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Lyomark Pharma GmbH

Not yet confirmed Manufacturing authorisation GMP certificate 82041 Oberhaching · Bayern lyomark.com ↗

Profile

Lyomark Pharma GmbH, based in Oberhaching near Munich, manufactures lyophilised and liquid sterile products, predominantly for the hospital market. The company also prepares marketing authorisation dossiers and periodic reports.

Services

Evidenced: named on the company’s own website. Unclear: checked, nothing conclusive found.

ServiceStatusEvidenceQuote from the company’s website (German)
Contract manufacturing of sterile products
Manufacturing
Evidenced

„Herstellung und Konfektionierung von Lyophilisaten (gefriertrocknete Arzneimittel) und Injektionslösungen“

Source · 10 Nov 2026 ↗
Regulatory affairs
Regulatory and safety
Evidenced

„Neben der Zurverfügungstellung der Dossiers unserer Produkte und der darauf basierenden Einreichung von Zulassungen sind auch folgende weitere Dienstleistungen erhältlich“

Source · 10 Nov 2026 ↗
Pharmacovigilance
Regulatory and safety
Evidenced

„Erstellung von Product Quality Reviews (PQR) und Periodic Safety Update Reports (PSUR)“

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_BY_04_MIA_2026_0021

Oberhaching

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_BY_04_GMP_2026_0046

Oberhaching

Source: EMA/EudraGMDP, reported by the competent state authority · as of 10 Nov 2026 ↗

Sites

Keltenring 17
82041 Oberhaching

Headquarters