Nelipak Healthcare Packaging
Costa Rica
Drug Product
Regulatory, Tech Transfer & Support Services
Company Overview
About
Nelipak Healthcare Packaging is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Quality Control, Stability Testing, Method Development
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:Costa Rica
Founded:2013
Employees:446
Capabilities & Services
Core Capabilities
- Peptide Synthesis
- Small Molecule API
- Formulation Development
Technology Platforms
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Inhalation
Containment Capabilities
BSL-2 (Biosafety Level 2)
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
Europe
Manufacturing Facilities
6 sites worldwide
Nelipak Healthcare Packaging - Costa Rica Facility
Costa Rica
Site Capabilities
Quality Control
Stability Testing
Method Development
Nelipak Healthcare Packaging - Ireland Facility
Ireland
Site Capabilities
Quality Control
Stability Testing
Method Development
Nelipak Healthcare Packaging - Netherlands Facility
Netherlands
Site Capabilities
Quality Control
Stability Testing
Method Development
Nelipak Healthcare Packaging - Puerto Rico Facility
Puerto Rico
Site Capabilities
Quality Control
Stability Testing
Method Development
Nelipak Healthcare Packaging - United Kingdom Facility
United Kingdom
Site Capabilities
Quality Control
Stability Testing
Method Development
Nelipak Healthcare Packaging - United States Facility
United States
Site Capabilities
Quality Control
Stability Testing
Method Development
Regulatory Approvals
Drug Approval SGP42M
EMA · #APR-YCKIZIL0 · 2018-11-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-7GZDTX4S
Issued: 2020-12-13
Expires: 2025-05-14
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-EMCTQDC9
Issued: 2020-04-21
Expires: 2025-05-11
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-PAHXPUS3
Issued: 2020-07-04
Expires: 2025-05-12
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-HNFE6JVG
Issued: 2020-10-08
Expires: 2025-07-19
Customer Reviews
No reviews available yet.
Company Documents
No documents available.
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