Recently, Qingdao Baiyang Pharmaceutical Co., Ltd. (referred to as "Qingdao Baiyang"), a subsidiary of Shanghai Baiyang Pharmaceutical Co., Ltd., received a formal notice from the US Food and Drug Administration (FDA) that Qingdao Baiyang has passed the FDA's cGMP (current Good Manufacturing Practice) on-site inspection with zero "483" defects under NAI (No Action Marked, no need for modification). This is the second time that Qingdao Baiyang has passed the FDA inspection with zero "483" defects, following its "zero defect" inspection in 2016.

The FDA is globally recognized as one of the most authoritative and rigorous institutions for drug quality regulation. The 483 report is a report issued by the FDA based on cGMP standards, detailing the on-site inspection results of pharmaceutical companies' quality systems. During the 5-day on-site inspection of Qingdao Baiyang Pharmaceutical, FDA inspection experts conducted a comprehensive, meticulous, and detailed inspection of the pharmaceutical factory's R&D and production management level, focusing on product quality assurance system, production system, factory facilities and equipment system, material system, packaging and labeling system, laboratory system, and other related content. They highly praised the company's strict adherence to the quality management system and continuous optimization of key processes, and ultimately gave a "zero defect" conclusion.

The "zero defect" inspection once again marks the continuous recognition of the company's high-quality production and manufacturing standards by international authoritative institutions, and also lays a solid foundation for the company to expand domestic and international markets with more innovative products and enhance international competitiveness.

As a high-end R&D and manufacturing platform for sustained-release drugs under Baiyang Pharmaceutical, Qingdao Baiyang Pharmaceutical has always adhered to the lifeline of high-quality drug standards, focusing on advanced formulation technologies such as osmotic pumps, pellet coatings, and skeleton tablets. Multiple products are produced and sold simultaneously in China and the United States. Among them, the osmotic pump controlled release formulation metformin hydrochloride sustained-release tablets Nida ® It was launched and sold in the United States as early as 2019, and entered the national medical insurance in 2023 with unique clinical value and dosage form advantages; Celecoxib Capsules Nike ®、 Nifedipine controlled-release tablets Knight ® Wait for multiple products to be selected for national procurement.

In addition to the research and development of high-end sustained-release dosage forms, Qingdao Baiyang Pharmaceutical's parent company, Baiyang Pharmaceutical, as a new force in Chinese national pharmaceuticals, has also laid out modern research and development and production of traditional Chinese medicine, establishing a complete process of modern Chinese medicine industry covering research and development, medicinal herb planting and processing, traditional Chinese medicine extraction to finished product formulation production. Its self-developed innovative traditional Chinese medicine product Fuzheng Huayu series is an innovative traditional Chinese patent medicines and simple preparations product that has been verified by evidence-based medicine to reversibly transform liver fibrosis, and it is the first traditional Chinese patent medicines and simple preparations in the field of liver disease to complete the phase II clinical trial in the United States in China.

Against the backdrop of national policies that continue to encourage innovative drug research and development and accelerate the launch of new drugs, Baiyang Pharmaceutical is also closely cooperating with national research institutions to accelerate the pace of innovation. In the future, it is expected to undertake more high-end preparations and modern Chinese medicine original research products. At the same time, on the basis of strictly implementing the quality management standards for drug production, we will benefit patients with more original intellectual property rights and innovative products that can truly optimize medical scenarios, and better serve human health.