Cook MyoSite
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Advanced Modalities
Analytical & Bioanalytical Services
Company Overview
About
Cook MyoSite is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Infectious Disease
Quick Facts
HQ:United States
Founded:2009
Employees:1,958
Capabilities & Services
Core Capabilities
- Small Molecule API
- Small Molecule Drug Product
- Oral Solid Dose
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Oral Solid Dose
Containment Capabilities
OEB 4 (1-10 µg/m³)
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Global
Regulatory Approvals
Drug Approval F5Z6SM
FDA · #APR-9HI615A2 · 2018-06-01
Drug Approval Y719YA
FDA · #APR-YD6SNLQY · 2020-12-01
Certifications
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-2KSR75MS
Issued: 2020-09-24
Expires: 2025-01-11
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-CMRFZBAF
Issued: 2020-09-27
Expires: 2025-04-02
WHO GMP
World Health Organization
Cert #: CERT-1RY601MB
Issued: 2020-06-09
Expires: 2025-02-12
Health Canada GMP
Health Canada
Cert #: CERT-UBOIJWXR
Issued: 2020-03-15
Expires: 2025-01-28
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Key facts about Cook MyoSite
- Cook MyoSite is headquartered in the United States.
- Cook MyoSite was founded in 2009.
- Cook MyoSite has 1,958 employees.
- Cook MyoSite's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.
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