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Jiangsu Hengrui

Dolder’s Premium Supplier Jiangsu Hengrui Medicine strives for a US FDA audit for medicinal products


India and China have a distinctive fine chemical industry and are therefore important procurement markets for active substances (API) for the production of medicinal products. The number of API manufacturers in both countries is extraordinarily high, and Western quality standards have been documented by many companies both by the European authorities as well as by the US FDA in the form of on-site inspections.


High quality standards in India for the production of medicinal products
India distinguishes itself from China in that a number of companies associated with the local pharmaceutical industry have established the necessary quality standards for being able to export medicinal products to the USA. Until now in China, there has not been a large number of official inspections by the US FDA that would legitimize the export to the USA. The cause for this is surely that the high quality standards of a US FDA inspection have scared Chinese pharmaceutical companies away and the necessary quality standards for medicinal products have not yet been implemented adequately.


FDA inspection anticipated at Jiangsu Hengrui
For many years, Jiangsu Hengrui Medicine has been Dolder AG’s partner for the agents Oxaliplatin, Irinotecan, Etoposid, and Letrozol. Dolder is pleased to announce that this Chinese API Premium Supplier will soon (Q1 2010) be inspected by the US FDA for the medicinal products produced by Hengrui. This circumstance expresses yet again that Jiangsu Hengrui has constantly improved its quality management system and it has successfully implemented Western levels, not just at its new API location in Dapu; it also wants to implement these consistently at its other medicinal product production locations.

Dolder Pharma API: A reliable Partner - since 1898
Dolder Pharma API is a highly qualified, special distributor with additional services for active pharmaceutical ingredients (API). We operate world-wide and set our focus on selected markets in Europe, Asia and Latin America.