Swiss American CDMO

CDMO

United States

https://www.swissamerican.com/

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Drug Product

Analytical & Bioanalytical Services

Regulatory, Tech Transfer & Support Services

Company Overview

About

Swiss American CDMO is a pharmaceutical CDMO offering comprehensive services.

Key Expertise

Specialized in Quality Control, Stability Testing, Method Development

Therapeutic Areas

Oncology

Hematology

Quick Facts

HQ:United States

Founded:1993

Employees:670

Capabilities & Services

Core Capabilities

Oral Solid Dose
Solid Dose Manufacturing
Formulation Development

Types of Organization

GMP Manufacturing

Quality Systems

Regulatory Support

Dosage Forms

Lyophilized (Freeze-Dried)

Sterile Injectable

Containment Capabilities

OEB 5 (≤1 µg/m³)

Cytotoxic / ADC Handling

Production Scales

R&D / Pre-clinical

Lab Scale

Pilot Scale

Markets Served

Asia-Pacific

Regulatory Approvals

Drug Approval B66RRE

PMDA · #APR-5HFWVYS5 · 2019-10-01

Drug Approval JI5JXM

FDA · #APR-UF8G6UHM · 2021-09-01

Case Studies

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

Certifications

EMA GMP Certificate

European Medicines Agency

Cert #: CERT-OWAWZEMO

Issued: 2020-05-12

Expires: 2025-08-05

ISO 9001:2015

International Organization for Standardization

Cert #: CERT-UXM4TK8J

Issued: 2020-08-08

Expires: 2025-03-11

WHO GMP

World Health Organization

Cert #: CERT-E0PZXKQ7

Issued: 2020-11-04

Expires: 2025-06-08

Health Canada GMP

Health Canada

Cert #: CERT-GAOVTAJP

Issued: 2020-06-27

Expires: 2025-01-04

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Key facts about Swiss American CDMO

Swiss American CDMO is headquartered in the United States.
Swiss American CDMO was founded in 1993.
Swiss American CDMO has 670 employees.
Swiss American CDMO's capabilities include Oral Solid Dose, Solid Dose Manufacturing and Formulation Development.

Find CDMOs like Swiss American CDMO

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CDMOs in United States CDMOs in North America Oral Solid Dose CDMOs Formulation Development CDMOs Lyophilized (Freeze-Dried) CDMOs Sterile Injectable CDMOs OEB 5 (≤1 µg/m³) CDMOs Cytotoxic / ADC Handling CDMOs