Evonik Operations GmbH

Certification Body: DQS GmbH
Site Location: Darmstadt, Weiterstadt, Germany
Site Address: 1) Kirschenallee 64293 Darmstadt, Germany 2) Riedbahnstrasse 70, 64331 Weiterstadt, Germany
Scope: GDP, GMP
Full Certification Details

Manufacturing, testing, packaging, storage, and release of Acrylate/Methacrylate-copolymers (trade name: EUDRAGIT®) used as functional excipients for controlled release of active pharmaceutical ingredients for oral and dermal dosage forms. Manufacturing, testing, packaging, storage, and release of Biodegradable Polymers (trade name: RESOMER®) used as functional excipients for controlled release of active pharmaceutical ingredients or as raw materials for medical devices and applications. Release and distribution of coated HPMC capsules (trade name: EUDRACAP®) used as functional excipients for specific target site release of actives for oral dosage forms

Manufacturing, testing, packaging, storage, and release of biodegradable Polymers (trade name: RESOMERS®) used as functional excipients for controlled release of active pharmaceutical ingredients or a raw materials for medical devices and applications.

 

Issue Date: 12 January, 2023
Expiry Date: 11 January, 2026
Registration Number: 527392 EXCI
Certified Since: 27 January, 2014
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