ANDA: Abbreviated New Drug Application

Imagine needing government approval to sell a product in a foreign country, but because the product is a proven copy of something already approved and safely sold there for years, the approval process can reasonably skip re-proving the drug's basic safety and effectiveness from scratch, and instead focus on proving your version is equivalent. An ANDA is exactly that streamlined pathway for generic drugs entering the US market.

An Abbreviated New Drug Application is the regulatory filing an Indian, or any, generic manufacturer submits to the US FDA to gain approval to sell a generic version of a drug whose original branded version has already been approved and is off patent, focusing the review specifically on demonstrating bioequivalence to the original, rather than repeating full clinical trials. Indian pharmaceutical companies collectively hold a very large share of total ANDA approvals granted by the US FDA, reflecting India's position as one of the world's largest suppliers of generic medicines to the American market.

A company's ANDA pipeline, how many applications it has pending approval and how many have already been cleared, is one of the most closely watched indicators of an Indian generic pharma company's future US revenue growth, since each approved ANDA effectively represents a new product the company can legally sell into the world's largest pharmaceutical market.