Berkshire Sterile Manufacturing

CDMO

United States

https://berkshiresterilemanufacturing.com/

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Drug Product

Analytical & Bioanalytical Services

Clinical Trial Supply & Logistics

Company Overview

About

Berkshire Sterile Manufacturing is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in Solid Dose Manufacturing, Oral Liquids, Topicals

Therapeutic Areas

Infectious Disease

Quick Facts

HQ:United States

Founded:2008

Employees:2,689

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

OEB 4 (1-10 µg/m³)

Production Scales

Pilot Scale

Phase I Clinical Trials

Clinical

Markets Served

Global

Regulatory Approvals

Drug Approval WUIK7F

EMA · #APR-UC8QMAGV · 2022-01-01

Drug Approval 135990

PMDA · #APR-D8CL2S9Z · 2018-04-01

Certifications

ISO 13485:2016

International Organization for Standardization

Cert #: CERT-V2IK0EK4

Issued: 2020-02-05

Expires: 2025-10-15

WHO GMP

World Health Organization

Cert #: CERT-8RBZB21L

Issued: 2020-07-15

Expires: 2025-11-16

Health Canada GMP

Health Canada

Cert #: CERT-HON12AO1

Issued: 2020-02-07

Expires: 2025-12-19

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Key facts about Berkshire Sterile Manufacturing

Berkshire Sterile Manufacturing is headquartered in the United States.
Berkshire Sterile Manufacturing was founded in 2008.
Berkshire Sterile Manufacturing has 2,689 employees.
Berkshire Sterile Manufacturing's capabilities include Small Molecule API, Small Molecule Drug Product and Oral Solid Dose.

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