Cambrex

Overview

Cambrex is a contract development and manufacturing organization (CDMO) providing comprehensive drug substance, drug product, and analytical services to pharmaceutical partners.

Drug Substance Services

• Custom API Development & Manufacturing: Full-range pharmaceutical API custom development services at every stage of the lifecycle, including process development, analytical development, process safety, and portfolio optimization. Capabilities span lab-, kilo-, and pilot-scale manufacturing for preclinical studies and all phases of clinical trials.
• Generic API Manufacturing: Over 40 years of generic API manufacturing experience with sites in Italy, Sweden, and the USA, supplying advanced GMP intermediates and reference standards.
• Peptide Development & Manufacturing: Cutting-edge capabilities in peptide development and manufacturing, including custom peptide synthesis and peptide crystallization.
• Specialty Solutions: Technologies for complex API manufacturing challenges, including biocatalysis, continuous flow chemistry, highly potent APIs (HPAPIs), controlled substances, complex synthetics, crystallization process development, and in-line analytics.
• Technology Transfer: Specialized expertise in seamless drug substance technology transfers and quick onboarding.
• Reactor Build and Design: Custom reactor design and engineering for process development and commercial manufacturing scale-up.

Analytical Services

• IND enabling services providing supporting analytical data for IND submissions.
• Analytical testing capabilities.

Regulatory & Quality

Cambrex supports regulatory submissions and maintains GMP compliance across manufacturing operations.