{"id":6122,"date":"2021-12-01T11:13:58","date_gmt":"2021-12-01T05:43:58","guid":{"rendered":"https:\/\/tradebrains.in\/features\/sai-life-sciences\/"},"modified":"2021-12-01T11:13:58","modified_gmt":"2021-12-01T05:43:58","slug":"sai-life-sciences","status":"publish","type":"post","link":"https:\/\/tradebrains.in\/features\/sai-life-sciences\/","title":{"rendered":"Sai Life Sciences&#8217; pharmaceutical API manufacturing site receives Certificate of Inspection from PMDA, Japan"},"content":{"rendered":"<div class=\"trade-content_2\" style=\"margin-left: auto;margin-right: auto;text-align: center;\" id=\"trade-3627349300\"><p><a href=\"https:\/\/tradebrains.in\/get\/telegram\/\"><img decoding=\"async\" class=\"alignnone wp-image-101992\" src=\"https:\/\/tradebrains.in\/features\/wp-content\/uploads\/2023\/01\/telegram-channel-300x119.png\" alt=\"\" width=\"148\" height=\"59\" \/><\/a> <a href=\"https:\/\/news.google.com\/publications\/CAAqBwgKMN3Epgswxc--Aw?hl=en-IN&amp;gl=IN&amp;ceid=IN%3Aen\"><img decoding=\"async\" class=\"alignnone wp-image-123430\" src=\"https:\/\/tradebrains.in\/features\/wp-content\/uploads\/2024\/05\/follow-on-google-news-300x82.png\" alt=\"follow-on-google-news\" width=\"222\" height=\"61\" srcset=\"https:\/\/tradebrains.in\/features\/wp-content\/uploads\/2024\/05\/follow-on-google-news-300x82.png 300w, https:\/\/tradebrains.in\/features\/wp-content\/uploads\/2024\/05\/follow-on-google-news-150x41.png 150w, https:\/\/tradebrains.in\/features\/wp-content\/uploads\/2024\/05\/follow-on-google-news.png 468w\" sizes=\"(max-width: 222px) 100vw, 222px\" \/><\/a><\/p>\n<\/div><p>HYDERABAD, India, Dec. 1, 2021 \/PRNewswire\/ &#8212; Sai Life Sciences, a leading global Contract Research, Development &#038; Manufacturing Organization (CRO\/ CDMO), today announced that the Japanese regulatory agency, Pharmaceuticals and Medical Devices Agency (PMDA) completed a paper-based compliance inspection of its intermediate &#038; API manufacturing facility in Bidar, India and issued a Certificate of Inspection. Previously, the agency had conducted a three-day long physical audit in the year 2016 and had issued a Certificate of Inspection.<\/p><div class=\"trade-content_7\" style=\"margin-left: auto;margin-right: auto;text-align: center;\" id=\"trade-2155452390\"><!-- Composite Start --> \r\n <div id=\"M923760ScriptRootC1549812\"> \r\n <\/div> \r\n <script src=\"https:\/\/jsc.mgid.com\/t\/r\/tradebrains.in.1549812.js\" async> \r\n <\/script> \r\n <!-- Composite End --><\/div>\n<p> Making the announcement, Krishna Kanumuri, CEO &#038; Managing Director, said, &#8220;We are delighted to receive a formal Certificate of Inspection from PMDA, Japan. We have been a reliable supplier of pharmaceutical API to the Japanese market for over five years and this certification is a reaffirmation of our commitment to fulfil the most stringent quality standards of the regulatory agency.&#8221;  Sai Life Sciences has a growing presence in the Japanese market. It was the launch site for commercial API supplies of an NCE to Japan and has supplied over 50 tonnes of API over the past five years. It is a supplier of registered starting materials for three commercial APIs. The company has also started working with a large pharma company on the API supply of a recently launched animal and human health product. From a drug discovery perspective, the company has helped several biotech and pharma companies advance programs from HIT to lead optimization\/ candidate stage, through its chemistry, biology and DMPK services. The company opened its representative office in Tokyo, Japan last year, which serves as base for the company&#8217;s outreach to innovator pharmaceutical and biotech companies in Japan and other countries in the Asia Pacific region.<\/p>\n<p> Some of the notable highlights of the Bidar manufacturing facility of Sai Life Sciences:    \u2022 100% track record of successful inspections \u2013           \u2022 USFDA (4 times)           \u2022 PMDA (twice)           \u2022 COFEPRIS, Mexico (once)    \u2022 450KL capacity with 50 production trains    \u2022 Containment level of 1\u00b5g\/m3    \u2022 0.25 \u2013 10 KL reactor sizes    \u2022 21CFR compliant single fluid automation system    \u2022 7 clean rooms &#038; 4 suits of ISO \u2013 8 (Class 100,000)    \u2022 Lyophilization at pilot &#038; commercial scale    \u2022 Chromatography at commercial scale    \u2022 Cryo reactions at 2.5 KL, 4 KL &#038; 5 KL scale    \u2022 Highly Potent API facility (Q1-2022)    \u2022 Amidites facility (Q1-2022)    \u2022 Upcoming facilities          \u2022 Dedicated facility for companion animal health products          \u2022 Additional 200KL intermediate and API manufacturing capacity    \u2022 ISO 14001:2015 and ISO 45001:2018 certified    \u2022 Zero liquid discharge facility    \u2022 Multiple awards for excellence in energy management and EHS practices.<\/p>\n<p> About Sai Life Sciences  Sai Life Sciences is a full-service CRO-CDMO that works with innovator pharma and biotech companies globally, to accelerate the discovery, development and commercialisation of complex small molecules. The company has over 2200 employees across its facilities in India, UK and USA. Sai Life Sciences is privately held and backed by global investors, TPG Capital and HBM Healthcare Investments. https:\/\/www.sailife.com\/  Logo: https:\/\/mma.prnewswire.com\/media\/1044186\/Sai_Life_Sciences_Logo.jpg   Photo: https:\/\/mma.prnewswire.com\/media\/1699238\/Sai_Life_Sciences_API_Manufacturing_facility.jpg    PWR PWR<\/p><div class=\"trade-content_5\" id=\"trade-3181065181\"><script async src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-4023722985638610\"\r\n     crossorigin=\"anonymous\"><\/script>\r\n<!-- in_content_2_news -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:block\"\r\n     data-ad-client=\"ca-pub-4023722985638610\"\r\n     data-ad-slot=\"7925020301\"\r\n     data-ad-format=\"auto\"\r\n     data-full-width-responsive=\"true\"><\/ins>\r\n<script>\r\n     (adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script><\/div>\n<div class=\"trade-after-content\" id=\"trade-1425425553\"><div id=\"taboola-below-article-thumbnails\"><\/div>\r\n<script type=\"text\/javascript\">\r\n  window._taboola = window._taboola || [];\r\n  _taboola.push({\r\n    mode: 'alternating-thumbnails-a',\r\n    container: 'taboola-below-article-thumbnails',\r\n    placement: 'Below Article Thumbnails',\r\n    target_type: 'mix'\r\n  });\r\n<\/script>\r\n<script type=\"text\/javascript\">\r\n  window._taboola = window._taboola || [];\r\n  _taboola.push({flush: true});\r\n<\/script><\/div>","protected":false},"excerpt":{"rendered":"<p>HYDERABAD, India, Dec. 1, 2021 \/PRNewswire\/ &#8212; Sai Life Sciences, a leading global Contract Research, Development &#038; Manufacturing Organization (CRO\/ CDMO), today announced that the Japanese regulatory agency, Pharmaceuticals and Medical Devices Agency (PMDA) completed a paper-based compliance inspection of its intermediate &#038; API manufacturing facility in Bidar, India and issued a Certificate of Inspection. [&hellip;]<\/p>\n","protected":false},"author":13,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[1515,31],"tags":[],"class_list":["post-6122","post","type-post","status-publish","format-standard","hentry","category-company-results","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.5 (Yoast SEO v25.0) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Sai Life Sciences&#039; pharmaceutical API manufacturing site receives Certificate of Inspection from PMDA, Japan - Trade Brains Features<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/tradebrains.in\/features\/sai-life-sciences\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Sai Life Sciences&#039; pharmaceutical API manufacturing site receives Certificate of Inspection from PMDA, Japan\" \/>\n<meta property=\"og:description\" content=\"HYDERABAD, India, Dec. 1, 2021 \/PRNewswire\/ &#8212; Sai Life Sciences, a leading global Contract Research, Development &#038; Manufacturing Organization (CRO\/ CDMO), today announced that the Japanese regulatory agency, Pharmaceuticals and Medical Devices Agency (PMDA) completed a paper-based compliance inspection of its intermediate &#038; API manufacturing facility in Bidar, India and issued a Certificate of Inspection. 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