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Recently, Baolingbao Biology Co., Ltd. (hereinafter referred to as the "Company" or "Baolingbao") received the Notice of GMP Compliance Inspection for Pharmaceuticals issued by the Shandong Provincial Drug Administration. This marks the successful passing of the Good Manufacturing Practice (GMP) compliance inspection by the Company’s lactulose active pharmaceutical ingredient (API) production line. It represents a solid stride taken by the Company into the medical and healthcare sector, as well as a core milestone in its strategic transformation journey.
The passing of the GMP compliance inspection for the lactulose API production line verifies that Baolingbao’s hardware facilities and quality management systems for API production meet national pharmaceutical manufacturing standards, equipping the Company with compliant and high-quality production capacity. This inspection clearance accelerates the market launch process of the Company’s lactulose API and constitutes a pivotal step for Baolingbao to expand its business from functional food ingredients to pharmaceuticals and the broader health industry. The domestic market launch of the Company’s lactulose API has entered its final phase; the drug registration application for this product has been accepted by the National Medical Products Administration (NMPA), pending the issuance of the Drug Registration Certificate by the authority.
Moving forward, the Company will continuously refine its GMP quality management system, strengthen pharmaceutical production control and quality assurance capabilities, strictly adhere to compliance requirements, and deepen quality management efforts. These initiatives will build robust momentum for the Company’s high-quality development and the transformation and upgrading of its pharmaceutical-focused strategy.
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