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Advancing Global Biopharmaceutical Supply: Boehringer Ingelheim Secures EMA and FDA Approvals

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Boehringer Ingelheim Biopharmaceuticals China (BioChina), in collaboration with a valued partner, has achieved a significant milestone with the successful completion of pre-approval inspections of a biopharmaceutical product conducted by both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). This achievement paves the way for the approved supply of a biopharmaceutical product to the EU and US markets, sourced from manufacturing facilities operated by Boehringer Ingelheim Biopharmaceuticals China.

The rigorous inspections conducted by regulatory authorities not only underscored Boehringer Ingelheim Biopharmaceuticals China’s commitment to excellence but also served as a testament to its unwavering dedication to meeting and exceeding stringent quality and safety standards. These inspections, carried out by esteemed regulatory bodies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), evaluated the company’s adherence to a myriad of rigorous guidelines and protocols.

Among the key standards assessed were those outlined by the International Council for Harmonisation (ICH), which provides globally recognized benchmarks for the development, manufacturing, and registration of pharmaceutical products. Compliance with ICH guidelines ensures harmonization of regulatory requirements across different regions, facilitating the global acceptance of pharmaceutical products and enhancing patient safety.

Boehringer Ingelheim’s Shanghai Site Meets Global GxP Standards in Key Regulatory Inspections

The inspections evaluated Boehringer Ingelheim Biopharmaceuticals China’s adherence to Good Manufacturing Practice (GxP) regulations, which are integral to ensuring the consistent production of safe and high-quality pharmaceutical products. GxP encompasses a broad range of quality assurance practices, including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and Good Clinical Practice (GCP), each of which plays a crucial role in safeguarding product quality and patient well-being.

Furthermore, the assessments encompassed compliance with international manufacturing protocols, which dictate the standards and procedures governing pharmaceutical manufacturing processes. These protocols encompass various aspects of manufacturing, including facility design and maintenance, equipment calibration and validation, personnel training, and quality control measures, all of which are essential for ensuring the integrity and reliability of the manufacturing process.

The inspections took place at Boehringer Ingelheim’s state-of-the-art OASIS manufacturing site located in Shanghai, China. This cutting-edge facility is equipped with advanced technologies and infrastructure designed to support the production of biopharmaceutical products at the highest standards of quality and efficiency. The site’s strategic location in Shanghai, a hub of pharmaceutical innovation and manufacturing excellence, further enhances its ability to meet the diverse needs of global markets.


A Decade of Excellence and Innovation in Global Biopharmaceutical Standards Compliance

Through meticulous attention to detail and unwavering commitment to excellence, Boehringer Ingelheim Biopharmaceuticals China has demonstrated its readiness to meet the rigorous standards set forth by regulatory authorities. By ensuring compliance with ICH guidelines, GxP regulations, and international manufacturing protocols, the company has reaffirmed its dedication to upholding the highest standards of quality, safety, and efficacy in the production of biopharmaceutical products.

As an integral part of Boehringer Ingelheim Biopharmaceuticals’ global manufacturing network, BioChina remains steadfast in its commitment to delivering safe, effective, and top-quality medications to patients worldwide. Ulrike Falk, Head of Global Quality Biopharma Operations at Boehringer Ingelheim, emphasizes the significance of these approvals, stating that they validate the company’s dedication to making a positive impact on patients’ lives for generations to come.

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The journey towards securing approvals for supply began over a decade ago when Boehringer Ingelheim commenced its contract manufacturing operations in China in 2013. Notably, Boehringer Ingelheim was a trailblazer in leveraging the Marketing Authorization Holder (MAH) system within China’s revised Drug Administration Law, demonstrating its commitment to innovation and compliance with evolving regulatory frameworks.

Boehringer Ingelheim Leads with First Successful Application of MAH System

Through its collaboration and provision of manufacturing services for this biopharmaceutical, Boehringer Ingelheim Biopharmaceuticals China achieved another milestone by being the first company to successfully apply the MAH system under the new regulatory landscape in China. This achievement is underscored by the recent approvals granted by esteemed health authorities such as EMA, the South Korean Ministry of Food and Drug Safety (MFDS), and now the FDA.

Dr. Yuguo Zang, Head of BioChina at Boehringer Ingelheim, emphasizes BioChina’s dedication to expanding its global footprint and supporting its long-standing partner in reaching new markets. This achievement reflects BioChina’s commitment to delivering high-quality products that improve patient outcomes worldwide.

This milestone not only highlights Boehringer Ingelheim’s capabilities in providing top-tier manufacturing services but also reinforces its commitment to supporting local partners in meeting global patient needs. With a legacy spanning over a century, Boehringer Ingelheim remains dedicated to developing breakthrough therapies that address unmet medical needs and improve lives across the globe.

Resource: Boehringer Ingelheim, April 09, 2024

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