Tablets & Capsules

TC0319

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8 March 2019 Tablets & Capsules In other news, the agency granted 59 drug approvals in 2018. This exceeds the 2017 record of 46 novel drug approvals, which at the time had been the most approved in a sin- gle year in two decades. EMA relocates to Netherlands AMSTERDAM, Netherlands— The European Medicines Agency (EMA) is relocating its offices from London to the Netherlands. The regulatory agency expects to lose 25 percent of its staff as a result of the move, which was made necessary by Brexit. The agency's new address is Domenico Scarlattilaan 6, 1083 HS Amsterdam, Netherlands. IPEC-Americas publishes DMF revision for pharmaceutical excipients ARLINGTON, VA—IPEC-Ameri- cas published the first revision of the US Drug Master File Guide for Phar- maceutical Excipients, which offers best practices for submission of an excipient drug master file using the ICH Common Technical Document format. The free guide is available for download at ipecamericas.org/refer ence-center/document-depot. FDA approves first vigabatrin generic SILVER SPRING, MD—The FDA approved the first generic version of Sabril (vigabatrin), a treatment for complex partial seizures. Sabril is manufactured by Lundbeck, Copen- hagen, Denmark, and the generic ver- sion is manufactured by Teva Phar- maceuticals, Petah Tikva, Israel. USP publishes dictionary of USAN and International Drug Names NORTH BETHESDA, MD—The United States Pharmacopeia (USP) published the 2019 version of its Dictionary of United States Adopted Names (USAN) and International Drug Names, a resource that can help scientists and professionals ensure official compliance, avoid misbranding in product labeling, research established generic drug names, preserve trademark rights to drug brand names by using proper Approval to Tentatively Approved ANDAs," which provides recom- mendations for applicants preparing and submitting amendments to ten- tatively approved abbreviated new drug applications (ANDAs), includ- ing requests for final approval. This guidance also features tips for the timing and content of amendments to tentatively approved ANDAs to facilitate submission in a timely fash- ion that can result in final approval on the earliest lawful approval date. Capsule, Qingdao Capsule, Leefan Capsule, and Sunil Healthcare. industry news FDA publishes ANDA draft guidance S I L V E R S P R I N G , M D — T h e FDA published a draft guidance for industry "ANDA Submissions – Amendments and Requests for Final NILFISK PNEUMATIC CONVEYORS Transfer empty capsules without dispersion or contamination The Nilfisk 9505 pneumatically conveys empty capsules at a preset speed, the capsules pass from the container to the filling machine hopper damage free. nilfiskindustrialvacuums.com Small footprint and multiple configurations Three filtration stages AISI 316L stainless steel construction Capsule level sensors Visit INTERPHEX Booth #2537 for a live product demonstration.

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