Intec Pharma develops and produces Accordion Pill™ capsules for its clinical trials and research collaborations at its existing manufacturing facility in Jerusalem, Israel including the supply for its global Phase 3 clinical trial of the Company’s lead product candidate, Accordion Pill Carbidopa/Levodopa (AP-CD/LD) as a treatment for the severe symptoms in advanced Parkinson’s Disease patients. This production and packaging facility was granted the Certificate of GMP Compliance of Manufacturer from the Israeli Ministry of Health, which applies in Israel, as well as in the EU, in accordance with the Conformity Assessment and Acceptance of Industrial Products (CAA) agreement between the EU and Israel.
In March 2018, Intec Pharma partnered with LTS Lohmann Therapie-Systeme AG (“LTS”) for the commercial scale manufacture of the AP-CD/LD. Under the agreement, LTS will manufacture the AP-CD/LD capsules using Intec’s proprietary Accordion Pill production technology in LTS’ manufacturing facility in Andernach, Germany. LTS is the global leader in formulation and film technology manufacture for the pharmaceutical industry.
LTS’ Andernach facility is compliant with the U.S. Food and Drug Administration’s current Good Manufacturing Practices (“cGMP”) requirements that assure the proper design, monitoring and control of manufacturing processes and facilities. Furthermore, LTS´ Andernach facility has successfully passed audits from all major global regulatory agencies including the European EMA, J-PMDA, KFDA, CFDA and ANVISA.
Built on nearly ten years of research and development, Intec Pharma’s state-of-the-art and proprietary manufacturing process for the Accordion Pill is a core asset that is protected by several layers of intellectual property and significant know-how.
To learn more about our manufacturing capabilities, please contact email@example.com.