Regulatory, Tech Transfer & Support Services
Company Overview
About
GYMA Laboratories Inc. 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:United States
Founded:1996
Employees:972
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
Production Scales
Phase II
Clinical
Pilot Scale
Markets Served
North America
Europe
Regulatory Approvals
Drug Approval JCZQEP
PMDA · #APR-ZIAD2W71 · 2022-05-01
Drug Approval ZGA4AY
FDA · #APR-9SL2OMPV · 2020-01-01
Certifications
EMA GMP Certificate
European Medicines Agency
Cert #: CERT-FIUP0JBK
Issued: 2020-11-04
Expires: 2025-06-18
ISO 9001:2015
International Organization for Standardization
Cert #: CERT-ZCQCWQHO
Issued: 2020-04-19
Expires: 2025-06-27
Health Canada GMP
Health Canada
Cert #: CERT-33TLNOS0
Issued: 2020-04-28
Expires: 2025-03-20
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Key facts about GYMA Laboratories Inc.
- GYMA Laboratories Inc. is headquartered in the United States.
- GYMA Laboratories Inc. was founded in 1996.
- GYMA Laboratories Inc. has 972 employees.
- GYMA Laboratories Inc.'s capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.
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