Encap Drug Delivery, part of Capsugel’s Dosage Form Solutions business unit, will collaborate with Lipocine, a specialty pharmaceutical company, to manufacture Phase III clinical trial and ICH stability registration batches of Lipocine’s oral testosterone product, LPCN 1021. The product will be manufactured in the company’s high-potency suite at its Livingston, Scotland, R&D site. LPCN 1021 is under development as a testosterone product to treat symptoms related to currently marketed testosterone replacement products. The investigational drug is designed for twice-daily oral dosing.
Encap has completed the transfer of the manufacturing process and validation of all related test methods (in-process and finished product) for LPCN 1021 to its site in Livingston. In addition, Encap has manufactured all the investigational new drug registration batches for the upcoming Phase III clinical supply and stability registration.
Source: Encap Drug Delivery