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MRI GmbH – Address & Contact
MRI GmbH Overview
MRI GmbH is a contract manufacturer for pharmaceuticals or medical devices based in Hessisch Lichtenau, Lower Saxony. The company produces on behalf of other companies and has a manufacturing license in accordance with Section 13 AMG.
Leistungen & Kapazitäten
MRI GmbH offers contract manufacturing services for pharmaceuticals and/or medical devices. This typically includes synthesis, formulation, filling, packaging and quality control. All processes take place under GMP-compliant conditions.
Location & Contact
MRI GmbH can be reached at the following address: Lilienthalstr 17, 37235 Hessisch Lichtenau – Phone: 056027248. For current information and enquiries, please contact the company directly.
More information: Lohnhersteller in Niedersachsen or all Lohnhersteller in Germany on Sanoliste.
Contract Manufacturing in der Pharmaindustrie
Contract manufacturing organizations (CMOs) such as MRI GmbH produce pharmaceuticals, nutritional supplements or medical devices on behalf of other companies. Contract manufacturing typically includes active ingredient synthesis, formulation, filling, primary and secondary packaging through to release by a qualified person (QP). The CMO market is growing worldwide as more and more pharmaceutical companies outsource production to specialized partners.
GMP-Anforderungen & Herstellungserlaubnis
As a contract manufacturer, MRI GmbH requires a manufacturing permit in accordance with Section 13 AMG. Production must comply with the rules of Good Manufacturing Practice (GMP), which are defined in the EU by EudraLex Volume 4. Regular inspections by the responsible state authority and a comprehensive quality management system are mandatory. Each batch is checked by a qualified person (QP) before release.
Standortvorteil Niedersachsen
Lower Saxony offers contract manufacturers such as MRI GmbH access to qualified specialists, a strong supplier industry and renowned pharmaceutical research institutions. The Hessisch Lichtenau location enables short distances to clients and efficient logistics in the European internal market.
Frequently asked questions about MRI GmbH
Was ist MRI GmbH?
MRI GmbH ist ein Lohnhersteller mit Sitz in Hessisch Lichtenau. Das Unternehmen produziert im Auftrag andere pharmazeutische Produkte oder Medizinprodukte und verfügt über eine GMP-Herstellungserlaubnis nach AMG.
What is contract manufacturing in the pharmaceutical industry?
Contract manufacturing refers to the production of pharmaceutical or medical products on behalf of third-party companies. Contract manufacturers hold GMP manufacturing licences pursuant to Section 13 of the German Medicines Act (AMG) and are subject to regulatory supervision.
Welche Leistungen bietet MRI GmbH an?
MRI GmbH bietet Lohnherstellungsdienstleistungen für pharmazeutische oder medizinische Produkte an. Das genaue Leistungsspektrum umfasst je nach Spezialisierung Konfektionierung, Herstellung, Abfüllung oder Qualitätskontrolle.
What is the difference between a CMO and a CDMO?
A CMO (Contract Manufacturing Organization) exclusively carries out contract manufacturing. A CDMO (Contract Development and Manufacturing Organization) additionally offers development services \u2013 from formulation development through scale-up to process validation. MRI GmbH operates as a contract manufacturer in this market.
What is a Qualified Person (QP)?
The Qualified Person (QP) is an expert required by law under Section 14 of the German Medicines Act (AMG) who inspects and releases each batch of medicines before it is placed on the market. The QP bears personal responsibility for ensuring that each batch has been manufactured and tested in accordance with GMP.
What certifications does a contract manufacturer require?
Contract manufacturers require a manufacturing licence pursuant to Section 13 of the German Medicines Act (AMG), a GMP certificate based on regular authority inspections and, depending on the client, additional certifications such as ISO 9001, ISO 13485 (for medical devices) or FDA registration for the US market.
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