R.W. Hartnett Company

CDMO

United States

https://www.rwhartnett.com/

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Manufacturing & Lab Equipment

Company Overview

About

R.W. Hartnett Company is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization

Therapeutic Areas

Rare Disease

Metabolic

Quick Facts

HQ:United States

Founded:2017

Employees:2,250

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

Containment Capabilities

BSL-2 (Biosafety Level 2)

Production Scales

Pilot Scale

Phase I Clinical Trials

Clinical

Markets Served

Europe

Regulatory Approvals

Drug Approval X2BGI4

Health Canada · #APR-HC5UFI78 · 2019-02-01

Drug Approval AM0X0M

Health Canada · #APR-Y8F06D0Q · 2020-03-01

Case Studies

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

Certifications

EMA GMP Certificate

European Medicines Agency

Cert #: CERT-X150PNL6

Issued: 2020-07-17

Expires: 2025-03-22

ISO 9001:2015

International Organization for Standardization

Cert #: CERT-TL5H9S9C

Issued: 2020-05-14

Expires: 2025-08-15

MHRA GMP

UK Medicines and Healthcare products Regulatory Agency

Cert #: CERT-VF6UEMCW

Issued: 2020-09-17

Expires: 2025-07-22

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-CC7FLVY6

Issued: 2020-09-05

Expires: 2025-10-26

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Key facts about R.W. Hartnett Company

R.W. Hartnett Company is headquartered in the United States.
R.W. Hartnett Company was founded in 2017.
R.W. Hartnett Company has 2,250 employees.
R.W. Hartnett Company's capabilities include Biologics Drug Substance, Biologics Drug Product and Biologics Manufacturing.

Find CDMOs like R.W. Hartnett Company

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CDMOs in United States CDMOs in North America Biologics Drug Substance CDMOs Biologics Drug Product CDMOs Prefilled Syringe CDMOs Sterile Injectable CDMOs BSL-2 (Biosafety Level 2) CDMOs