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Transfer of the production of active ingredients, excipients and finished products back to the EU

Many pharmaceutical manufacturers purchase the majority of their active ingredients and excipients from non-EU countries, a majority of them from Asia. If there are quality problems in production, for example due to impurities (e.g. nitrosamines in sartans), or if production or export is stopped or there are logistical problems, the production of finished products in Europe also comes to a standstill.

The ABDA – Bundesvereinigung Deutscher Apothekerverbände e. V. (Federal Association of German Pharmacists) has already repeatedly criticised supply bottlenecks* for drugs, which could even lead to supply shortages in the worst case. Its cause is seen in particular in the relocation of production to the Far East.

ABDA has already reported in its fact sheet of December 2020: “The number of unavailable medicines has almost quadrupled from 4.7 (2017) to 9.3 (2018) to 18.0 (2019) million packs within two years. This means that every 36th medicinal product is affected (…)”. For the first half of 2020 alone, the association assumes 12.1 million unavailable packs. These include antibiotics, antihypertensives, gastric acid blockers or analgesics as well as antidepressants and antiepileptics.

For millions of affected patients throughout Europe, a new medicines strategy of the European Commission should be an important step towards solving this problem. It is supposed to include the obligation for pharmaceutical companies and wholesalers to report impending supply bottlenecks as well as efforts to increase the production of active substances and medicines in the EU.

These demands are beginning to have an effect: in the meantime, a number of companies are planning to transfer their production back to Germany or the EU.

BioChem Labor für biologische und chemische Analytik GmbH, as a GMP-certified quality control laboratory for microbiology, physico-chemical analysis and molecular biology/bioanalytics, will be pleased to support you if you are also planning such a transfer. This applies to active ingredients and excipients as well as to finished products that are supposed to be produced on site again.

Please contact us if you are interested in our analyses. Our experts will be pleased to provide you with further information.

Further information (excerpt):

*A supply bottleneck is defined as an interruption of a usual delivery lasting more than 2 weeks or a significantly increased demand that exceeds the supply.

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