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RubiePharm Arzneimittel GmbH

Not yet confirmed Manufacturing authorisation GMP certificate 36396 Steinau · Hessen rubiepharm.de ↗

Profile

RubiePharm Arzneimittel GmbH, based in Steinau an der Straße, carries out contract manufacturing of suppositories, ovules, ointments, creams and gels, as well as food supplements. Its services include packaging, material sourcing and stability programmes.

Services

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

ServiceStatusEvidenceQuote from the company’s website (German)
Contract manufacturing of liquids and semi-solids
Manufacturing
Evidenced

„Effizient ist die Lohnfertigung von RubiePharm auch bei der Herstellung von Salben, Cremes und Gelen.“

Source · 10 Nov 2026 ↗
Filling and packaging
Manufacturing
Evidenced

„Die Folie wird bedruckt und tiefgezogen, die Suppositorienhülsen werden befüllt und in Riegel geschnitten. Abschließend erfolgt die Konfektionierung mit Gebrauchsinformation und Faltschachtel.“

Source · 10 Nov 2026 ↗
Contract analytical testing
Testing and analytics
Evidenced

„Analytische Prüfungen aller Rohstoffe und Fertigprodukte“

Source · 10 Nov 2026 ↗
Stability testing
Testing and analytics
Evidenced

„Stabilitätsprogramme nach ICH-Standard für unterschiedliche Klimazonen“

Source · 10 Nov 2026 ↗
Analytical method development and validation
Testing and analytics
Evidenced

„Validierung oder Transfer analytischer Methoden“

Source · 10 Nov 2026 ↗
Qualification and validation
Engineering and validation
Evidenced

„Prozessvalidierungen“

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_HE_01_MIA_2024_0010

Steinau

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_HE_01_GMP_2026_0149

Steinau

DE_HE_01_GMP_2026_0150

Steinau

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

Sites

Brueder-Grimm-Strasse 121
36396 Steinau

Headquarters

Brueder-Grimm-Strasse 62
36396 Steinau