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8 July 2018 Tablets & Capsules share because it has a simple manu- facturing process, a high specific sur- face area, and superior adsorption characteristics. Desiccant end uses include APIs, tablets, capsules, diag- nostic kits, and nutraceutical product packaging. Of these, the tablet seg- ment will grow at a significant pace because desiccants provide tablets with good mechanical strength, bet- ter protection from moisture, and excellent heat stability. North America is predicted to hold the big- gest share by 2025 due to strong gov- ernment support, increasing R&D spending, and a growing manufactur- ing base. The report identifies Capitol Scientific, Clariant, CSP Technologies, Desiccare, Du Pont, Multisorb Technologies, Munters, O k e r - C h e m i e , P r o f l u t e , R o t o r Source, Sanne, and W. R. Grace, as key players in this market. industry news FDA issues draft guidance on DSCSA waivers, GMP for APIs SILVER SPRINGS, MD—The FDA published the draft guidance "Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act," outlining the process by which the agency grants exemp- tions from the Drug Supply Chain Security Act (DSCSA) requirements. The agency will assess whether or not an exemption or waiver of require- ments is warranted because compli- ance would cause undue economic hardship or due to an emergency medical reason. Companies request- ing waivers and exemptions will be notified in writing of the FDA's decision and an explanation for the determination. The agency also published a final g u i d a n c e o n t h e I n t e r n a t i o n a l Council for Harmonisation's (ICH) Q7 guidelines for good manufactur- ing practices (GMPs) for APIs, clari- fying the interpretation and imple- mentation of the document. The FDA states that it expects annual product quality reviews from manu- facturers but that time frames can be adjusted to more or less than 12 months with proper justification. Reviews should include stability, complaints, returns, recalls, and trend analysis and should be completed even if no manufacturing happened during the review period. IPEC-Americas publishes revision, acquires ExcipientFest A R L I N G T O N , V A — I P E C - Americas published the first revision of its US Drug Master File (DMF) guide for pharmaceutical excipients, which explains best practices for submitting an excipient drug master file using the ICH Common Technical Document format. The guide focuses on US Type IV (excipient) DMF content, format, filing, and review. The docu- ment can be downloaded for free at http://bit.ly/IPECDocumentDepot. Budenheim offers a comprehensive range of superior phosphate products ... covering liquid and solid dosage forms and a wide range of functionalities for pharmaceutical companies. All DI-CAFOS ® and TRI-CAFOS ® grades for direct compression offer several advantages which include excellent flow properties, high tablet hardness and high content uniformity which are essential for high speed tablet manufacturing. ... and extensive global services, in- cluding technical and regulatory support completes the offer to our customers and has made Budenheim a leading player in this segment. Our Tabletting Competence Center enables us to run trials under real production conditions, helps us to understand the require- ments of the market and to develop customized solutions for you. TRI - CAFOS ® Superior excipients meeting your formulation challenges DI - CAFOS ® Visit us at CPHI Worldwide 2018 Hall 8 | Booth 102 Budenheim USA, Inc. | 885 Grandview Avenue Suite 120 | Columbus, Ohio 43215 Phone +1 (614) 345 2400 | pharma@budenheim.com | www.budenheim.com