{"id":29112,"date":"2022-03-14T13:16:29","date_gmt":"2022-03-14T07:46:29","guid":{"rendered":"https:\/\/tradebrains.in\/features\/biz-alembic-usfda-2\/"},"modified":"2022-03-14T13:16:29","modified_gmt":"2022-03-14T07:46:29","slug":"biz-alembic-usfda-2","status":"publish","type":"post","link":"https:\/\/tradebrains.in\/features\/biz-alembic-usfda-2\/","title":{"rendered":"Alembic Pharma gets USFDA nod for generic product"},"content":{"rendered":"<div class=\"trade-content_2\" style=\"margin-left: auto;margin-right: auto;text-align: center;\" id=\"trade-2883243612\"><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> New Delhi, Mar 14 (PTI) Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market Macitentan tablets, which is used to treat high blood pressure, in the American market.<\/p><div class=\"trade-content_7\" style=\"margin-left: auto;margin-right: auto;text-align: center;\" id=\"trade-910725707\"><!-- 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> The company said it has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Macitentan tablets, 10 mg.<\/p>\n<p> The tentatively approved ANDA is therapeutically equivalent to the Actelion Pharmaceuticals US, Inc&#8217;s Opsumit Tablets, 10 mg, which are indicated for the treatment of pulmonary arterial hypertension.<\/p>\n<p> As per IQVIA, Macitentan tablets had an estimated market size of USD 797 million for 12 months ending December 2021.<\/p><div class=\"trade-content_5\" id=\"trade-1487484800\"><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<p> The drug firm said it has received 22 approvals in the year-to-date (YTD) period and has cumulative total of 161 ANDA approvals so far from the USFDA. PTI MSS  MSS HRS hrs<\/p>\n<div class=\"trade-after-content\" id=\"trade-3296384020\"><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>New Delhi, Mar 14 (PTI) Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market Macitentan tablets, which is used to treat high blood pressure, in the American market. The company said it has received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new [&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":[31],"tags":[],"class_list":["post-29112","post","type-post","status-publish","format-standard","hentry","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>Alembic Pharma gets USFDA nod for generic product - 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\/biz-alembic-usfda-2\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Alembic Pharma gets USFDA nod for generic product\" \/>\n<meta property=\"og:description\" content=\"New Delhi, Mar 14 (PTI) Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market Macitentan tablets, which is used to treat high blood pressure, in the American market. 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