Encap Drug Delivery, part of Capsugel's Dosage Form Solutions (DFS) business, has entered a collaboration with Lipocine, Inc. to manufacture Phase III trial and ICH stability registration batches of Lipocine's oral testosterone product, LPCN 1021.
The product will be manufactured at Encap's high-potency R&D suite in Livingston, Scotland. Encap has completed the transfer of the manufacturing process and validation of all related test methods for LPCN 1021 to its Livingston site. Additionally, Encap has successfully manufactured all the IND registration batches for the upcoming Phase III supply and stability registration.
"We are delighted to have been chosen by Lipocine for the manufacture of this important product," said Dr. Stephen Brown, managing director at Encap Drug Delivery. "Encap has built its profile over the last few years in product development and clinical trial manufacturing. This collaboration highlights our long-standing and significant expertise in commercial-scale manufacturing and our ability to handle high-potent active pharmaceutical ingredients."