Minaris Regenerative Medicine (RM Minaris)

Germany

https://www.rm.minaris.com/en/

Advanced Modalities

Analytical & Bioanalytical Services

Regulatory, Tech Transfer & Support Services

Company Overview

About

Minaris Regenerative Medicine (RM Minaris) is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization

Therapeutic Areas

Neurology

Quick Facts

HQ:Germany

Founded:2002

Employees:588

Capabilities & Services

Core Capabilities

Cytotoxic / ADC Handling
High-Potency API
Sterile Fill/Finish

Technology Platforms

GMP Manufacturing

Quality Systems

Regulatory Support

Dosage Forms

Topical / Transdermal

Containment Capabilities

OEB 4 (1-10 µg/m³)

Production Scales

Pilot Scale

Phase I Clinical Trials

Clinical

Markets Served

Global

Manufacturing Facilities

3 sites worldwide

Minaris Regenerative Medicine (RM Minaris) - Germany Facility

Germany

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Site Capabilities

API Manufacturing

Sterile Fill/Finish

Lyophilization

Minaris Regenerative Medicine (RM Minaris) - Japan Facility

Japan

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Site Capabilities

API Manufacturing

Sterile Fill/Finish

Lyophilization

Minaris Regenerative Medicine (RM Minaris) - United States Facility

United States

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Site Capabilities

API Manufacturing

Sterile Fill/Finish

Lyophilization

Regulatory Approvals

Drug Approval NE4A8I

Health Canada · #APR-M1PU74S2 · 2019-07-01

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Drug Approval ZNUYI3

EMA · #APR-1ZVL6HHJ · 2022-05-01

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Certifications

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-8FMV7X5X

Issued: 2020-06-11

Expires: 2025-03-18

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MHRA GMP

UK Medicines and Healthcare products Regulatory Agency

Cert #: CERT-MAUXIE04

Issued: 2020-04-02

Expires: 2025-02-04

Download

Customer Reviews

4.1

Overall Rating

Project Management4.3

Technology Transfer4.2

On-Time Delivery4.5

Communication Responsiveness3.6

Innovation4.1

Company Documents

No documents available.

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