The critical building block for generic pharmaceutical is the ability to grow their product line organically. In order to achieve this organic, internal growth, companies must submit and receive FDA approval for Abbreviated New Drug Applications (ANDAs). Beginning with developing a reverse engineering method (taking apart an object or formulation to see how it works in order to duplicate or enhance) for the innovator drug, ensuring it meets established bioequivalence standards, and subsequently filing applications with FDA, a commercial entity earns ANDA approval. Upon patent expiration (for the innovator drug), the filing enterprise will be able to manufacture, market, and sell their drug.
Often when generic companies receive FDA ANDA approvals, they inform the industry via well placed press releases. The following documents represent some of Aurobindo’s current press releases.