Onyx Scientific
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Drug Product
Analytical & Bioanalytical Services
Company Overview
About
Onyx Scientific is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals
Therapeutic Areas
Respiratory
Allergy
Quick Facts
HQ:United Kingdom
Founded:2007
Employees:1,854
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Manufacturing
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Sterile Injectable
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Europe
International Regulatory
EU GMP Certificates
1
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval SOG2RE
EMA · #APR-6A6B46BD · 2019-03-01
Drug Approval KLDCIW
PMDA · #APR-1U2F75ZT · 2018-11-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-I6MHUNYZ
Issued: 2020-11-01
Expires: 2025-02-14
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-FSWXFUAA
Issued: 2020-05-28
Expires: 2025-11-10
WHO GMP
World Health Organization
Cert #: CERT-QSPFJMK7
Issued: 2020-05-14
Expires: 2025-01-27
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-XU4WPNPS
Issued: 2020-05-05
Expires: 2025-11-08
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Key facts about Onyx Scientific
- Onyx Scientific is headquartered in the United Kingdom.
- Onyx Scientific was founded in 2007.
- Onyx Scientific has 1,854 employees.
- Onyx Scientific's capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.
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