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The examination of extractable and leachable substances (such as plasticizers, antioxidants, stabilizers and dyes) is extremely important for the protection of patients and for regulatory documentation destined for authorities such as the FDA and EMA. In recent years, the pharmaceutical industry has developed a better understanding of the impact of extractables and leachables on patient safety and drug product interaction, leading to increased scrutiny by the regulators. When there is a change

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2 All

01 1Cambrex Corporation

02 1Curida AS

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01

Curida AS

PHYSICAL & PHYSIO-CHEMICAL DETERMINATION...

Pharmex

Not Confirmed

02

Cambrex Corporation

CHEMICAL CHARACTERIZATION

Pharmex

Not Confirmed