Drug Product
Excipients & Specialty Ingredients
Regulatory, Tech Transfer & Support Services
Company Overview
About
Chematek S.p.A. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Italy
Founded:2008
Employees:406
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
Cytotoxic / ADC Handling
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
North America
Regulatory Approvals
Drug Approval 9ILIMJ
FDA · #APR-T6OAX04V · 2019-07-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-DYNVUTQA
Issued: 2020-03-04
Expires: 2025-01-23
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-21TUOWTH
Issued: 2020-01-23
Expires: 2025-09-25
Health Canada GMP
Health Canada
Cert #: CERT-K8C5BZLB
Issued: 2020-09-12
Expires: 2025-02-08
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Key facts about Chematek S.p.A.
- Chematek S.p.A. is headquartered in Italy.
- Chematek S.p.A. was founded in 2008.
- Chematek S.p.A. has 406 employees.
- Chematek S.p.A.'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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