Certified quality

GMP certificate (current Good Manufacturing Practice)

cGMP describes guidelines for “good manufacturing practice”. The focus here is on the quality assurance of the production processes and production environment for the processing of pharmaceuticals, active agents and medical devices.

Quality management system (QM system)
We employ a QM system that includes the “good manufacturing practice” in accordance with our activities. All in-house divisions concerned with the creation, maintenance and implementation of the QM system are permanently subject to the requirements of the EU GMP guideline.

Qualified Person
The Qualified Person checks the batch release and thus the formal and substantive accuracy of the batch documentation in accordance with the EU GMP guideline.

Accreditation in Japan

We are accredited in Japan as a certified manufacturer. In cooperation with our Japanese business agent, we will be happy to assist you to obtain accreditation for your products for the Japanese market as well.

FDA authorization (Food and Drug Administration)

To complay with the periodic inspections conducted by the Food and Drug Administration of the United States, our company has an additional production qualification for the American market.

Manufacturing authorization

Our company has a manufacturing authorization in compliance with §13 AMG (German Medicinal Products Act).
As such, our cGMP conformity is regularly confirmed by the
responsible authorities.

Download certificates

GMP-Zertifikat Humanarzneimittel

GMP-Zertifikat Humanarzneimittel

GMP-Zertifikat_Humanarzneimittel

Download PDF

GMP-Zertifikat Tierarzneimittel

GMP-Zertifikat Tierarzneimittel

GMP-Zertifikat Tierarzneimittel

Download PDF

FDA Approval Letter

FDA Approval Letter

FDA
Approval Letter

Download PDF

Herstellungserlaubnis

Herstellungserlaubnis

Herstellungserlaubnis

Download PDF

Herstellungserlaubnis EN

Herstellungserlaubnis EN

Herstellungserlaubnis EN

Download PDF

Akkreditierung Japan Ministry of Agriculture and Fisheries

Akkreditierung Japan Ministry of Agriculture and Fisheries

Akkreditierung Japan Ministry of Agriculture and Fisheries

Download PDF

Akkreditierung Japan Ministry of Health, Labour and Welfare sterile Wirkstoffe

Akkreditierung Japan Ministry of Health, Labour and Welfare sterile Wirkstoffe

Akkreditierung Japan Ministry of Health, Labour and Welfare sterile Wirkstoffe

Download PDF

Akkreditierung Japan Ministry of Health, Labour and Welfare nicht sterile Wirkstoffe

Akkreditierung Japan Ministry of Health, Labour and Welfare nicht sterile Wirkstoffe

Akkreditierung Japan Ministry of Health, Labour and Welfarenicht sterile Wirkstoffe

Download PDF