Scienture LLC
Prioritizing Patients. Improving Outcomes.
A Branded Specialty Pharmaceutical Company
Focusing on the unmet medical needs of patients through innovative pharmaceutical products
Scienture LLC is a NY based pharmaceutical research company. We are a highly experienced team of industry professionals who are passionate about developing unique specialty product concepts and solutions that bring enhanced value to patients and healthcare systems. Our assets in development are across therapeutics areas, indications and cater to different market segments
Our Mission
Our mission is to identify and develop innovative technology-based product concepts to create a portfolio of value-added specialty pipeline. The targeted portfolio will consist of short term and long-term opportunities with efficient development, regulatory, and commercial pathways.
Our History
Scienture LLC was founded by Shankar Hariharan, Ph.D., with the core purpose of using technology based concepts to design and develop novel branded drug products. During the course of his long career in the pharmaceutical industry he has successfully championed many differentiated approaches to drug development with the ultimate goal of bringing products to the market that significantly improve the standard of care, while providing broad access to patients. Our Leadership team and BOD consists of some of the most renowned names in the industry with proven experience across several facets of the business.
Aug 2024
July 2024
Dec 2023
Commack, NY, December 19th, 2023 - Scienture LLC, a New York-based branded pharmaceutical company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has accepted the 505(b)2 New Drug Application (NDA) for SCN-102, a key product in its innovative specialty product pipeline. This significant milestone follows the original NDA submission in October 2023, with a 10-month review cycle, and sets the Prescription Drug User Fee Act (PDUFA) goal date for August 2024.
SCN-102 is part of Scienture's commitment to developing unique specialty products using cutting-edge drug delivery technology concepts, including drug-device combinations. The company's primary focus is on indications in the cardiovascular and central nervous system space, along with other selected therapeutic areas.
Shankar Hariharan, Founder, President, and CEO of Scienture, expressed his enthusiasm about this milestone, stating, "The acceptance of the NDA for SCN-102 by the FDA is a significant achievement for Scienture. It validates our dedication to advancing high-technology solutions in the drug delivery arena and underscores our commitment to addressing unmet medical needs. This milestone is not only crucial for Scienture but also for the broader market seeking alternatives and superior treatment options.”
This announcement comes as Scienture marks another achievement, having successfully completed capital raise of $2 million in August 2023. The funding supports Scienture's mission to bring value-added specialty products to the market, with a focus on providing affordable and efficient access to high-value solutions.
About Scienture
Scienture Inc. is a NY based branded, specialty pharmaceutical company. We are a highly experienced team of industry professionals who are passionate about developing unique specialty product concepts and solutions that bring enhanced value to patients and healthcare systems. Our assets in development are across therapeutics areas, indications and cater to different market segments. Learn more at http://www.scienture.com/
Nov 2023
Hauppauge, NY, November 16th, 2023 - Scienture INC, a leading New York-based pharmaceutical company, is pleased to announce the well-deserved promotions of two key employees following the recent board meeting held on November 15, 2023. These promotions signify Scienture's commitment to recognizing and nurturing talent within the organization.
Rahul Surana, previously serving as the Senior Vice President of Corporate Strategy and Business Development, has been promoted to the role of Senior Vice President and Chief Operating Officer (COO). Rahul has played a pivotal role in shaping Scienture's strategic direction and driving business/product development initiatives. Shankar Hariharan, Founder, President, and CEO of Scienture, commented on Rahul Surana's promotion, stating, "We are thrilled to announce Rahul's well-deserved promotion to Senior Vice President and Chief Operating Officer. His technical ability, strategic insights, leadership, and dedication have been instrumental in Scienture's growth. We have great confidence that Rahul will continue to contribute significantly to our organization's success in his new role."
Scienture is also delighted to announce the promotion of Shreena Patel. Shreena, who previously held the position of Senior Director of Regulatory Affairs and Project Management, has been promoted to the role of Vice President of Regulatory Affairs and Project Management. Shreena's expertise in regulatory affairs has been crucial in navigating complex pharmaceutical regulatory landscape and ensuring the success of Scienture's projects. Shankar Hariharan further remarked on Shreena Patel's promotion, saying, "Shreena has demonstrated exceptional skills and dedication in her role, ensuring that Scienture adheres to the highest development and regulatory standards. Her promotion to Vice President is a testament to her contributions and our confidence in her ability to lead our regulatory affairs efforts."
These promotions come at a significant juncture for Scienture as the company continues its trajectory of growth and innovation. The leadership team looks forward to the continued contributions of Rahul Surana and Shreena Patel in their new roles.
About Scienture
Scienture Inc. is a NY based branded, specialty pharmaceutical company. We are a highly experienced team of industry professionals who are passionate about developing unique specialty product concepts and solutions that bring enhanced value to patients and healthcare systems. Our assets in development are across therapeutic areas, indications and cater to different market segments. Learn more at https://www.scienture.com/.
Sept 2023
Hauppauge, NY, September 18, 2023 - Scienture INC, a leading New York-based pharmaceutical company, is pleased to announce a significant milestone in its pursuit of groundbreaking pharmaceutical innovations. The company has successfully raised $2 million in convertible debt financing from NanoCapital, a distinguished financial institution with a keen interest in supporting visionary enterprises. Arun Agarwal, a current Scienture Board member, will act as NanoCapital’s representative on Scienture's Board of Directors, fostering a strategic partnership between the two organizations.
Shankar Hariharan, President and CEO of Scienture, expressed his enthusiasm for this latest development, stating, "We are thrilled to welcome NanoCapital as a partner in Scienture's mission to improve the quality of healthcare. This infusion of capital will be instrumental in propelling at least two of our innovative projects forward. We look forward to leveraging NanoCapital's expertise and financial support to accelerate our efforts in bringing transformative pharmaceutical solutions to market."
Arun Agarwal, the NanoCapital representative on Scienture's Board, shared his perspective on the partnership, saying, "Scienture's commitment to advancing cutting-edge drug delivery technologies aligns perfectly with NanoCapital's vision of supporting visionary companies with high-impact potential. We believe in Scienture's capabilities and innovative spirit, and we are excited to be part of their journey towards improving healthcare outcomes."
Scienture Inc. has been making significant strides in the pharmaceutical sector, and this financing from NanoCapital comes at a crucial juncture as Scienture prepares to file its first new drug application soon. The funds secured will enable Scienture to expedite the development and commercialization of its groundbreaking pharmaceutical products, which are poised to address unmet medical needs and enhance clinical outcomes.
About Scienture Scienture Inc. is a NY based branded, specialty pharmaceutical company. We are a highly experienced team of industry professionals who are passionate about developing unique specialty product concepts and solutions that bring enhanced value to patients and healthcare systems. Our assets in development are across therapeutics areas, indications and cater to different market segments. For more information about Scienture Inc. and its pioneering pharmaceutical initiatives, please visit http://www.scienture.com/.
Hauppauge, NY, September 14th, 2023. Scienture INC, a leading branded and specialty pharmaceutical company, is pleased to announce a significant addition to its Board of Directors. Martin Gargiule, a seasoned finance and accounting professional with over 25 years of expertise, has joined the board, bringing a wealth of strategic financial knowledge to the organization.
Martin Gargiule's distinguished career encompasses leadership roles in financial planning and analysis, accounting, treasury management, and mergers and acquisitions. His most recent role was as the Chief Financial Officer at Douglas Electrical Components, LLC. Before stepping into his role at Douglas Electrical Components, Martin held the position of VP of Finance at Advantice Health, where he played a pivotal role in formulating both annual and strategic financial plans. His contributions extended to facilitating the acquisition of key products and overseeing the ultimate sale of Advantice. Prior to Advantice Health, Martin built a rich career in the pharmaceutical sector, assuming roles such as VP Finance - Financial Planning & Analysis at Amneal Pharmaceuticals, VP Finance - Corporate Controller at G&W Laboratories, and various financial and accounting positions at Sandoz and Mylan. Martin's journey commenced at Deloitte, where he served as an Audit Manager specializing in audits of SEC registered manufacturing clients. Holding the designation of Certified Public Accountant, Martin Gargiule earned his Bachelor of Science and Business Administration in Accounting from Slippery Rock University.
Dr. Shankar Hariharan, President and CEO of Scienture, commented, "With Martin Gargiule joining the Board, we are confident that his extensive financial knowledge and strategic vision will be instrumental in advancing Scienture's mission of developing unique specialty product concepts that enhance value for patients and healthcare systems." This is the second expansion of the Board since it was formed 3 years ago. Along with Dr. Hariharan, Sandeep Gupta, PhD, Founder and CEO of Asana Biosciences, Polireddy Dondeti, PhD, President and CEO of Saptalis Pharmaceuticals, and Arun Agarwal, CEO of White Lotus Group also serve on Scienture’s Board currently.
About Scienture Scienture Inc. is a NY based branded, specialty pharmaceutical company. We are a highly experienced team of industry professionals who are passionate about developing unique specialty product concepts and solutions that bring enhanced value to patients and healthcare systems. Our assets in development are across therapeutics areas, indications and cater to different market segments. Learn more at https://www.scienture.com/.
Dec 2022
Hauppauge, NY, December 21st, 2022. Scienture INC, a New York based branded pharmaceutical company, provided an update today for the current status of projects in development and capital raise efforts. Scienture has a differentiated specialty product pipeline for indications in cardiovascular, CNS and pain therapeutic areas. For three of the products (SCN-102, SCN-104 and SCN-107), the company successfully completed pre-IND meetings with the FDA.
The IND for SCN-102 was submitted and cleared in Oct 2022 and clinical studies were initiated. The product is in the late stages of development and the company plans to file the NDA in 2023.
SCN-104, a drug device combination product, is in advanced stages of development. Formulation development and pilot PK study are successfully completed and the device development is on track.
SCN-106, which is a biosimilar product in early stages of development, clone selection has been successfully completed and the BIA meeting is planned in early 2023.
SCN-107 is in the formulation optimization stage and pre-clinical studies are planned for 2023.
In terms of capital, Scienture raised $3 million USD over the past year in convertible notes to support the development of the pipeline.
“2022 has been a strong year for Scienture team. We had multiple effective pre-IND meetings for our development programs and a successful IND submission for SCN-102 which paved the way for initiating clinical studies. I am extremely proud of the team that made it possible and thankful to all our investors for their continuous support. We are excited and look forward to continuing the rapid progress we have made on each of our development programs”, commented Shankar Hariharan, Founder, President and CEO.
About Scienture
Scienture Inc. is a NY based branded, specialty pharmaceutical company. We are a highly experienced team of industry professionals who are passionate about developing unique specialty product concepts and solutions that bring enhanced value to patients and healthcare systems. Our assets in development are across therapeutics areas, indications and cater to different market segments. Learn more at http://www.scienture.com/
Oct 2022
Hauppauge, NY, October 21st, 2022. Scienture Inc, a specialty pharmaceutical company based in Long Island NY, today announced that it received agency approval to initiate the proposed IND opening studies for SCN-102, their lead 505(b)(2) NDA program. SCN-102 is an oral liquid for cardiovascular use and is in advanced stages of development. Scienture had previously submitted an IND application with extensive information on the pre-clinical, safety, CMC and the proposed clinical program and sought agency’s approval to initiate human trials.
“This is a significant milestone achieved for Scienture. This IND was the first one filed under the Scienture name, and its clearance is a substantial inflection point for the company to date. We plan to initiate the IND opening study before the end of 2022”, remarked Shankar Hariharan, Founder, President and CEO of Scienture.
About Scienture
Scienture Inc. is a NY based branded, specialty pharmaceutical company. We are a highly experienced team of industry professionals who are passionate about developing unique specialty product concepts and solutions that bring enhanced value to patients and healthcare systems. Our assets in development are across therapeutics areas, indications and cater to different market segments. Learn more at http://www.scienture.com/.
Sept 2022
Hauppauge, NY, September 8th, 2022. Scienture Inc, a specialty pharmaceutical company based in Long Island NY, announced a positive Pre-IND response inclusive of the confirmation of the regulatory pathway for approval, from FDA on their 505 (b)(2) NDA program, SCN-107. The product SCN-107 is a long-acting injection product indicated for pain. Scienture had sought a pre-IND meeting with the agency and had previously submitted a briefing book with early stage development data and questions pertaining to clinical, pre-clinical, safety, CMC development plan.
“SCN-107 is a complex long-acting injection product. Developing an early understanding with the FDA on the preclinical, clinical and CMC requirements to work out a development roadmap is critical to the success of the project. We are happy with the feedback and will continue to work with the agency to ensure that all the regulatory requirements are fulfilled for a successful NDA submission and approval”, quoted Shankar Hariharan, Founder, President and CEO of Scienture.
About Scienture
Scienture Inc. is a NY based branded, specialty pharmaceutical company. We are a highly experienced team of industry professionals who are passionate about developing unique specialty product concepts and solutions that bring enhanced value to patients and healthcare systems. Our assets in development are across therapeutics areas, indications and cater to different market segments. Learn more at http://www.scienture.com/.
Oct 2021
*Hauppauge, NY, October 10th, 2021. *Scienture Inc, a specialty pharmaceutical company based in Long Island NY, today announced a positive Pre-IND response from the FDA on SCN-102, their lead 505(b)(2) NDA program. SCN-102 is an oral liquid for cardiovascular use and is in advanced stages of development. Scienture had sought a Pre-IND meeting with FDA to discuss the development program and submitted a briefing book with questions pertaining to clinical, pre-clinical, safety and CMC development plan.
“Feedback on the SCN-102 development program with the FDA is a critical step for Scienture to bring this product to market to fulfill an unmet need for patients. We are happy with the FDA feedback as it provides a clear development path forward. We will continue to work with the agency to ensure that all the regulatory requirements are fulfilled for a successful NDA submission and approval”, remarked Shankar Hariharan, Founder, President and CEO of Scienture.
About Scienture
Scienture Inc. is a NY based branded, specialty pharmaceutical company. We are a highly experienced team of industry professionals who are passionate about developing unique specialty product concepts and solutions that bring enhanced value to patients and healthcare systems. Our assets in development are across therapeutics areas, indications and cater to different market segments. Learn more at http://www.scienture.com/
*Hauppauge, NY, October 11th, 2021. *Scienture Inc, a specialty pharmaceutical company based in Long Island NY, announced a positive Pre-IND response from FDA on one of their 505 (b)(2) NDA program, SCN-104. The product SCN-104 is a multi-fix-dose pen injector-based drug device combination product for convenient self-injection for CNS/Pain and is in advanced stages of development. Scienture had sought a pre-IND meeting with the agency and had previously submitted a briefing book with questions pertaining to clinical, pre-clinical, safety, CMC development plan.
“With SCN-104 being a drug-device combination delivering multiple doses, it was important for Scienture to get an agreement on the clinical and device development program with the agency. We are happy with the FDA feedback as it helps us develop a clear strategy going forward. We will continue to work with the agency to ensure that all the regulatory requirements are fulfilled for a successful NDA submission and approval”, remarked Shankar Hariharan, Founder, President and CEO of Scienture.
About Scienture
Scienture Inc. is a NY based branded, specialty pharmaceutical company. We are a highly experienced team of industry professionals who are passionate about developing unique specialty product concepts and solutions that bring enhanced value to patients and healthcare systems. Our assets in development are across therapeutics areas, indications and cater to different market segments. Learn more at http://www.scienture.com
Feb 2021
Hauppauge, NY, February 1st, 2021.Shankar Hariharan, President and CEO of Scienture, announced the addition of two new Directors Mr. Arun Agarwal and Narasimhan Mani, PhD, MBA, to company’s Board.
Mr. Arun Agarwal is a former Wall Street healthcare investment banker whose clients included some of the largest healthcare entities in the country. Formed in 2002, White Lotus Group, a real estate development firm, continues to facilitate a variety of real estate and healthcare projects totaling over $1.5 billion. Arun is a 1998 graduate from the Wharton School of Finance at the University of Pennsylvania, where he was awarded the Wharton Award for Academic Achievement. He also serves on the Boards of TinkRworks, NanoThernastics, Greater Omaha YMCA, HELP Foundation and Bemis Contemporary Arts.
Narasimhan Mani, PhD, MBA, is a proven leader with over 22 years of experience in both the scientific and business areas of the pharmaceutical industry. He is currently the CEO of Xiromed, a fast growing generic and specialty product company. His experience over the years includes multifunctional leadership roles, in branded and generic product segments, across product development, manufacturing operations, portfolio management, business development, M&A and Sales & Marketing. He held leadership positions at Elan Pharmaceuticals, Forest Laboratories, Par Pharmaceuticals, Johnson & Johnson, and Amneal Pharmaceuticals. Dr. Mani received his PhD in Pharmaceutics, from the University of Georgia, Athens and MBA in Finance and Marketing, from Columbia Business School, New York, NY.
Dr. Hariharan, who is also the chairman of the Board commented, “I am pleased to welcome Arun Agarwal and Narasimhan Mani to the Board of Directors. Their addition will be a major boost to Scienture’s growth prospects and outreach in the future.” This is the first expansion to the Board since it was formed a year ago. Sandeep Gupta, PhD, Founder and CEO of Asana Biosciences and Polireddy Dondeti, PhD, President and CEO of Saptalis Pharmaceuticals, also serve on Scienture’s Board currently.
About Scienture
Scienture Inc. is a NY based branded, specialty pharmaceutical company. We are a highly experienced team of industry professionals who are passionate about developing unique specialty product concepts and solutions that bring enhanced value to patients and healthcare systems. Our assets in development are across therapeutics areas, indications and cater to different market segments. Learn more at https://www.scienture.com/.
Jan 2021
Hauppauge, NY, January 29th, 2021. Scienture Inc, a New York based branded pharmaceutical company, today announced that Lawrence Olanoff, MD, PhD has joined the company’s Scientific Advisory Board. Dr. Olanoff is an adjunct Assistant Professor and Special Advisor to the President for Corporate Relations at the Medical University of South Carolina. From 2006-2010, he served as President and Chief Operating Officer for Forest Laboratories, Inc. From 2005 to 2006, Dr. Olanoff was CEO of Celsion Corporation. Prior to 2005, he served as Executive VP of Research and Development and Chief Scientific Officer of Forest, and held senior clinical research roles at Sandoz Pharmaceutical Corporation and the Upjohn Company. During his pharmaceutical development career, Dr. Olanoff made substantial contributions leading to thirty new drug approvals, either as new chemical entities or as supplemental indications, over a range of therapeutic areas. He is Chairman of the board of directors of Mitochondria in Motion, and serves as a member of the Board of Ironwood Pharmaceuticals and Ichnos Sciences, as well as several non-profit organizations. Dr. Olanoff also held past directorships on the boards of Forest Laboratories, Axovant Sciences Ltd. and the Celsion Corporation. He received his Ph.D. in biomedical engineering and M.D. degree from Case Western Reserve University, was an internal medicine resident and clinical pharmacology fellow at the Medical University of SC and is the author of some 40 scientific publications on topics including controlled drug delivery, pharmacokinetics, drug metabolism and clinical toxicology.
“We are extremely delighted and privileged to have Dr. Olanoff on the Scientific Advisory Board. He brings in a broad perspective on entire pharmaceutical development with his experience in the industry and academia and perfectly augments our two other SAB members Suneel Gupta, PhD and Wantanee Phuapradit, PhD. Having worked with Dr. Olanoff in the past, I know the depth of his commitment to helping the patients and serving unmet medical needs”, remarked Shankar Hariharan, Founder, President and CEO of Scienture.
About Scienture
Scienture Inc. is a NY based branded, specialty pharmaceutical company. We are a highly experienced team of industry professionals who are passionate about developing unique specialty product concepts and solutions that bring enhanced value to patients and healthcare systems. Our assets in development are across therapeutics areas, indications and cater to different market segments. Learn more at http://www.scienture.com/
Oct 2020
Hauppauge, NY, October 26th, 2020. Scienture LLC, a New York based branded pharmaceutical company, today announced that it completed its first round Series Seed capital raise of $6 million. The company, founded in July 2019, is in active development of a differentiated pipeline of specialty products which bring significant enhancement and transformation to the current standard of care. The products are driven by unique, cutting edge drug delivery technology concepts, inclusive of drug-device combinations. The predominant focus is on indications in the CNS space and additionally in a few other selected therapeutic areas.
“The completion of the Series Seed capital raise is an important first step for Scienture in its vision to bring value added specialty products to the market. We thank the support of all our investors in this funding round. Along with them and our leadership team at Scienture, we are deeply committed to serving unmet medical needs by employing high technology solutions in the drug delivery arena. Our goal is to provide affordable and efficient access to high value products with enhanced clinical outcomes to patients, caregivers and the healthcare system. We are excited and look forward to continuing the rapid progress we have made on each of our development programs”, commented Shankar Hariharan, Founder, President and CEO.
About Scienture
Scienture Inc. is a NY based branded, specialty pharmaceutical company. We are a highly experienced team of industry professionals who are passionate about developing unique specialty product concepts and solutions that bring enhanced value to patients and healthcare systems. Our assets in development are across therapeutics areas, indications and cater to different market segments. Learn more at http://www.scienture.com/
Jan 2020
Product development activities started and underway with our strategic development partners.
Nov 2019
Initiation of IP application process for our new and novel product concepts.
Oct 2019
Scienture establishes its corporate offices in Hauppauge, NY.