Less is more in API process development

The U.S. pharmaceutical industry continues to use costly complex manufacturing processes to make active pharmaceutical ingredients (APIs). Meanwhile, API manufacturers in China and India are using more simple process chemistries to produce generic therapies at a fraction of the cost of nongeneric U.S. drugs. These simpler processes also lend themselves easily to process analytical technology (PAT) and more advanced process control. In this white paper, EPCOT International Inc. reviews recent API process patents and offers potential cost-reduction strategies for each.

The answer for U.S. manufacturers, according to EPCOT, is using less complex laboratory synthesis processes that can be scaled up easily once drug efficacy has been demonstrated. API process developers need to ask and ensure an answer to the question, is this process as inexpensive, profitable, safe and environmentally friendly as it can be? According to EPCOT, that this approach should simplify process control via PAT, eliminate rework, slash inventories and improve product quality.

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