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Showing posts from May, 2025

Syntegon Reports Accelerated Growth in 2024 Results

  Syntegon delivers record results in 2024 New strategy fuels accelerated growth following CEO transition in late 2023 Order intake increased by 11% to 1.8 billion EUR and revenue grew by 7% to 6 billion EUR Strong EBITDA improvement by 15% to 222 million EUR and 14% EBITDA margin (up 100 bps) Focused cash flow generation program delivers strong improvement Strategic focus on turnkey solutions for the global Pharmaceutical and Biotech industries Accelerated growth and further results improvement targeted in 2025 Waiblingen, May 15, 2025 – The Syntegon Group, a leading strategic partner to the global pharmaceutical, biotech and food industries, reported record results for fiscal year 2024. Driven by its newly introduced corporate strategy focused on growth, operational excellence and long-term value creation, Syntegon achieved accelerated growth, strong profitability, and improved cash flow. Strategic initiatives launched in 2024 included targeted investments in portfolio expansion ...

Particulate Matter in Injectables: Risks and Controls

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  Based on available data from US FDA between Aug 2017 to Feb 2024, approximately 31% of injectable drug recalls were due to the presence of particulates contamination [1]. Even as improvement measures are being adopted by the pharmaceutical manufacturers to reduce the occurrence of particulate-related recalls, the issue of particulates in drugs continues to be an important topic that is scrutinized by US FDA. In December 2021, US FDA further introduced a draft guidance for industry ‘Inspection of Injectable Products for Visible Particulates’, which emphasizes the importance of using ‘a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination’. Although the United States Pharmacopeial (USP) General Chapters, such as USP <787>, ...