Issue link: http://www.e-digitaleditions.com/i/880535
Recent news items on companies that develop, manufacture, and provide products and services that support development of orally inhaled and nasal drug products Inhalation OctOber 2017 7 Industry news Astech certified to revised ISO 9001:2015 standard RUNCORN, UNITED KING- D O M — A s t e c h P r o j e c t s h a s announced its recent transition to the revised international standard for Quality Management Systems (QMS) ISO 9001:2015 and indi- cates it has become one of the few robotics and automation companies certified to the new standard. The principal changes from the prior I S O 9 0 0 1 : 2 0 0 8 i n c l u d e a n increased focus on risk and opportu- nities. Organizations are required to demonstrate they have determined, considered and, where necessary, taken action to address any risks or opportunities that may positively or negatively impact their quality man- agement system's ability to deliver its intended outcomes or impact customer satisfaction. Another fun- damental change in the standard is bringing quality management and continual improvement to the core of an organization. Astech has pro- vided advanced automated systems, since its formation in 1995, for a range of advanced manufacturing and regulated industries including pharmaceutical, medical device and consumer healthcare. It is part of the Schauenburg International group of companies, which has more than 30 sites worldwide. AstraZeneca to expand manufacturing in Sydney S Y D N E Y , A U S T R A L I A — According to Australian Manufac- turing, AstraZeneca has announced a $100 million expansion of its Syd- ney manufacturing facility, in part to satisfy the growing demand in China for inhaler products for the treatment of asthma and COPD. e expansion will include installa- tion of three additional production lines at its North Ryde plant and adds to a $100 million investment the company has made at the facility over the last few years. AstraZeneca Chief Executive Pascal Soriot spoke from London, UK, explaining the company wants to produce approxi- mately $2.6 billion of exports from Australia to a wide variety of markets including China, "These products are growing very, very rapidly." Aus- tralian Prime Minister Malcolm Turnbull welcomed the announce- ment and the jobs it will create and indicated AstraZeneca is the leading pharmaceutical manufacturer in Australia. Otsuka, Mylan to commer- cialize Deltyba™ (dela- manid) for MDR-TB in high-burden countries TOKYO, JAPAN, HERTFORD- SHIRE, UNITED KINGDOM, PITTSBURGH, PENNSYLVA- NIA—PR Newswire reports that Otsuka Pharmaceutical Co. Ltd. and Mylan NV have entered into a license agreement between subsid- iaries Otsuka Novel Products GmbH (ONPG) and Mylan Phar- m a c e u t i c a l s P r i v a t e L i m i t e d (Mylan) to commercialize dela- manid for adults with pulmonary multidrug-resistant tuberculosis (MDR-TB) in low- and middle-in- come countries. Delamanid was discovered and developed, and is currently marketed by Otsuka as Deltyba TM (delamanid). Mylan will