We offer a comprehensive service package to achieve approval for the market launch of new products. Depending on the target market, we are either in direct contact with the respective regulatory authorities or in cooperation with partners. Regulatory filings for a wide variety of medicinal products in all major target markets as well as numerous niche markets worldwide are proof of our high-quality work.

Our plant is periodically inspected by regulatory authorities from all over the world to ensure that our manufacturing process is officially certified. We are approved for delivery to the USA, Japan and many other major export countries.


Based on high quality

The basis for approval is our carefully planned and comprehensible development work. We prepare the documentation required for approval electronically and submit it in this form to the authorities for review.

FIDELIO Healthcare Limburg GmbH

Mundipharmastraße 2
65549 Limburg an der Lahn
+49 6431 908830
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