Cambridge Isotope Laboratories, Inc.
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Excipients & Specialty Ingredients
Analytical & Bioanalytical Services
Company Overview
About
Cambridge Isotope Laboratories, Inc. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:France
Founded:1999
Employees:1,550
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
Phase II
Clinical
Pilot Scale
Markets Served
North America
Manufacturing Facilities
2 sites worldwide
Cambridge Isotope Laboratories, Inc.
3 Highwood Drive, Tewksbury, Massachusetts, 01876
Site Capabilities
1 capabilityAPI MANUFACTURE
Cambridge Isotope Laboratories, Inc.
50 Frontage Road, Andover, Massachusetts, 01810
Site Capabilities
1 capabilityAPI MANUFACTURE
Regulatory Approvals
Drug Approval Q713XK
EMA · #APR-0FUHX385 · 2022-01-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-DTOCI983
Issued: 2020-03-19
Expires: 2025-03-03
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-EJSN90B6
Issued: 2020-08-24
Expires: 2025-05-16
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-BPQKPIMF
Issued: 2020-04-11
Expires: 2025-09-06
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-2IRIANRC
Issued: 2020-02-25
Expires: 2025-05-15
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Key facts about Cambridge Isotope Laboratories, Inc.
- Cambridge Isotope Laboratories, Inc. is headquartered in France.
- Cambridge Isotope Laboratories, Inc. was founded in 1999.
- Cambridge Isotope Laboratories, Inc. has 1,550 employees.
- Cambridge Isotope Laboratories, Inc. has 2 manufacturing sites listed on CDMO Hub, in Tewksbury, United States and Andover, United States.
- Cambridge Isotope Laboratories, Inc.'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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