Osmopharm S.A.
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Drug Product
Analytical & Bioanalytical Services
Company Overview
About
Osmopharm S.A. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Switzerland
Founded:2018
Employees:2,030
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
Pilot Scale
Clinical
Commercial Scale
Markets Served
Asia-Pacific
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval 3764K0
FDA · #APR-HQ591WD6 · 2018-10-01
Drug Approval NUKCWH
Health Canada · #APR-ND8E1BF3 · 2019-01-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-WHMSYP35
Issued: 2020-10-18
Expires: 2025-03-04
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-8405XDH9
Issued: 2020-02-20
Expires: 2025-08-01
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-RB0UCZL7
Issued: 2020-05-03
Expires: 2025-11-05
WHO GMP
World Health Organization
Cert #: CERT-BEKEXRL2
Issued: 2020-10-21
Expires: 2025-08-27
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Key facts about Osmopharm S.A.
- Osmopharm S.A. is headquartered in Switzerland.
- Osmopharm S.A. was founded in 2018.
- Osmopharm S.A. has 2,030 employees.
- Osmopharm S.A.'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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