Oakwood Laboratories LLC

CDMO

United States

https://oakwoodlabs.com/

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Drug Product

Analytical & Bioanalytical Services

Company Overview

About

Oakwood Laboratories LLC is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in Formulation Development, Process Development, Scale-up

Therapeutic Areas

Cardiovascular

Endocrinology

Quick Facts

HQ:United States

Founded:1991

Employees:1,989

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

Production Scales

Phase III Clinical Trials

Commercial Scale

Clinical

Markets Served

North America

Europe

Manufacturing Facilities

2 sites worldwide

Oakwood Laboratories LLC

7670 First Pl Ste A, Oakwood Village, Ohio, 44146

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Oakwood Laboratories, L.L.C.

27070 Miles Rd., Solon, Ohio, 44139

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Site Capabilities

3 capabilities

MANUFACTURE

PACK

REPACK

Regulatory Approvals

Drug Approval T78VZ4

Health Canada · #APR-AC3L74GO · 2019-03-01

Drug Approval EA8ZO5

EMA · #APR-1NMBR0UJ · 2018-11-01

Case Studies

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

Certifications

ISO 13485:2016

International Organization for Standardization

Cert #: CERT-JTAKZC93

Issued: 2020-01-15

Expires: 2025-01-25

ISO 9001:2015

International Organization for Standardization

Cert #: CERT-OPMFBQVL

Issued: 2020-12-01

Expires: 2025-02-26

FDA Registration

U.S. Food and Drug Administration

Cert #: CERT-BKZ52UKO

Issued: 2020-10-22

Expires: 2025-09-21

EMA GMP Certificate

European Medicines Agency

Cert #: CERT-AL6O6V3M

Issued: 2020-02-05

Expires: 2025-09-13

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Key facts about Oakwood Laboratories LLC

Oakwood Laboratories LLC is headquartered in the United States.
Oakwood Laboratories LLC was founded in 1991.
Oakwood Laboratories LLC has 1,989 employees.
Oakwood Laboratories LLC has 2 manufacturing sites listed on CDMO Hub, in Oakwood Village, United States and Solon, United States.
Oakwood Laboratories LLC's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).

Find CDMOs like Oakwood Laboratories LLC

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

CDMOs in United States CDMOs in North America Sterile Injectable CDMOs Fill-Finish CDMOs Fill/Finish (Vials) CDMOs Cartridge / Pen CDMOs

Key facts about Oakwood Laboratories LLC

Oakwood Laboratories LLC is headquartered in the United States.

Oakwood Laboratories LLC was founded in 1991.

Oakwood Laboratories LLC has 1,989 employees.

Oakwood Laboratories LLC has 2 manufacturing sites listed on CDMO Hub, in Oakwood Village, United States and Solon, United States.

Oakwood Laboratories LLC's capabilities include Sterile Injectable, Sterile Fill/Finish and Fill/Finish (Vials).