In Focus: Next wave of API manufacturing

Low cost options coupled with easy availability and assurance of supplies brought India and China markets to the forefront of active pharmaceutical ingredients (API) manufacturing, writes Shruti Kulkarni, senior research analyst at Beroe Inc. But some issues such as the rising cost of manufacturing and quality factors over the last couple of years have started to surface. In the backdrop of bans on some API imports by the US Food and Drug Administration and the European directorate for the Quality of Medicines (EDQM), the industry may be potentially trying to diversify its sourcing needs towards other markets.

In this paper we have analyzed other markets and found that Taiwan, Mexico, and Argentina are potential markets for API manufacturing as an alternative to India and China.

Introduction