“AND WE THOUGHT this kind of thing was only supposed to be happening in China and India,” said Joseph Acker, president of the Synthetic Organic Chemical Manufacturers Association. Acker was speaking earlier this month at the groundbreaking ceremony for a commercial-scale active pharmaceutical ingredient (API) manufacturing facility that Cambridge Major Laboratories (CML) is building in Germantown, Wis. Acker and others at the podium, which was set up near CML’s existing clinical-scale API facility, lauded Michael W. Major, the company’s founder and chief executive officer, for his $30 million bet on U.S. API manufacturing. They noted that the investment goes counter to the general trend of siting such projects in lower cost Asian countries. “Successful entrepreneurs see possibilities others don’t,” Acker said of Major, pointing to several factors—including the Food & Drug Administration’s difficulty in ensuring the quality of imports—that may put Major at the leading edge of a reversal in the off-shoring ...