Tablets & Capsules


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Tablets & Capsules September 2017 9 industry news Guidances address repackaging, child-resistant packaging SILVER SPRINGS, MD—The FDA published a draft "Guidance for Industry: Expiration Dating of Unit- Dose Repackaged Solid Oral Dosage Form Drug Products." It states that the Agency doesn't intend to enforce expi- ration date requirements if a product's expiration date is 6 months or less from the repackaging date. Repackagers must also use unit-dose containers that comply with USP Class A or Class B; use container-closures that provide light protection as good or better than the product's original container-closure (for light-sensitive products); process products whose original package is unopened prior to repackaging; match the storage conditions described on the original label; and not process products whose label warns against repackaging. A second draft Guidance, "Child- Resistant Packaging Statements in Drug Product Labeling," describes how firms should identify child-resis- tant packaging to patients, how requirements differ for over-the- counter and prescription products, and where to place label statements. Perrigo to sell API, consumer healthcare businesses DUBLIN, IRELAND—Perrigo, a pharmaceutical manufacturer, will sell its Israel-based API business for $110 million. It will also sell its Russian consumer healthcare business. FDA approves AbbVie's 8-week HCV treatment SILVER SPRINGS, MD—The FDA approved Mavyret (glecaprevir and pibrentasvir). It is the first 8-week treat- ment for all chronic hepatitis C virus (HCV) genotypes 1 to 6 for adult patients without cirrhosis and who have not been previously treated. Standard treatments usually last 12 weeks or more. With this new regimen, patients take three tablets with food once daily. The product is manufactured by AbbVie, North Chicago, IL. FDA approves Puma's breast cancer treatment SILVER SPRINGS, MD—The FDA approved Nerlynx (neratinib) tablets for treatment of stage HER2- overexpressed/amplified breast can- cer in adult patients following adju- vant trastuzumab-based therapy. Patients take six tablets daily. The product is manufactured by Puma Biotechnology, Los Angeles, CA. ISPE publishes risk-based manufacturing guide BETHESDA, MD—The Internat- ional Society for Pharmaceutical Engineering (ISPE) published the sec- ond edition of "Baseline Guide: Risk- Based Manufacture of Pharmaceutical Products." It provides a scientific approach—based on ICH Q9 Quality Risk Management—to manage the risk of cross-contamination within shared facilities. The guide is available for purchase at ISPE's website. MWI Engineering Excellenc Man and Machine in Harmo ce: ony MWI Features and Benefits • Able to weight inspect tablets, capsules and softgels with very few change parts • All change parts needed are included MultiDose Weight Inspectio 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 Qualicaps ® full & capsules at h N-230 and Learn more about Q line of equipment & Pharma Expo Booth at MADE IN JAPAN

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