China’s export of western medicine products reached USD36.883 billion in 2018, wherein, the export of western medicine preparations reached USD4.100 billion, growing by 18.64% year on year.

Related: Dual tailwinds for the injection export of Chinese pharmaceutical enterprises to the U.S.
Among all the drug dosage forms exported, the quality standards for injections exported to countries with regulated markets are the strictest as injections are directly injected into bodies. The strong regulation of the FDA over sterile injections has led to a generic injection drug market with high concentration and incomplete competition, and compliant generic injection drugs have become scarce resources with high barriers but also bringing high income.
According to statistics, there are only 8 Chinese pharmaceutical enterprises that have received injection ANDA approvals from the FDA, wherein, only the 4 preparation exporters: Hengrui Medicine, King-Friend, Qilu Pharmaceutical, and Poly Pharm can continuously supply to the U.S. market.
4 Chinese Pharmaceutical Enterprises that Continue to Supply Injections to the U.S. Market | |
Enterprise name | Number of injection ANDAs approved by the FDA |
Hengrui Medicine | 10 |
King-Friend | 10 |
Qilu Pharmaceutical | 8 |
Poly Pharm | 6 |
Source: The FDA
Hengrui Medicine
The oncology drug irinotecan produced by Hengrui Medicine passed the certification of the U.S. FDA in Dec. 2011 to become the first Chinese-produced injection marketed in the U.S. Hengrui Medicine has continued to increase the R&D investment in recent years and built its quality system according to standards of the U.S. FDA, to promote the "going out" international strategy of Chinese-produced preparations.
So far, Hengrui Medicine has a total of 10 injection ANDA approval numbers from the FDA, tying for the first place with King-Friend, being a leader in the internationalization of Chinese-produced injection products; many of its injection varieties have achieved large-scale sales, and the exported injection products are based on oncology drugs and anesthetics in which Hengrui Medicine has advantages.










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