Drug Product
Company Overview
About
Cultech Ltd. is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Cardiovascular
Endocrinology
Quick Facts
HQ:United Kingdom
Founded:2018
Employees:2,505
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
OEB 4 (1-10 µg/m³)
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Global
International Regulatory
EU GMP Certificates
2
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval 2WUC1N
FDA · #APR-V4YGIE6Z · 2018-01-01
Drug Approval KHKZ01
FDA · #APR-FTXQUJKP · 2018-01-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-NTO8B8J3
Issued: 2020-06-28
Expires: 2025-04-03
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-SGHP73QM
Issued: 2020-12-18
Expires: 2025-06-01
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-8QXWTUVD
Issued: 2020-08-08
Expires: 2025-10-08
Health Canada GMP
Health Canada
Cert #: CERT-FQNJLHTJ
Issued: 2020-07-02
Expires: 2025-08-12
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Key facts about Cultech Ltd.
- Cultech Ltd. is headquartered in the United Kingdom.
- Cultech Ltd. was founded in 2018.
- Cultech Ltd. has 2,505 employees.
- Cultech Ltd.'s capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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