Cardiovascular and metabolic drugs

These are some of the most prescribed medicines worldwide, and many are off patent, so they are produced in large volumes by generic API manufacturers. Common examples include amlodipine besylate, losartan potassium, atorvastatin calcium, clopidogrel bisulfate, metoprolol succinate and metformin hydrochloride. The salt form often defines the product and must match the registered formulation.

Key quality topics are related substances, residual solvents, chiral purity for single-enantiomer drugs, polymorphic form and particle size. Nitrosamine impurities became a major issue in the sartan and metformin supply chains, so ask suppliers for a nitrosamine risk assessment and test results. Confirm the drug master file or CEP status, and check whether the API is manufactured under GMP at the site named on the documents.