männer – Solutions for Plastics (Otto Männer GmbH, Barnes Group)
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Manufacturing & Lab Equipment
Company Overview
About
männer – Solutions for Plastics (Otto Männer GmbH, Barnes Group) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:Germany
Founded:1993
Employees:2,687
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Global
Regulatory Approvals
Drug Approval 52U7JK
Health Canada · #APR-VVB2P5OC · 2022-05-01
Drug Approval KEMNS2
PMDA · #APR-08KWSD9J · 2018-08-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-S257K2XY
Issued: 2020-03-11
Expires: 2025-04-24
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-ZC36DRPK
Issued: 2020-11-17
Expires: 2025-01-28
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-KZXCV1RK
Issued: 2020-08-24
Expires: 2025-07-12
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Key facts about männer – Solutions for Plastics (Otto Männer GmbH, Barnes Group)
- männer – Solutions for Plastics (Otto Männer GmbH, Barnes Group) is headquartered in Germany.
- männer – Solutions for Plastics (Otto Männer GmbH, Barnes Group) was founded in 1993.
- männer – Solutions for Plastics (Otto Männer GmbH, Barnes Group) has 2,687 employees.
- männer – Solutions for Plastics (Otto Männer GmbH, Barnes Group)'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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