FusionPharma B.V.

CDMO

Germany

https://fusionpharmabv.com

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Excipients & Specialty Ingredients

Analytical & Bioanalytical Services

Contract Research Organization

Company Overview

About

FusionPharma B.V. is a leading contract development and manufacturing organization headquartered in Germany. We specialize in Fill/Finish, Packaging with state-of-the-art facilities serving clients globally.

Key Expertise

Packaging & Labeling, Liquid/Semi-Solid, Small Molecule API, Microbiology Testing, Cell & Gene Therapy

Therapeutic Areas

Respiratory

Allergy

Quick Facts

HQ:Germany

Founded:2006

Employees:14,250

Capabilities & Services

Core Capabilities

Biologics Drug Substance
Biologics Manufacturing
Formulation Development

Types of Organization

Commercial Manufacturing

Contract Research Organization (CRO)

Dosage Forms

Sterile Injectable

Containment Capabilities

BSL-2 (Biosafety Level 2)

Production Scales

Phase III Clinical Trials

Commercial Scale

Clinical

Batch Sizes

1L-10L

1000L-5000L

5000L+

10L-100L

Markets Served

Europe

Manufacturing Facilities

3 sites worldwide

FusionPharma B.V. - Headquarters

797 Industrial Park, Berlin, Berlin, 55190

View on Map

48,907 sq ft

Established 2002

Site Capabilities

8 capabilities

Biologics Drug Substance

Sterile Injectable

Small Molecule Drug Product

Stability Studies

Analytical Services

Aseptic Processing

FusionPharma B.V. - Incheon Facility

431 Industrial Boulevard, Incheon, Incheon, 71409

View on Map

428,755 sq ft

Established 2000

Site Capabilities

7 capabilities

Cell & Gene Therapy

Liquid/Semi-Solid

Antibody-Drug Conjugates (ADC)

Fill/Finish (Vials)

Method Development & Validation

Regulatory Support

FusionPharma B.V. - Munich Facility

425 Industrial Drive, Munich, Munich, 28230

View on Map

252,207 sq ft

Established 1991

Site Capabilities

6 capabilities

Supply Chain Management

Fill/Finish (Vials)

Biologics Drug Product

Small Molecule API

Regulatory Support

Oral Solid Dose

Regulatory Approvals

Drug Approval DFF9AP

EMA · #APR-F94H4NJ3 · 2019-03-01

Drug Approval O9GD5Q

PMDA · #APR-KNK2F9XH · 2019-12-01

Product Portfolio

Precision Fill-Finish Service

Brochure

Our specialized service offering for Metabolic Disease applications.

Ointment

Injectable

Solution

Delivery: Oral, Inhalation

Advanced Fill-Finish Service

Brochure

Our comprehensive service offering for Ophthalmology applications.

Solution

Injectable

Suspension

Delivery: Topical, Intramuscular

Certifications

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-Z1LIQT68

Issued: 2020-03-21

Expires: 2025-11-14

WHO GMP

World Health Organization

Cert #: CERT-5R7VGWWW

Issued: 2020-02-20

Expires: 2025-10-24

MHRA GMP

UK Medicines and Healthcare products Regulatory Agency

Cert #: CERT-7GQP9TSD

Issued: 2020-08-14

Expires: 2025-04-19

Customer Reviews

4.4

Overall Rating(Based on 11 reviews)

Project Management4.6

Technology Transfer4.3

On-Time Delivery4.5

Communication Responsiveness3.8

Innovation4.8

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Key facts about FusionPharma B.V.

FusionPharma B.V. is headquartered in Germany.
FusionPharma B.V. was founded in 2006.
FusionPharma B.V. has 14,250 employees.
FusionPharma B.V. has 3 manufacturing sites listed on CDMO Hub, in Berlin, Germany, Incheon, South Korea and Munich, Germany.
FusionPharma B.V.'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.

Find CDMOs like FusionPharma B.V.

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 BSL-2 (Biosafety Level 2) CDMOs

Key facts about FusionPharma B.V.

FusionPharma B.V. is headquartered in Germany.

FusionPharma B.V. was founded in 2006.

FusionPharma B.V. has 14,250 employees.

FusionPharma B.V. has 3 manufacturing sites listed on CDMO Hub, in Berlin, Germany, Incheon, South Korea and Munich, Germany.

FusionPharma B.V.'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.