Sovereign Pharmaceuticals, LLC

CDMO

United States

https://www.sovereignpharma.com/

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Drug Product

Analytical & Bioanalytical Services

Chemistry, Manufacturing and Controls

Company Overview

About

Sovereign Pharmaceuticals, LLC 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:2009

Employees:100

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

OEB 4 (1-10 µg/m³)

Production Scales

Phase III Clinical Trials

Commercial Scale

Clinical

Markets Served

Global

Manufacturing Facilities

1 site worldwide

Sovereign Pharmaceuticals, LLC

7549 Pebble Drive, Fort Worth, Texas, 76118

View on Map

Site Capabilities

2 capabilities

ANALYSIS

MANUFACTURE

International Regulatory

EU GMP Certificates

Regulatory Bodies

EMA/EudraGMDP

Regulatory Approvals

Drug Approval M7M5CW

PMDA · #APR-94GBZYFK · 2018-05-01

Case Studies

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

Certifications

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-MRCLZJBC

Issued: 2020-11-27

Expires: 2025-12-03

ISO 9001:2015

International Organization for Standardization

Cert #: CERT-MATSDYA0

Issued: 2020-02-19

Expires: 2025-07-02

ISO 13485:2016

International Organization for Standardization

Cert #: CERT-9KXY0VT7

Issued: 2020-11-14

Expires: 2025-07-03

WHO GMP

World Health Organization

Cert #: CERT-FEV52UHZ

Issued: 2020-05-15

Expires: 2025-05-03

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Key facts about Sovereign Pharmaceuticals, LLC

Sovereign Pharmaceuticals, LLC is headquartered in the United States.
Sovereign Pharmaceuticals, LLC was founded in 2009.
Sovereign Pharmaceuticals, LLC has 100 employees.
Sovereign Pharmaceuticals, LLC has one manufacturing site listed on CDMO Hub, in Fort Worth, United States.
Sovereign Pharmaceuticals, LLC's capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.

Find CDMOs like Sovereign Pharmaceuticals, LLC

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

CDMOs in United States CDMOs in North America Small Molecule API CDMOs Formulation Development CDMOs Inhalation CDMOs OEB 4 (1-10 µg/m³) CDMOs

Key facts about Sovereign Pharmaceuticals, LLC

Sovereign Pharmaceuticals, LLC is headquartered in the United States.

Sovereign Pharmaceuticals, LLC was founded in 2009.

Sovereign Pharmaceuticals, LLC has 100 employees.

Sovereign Pharmaceuticals, LLC has one manufacturing site listed on CDMO Hub, in Fort Worth, United States.

Sovereign Pharmaceuticals, LLC's capabilities include Peptide Synthesis, Small Molecule API and Formulation Development.