Grand River Aseptic Manufacturing (GRAM)
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Drug Product
Analytical & Bioanalytical Services
Company Overview
About
Grand River Aseptic Manufacturing (GRAM) is a pharmaceutical CDMO offering comprehensive services.
Key Expertise
Specialized in Gene Therapy, Cell Therapy, mRNA
Therapeutic Areas
Immunology
Rheumatology
Quick Facts
HQ:United States
Founded:2019
Employees:1,246
Capabilities & Services
Core Capabilities
- Peptide Synthesis
- Small Molecule API
- Formulation Development
Types of Organization
GMP Manufacturing
Quality Systems
Regulatory Support
Dosage Forms
Inhalation
Containment Capabilities
Cytotoxic / ADC Handling
Production Scales
R&D / Pre-clinical
Lab Scale
Pilot Scale
Markets Served
North America
Manufacturing Facilities
2 sites worldwide
Grand River Aseptic Manufacturing Inc.
6670 Patterson Ave. SE Suite 1A, Caledonia Township, Michigan, 49316
Site Capabilities
5 capabilitiesANALYSIS
LABEL
MANUFACTURE
PACK
STERILIZE
Grand River Aseptic Manufacturing, Inc.
524 Butterworth St SW, Grand Rapids, Michigan, 49504
Site Capabilities
3 capabilitiesANALYSIS
MANUFACTURE
STERILIZE
International Regulatory
EU GMP Certificates
4
Regulatory Bodies
EMA/EudraGMDP
Regulatory Approvals
Drug Approval R8O3UM
Health Canada · #APR-5395H3IU · 2020-02-01
Drug Approval N39G2X
Health Canada · #APR-X628WDH1 · 2018-11-01
Case Studies
0 published case studies showcasing past projects, challenges and outcomes.
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-EIYPN4Z9
Issued: 2020-12-01
Expires: 2025-03-19
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-402BYKKE
Issued: 2020-09-03
Expires: 2025-10-25
WHO GMP
World Health Organization
Cert #: CERT-P2EHCTDP
Issued: 2020-07-02
Expires: 2025-12-07
Health Canada GMP
Health Canada
Cert #: CERT-ZOC65BGE
Issued: 2020-11-04
Expires: 2025-11-06
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Key facts about Grand River Aseptic Manufacturing (GRAM)
- Grand River Aseptic Manufacturing (GRAM) is headquartered in the United States.
- Grand River Aseptic Manufacturing (GRAM) was founded in 2019.
- Grand River Aseptic Manufacturing (GRAM) has 1,246 employees.
- Grand River Aseptic Manufacturing (GRAM) has 2 manufacturing sites listed on CDMO Hub, in Caledonia Township, United States and Grand Rapids, United States.
- Grand River Aseptic Manufacturing (GRAM)'s capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.
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