Overview about API manufacturing for the European market

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23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

EudraGMDP provides some interesting information about the API manufacturing sites as well as about importers, distributors of APIs to be used as starting material in Medicinal Products for human use in Europe. Although the database is still not complete (not all competent authorities in Europe have established a system to make sure that all registration data will be entered into EudraGMDP in a timely manner) the current information is already very interesting.

Currently (as per 19 March 2015) the database counts 3.275 API manufacturing sites, importers or distributors located outside Europe. On the other side 936 API manufacturing sites, importers or distributors are located in EEA countries (EU Member states plus Norway, Liechtenstein and Iceland). According to the database India counts for 1.473 companies and China for 1102 companies. The USA only counts for 198 and Switzerland for 71 companies. Within the EEA the United Kingdom counts 138 countries while Italy counts for 71and Spain for 192. Still work is needed to put all information into the database as France does not have a single entry and Germany only 3.

But the database is a good source to find some basic information about API manufacturers, importers and distributors. Each company registration file is available and allows to check the date of issue of the registration and the products concerned. However, it must be stated that a registration does not mean that an inspection took place. A registration will be granted also without a prior inspection at the company.

Source: API Registration in EudraGMDP