Tianjin Pharmaceutical Co., Ltd.On the evening of October 23, the company issued a statement saying that it had recently received the results of a GMP on-site inspection from the Korean Ministry of Food and Drug Safety (MFDS).
From September 8th to 10th, Tianjin Pharmaceutical Group's production base located at No. 19, Xinyejiu Street, West Zone, Tianjin Economic-Technological Development Area, received methionine raw material.The site underwent GMP inspection and passed the Korean MFDS requirements with "zero defects".
Methionine, an essential amino acid for the human body, is a core raw material for various amino acid infusions and compound amino acid preparations. Clinically, it is used as an adjunct treatment for chronic hepatitis and cirrhosis, as well as a supportive treatment for toxic liver disease.
Industry insiders believe that the scope of this inspection focused on methionine raw materials , and passing with "zero defects" means that the company's quality system, production facilities and process control for this production line have met the standards of the Korean market, providing substantial access guarantee for subsequent development of the Korean market.
Against the backdrop of normalized centralized procurement and a downward shift in the price center of domestic generic drugs, Tianjin Pharmaceutical Group is transforming its quality compliance capabilities into competitive advantages for overseas markets. The company's Q3 2026 report shows that it achieved operating revenue of RMB 1.864 billion in the first three quarters, a slight adjustment year-on-year due to the impact of centralized procurement and intensified market competition; however, net cash flow from operating activities reached RMB 299.7 million, a year-on-year increase of 678.71%, indicating significant improvements in supply chain management and working capital efficiency, providing a safety margin for international certification, overseas registration, and capacity expansion.
South Korea is one of the markets in Northeast Asia with relatively high regulatory thresholds for pharmaceuticals. The company stated that this "zero-defect" result not only benefits the single product methionine, but also serves as a model for Jinyao Pharmaceutical's expansion of its amino acid and steroid hormone raw material markets to South Korean customers.
As newly approved formulations and high-barrier APIs are successively introduced into domestic and international channels, Tianjin Pharmaceutical's synergistic advantages in "cost control, quality compliance, and global registration" are expected to continue to be released, providing support for medium- and long-term performance recovery and valuation logic repair.
Previously, the company's amino acid raw materials such as methionine had gradually entered the European and American markets and emerging regulated markets. This breakthrough in South Korean market access echoes the progress of international registration for betamethasone/betamethasone dipropionate and other products.
The company stated that it will continue to benchmark against international quality management systems, embedding international certification standards such as unannounced inspections, MFDS, FDA, and CEP into its daily production and operations. In the short term, the South Korean market opens up new growth opportunities; in the medium to long term, international quality endorsement will enhance its quality reputation in domestic centralized procurement bidding, and pave the way for the simultaneous export of multiple APIs and formulations.

Source: https://finance.eastmoney.com/a/202610253907161633.html