Hebei Changshan Biochemical Pharma Co. Ltd
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Drug Product
Company Overview
About
Hebei Changshan Biochemical Pharma Co. Ltd is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Formulation Development, Process Development, Scale-up
Therapeutic Areas
Rare Disease
Metabolic
Quick Facts
HQ:China
Founded:2014
Employees:2,944
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
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
North America
Manufacturing Facilities
1 site worldwide
HEBEI CHANGSHAN BIOCHEMICAL PHARMACEUTICAL CO.,LTD.
No.71, Menglong Street, South District of Zhengding High-tech Industrial Development Zone, Shijiazhuang, Hebei, 050800
Site Capabilities
3 capabilitiesANALYSIS
API MANUFACTURE
MANUFACTURE
Regulatory Approvals
Drug Approval 792MVZ
FDA · #APR-RK30IEJR · 2020-02-01
Certifications
ISO 13485:2016
International Organization for Standardization
Cert #: CERT-OFUM4MEN
Issued: 2020-04-25
Expires: 2025-04-20
WHO GMP
World Health Organization
Cert #: CERT-J21YI8VM
Issued: 2020-02-03
Expires: 2025-10-28
MHRA GMP
UK Medicines and Healthcare products Regulatory Agency
Cert #: CERT-SFDOGDE1
Issued: 2020-09-12
Expires: 2025-10-06
Health Canada GMP
Health Canada
Cert #: CERT-USMA9W7M
Issued: 2020-04-27
Expires: 2025-12-05
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Key facts about Hebei Changshan Biochemical Pharma Co. Ltd
- Hebei Changshan Biochemical Pharma Co. Ltd is headquartered in China.
- Hebei Changshan Biochemical Pharma Co. Ltd was founded in 2014.
- Hebei Changshan Biochemical Pharma Co. Ltd has 2,944 employees.
- Hebei Changshan Biochemical Pharma Co. Ltd has one manufacturing site listed on CDMO Hub, in Shijiazhuang, China.
- Hebei Changshan Biochemical Pharma Co. Ltd's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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