Leadcandidate
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Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Leadcandidate 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:2007
Employees:2,711
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
BSL-2 (Biosafety Level 2)
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Europe
Regulatory Approvals
Drug Approval KO8VTY
EMA · #APR-DKKIOB6U · 2020-05-01
Drug Approval 3BCVMY
FDA · #APR-LTLMA36N · 2021-05-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-9JMSIDXG
Issued: 2020-06-17
Expires: 2025-06-14
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-EUUTX0XI
Issued: 2020-12-05
Expires: 2025-05-27
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-G94QEY56
Issued: 2020-07-28
Expires: 2025-09-11
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Key facts about Leadcandidate
- Leadcandidate is headquartered in the United Kingdom.
- Leadcandidate was founded in 2007.
- Leadcandidate has 2,711 employees.
- Leadcandidate's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).
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