{"id":98152,"date":"2023-03-29T17:35:00","date_gmt":"2023-03-29T12:05:00","guid":{"rendered":"https:\/\/tradebrains.in\/features\/?p=98152"},"modified":"2023-03-29T17:31:37","modified_gmt":"2023-03-29T12:01:37","slug":"biz-granules-india-usfda-4","status":"publish","type":"post","link":"https:\/\/tradebrains.in\/features\/biz-granules-india-usfda-4\/","title":{"rendered":"Granules India receives USFDA approval for generic gabapentin tablets"},"content":{"rendered":"<div class=\"trade-content_2\" style=\"margin-left: auto;margin-right: auto;text-align: center;\" id=\"trade-753877939\"><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>Pharmaceuticals firm Granules India Ltd on Wednesday said it has received approval from the US health regulator for its generic gabapentin tablets indicated for management of postherpetic neuralgia in adults.<\/p><div class=\"trade-content_7\" style=\"margin-left: auto;margin-right: auto;text-align: center;\" id=\"trade-836859469\"><!-- 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><p>The approval by the US Food &amp; Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Gabapentin tablets of strengths 600 mg and 800 mg, Granules India said in a regulatory filing.<\/p><p>These tablets are bioequivalent to the reference listed drug product, Neurontin Tablets, 600 mg and 800 mg, of Viatris Specialty LLC.<\/p><p>Gabapentin tablets are indicated for management of postherpetic neuralgia in adults; and as an adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalisation, in adults and pediatric patients aged 3 years and older with epilepsy, the company added.<\/p><div class=\"trade-content_5\" id=\"trade-3833986161\"><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><p>Gabapentin tablets had annual sales of approximately USD 145 million in the US, it said citing IQVIA\/IMS Health January 2023 data.<\/p><p>Granules now has a total of 55 ANDA approvals from USFDA with 53 final approvals and two tentative approvals, it added. PTI RKL HVA<\/p><div class=\"trade-after-content\" id=\"trade-1517778199\"><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>Pharmaceuticals firm Granules India Ltd on Wednesday said it has received approval from the US health regulator for its generic gabapentin tablets indicated for management of postherpetic neuralgia in adults. The approval by the US Food &amp; Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for Gabapentin tablets of strengths 600 mg [&hellip;]<\/p>\n","protected":false},"author":13,"featured_media":49884,"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":[1696,31],"tags":[],"class_list":["post-98152","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-corporate-action","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>Granules India receives USFDA approval for generic gabapentin tablets - Trade Brains Features<\/title>\n<meta name=\"description\" content=\"Pharmaceuticals firm Granules India Ltd on Wednesday said it has received approval from the US health regulator for its generic gabapentin tablets indicated for management of postherpetic neuralgia in adults.\" \/>\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-granules-india-usfda-4\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Granules India receives USFDA approval for generic gabapentin tablets\" \/>\n<meta property=\"og:description\" content=\"Pharmaceuticals firm Granules India Ltd on Wednesday said it has received approval from the US health regulator for its generic gabapentin tablets indicated for management of postherpetic neuralgia in adults.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/tradebrains.in\/features\/biz-granules-india-usfda-4\/\" \/>\n<meta property=\"og:site_name\" content=\"Trade Brains Features\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/TradeBrainsOfficial\/\" \/>\n<meta property=\"article:published_time\" content=\"2023-03-29T12:05:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/tradebrains.in\/features\/wp-content\/uploads\/2022\/06\/Pharma-1-Cover-Image.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1280\" \/>\n\t<meta property=\"og:image:height\" content=\"854\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"PTI News\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:image\" content=\"https:\/\/tradebrains.in\/features\/wp-content\/uploads\/2022\/06\/Pharma-1-Cover-Image.jpg\" \/>\n<meta name=\"twitter:creator\" content=\"@TradeBrainsGrp\" \/>\n<meta name=\"twitter:site\" content=\"@TradeBrainsGrp\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"PTI News\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minute\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/tradebrains.in\/features\/biz-granules-india-usfda-4\/\",\"url\":\"https:\/\/tradebrains.in\/features\/biz-granules-india-usfda-4\/\",\"name\":\"Granules India receives USFDA approval for generic gabapentin tablets - 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