Gesellschaft für Micronisierung mbH

CDMO

Germany

https://www.mikronisierung.de/

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Drug Product

Analytical & Bioanalytical Services

Company Overview

About

Gesellschaft für Micronisierung mbH is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization

Therapeutic Areas

Respiratory

Allergy

Quick Facts

HQ:Germany

Founded:2015

Employees:1,119

Capabilities & Services

Core Capabilities

Biologics Drug Substance
Biologics Manufacturing
Formulation Development

Types of Organization

GMP Manufacturing

Quality Systems

Regulatory Support

Dosage Forms

Sterile Injectable

Containment Capabilities

OEB 4 (1-10 µg/m³)

Production Scales

Phase III Clinical Trials

Commercial Scale

Clinical

Markets Served

Global

International Regulatory

EU GMP Certificates

Regulatory Bodies

EMA/EudraGMDP

Regulatory Approvals

Drug Approval PJV1B3

FDA · #APR-Q6H2V4CV · 2022-10-01

Drug Approval GMH5WV

EMA · #APR-6G1X7W2D · 2019-06-01

Certifications

EMA GMP Certificate

European Medicines Agency

Cert #: CERT-18YHVQAK

Issued: 2020-11-13

Expires: 2025-05-20

ISO 13485:2016

International Organization for Standardization

Cert #: CERT-VMDAHC4E

Issued: 2020-07-15

Expires: 2025-01-10

Health Canada GMP

Health Canada

Cert #: CERT-33PCBDEA

Issued: 2020-09-25

Expires: 2025-09-16

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Key facts about Gesellschaft für Micronisierung mbH

Gesellschaft für Micronisierung mbH is headquartered in Germany.
Gesellschaft für Micronisierung mbH was founded in 2015.
Gesellschaft für Micronisierung mbH has 1,119 employees.
Gesellschaft für Micronisierung mbH's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.

Find CDMOs like Gesellschaft für Micronisierung mbH

Directory pages this company appears in, each with the full list of matching manufacturers.

CDMOs in Germany CDMOs in Europe Biologics Drug Substance CDMOs Formulation Development CDMOs Sterile Injectable CDMOs OEB 4 (1-10 µg/m³) CDMOs

Key facts about Gesellschaft für Micronisierung mbH

Gesellschaft für Micronisierung mbH is headquartered in Germany.

Gesellschaft für Micronisierung mbH was founded in 2015.

Gesellschaft für Micronisierung mbH has 1,119 employees.

Gesellschaft für Micronisierung mbH's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.