PMC Isochem (Isochem SAS, PMC Group)
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
PMC Isochem (Isochem SAS, PMC Group) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:France
Founded:2017
Employees:1,446
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
Cytotoxic / ADC Handling
Production Scales
Commercial Scale
Large Scale (Metric Ton+)
Markets Served
North America
Manufacturing Facilities
2 sites worldwide
PMC Isochem
4 Rue Marc Sangnier, Pithiviers, Loiret, 45300
Site Capabilities
1 capabilityAPI MANUFACTURE
PMC Isochem
4 Rue Philippe Lebon, Gennevilliers, Hauts-de-Seine F-, 92230
Site Capabilities
1 capabilityAPI MANUFACTURE
International Regulatory
EU GMP Certificates
25
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval JHG70F
FDA · #APR-ZSD5C4MA · 2018-04-01
Drug Approval KI71VJ
EMA · #APR-EXMLEKUI · 2022-06-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-1V6PH5N4
Issued: 2020-05-19
Expires: 2025-04-14
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-M1P11GOU
Issued: 2020-11-16
Expires: 2025-07-23
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-P8SM9MPD
Issued: 2020-06-09
Expires: 2025-10-25
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Key facts about PMC Isochem (Isochem SAS, PMC Group)
- PMC Isochem (Isochem SAS, PMC Group) is headquartered in France.
- PMC Isochem (Isochem SAS, PMC Group) was founded in 2017.
- PMC Isochem (Isochem SAS, PMC Group) has 1,446 employees.
- PMC Isochem (Isochem SAS, PMC Group) has 2 manufacturing sites listed on CDMO Hub, in Pithiviers, France and Gennevilliers, France.
- PMC Isochem (Isochem SAS, PMC Group)'s capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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