Presence of Indian Pharmaceutical Industries in US Market: An Empirical Analysis

Abstract

The United States is the largest pharmaceutical market in the world with generic sales accounting for US$58.5 billion and is India's largest export destination. India accounts for one out of every four Abbreviated New Drug Application (ANDA) approvals in the years 2007 and 2008, ranks first in total Type II active Drug Master Files (DMFs) with US Food and Drug Administration and it also received 31 per cent of all tentative approvals (as on 11 December 2008). In 2008, the exports of formulations from India to top 28 regulated countries surpassed Active Pharmaceutical Ingredient (API) exports firmly demonstrating the shift in credibility and Quality Compliance. India has rich vendor base with 3.75 DMFs per molecule and has filed more than 450 different APIs. Has India tapped the US market to its fullest potential? Where do the opportunities for further growth for India lies in this market? To answer this question, a comprehensive study of DMFs and ANDAs filings by their therapeutic categories, dosage forms, strengths, companies, countries and other key parameters like patents was undertaken. The study reveals that ANDAs from India are confined to small number of highly competitive molecules, and has to move into the new orbit of working in complex chemistry, Biotech-based medicines, and advanced formulations.