Report: FDA Licensed Two Uyghur Region Drugmakers for Export to US
A new report from C4ADS says that although only 4% of Chinese pharmaceuticals are manufactured in Xinjiang province, FDA registrations of companies in the Uyghur region show that imports that should be banned under the Uyghur Forced Labor Prevention Act are happening.
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The researcher says that 76 pharmaceutical products exported from China are only produced in the Xinjiang Uyghur Autonomous Region. However, some of those products, such as conjugated estrogen tablets and creams, go to an Indian manufacturer, so U.S. importers that source from India may not realize the link to Uyghur forced labor.
"At least two XUAR-based pharmaceutical companies are currently registered with the FDA, meaning these companies are authorized to import to the United States. According to the UFPLA’s rebuttable presumption, these XUAR-based entities should not be allowed to distribute in or export to the U.S. market," the Side Effects report said.
There is one pharma company on the UFLPA entity list, the report said -- Chenguang Biotech Group.
The report asks the UFLPA entity list task force to add Sinopharm, Xinjiang Deyuan Bioengineering, Xinjiang Nuziline Bio-Pharmaceutical (the estrogen producer) and Xinjiang Huashidan Pharmaceutical to the list. Sinopharm is China's biggest drug manufacturer; Xinjiang is its fourth-largest manufacturing base, the report said. It said there is no clear data about the exporting practices of Xinjiang Deyuan Bioengineering. The last firm primarily makes Chinese traditional medicine, but does make some painkillers.
The researcher's investigation of licensing records in China found that 14 products are only made in Xinjiang:
- Licorice sweetener R-19
- Dipotassium glycyrrhizinate
- Naproxen sodium extended-release tablets
- Garlic enteric coated tablets
- Fruity vitamin C Tablets
- Glycyrrhizic acid monoammonium salt A
- Allicin soft capsules
- Calcium gluconate oral solution (sugar-free type)
- Licorice sweetener R-21
- Lamb stomach extract
- Oral rehydration salt powder (I)
- Haloperidol oral solution
- Trisodium glycyrrhizinate
- Aminophen and pseudoephedrine effervescent granules.
So, the paper posits, if a U.S. company is importing any of those products from China, it is likely to be under UFLPA's purview.
"Ownership data suggests that -- possibly in response to the UFLPA’s rebuttable presumption -- XUAR-based entities are registering in different provinces within China or even Vietnam to obscure their manufacturing in XUAR," the report said. "For example, five of the privately owned manufacturers licensed in XUAR are incorporated elsewhere, despite the fact that their business is concentrated to the region."