Gracecustompharma (Grace FCMS)

CDMO

United States

https://grace.com/industries/pharmaceutical-solutions/fine-chemicals/custom-apis/

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Drug Product

Company Overview

About

Gracecustompharma (Grace FCMS) is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in Biologics Manufacturing, Monoclonal Antibodies, Vaccines

Therapeutic Areas

Infectious Disease

Quick Facts

HQ:United States

Founded:1996

Employees:1,624

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

Containment Capabilities

BSL-2 (Biosafety Level 2)

Production Scales

Phase II

Clinical

Pilot Scale

Markets Served

Europe

Regulatory Approvals

Drug Approval 8UPK4Y

FDA · #APR-K9YAQ4X6 · 2018-04-01

Case Studies

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

Certifications

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-H51H3Z5X

Issued: 2020-09-28

Expires: 2025-02-08

MHRA GMP

UK Medicines and Healthcare products Regulatory Agency

Cert #: CERT-FQINTFI3

Issued: 2020-07-01

Expires: 2025-09-09

Health Canada GMP

Health Canada

Cert #: CERT-MVOLOLHC

Issued: 2020-01-06

Expires: 2025-11-09

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Key facts about Gracecustompharma (Grace FCMS)

Gracecustompharma (Grace FCMS) is headquartered in the United States.
Gracecustompharma (Grace FCMS) was founded in 1996.
Gracecustompharma (Grace FCMS) has 1,624 employees.
Gracecustompharma (Grace FCMS)'s capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.

Find CDMOs like Gracecustompharma (Grace FCMS)

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 Small Molecule Drug Product CDMOs Oral Solid Dose CDMOs Oral Solid Dose CDMOs BSL-2 (Biosafety Level 2) CDMOs