Thanks to science evolution, the pharmaceutical industry is developing an increasing number of new active pharmaceutical ingredients (APIs) with improved pharmacological activity; these APIs are in many occasions classified as Highly Potent (HPAPI). Increasing potency and advances in formulation and process technologies can frequently lead to lower strength and hence smaller batch sizes. This is particularly true in oncology, orphan designations, niche therapies or personalized treatments.
Over the last decade, a growing number of API companies have started their own development of final dosage forms (FDF), especially for the above-mentioned areas. This vertical integration API/FDF creates more attractive propositions in the business-to-business arena and can open the path for direct entry to the highly profitable FDF market.
Thanks to a collaboration with innovative and outstanding partner organizations, Oriento can offer to API manufacturers interested on developing their own FDFs, the possibility to develop high quality dossiers containing APIs up to OEB4.
Oriento can provide advice, supervision and support to generate a solid CMC (chemistry, manufacturing and controls) package based on sound scientific knowledge and intellectual property (IP). Oriento can also provide the support to complete the CTD (common technical document) including clinical studies (e.g. bioequivalence), regulatory and commercial manufacturing.