Tablets & Capsules

TC0318

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Tablets & Capsules March 2018 9 MarketsandMarkets. The generic HPAPI segment is anticipated to have the highest growth during the forecast period because of numerous branded drugs coming off patent, an increase in generic manufacturers, increasing healthcare costs, and government initiatives promoting generic products. Key players in the global HPAPI market include Pfizer, Novartis, Sanofi, Hoffmann-La Roche, Eli Lilly, Bristol-Myers Squibb, Boehringer Ingelheim, Teva Pharmaceutical, Merck, AbbVie, and Mylan. Find these and other draft and final guidances at http://bit.ly/FDAGuidances. Tablet, capsule products to come off patent in 2018 BOYS TOWN, NE—In 2018, 19 brand-name solid oral dosage forms will come off patent, opening the door for the manufacture of generic versions. The five capsule products coming off patent this year are Lyrica (pregabalin), Revlimid (lenalidomide), Tikosyn (dofetilide), Pradaxa (dabigatran), and Namzaric (memantine/donepezil). The remaining 14 are tablet products. For a full list of products coming off patent in 2018 through 2022, visit http://bit.ly/ Off-PatentDrugs2018-2022. CDER launches site visit program SILVER SPRINGS, MD—The FDA's Center for Drug Evaluation and Research (CDER) launched an Experiential Learning Site Visit program, designed to expose Office of Pharmaceutical Quality (OPQ) staff to industry news FDA publishes draft guidances on public notifications, CHCs, hypertension treatments SILVER SPRING, MD—The FDA published a draft guidance on public warning and notification of recalled products. It outlines when a company should issue a public warning about a recall, describes the general timeline for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company's warning be deemed insufficient. In another draft guidance, titled "Labeling for Combined Hormonal C o n t r a c e p t i v e s , " t h e A g e n c y p r o v i d e s r e c o m m e n d a t i o n s o n information that should be included in the prescribing information for combined hormonal contraceptives (CHCs), which contain estrogen and progestin. Many of the labeling recommendations in this draft guidance represent class labeling that should be included in all CHC prescribing information, including oral solid dose CHCs. The FDA also published a draft guidance on developing fixed-dose combination drugs to treat hypertension. The guidance focuses on development of two-drug combinations of previously approved drugs, although it is also applicable to products containing three or more drugs. MWI Features and Benefits • Able to weight inspect tablets, capsules and softgels with very few change parts • All change parts needed are included with the unit • Easy operation • +/- 2mg accuracy with automatic calibration • Up to 100,000 per hour depending on dosage shape • Patent Pending MADE IN JAPAN MultiDose Weight Inspection MultiDose Weight Inspection Engineering Excellence: Man and Machine in Harmony Learn more about Qualicaps ® full line of equipment & capsules at www.qualicaps.com

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