients. The reason for the discrepancy isn't clear, but some companies are registered not as drug producers but as chemical makers, as apparently was the case at Changzhou SPL.
The Chinese State Food and Drug Administration has refused to comment on Changzhou SPL or other heparin suppliers.
Chinese companies have been making heparin for about 30 years, and industry executives and health experts at universities couldn't recall any incident of major health problems with the drug in China.
Although Li wouldn't talk about Hepalink's finances or market information, he allowed a reporter to briefly view inspection records and walk through the 100,000-square-foot facility, located in an economic zone near Hong Kong.
Hepalink's workshop and labs are replete with equipment imported from the U.S., Europe and Japan. The company takes out impurities from raw heparin in a process that includes filtration, sterilization and freeze-drying and takes about a month.
Li said his staff of 110 in quality management and 72 in logistics randomly inspects heparin suppliers, as well as the slaughterhouses that extract pulp from pig intestines.
Hepalink's annual shipments come from tens of millions of pigs. Li said that if there was a problem with any shipment, he had the ability to trace it to individual groups of pigs. He said Hepalink's pigs came from slaughterhouses registered with authorities and that buy pigs that have been vaccinated, quarantined and certified by the government.
It isn't clear whether intestines from a sick pig could create problems in a finished drug, nor do regulators specify testing of source pigs, but Li said traceability to the original stock was necessary to ensure quality and safety of the final product. In this regard, he said, "the most important standard is whether or not a pig is healthy enough to enter the human food chain."
Last year, Li said, Hepalink terminated about 10% of the company's crude heparin suppliers and slaughterhouses because they failed inspections.
Times staff writer Andrea Chang in Los Angeles contributed to this report.