Benzinga | Oct 18, 2021 08:12AM EDT

China SXT Pharma Obtained New Pharma Manufacturing Permit, Passed Its Good Manufacturing Process Compliance Inspection

China SXT Pharmaceuticals, Inc. (NASDAQ: SXTC) ("China SXT" or the "Company"), a specialty pharmaceutical company focusing on the research, development, manufacturing, marketing, and sales of Traditional Chinese Medicine Pieces ("TCMPs"), including Advanced TCMPs (Directly-Oral TCMP and After-Soaking-Oral TCMP), fine TCMPs, regular TCMPs, and TCM Homologous Supplements ("TCMHS") announced today that it recently received a new Pharmaceutical Manufacturing Permit ("PMP") from Jiangsu Province Medical Products Administration (JSMPA) with a new production scope of lyophilization processing. The Company also passed its pharmaceutical GMP compliance-inspection conducted by JSMPA for the Company's new lyophilization production facility. The Company believed that it will be the first Directly-Oral TCMP manufacturer nationwide in China passing such a GMP compliance-inspection for lyophilization processing.

Lyophilization processing, also known as freeze drying, is a process of freezing raw materials or products and removing the frozen water by sublimation (the ice turns directly into vapor without the liquid phase in the vacuum). After the lyophilization process, the raw materials or products become loose and fragile, which remarkably improves their aqueous solubility. Also, the dehydrated raw materials and products have extended shelf life. More importantly, this process is helpful in the manufacturing of products such as our Directly-Oral TCMPs and After-Soaking-Oral TCMPs that contain temperature-sensitive components as they are kept in a frozen and dry condition and remain unchanged.

The manufacture of our Directly-Oral TCMP product, Luxuejing, involves the lyophilization process, which helps us deliver much better quality products. Luxuejing is a precious Chinese medicine made from fresh bloods of Cuerus Nippon, which is approved to be used for approved indications including leukopenia, thrombocytopenia or hypoimmunity, chronic anemia, aplastic anemia, erectile dysfunction, and postoperative rehabilitation, "This permit for new production scope of lyophilization processing will contribute significantly to our continuous effort in leading research and development of new advanced TCMPs and pursuit of higher quality of the products. We believe it will further accelerate our R&D of new Advanced TCMPs, which is expected to expand our market share for the advanced Directly-Oral TCMP and After-Soaking-Oral TCMP products," Mr. Feng Zhou, Chief Executive Officer of China SXT, commented.