DUDLEY CHEM CORP.

CDMO

China

https://www.dudley-chem.com/

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Drug Product

Company Overview

About

DUDLEY CHEM CORP. is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in API Manufacturing, Sterile Fill/Finish, Lyophilization

Therapeutic Areas

Cardiovascular

Endocrinology

Quick Facts

HQ:China

Founded:2000

Employees:114

Capabilities & Services

Core Capabilities

Sterile Injectable
Sterile Fill/Finish
Fill/Finish (Vials)

Types of Organization

GMP Manufacturing

Quality Systems

Regulatory Support

Dosage Forms

Cartridge / Pen

Containment Capabilities

BSL-2 (Biosafety Level 2)

Production Scales

Phase III Clinical Trials

Commercial Scale

Clinical

Markets Served

Europe

Manufacturing Facilities

1 site worldwide

Dudley Chemicals, LLC

300 Terrace Dr Unit D, Mundelein, Illinois, 60060

View on Map

Site Capabilities

2 capabilities

ANALYSIS

RELABEL

Regulatory Approvals

Drug Approval 619HKX

PMDA · #APR-UJFXQVCI · 2018-05-01

Certifications

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-S7OZN01D

Issued: 2020-03-28

Expires: 2025-07-16

EMA GMP Certificate

European Medicines Agency

Cert #: CERT-KMHQ4JGQ

Issued: 2020-05-23

Expires: 2025-01-18

ISO 13485:2016

International Organization for Standardization

Cert #: CERT-2T329Y72

Issued: 2020-04-04

Expires: 2025-09-02

MHRA GMP

UK Medicines and Healthcare products Regulatory Agency

Cert #: CERT-0K8CDPOY

Issued: 2020-09-24

Expires: 2025-10-06

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Key facts about DUDLEY CHEM CORP.

DUDLEY CHEM CORP. is headquartered in China.
DUDLEY CHEM CORP. was founded in 2000.
DUDLEY CHEM CORP. has 114 employees.
DUDLEY CHEM CORP. has one manufacturing site listed on CDMO Hub, in Mundelein, United States.
DUDLEY CHEM CORP.'s capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).

Find CDMOs like DUDLEY CHEM CORP.

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

CDMOs in China CDMOs in Asia Sterile Injectable CDMOs Fill-Finish CDMOs Fill/Finish (Vials) CDMOs Cartridge / Pen CDMOs BSL-2 (Biosafety Level 2) CDMOs

Key facts about DUDLEY CHEM CORP.

DUDLEY CHEM CORP. is headquartered in China.

DUDLEY CHEM CORP. was founded in 2000.

DUDLEY CHEM CORP. has 114 employees.

DUDLEY CHEM CORP. has one manufacturing site listed on CDMO Hub, in Mundelein, United States.

DUDLEY CHEM CORP.'s capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).