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Generic applications

Development can be for exact generic copies if requested, or improved formulations, offering our clients a marketing advantage. Whenever possible we also try to minimize their total registration costs. Taking tablets as an example, we aim to develop a product that can be authorized via a biowaiver (e.g. similar dissolution profile for tablets). But if the active pharmaceutical ingredient (API) does not meet the relevant criteria, we try to optimize the formulation (e.g. palatability), whilst avoiding excipients that can affect bioavailability and maintaining a similar dissolution at low pH. This makes a bio-equivalence study less risky.

For injectables we often see that the preservative system of the European Reference Products (ERP) is not sufficient, so we use different excipients if needed. Although this may lead to many questions being posed when applying for a biowaiver, we have never failed an application for this reason. For generics we always look for the best ERP, since this principle is nowadays more followed than in the past; again this gives our clients a potential marketing advantage in most of the other markets. In all cases we can do total development starting from scratch if needed or partial development as a follow up on an existing product.