DIVERCHIM is a Small Molecule Drug Substance CDMO which focuses on developing and manufacturing high added-value ingredients:
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Drug candidates APIs
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APIs for Orphan Drugs and Rare Diseases
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Radiopharmaceutical Precursors
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Niche specialty chemicals
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Emergency medications
More than 20 years serving the development of New Chemical Entities,
from a CRO to a CDMO
Pharmaceuticals | Cosmetics | Specialty Chemicals |
---|---|---|
Diagnostics |
Memberships
Our values
Describe your image
Describe your image
Describe your image
Describe your image
Memberships
DIVERCHIM is highly committed in running its business with high level of ethical considerations and developing manufacturing processes that are environmentally responsible.
Safety
Gender Equality
45%
55%
Certification in progress
Yasmine
Bencheikh
HSE Manager
Claire
Brayer
Office Manager
Bruno
Dudot
Head of Large Scale Production
Benoît
Folléas
CSO, Head of Project
Management
Fabien
LAJUS
Head of QC Lab. And Analytical Development
Jessica
Le Manac'h
Head of HR and Accounting
François
Macarez
CEO
Cédric
Ngoulou
Head of Purchasing
Caroline
Perrain
QA and Regulatory Affairs Director
Comprehensive offering, from Preclinical stage to Commercial, dedicated to the
development and manufacturing of:
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Small molecule APIs (including RSM and advanced intermediates)
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Radiopharmaceutical precursors
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GMP excipients and Linkers
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Polymers, Nano-lipids and Hydrogels
Services
Development phase
Additional services include:
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Lyophilization and Solid aliquotation of Radiopharmaceutical precursors
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Reference standards
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Standalone analytics
• Team of 5 lead by QA Director, Org. chemist by training with 20-year experience in QA
• ICHQ7 based quality system
• GMP certification of the site since 2015
• Last audit: July-22
• Mock inspection Oct.- 2021(site registered by FDA since 2021)
• PAI expected Q4 2024 – Q1 2025
• DMF files submitted & accepted (EU+Switzerland + USA): 5
• DMF files to be submitted: 10
•Project management Director, member of Comex team
•Nomination of a dedicated PM at the start-up of each project
•Project team includes experts of all services to ensure a smooth execution to comply with customer’s request
•Management of activities (Route scouting, Developments, Validation, Stability studies, Production) handled by a PM
•The PM is the privileged contact of the customer during the whole product life cycle
State-of-the-art 3000 m² facility built in 2013 including:
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Our facility is strategically located just 20 kilometers north of Paris, near the Roissy-Charles de Gaulle airport
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This prime location provides us with exceptional connectivity, allowing for efficient logistics and accessibility to key international hubs
Lyophilization (Dispensing and Freeze-Drying capabilities)
“Ultra-clean” vials preparation in dedicated cGMP area
Development studies:
•Identification of CPP/KPP/nCPP
•Determination of PAR/NOR
•Ensure process robustness and GMP compliance
Current capacities:
- 400 2R Vials / run
- 180 10R vials / run
Additional capacities (investment in progress – operational T2/T3 2024):
- 1100 2R Vials / run
- 310 10R vials / run
(Dispensing and Freeze-Drying capabilities)
“Ultra-clean” vials preparation in dedicated cGMP area
Development studies:
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Identification of CPP/KPP/nCPP
-
Determination of PAR/NOR
-
Ensure process robustness and GMP compliance
Current capacities (2 equipment):
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400 / 1100 2R Vials / run
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180 / 310 10R vials / run