The boundaries of a generic product registration are expanding at a greater rate yearly. It has evolved far beyond the typical tablet, capsule, injectable dosage form, active ingredient form and formulations. Newer generation of drug products are developed as per current therapy guidelines for various diseases which includes multi drug therapy, newer dosage form of an existing drug, complex formulations of injectables and many other advancements.
There are various scenarios when a generic product registration is challenging due to these newer forms in comparison with the reference/innovator product (dosage form, API form, formulation etc). Example such as a Bilayered Tablet with one layer having an Extended Release formulation and the other layer having a immediate release formulation, depot injection form, API polymer complex and many others.
Our consultants are trained to identify these crucial complex generics and offer guidance to clients on the best route of registration in Malaysia, be it as a Generic or even a New Drug Product Hybrid. Contact us for more information!