De-formulation is the analysis of a product where a lab breaks down a material or product to determine the identity and quantity of its components. Sometimes known as “chemical reverse engineering,” this process enables scientists to take a medication and discover the contents of its core and coatings. This is the method necessary to create a generic version of a medication and requires various chemical processes to discover the exact contents of a formula.
Pharmaceutical de-formulation, the reverse engineering of a product’s formulation, is a necessary process to create generic drugs. Even before patent expiration, skilled chemists must perform a detailed analysis to identify, quantify, and characterize the original formula’s active pharmaceutical ingredients (APIs) and its excipients, whether it’s a drug or supplement.
Successful generics companies are the first to market after patent expiration, bringing bioequivalent products to pharmacies as quickly as possible. They achieve this through having solid reverse engineering programs and by utilising outside labs when necessary to help in the process.
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