{"id":11184,"date":"2024-11-27T09:26:37","date_gmt":"2024-11-27T09:26:37","guid":{"rendered":"https:\/\/jubilantbiosys.com\/new-staging\/?page_id=11184"},"modified":"2026-02-20T06:06:38","modified_gmt":"2026-02-20T06:06:38","slug":"non-gmp-and-gmp-manufacturing","status":"publish","type":"page","link":"https:\/\/www.jubilantbiosys.com\/new-staging\/non-gmp-and-gmp-manufacturing\/","title":{"rendered":"Non-GMP and GMP Manufacturing"},"content":{"rendered":"\n<div class=\"wp-block-group solutions-details-info-list\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<div class=\"wp-block-group solutions-details-head is-nowrap is-layout-flex wp-container-core-group-is-layout-8f761849 wp-block-group-is-layout-flex\">\n<h2 class=\"wp-block-heading\">Non-GMP and GMP Manufacturing<\/h2>\n<\/div>\n\n\n\n<div class=\"wp-block-group solutions-details-content\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<p class=\"wp-block-paragraph\">With full integrated cGMP facilities, our small to large scale manufacturing capacities and technologies provide reliable outsourcing services our clients need, spanning complete supply chain from early clinical-phase development to commercialization.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Jubilant Biosys brings decades of API development and manufacturing experience to deliver high quality drug substance.<\/p>\n\n\n\n<div class=\"wp-block-group solutions-details-tow-col-list-inner\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<p class=\"wp-block-paragraph\">Our \ufb02exibility allows us to manufacture from a lab scale of just a few grams to kilograms in our GMP pilot plant or to industrial quantities. Compliance with the highest cGMP standards is always assured for a qualified contract development and manufacturing process.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">As your <a href=\"https:\/\/www.jubilantbiosys.com\/new-staging\/services\/contract-development-and-manufacturing-organization\/\"><strong>CDMO partner<\/strong><\/a>, we deliver tailored end-to-end solutions spanning your supply chain at all stages, from drug development to commercialization.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Our understanding of the development process, and access to resources ensures fast and reliable supply of APIs. We provide seamless technology transfer from the research labs to cGMP manufacturing facilities.<\/p>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-group solutions-details-tow-col-list is-nowrap is-layout-flex wp-container-core-group-is-layout-8f761849 wp-block-group-is-layout-flex\">\n<div class=\"wp-block-group solutions-details-tow-col-list-inner\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul class=\"wp-block-list solutions-details-icon-list\">\n<li>Key Raw Materials<\/li>\n\n\n\n<li>GMP Starting Materials<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-group solutions-details-tow-col-list-inner\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul class=\"wp-block-list solutions-details-icon-list\">\n<li>Non-GMP Intermediates<\/li>\n\n\n\n<li>Intermediates &amp; APIs<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group solutions-details-head is-nowrap is-layout-flex wp-container-core-group-is-layout-8f761849 wp-block-group-is-layout-flex\">\n<h2 class=\"wp-block-heading\">Kilo Lab for GMP scale up is now operational at our API manufacturing site<\/h2>\n<\/div>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Capability<\/strong><\/h3>\n\n\n\n<div class=\"wp-block-group my-0 is-vertical is-layout-flex wp-container-core-group-is-layout-4fc3f8e1 wp-block-group-is-layout-flex\">\n<figure class=\"wp-block-image size-full is-resized\"><img loading=\"lazy\" decoding=\"async\" width=\"800\" height=\"416\" src=\"https:\/\/www.jubilantbiosys.com\/new-staging\/wp-content\/uploads\/2024\/12\/non-gmp-and-gmp-manufacturing-1kg-img.png\" alt=\"\" class=\"wp-image-12771\" style=\"width:600px\" srcset=\"https:\/\/www.jubilantbiosys.com\/new-staging\/wp-content\/uploads\/2024\/12\/non-gmp-and-gmp-manufacturing-1kg-img.png 800w, https:\/\/www.jubilantbiosys.com\/new-staging\/wp-content\/uploads\/2024\/12\/non-gmp-and-gmp-manufacturing-1kg-img-300x156.png 300w, https:\/\/www.jubilantbiosys.com\/new-staging\/wp-content\/uploads\/2024\/12\/non-gmp-and-gmp-manufacturing-1kg-img-768x399.png 768w\" sizes=\"auto, (max-width: 800px) 100vw, 800px\" \/><\/figure>\n<\/div>\n\n\n\n<div class=\"wp-block-group solutions-details-tow-col-list mt-0 mb-3 is-nowrap is-layout-flex wp-container-core-group-is-layout-8f761849 wp-block-group-is-layout-flex\">\n<div class=\"wp-block-group solutions-details-tow-col-list-inner\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h3 class=\"wp-block-heading\">Equipment<\/h3>\n\n\n\n<ul class=\"wp-block-list solutions-details-icon-list\">\n<li>10L, 30 L Hastelloy reactors.<\/li>\n\n\n\n<li>Independent Temperature Control Unit.<\/li>\n\n\n\n<li>10 L All Glass Reactors.<\/li>\n\n\n\n<li>Nutsche filter (5L) and VTD (2 tray).<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group solutions-details-tow-col-list mt-0 is-nowrap is-layout-flex wp-container-core-group-is-layout-8f761849 wp-block-group-is-layout-flex\">\n<div class=\"wp-block-group solutions-details-tow-col-list-inner\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<div class=\"wp-block-group solutions-details-head is-nowrap is-layout-flex wp-container-core-group-is-layout-8f761849 wp-block-group-is-layout-flex\">\n<h2 class=\"wp-block-heading\">Scale-up at Delhi sites up to 20 kg&nbsp;<\/h2>\n<\/div>\n\n\n\n<h5 class=\"wp-block-heading\"><strong><strong>Scale up<\/strong><\/strong><\/h5>\n\n\n\n<ul class=\"wp-block-list solutions-details-icon-list\">\n<li><strong>40<\/strong> Clients catered in past 3 years.<\/li>\n\n\n\n<li><strong>153<\/strong> Projects completed in past 3 years.<\/li>\n\n\n\n<li><strong>10<\/strong> Scale up NCE (Up to 20kg).<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-group solutions-details-tow-col-list-inner\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<figure class=\"wp-block-image size-full img-h-330\"><img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"400\" src=\"https:\/\/www.jubilantbiosys.com\/new-staging\/wp-content\/uploads\/2024\/12\/Non-GMP-and-GMP.png\" alt=\"\" class=\"wp-image-11561\" srcset=\"https:\/\/www.jubilantbiosys.com\/new-staging\/wp-content\/uploads\/2024\/12\/Non-GMP-and-GMP.png 400w, https:\/\/www.jubilantbiosys.com\/new-staging\/wp-content\/uploads\/2024\/12\/Non-GMP-and-GMP-300x300.png 300w, https:\/\/www.jubilantbiosys.com\/new-staging\/wp-content\/uploads\/2024\/12\/Non-GMP-and-GMP-150x150.png 150w\" sizes=\"auto, (max-width: 400px) 100vw, 400px\" \/><\/figure>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group solutions-details-tow-col-list is-nowrap is-layout-flex wp-container-core-group-is-layout-8f761849 wp-block-group-is-layout-flex\">\n<div class=\"wp-block-group solutions-details-tow-col-list-inner\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h5 class=\"wp-block-heading\"><strong>Key Activities<\/strong><\/h5>\n\n\n\n<ul class=\"wp-block-list solutions-details-icon-list\">\n<li>Route scouting, process design and optimization.<\/li>\n\n\n\n<li>Development and standardization of synthetic steps considering scalable manufacturing needs.<\/li>\n\n\n\n<li>Synthetic demonstration scale-up manufacturing.<\/li>\n\n\n\n<li><strong><a href=\"https:\/\/www.jubilantbiosys.com\/new-staging\/analytical-development\/\">Analytical method development<\/a><\/strong> &amp; stability studies.<\/li>\n\n\n\n<li>Salt screening and polymorph studies. Transfer of process technology to pilot plant for advanced molecules.<\/li>\n\n\n\n<li>Well-established kilo laboratory for the synthesis of compounds in multi-grams to kilograms level.<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-group solutions-details-tow-col-list-inner\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h5 class=\"wp-block-heading\"><strong>Equipment<\/strong><\/h5>\n\n\n\n<ul class=\"wp-block-list solutions-details-icon-list\">\n<li>Scale-up hoods to accommodate multiple 20L reactors.<\/li>\n\n\n\n<li>20L jacketed reactors with TCU.<\/li>\n\n\n\n<li>250 L SS reactor with independent TCU.<\/li>\n\n\n\n<li>100 L Double-jacketed Glass reactor and 130 L Hastelloy reactor with independent TCUs.<\/li>\n\n\n\n<li>Multiple centrifuges, Multiple Nutsche filter.<\/li>\n\n\n\n<li>Column area for 3 jumbo columns, Multiple Rotavap of 20L and 50L.<\/li>\n\n\n\n<li>Multi-mill, Jet-mill &amp; Sifters<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group solutions-details-head is-nowrap is-layout-flex wp-container-core-group-is-layout-8f761849 wp-block-group-is-layout-flex\">\n<h2 class=\"wp-block-heading\">GMP Scale up at our pilot plant in Nanjangud for scale up to 20 kg<\/h2>\n<\/div>\n\n\n\n<div class=\"wp-block-group solutions-details-tow-col-list mt-0 is-nowrap is-layout-flex wp-container-core-group-is-layout-8f761849 wp-block-group-is-layout-flex\">\n<div class=\"wp-block-group solutions-details-tow-col-list-inner\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<figure class=\"wp-block-image size-full img-h-330\"><img loading=\"lazy\" decoding=\"async\" width=\"460\" height=\"400\" src=\"https:\/\/www.jubilantbiosys.com\/new-staging\/wp-content\/uploads\/2025\/01\/GMP-Scale-up-at-our-pilot-plant-in-Nanjangud-for-scale-up-to-20-kg.png\" alt=\"\" class=\"wp-image-13775\" srcset=\"https:\/\/www.jubilantbiosys.com\/new-staging\/wp-content\/uploads\/2025\/01\/GMP-Scale-up-at-our-pilot-plant-in-Nanjangud-for-scale-up-to-20-kg.png 460w, https:\/\/www.jubilantbiosys.com\/new-staging\/wp-content\/uploads\/2025\/01\/GMP-Scale-up-at-our-pilot-plant-in-Nanjangud-for-scale-up-to-20-kg-300x261.png 300w\" sizes=\"auto, (max-width: 460px) 100vw, 460px\" \/><\/figure>\n\n\n\n<ul class=\"wp-block-list solutions-details-icon-list\">\n<li><strong>~30<\/strong> Clients catered in past 3 years.<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n\n\n\n<div class=\"wp-block-group solutions-details-tow-col-list is-nowrap is-layout-flex wp-container-core-group-is-layout-8f761849 wp-block-group-is-layout-flex\">\n<div class=\"wp-block-group solutions-details-tow-col-list-inner\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h5 class=\"wp-block-heading\"><strong>Key Activities<\/strong><\/h5>\n\n\n\n<ul class=\"wp-block-list solutions-details-icon-list\">\n<li>Different variety of reaction vessels including a coil reactor for continuous reactions.<\/li>\n\n\n\n<li>Distillation: Batch distillation, Atmospheric, Azeotropic high vacuum distillation.<\/li>\n\n\n\n<li>Filtration: Centrifuge\/Nutsche Filter\/Pressure Nutsche filter\/ Agitated Nutsche filter &amp; dryer.<\/li>\n\n\n\n<li>Drying: Vacuum Tray Dryer\/ Agitated Nutsche filter &amp; dryer\/RCVD\/FBD.<\/li>\n\n\n\n<li>Milling &amp; Size reduction: Air Jet Mill\/Multi mill\/Sifter Absorption: Scrubber for hazardous fumes.<\/li>\n\n\n\n<li>Hydrogenation: Separate area for hydrogenation Lyophilizer and Rotavaps for specific product requirements.<\/li>\n<\/ul>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-group solutions-details-tow-col-list-inner\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<h5 class=\"wp-block-heading\"><strong>Equipment<\/strong><\/h5>\n\n\n\n<ul class=\"wp-block-list solutions-details-icon-list\">\n<li>Capacity: 4.3KL (~250 kg\/month).<\/li>\n\n\n\n<li>cGMP Plant 23 Reactor system.<\/li>\n\n\n\n<li>8 Glass line reactors, 4 Hastelloy reactor, 13 SS reactors.<\/li>\n\n\n\n<li>2 Streams of clean rooms 250L SS Hydrogenator @ 10kg\/cm2.<\/li>\n\n\n\n<li>20L Rotavapour, 20L Lyophilizer.<\/li>\n\n\n\n<li>200ml Coil reactor for continuous flow reaction, 100L SS316L Reactor for cryo reaction (- 150\u00b0 C).<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><small>*Belongs to the parent company, Jubilant Pharmova Limited.<\/small><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">You can rely on Jubilant Biosys for high-quality API development and <a href=\"https:\/\/www.jubilantbiosys.com\/new-staging\/active-pharmaceutical-ingredients\/\"><strong>API manufacturing services<\/strong><\/a>, supporting programs from early pre-clinical and clinical phases through commercial supply.<\/p>\n\n\n\n<div class=\"wp-block-group action-row\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\"><a href='#' class='action-btn' data-bs-toggle='modal' data-bs-target='#GetInTouchModal' data-bs-direction='right'>Get In Touch <i class='fa-solid fa-caret-right'><\/i><\/a><\/div><\/div>\n<\/div><\/div>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Non-GMP and GMP Manufacturing With full integrated cGMP facilities, our small to large scale manufacturing capacities and technologies provide reliable outsourcing services our clients need, spanning complete supply chain from early clinical-phase development to commercialization. Jubilant Biosys brings decades of API development and manufacturing experience to deliver high quality drug substance. Our \ufb02exibility allows us [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"template-solutions-one.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-11184","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Non-GMP and GMP Manufacturing | Jubilant Biosys<\/title>\n<meta name=\"description\" content=\"Jubilant Biosys offers flexible Non-GMP and GMP manufacturing services, ensuring high-quality APIs from early development to commercialization with cGMP compliance.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.jubilantbiosys.com\/non-gmp-and-gmp-manufacturing\/\" \/>\n<meta property=\"og:locale\" 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