GBI Biomanufacturing

CDMO

United States

https://www.gbibio.com/

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Drug Product

Advanced Modalities

Analytical & Bioanalytical Services

Company Overview

About

GBI Biomanufacturing is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in Gene Therapy, Cell Therapy, mRNA

Therapeutic Areas

Infectious Disease

Quick Facts

HQ:United States

Founded:2015

Employees:2,091

Capabilities & Services

Core Capabilities

Small Molecule API
Small Molecule Drug Product
Oral Solid Dose

Types of Organization

GMP Manufacturing

Quality Systems

Regulatory Support

Dosage Forms

Oral Solid Dose

Production Scales

Pilot Scale

Phase I Clinical Trials

Clinical

Markets Served

North America

Europe

Regulatory Approvals

Drug Approval 5RJ17S

PMDA · #APR-A9OB4HQV · 2020-06-01

Drug Approval 4LTKHQ

Health Canada · #APR-L2P12P6O · 2019-12-01

Case Studies

0 published case studies showcasing past projects, challenges and outcomes.

Certifications

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-YZBI5QKH

Issued: 2020-07-03

Expires: 2025-11-09

EMA GMP Certificate

European Medicines Agency

Cert #: CERT-L2X9HEJ4

Issued: 2020-09-15

Expires: 2025-06-26

ISO 13485:2016

International Organization for Standardization

Cert #: CERT-T8CQXK9A

Issued: 2020-04-15

Expires: 2025-02-25

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Key facts about GBI Biomanufacturing

GBI Biomanufacturing is headquartered in the United States.
GBI Biomanufacturing was founded in 2015.
GBI Biomanufacturing has 2,091 employees.
GBI Biomanufacturing's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.

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