Grünenthal (Grünenthal PRO / CDMO)
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Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Grünenthal (Grünenthal PRO / CDMO) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Oncology
Hematology
Quick Facts
HQ:Chile
Founded:2011
Employees:2,669
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
OEB 5 (≤1 µg/m³)
Cytotoxic / ADC Handling
Production Scales
Phase III Clinical Trials
Commercial Scale
Clinical
Markets Served
Asia-Pacific
International Regulatory
EU GMP Certificates
3
Regulatory Bodies
EMA/EudraGMDP
EMA
Regulatory Approvals
Drug Approval AP10AJ
FDA · #APR-Z75U6E4F · 2018-08-01
Drug Approval HGR74I
PMDA · #APR-Y0PE81RH · 2020-02-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-7JQN82KZ
Issued: 2020-11-17
Expires: 2025-11-01
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-OXUOK6HE
Issued: 2020-06-19
Expires: 2025-10-18
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-Z79SBOKO
Issued: 2020-05-11
Expires: 2025-02-03
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Key facts about Grünenthal (Grünenthal PRO / CDMO)
- Grünenthal (Grünenthal PRO / CDMO) is headquartered in Chile.
- Grünenthal (Grünenthal PRO / CDMO) was founded in 2011.
- Grünenthal (Grünenthal PRO / CDMO) has 2,669 employees.
- Grünenthal (Grünenthal PRO / CDMO)'s capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.
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