On its website and in company literature, Porton claims that its main manufacturing site adheres to current Good Manufacturing Practices (cGMP), a set of constantly updated U.S. Food & Drug Administration standards that are followed by suppliers of active pharmaceutical ingredients to the U.S. market. Producers of unregulated API intermediates do not have to stick to cGMP standards. During a tour of the site, however, Ju volunteers that the plant is not strictly cGMP-compliant, but rather is loosely designed like a cGMP facility. Porton will become fully cGMP, he says, when it starts making regulated intermediates and custom-made APIs.
by Jean-François Tremblay |
November 27, 2006