Selkirk Pharma
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Drug Product
Analytical & Bioanalytical Services
Regulatory, Tech Transfer & Support Services
Company Overview
About
Selkirk Pharma is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:United States
Founded:2005
Employees:1,399
Capabilities & Services
Core Capabilities
- Biologics Drug Substance
- Biologics Drug Product
- Biologics Manufacturing
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Prefilled Syringe
Sterile Injectable
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
North America
Regulatory Approvals
Drug Approval TZK49U
PMDA · #APR-OC2FJ4AC · 2020-12-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-WYC8OB7L
Issued: 2020-10-24
Expires: 2025-10-25
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-2PSBIPYP
Issued: 2020-12-18
Expires: 2025-07-26
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Key facts about Selkirk Pharma
- Selkirk Pharma is headquartered in the United States.
- Selkirk Pharma was founded in 2005.
- Selkirk Pharma has 1,399 employees.
- Selkirk Pharma's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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