Originally, independent API suppliers developed, manufactured and sold APIs to supply local generics houses in essentially national markets. Now that the larger generics houses such as Sandoz and Teva are vertically integrated into API manufacture and carrying out synthesis and/or fermentation, suppliers are being forced to adapt. In addition, manufacturers in India and China (PRC) are evolving into formidable suppliers as they improve their processes and plants to comply with cGMP standards.
Facilities from both countries have been aggressive in filing Type II DMFs with the US FDA. In 2003, 132 Type II DMFs were filed for facilities based in India and 31 for PRC-based plants. In the first six months of 2004, PRC-based facilities filed 21 Type II DMFS, while Indian-based plants filed 72.
These changes have forced companies to reconsider their strategies for addressing the API market. There are two strategies emerging in the supply of off-patent APIs: some low-cost players are opting to slug it out in the commodity arena, while other niche players (strong in technical know-how) rule over small sectors of higher profitability.
Technology Catalysts can assist companies in the API supply chain in a number of ways:
1. For API Suppliers:
- Identification of niche compounds that can be profitably exploited
- Assistance in identifying required improvements prior to regulatory inspection
- Introduction to companies needing API supply
2. For API Customers:
- Identification of cGMP facilities for supply of API
- Introductions to companies that have technical expertise to provide specific APIs