AGON Pharma GmbH
Profile
AGON Pharma GmbH, based in Wendlingen, provides contract analytical services for batch release testing, stability studies in climatic chambers, and method validation and marketing authorisation support for medicinal products of other companies.
Services
Evidenced: named on the company’s own website. Unclear: checked, nothing conclusive found.
| Service | Status | EvidenceQuote from the company’s website (German) |
|---|---|---|
| Contract analytical testing Testing and analytics |
Evidenced |
„conduct release testing of your medicinal products for final batch release or quality control on your behalf“ Source · 10 Nov 2026 ↗ |
| Stability testing Testing and analytics |
Evidenced |
„We store your stability samples and monitor test times, and ensure appropriate removal from storage“ Source · 10 Nov 2026 ↗ |
| Analytical method development and validation Testing and analytics |
Evidenced |
„we are able to perform validation activities based on your specifications and in compliance with the ICH Guideline Validation of Analytical Procedures Q2 (R1)“ Source · 10 Nov 2026 ↗ |
| Regulatory affairs Regulatory and safety |
Evidenced |
„Benefit from over 30 years of experience in preparing and submitting national and international marketing authorisation documentation“ Source · 10 Nov 2026 ↗ |
Official credentials
Manufacturing authorisation
The competent authority of the federal state authorises the site to manufacture, test or import medicinal products (Section 13 of the German Medicinal Products Act, AMG). Without this authorisation it may not do so.
DE_BW_01_MIA_2026_0030
Wendlingen Am Neckar
Source: EMA/EudraGMDP, reported by the competent state authority · as of 10 Nov 2026 ↗GMP certificate
The authority has inspected the site and confirmed that it complies with Good Manufacturing Practice (GMP).
DE_BW_01_GMP_2026_0061
Wendlingen Am Neckar
Source: EMA/EudraGMDP, reported by the competent state authority · as of 10 Nov 2026 ↗Sites
Stuttgarter Strasse 2
73240 Wendlingen Am Neckar