Drug Product
Analytical & Bioanalytical Services
Company Overview
About
Serumwerk Bernburg AG is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:Germany
Founded:1998
Employees:1,715
Capabilities & Services
Core Capabilities
- Sterile Injectable
- Sterile Fill/Finish
- Fill/Finish (Vials)
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Cartridge / Pen
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
Global
Manufacturing Facilities
1 site worldwide
Serumwerk Bernburg AG
Hallesche Landstraße 105B, Bernburg, 06406
Site Capabilities
2 capabilitiesAPI MANUFACTURE
MANUFACTURE
International Regulatory
EU GMP Certificates
4
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval KQUYZS
EMA · #APR-XD6PLZXA · 2018-01-01
Drug Approval Z3AB1Y
EMA · #APR-00W81F5C · 2021-05-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-G30GR6SE
Issued: 2020-05-27
Expires: 2025-06-17
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-SV5AF4EH
Issued: 2020-05-24
Expires: 2025-04-25
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-CCVUUI0I
Issued: 2020-07-24
Expires: 2025-12-09
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-L75VFM7B
Issued: 2020-03-19
Expires: 2025-03-10
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Key facts about Serumwerk Bernburg AG
- Serumwerk Bernburg AG is headquartered in Germany.
- Serumwerk Bernburg AG was founded in 1998.
- Serumwerk Bernburg AG has 1,715 employees.
- Serumwerk Bernburg AG has one manufacturing site listed on CDMO Hub, in Bernburg, Germany.
- Serumwerk Bernburg AG's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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