Issue link: https://www.e-digitaleditions.com/i/292644
industry news CDER head disputes findings of study on overseas generics WASHINGTON, DC—The di - rec tor of the FDA's Center for Drug Evaluation and Research (CDER) cast doubt on the findings of a study of generic drug products manufac- tured overseas. The results showed that overseas generics contained more impurities than those made domestically. In a bylined article published at Bloomberg.com, CDER director Janet Woodcock said the study, conducted by Preston Mason of Brigham & Women's Hospital, Boston, MA, was flawed because the methods used to extract the active ingredient contaminated the samples. Mason, who briefed Congress about the findings in February, said he stood by the study's results. During the briefing, Mason called the gener- ics business "the Wild West." 8 April 2014 Tablets & Capsules markets Excipients demand to increase by 4.3 percent annually CLEVELAND, OH—US Demand for pharmaceutical excipients will increase 4.3 percent per year to $2.0 billion in 2018, according to a report from Freedonia Group, a market research firm. By volume, demand is expected to grow 1.9 percent annu- ally to 900 million pounds. The importance of specialty excipient blends will increase, and polymers— including cellulose derivatives, povi- done, starch, polyethylene glycol, acrylic polymers, and natural gums— are expected to benefit from the trend. Gains in shipments of oral drug products will help accelerate gains in demand for fillers, binders, coatings, flavoring agents, capsules, and disintegrants. The market share of delayed- or extended-release tablets and capsules and orally dis- solving tablets is expected to increase, further boosting demand for binders and disintegrants b-TOCFN_1-11_Masters 4/3/14 2:28 PM Page 8