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Minhai Biologics’ 13-valent pneumococcal vaccine has obtained a GMP certificate in Turkey, paving the way for its potential entry into the local market.

Release date:

2025-07-02

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Abstract

Recently, Minhai Biologics’ 13-valent pneumococcal polysaccharide conjugate vaccine has obtained a GMP certification issued by the Turkish Medicines and Medical Devices Agency. This certification confirms that the company’s PCV13 production facilities, processes, quality control systems, and overall quality management framework all comply with Turkey’s stringent pharmaceutical manufacturing quality standards, thereby establishing that the product meets the necessary requirements for market access in Turkey. As a “crossroads” connecting Europe and Asia, Turkey enjoys a distinct geographical advantage. The country’s economy is growing rapidly, with its GDP ranking among the top 20 globally. In 2024, Turkey’s total population was approximately 8…

Recently, Minhai Biologics’ 13-valent pneumococcal polysaccharide conjugate vaccine has been awarded a GMP certification by the Turkish Medicines and Medical Devices Agency. This certification confirms that the company’s PCV13 production facilities, processes, quality control systems, and quality management framework all comply with Turkey’s stringent Good Manufacturing Practices, thereby establishing that the product meets the requirements for market access in Turkey.

Turkey is a “crossroads” connecting Europe and Asia, enjoying a distinct geographical advantage. The country’s economy has been growing rapidly, with its GDP ranking among the top 20 worldwide. In 2024, Turkey’s total population was approximately 85.66 million, and the number of newborns in 2023 was around 950,000. In recent years, both the nation’s public health standards and healthcare spending have improved significantly.

As a member of the PIC/S alliance—an authoritative international organization that promotes global harmonization of GMP standards—Turkey’s GMP certification wields significant influence in the international pharmaceutical regulatory landscape. With the recent attainment of Turkish GMP certification, Minhai Biologics’ portfolio of high‑quality vaccine products, including its 13‑valent pneumococcal vaccine, is poised to enter the Turkish market. This milestone also lays a solid foundation for the company and its local partners to further expand into neighboring markets in the Middle East, Africa, and beyond, thereby fostering synergistic development within the regional vaccine industry and ushering in a new era of international vaccine cooperation that delivers both economic and social benefits.

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