MILAN, Italy, May 07, 2024 (GLOBE NEWSWIRE) -- Dipharma Francis S.r.l. (Dipharma), a global Contract Development and Manufacturing Organization (CDMO) and leading manufacturer of New Chemical Entities (NCE), Generic Active Pharmaceutical Ingredients and Advanced Intermediates, proudly announced that Dipharma Inc., its US facility located in Kalamazoo, MI, has been inspected by the U.S.

意大利米兰，2024年5月7日（环球通讯社）--Dipharma Francis S.r.l.（Dipharma），一家全球合同开发和制造组织（CDMO），新化学实体（NCE）、通用活性药物成分和先进中间体的领先制造商，自豪地宣布，其位于密歇根州卡拉马祖的美国工厂Dipharma Inc.已接受美国的检查。

Food and Drug Administration (FDA) and has received the Establishment Inspection Report (EIR), satisfactorily closing the inspection process. The rigorous inspection took place in the second week of January this year. At the closing meeting the inspectors congratulated the Dipharma team members on the Current Good Manufacturing Practices (CGMP) Systems they created and their overall commitment to quality.

食品和药物管理局（FDA），并已收到机构检查报告（EIR），圆满结束了检查过程。严格的检查是在今年1月的第二周进行的。在闭幕会议上，检查员祝贺Dipharma团队成员目前创建的良好制造规范（CGMP）系统及其对质量的总体承诺。

Since 1970, Dipharma Group has achieved an unbroken positive record of inspections by the major international Regulatory Agencies, and this new achievement demonstrates the Company’s extensive experience in ensuring compliance with the highest global quality standards. With this accomplishment, Dipharma Inc.

自1970年以来，迪法玛集团在主要国际监管机构的检查方面取得了从未间断的积极记录，这一新成就证明了该公司在确保符合全球最高质量标准方面的丰富经验。凭借这一成就，Dipharma Inc。

expands the range of services offered to its international clients to include commercial deliveries. Furthermore, it enhances the vertical integration of all Dipharma’s CGMP manufacturing processes, in all four facilities, from preclinical to commercial scale. 'The successful closure of the FDA's Pre-Approval Inspection (PAI) marks a significant achievement for our US facility, Dipharma Inc.

扩大了向国际客户提供的服务范围，包括商业交付。此外，它还增强了Dipharma从临床前到商业规模的所有四个设施中所有CGMP制造过程的垂直整合。”FDA批准前检查（PAI）的成功关闭标志着我们的美国工厂Dipharma Inc.取得了重大成就。

Congratulations to the whole team for this great accomplishment,' stated Jorge Nogueira, Chief Executive Officer of Dipharma Francis. 'This inspection, the first conducted by the FDA at our US facility, underscores the Dipharma Group's unwavering commitment to continuously improve our GMP Syst.

Dipharma Francis首席执行官豪尔赫·诺盖拉（JorgeNogueira）表示，祝贺整个团队取得了这一巨大成就这是FDA首次在我们的美国工厂进行的检查，突显了Dipharma集团坚定不移地致力于不断改进我们的GMP系统。