Tablets & Capsules

TC0717

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8 July 2017 Tablets & Capsules industry news IPEC publishes risk assessment guide for excipients ARLINGTON, VA—IPEC-Amer icas and IPEC Europe published a risk–assessment guide for excipient makers, users, and distributors. It cov- ers quality risk management; the scien- tific principles of risk identification and assessment; and an outline of the process and how to use the appropri- ate risk assessment methodologies. The guide is available for free at IPEC's website. FDA publishes product-specific guidances for generics SILVER SPRINGS, MD—On May 1, the FDA published or revised 37 product-specific draft guidances for generic drug development since May 1. Twenty-seven address solid oral dosage products. Recro adds tabletting suite GAINESVILLE, GA—Recro Gain- esville, the CDMO subsidiary of Recro Pharma, added a tabletting suite and hired almost a dozen scientists to work in development. The suite includes a Fette FE 55 press for making single- and bi-layer tablets. Recro spe- cializes in developing and manufactur- ing delayed-, sustained-, and combina- tion-release solid dosage forms. FDA approves first opioid with abuse-deterrent claim, asks Endo to withdraw Opana ER SILVER SPRINGS, MD—The FDA approved RoxyBond (oxycodone hydrochloride) tablets to manage severe pain that requires opioid anal- gesic and for which alternative treat- ments are inadequate. It is the first immediate-release opioid approved by the Agency with abuse-deterrent claims. It is manufactured by Inspirion Delivery Sciences, Morristown, NJ. In other news, the FDA requested that Endo Pharmaceuticals remove Opana ER, an extended-release opioid, from the market. Approved in 2006, Opana ER was reformulated in 2012 to deter abuse, but the company didn't Custom Manufacturing and Packaging Extensive expertise in developing, manufacturing and packaging: • DIETARY SUPPLEMENTS • COSMETICS • OTC PHARMACEUTICALS • HOMEOPATHICS • ANIMAL CARE PRODUCTS 248 Main Street. Lancaster, NH 03584 For more information, please contact us at info@trividiams.com www.trividiams.com FOR MORE THAN 150 YEARS, TRIVIDIA MANUFACTURING SOLUTIONS HAS BEEN COMMITTED TO THE HIGHEST STANDARDS OF QUALITY, CUSTOMER SERVICE AND VALUE. • LIQUIDS • LOTIONS • TABLETS • CAPSULES • CREAMS • GELS VISIT US IN VEGAS AT SSW BOOTH #B148

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