Pharmchem
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Drug Product
Company Overview
About
Pharmchem is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:United States
Founded:2017
Employees:204
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
OEB 4 (1-10 µg/m³)
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
Global
Regulatory Approvals
Drug Approval GQP30G
Health Canada · #APR-1IFT4D36 · 2020-12-01
Drug Approval TRNGJ0
Health Canada · #APR-XIRDQ5XV · 2019-01-01
Certifications
FDA Registration
U.S. Food and Drug Administration
Cert #: CERT-SAQXH80Y
Issued: 2020-12-10
Expires: 2025-07-26
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-0XWF3BRZ
Issued: 2020-07-03
Expires: 2025-10-06
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-8NPGPDY1
Issued: 2020-03-01
Expires: 2025-02-24
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Key facts about Pharmchem
- Pharmchem is headquartered in the United States.
- Pharmchem was founded in 2017.
- Pharmchem has 204 employees.
- Pharmchem's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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