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CUSTOM DEVELOPMENT/PRODUCTION OF API

Apart from sourcing from existing producers, one of our core expertise lies in our ability to manage from development to commercial release stage the custom or toll production of most types of APIs.

 

We have all experienced at one point the need to evaluate our current API source(s) and consider the custom or toll approach. This may become viable when:

  •  API is no longer available from a GMP facility or is no longer supported by regulatory (USDMF, CEP, EDMF etc)

  • Current or market pricing has become unworkable from existing sources

  • Quality issues exist with current suppliers

  • Strategic intents or relationship issues drives decision to change

  • The need to set up a secondary/fallback source

  • Purchase volumes have fallen below certain minimum order thresholds or vaible price breaks or bundling with other users is no longer possible

  • Geographic rationale for source change (product stability during transport, political instability, export/import restrictions or controls, currency exchange volatility)

  • If the business warrants or justifies the approach, we will identify and qualify viable custom production options and put forward a detailed project management timeline adapted to match your needs. We will manage this timeline and deliverables to your satisfaction. Through our network of GMP and cGMP facilities big and small, we have been able to set up the production of several APIs over the years. Just this last year (2008), we have successfully re-established the fast track development and commercial production of three APIs for our clients. If you would like to discuss this further with us, please do not hesitate to communicate with us.