DifGen Pharmaceuticals 完成 Tafamidis 61 mg 胶囊欧洲分散审批程序
DifGen Pharmaceuticals Announces First Major European Milestone with Successful Completion of Decentralised Procedure for Tafamidis 61 mg Capsules
DifGen Pharmaceuticals 宣布 Tafamidis 61 mg 胶囊成功完成欧洲分散审批程序（DCP），这是该公司在欧洲的首个重大监管里程碑。公司计划借此与欧洲成熟药企洽谈授权、监管及战略合作机会。该成果体现其在复杂仿制药与差异化剂型上的开发与监管能力。
Significant regulatory achievement marks an important step in DifGen's European expansion and strengthens its foundation for strategic partnerships
, /PRNewswire/ -- DifGen Pharmaceuticals LLC ("DifGen"), a U.S.-based pharmaceutical company focused on the development, manufacturing and commercialization of complex and differentiated medicines, today announced the successful completion of the European Decentralised Procedure (DCP) for Tafamidis 61 mg Capsules, marking the Company's first major regulatory milestone in Europe.
The successful completion of the DCP represents a significant achievement for DifGen and demonstrates its ability to advance differentiated, technically challenging pharmaceutical products through stringent European regulatory procedures.
"This is a landmark moment for DifGen. Successfully completing our first major European regulatory procedure demonstrates the strength of our scientific, development and regulatory teams and represents an important step in our international growth journey. Europe is a key component of our long-term global strategy, and this milestone strengthens our development portfolio while establishing a solid foundation for future strategic partnerships across the region," said Ramandeep Singh Jaj and Santhanakrishnan Srinivasan, Co-Founders and Co-CEOs of DifGen Pharmaceuticals.
Building on this regulatory milestone, DifGen intends to engage with established pharmaceutical companies across Europe to evaluate potential licensing, regulatory and strategic collaboration opportunities, consistent with applicable regulatory and intellectual property requirements.
This achievement reflects DifGen's continued investment in complex generics, specialty pharmaceutical products and differentiated dosage forms, supported by its manufacturing and research and development infrastructure in Florida.
As DifGen continues to expand its international presence, the Company remains focused on leveraging its scientific expertise, regulatory capabilities and strategic partnerships to advance a diversified pharmaceutical portfolio across highly regulated global markets.
About DifGen Pharmaceuticals LLC
DifGen Pharmaceuticals LLC is a U.S.-based pharmaceutical company focused on the development, manufacturing and commercialization of complex generics, specialty pharmaceuticals and differentiated dosage forms.
With integrated scientific, regulatory, manufacturing and commercial capabilities, DifGen is committed to advancing high-quality pharmaceutical products through innovative development approaches and strategic partnerships across the United States and international markets.
For more information about DifGen Pharmaceuticals LLC, please visit www.difgen.com.
Media & Business Inquiries
DifGen Pharmaceuticals LLC
Contact Person: Roberta Loomar
Title: Global General Counsel
Email: [email protected]
Telephone: +19546051796
SOURCE DifGen Pharmaceuticals
来源：PR Newswire Health · prnewswire.com