Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Bachem AG is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Germany
Founded:1991
Employees:773
Capabilities & Services
Core Capabilities
- Oral Solid Dose
- Solid Dose Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Lyophilized (Freeze-Dried)
Sterile Injectable
Containment Capabilities
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Asia-Pacific
Manufacturing Facilities
1 site worldwide
Bachem AG
Hauptstrasse 144, Bubendorf, 4416
Site Capabilities
2 capabilitiesANALYSIS
API MANUFACTURE
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval H6Y1GS
Health Canada · #APR-SQYRHPTM · 2022-10-01
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-J6VPHMSW
Issued: 2020-12-16
Expires: 2025-02-13
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-AK0YY4S1
Issued: 2020-11-02
Expires: 2025-01-21
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Key facts about Bachem AG
- Bachem AG is headquartered in Germany.
- Bachem AG was founded in 1991.
- Bachem AG has 773 employees.
- Bachem AG has one manufacturing site listed on CDMO Hub, in Bubendorf, Switzerland.
- Bachem AG's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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