Goodwin Biotechnology (GBI)

CDMO

United States

https://www.gbibio.com/

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Drug Product

Advanced Modalities

Analytical & Bioanalytical Services

Company Overview

About

Goodwin Biotechnology (GBI) is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in Quality Control, Stability Testing, Method Development

Therapeutic Areas

Respiratory

Allergy

Quick Facts

HQ:United States

Founded:1991

Employees:1,256

Capabilities & Services

Core Capabilities

Biologics Drug Substance
Biologics Manufacturing
Formulation Development

Types of Organization

GMP Manufacturing

Quality Systems

Regulatory Support

Dosage Forms

Sterile Injectable

Containment Capabilities

OEB 5 (≤1 µg/m³)

Cytotoxic / ADC Handling

Production Scales

R&D / Pre-clinical

Lab Scale

Pilot Scale

Markets Served

Asia-Pacific

Manufacturing Facilities

1 site worldwide

Goodwin Biotechnology, Inc

1850 N.W. 69th Avenue, Plantation, Florida, 33313

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Site Capabilities

1 capability

API MANUFACTURE

Regulatory Approvals

Drug Approval 30A0M9

EMA · #APR-WUXE2E0F · 2021-05-01

Drug Approval 6QHK27

Health Canada · #APR-V9RCS9ZS · 2020-02-01

Case Studies

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

Certifications

ISO 9001:2015

International Organization for Standardization

Cert #: CERT-AOV2KV6E

Issued: 2020-08-19

Expires: 2025-10-21

ISO 13485:2016

International Organization for Standardization

Cert #: CERT-SGOTE5A4

Issued: 2020-11-25

Expires: 2025-10-15

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Key facts about Goodwin Biotechnology (GBI)

Goodwin Biotechnology (GBI) is headquartered in the United States.
Goodwin Biotechnology (GBI) was founded in 1991.
Goodwin Biotechnology (GBI) has 1,256 employees.
Goodwin Biotechnology (GBI) has one manufacturing site listed on CDMO Hub, in Plantation, United States.
Goodwin Biotechnology (GBI)'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.

Find CDMOs like Goodwin Biotechnology (GBI)

Directory pages this company appears in, each with the full list of matching manufacturers.

CDMOs in United States CDMOs in North America Biologics Drug Substance CDMOs Formulation Development CDMOs Sterile Injectable CDMOs OEB 5 (≤1 µg/m³) CDMOs Cytotoxic / ADC Handling CDMOs

Key facts about Goodwin Biotechnology (GBI)

Goodwin Biotechnology (GBI) is headquartered in the United States.

Goodwin Biotechnology (GBI) was founded in 1991.

Goodwin Biotechnology (GBI) has 1,256 employees.

Goodwin Biotechnology (GBI) has one manufacturing site listed on CDMO Hub, in Plantation, United States.

Goodwin Biotechnology (GBI)'s capabilities include Biologics Drug Substance, Biologics Manufacturing and Formulation Development.