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China SXT Pharmaceuticals, Inc. Obtained a New Pharmaceutical Manufacturing Permit and Passed Its GMP Compliance-Inspection

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On October 18, 2021, China SXT Pharmaceuticals, Inc. (NASDAQ: SXTC) announced it received a new Pharmaceutical Manufacturing Permit from the Jiangsu Province Medical Products Administration. This permit allows the company to expand its production to include lyophilization processing, a technique that enhances product stability and solubility. The company claims it will be the first in China to manufacture Directly-Oral TCMPs under this new permit. The lyophilization process is essential for their product Luxuejing, aimed at treating various health conditions.

Positive
  • Received a new Pharmaceutical Manufacturing Permit allowing lyophilization processing.
  • Passed GMP compliance-inspection for the new production facility.
  • Expected to be the first manufacturer of Directly-Oral TCMPs in China to utilize lyophilization processing.
  • Lyophilization improves product quality, stability, and shelf life.
Negative
  • None.

TAIZHOU, China, Oct. 18, 2021 /PRNewswire/ -- 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.

About China SXT Pharmaceuticals, Inc.

Founded in 2005 and headquartered in Taizhou City, Jiangsu Province, China, China SXT Pharmaceuticals, Inc. is an innovative pharmaceutical company focusing on the research, development, manufacture, marketing and sales of traditional Chinese medicine pieces, which is a type of Traditional Chinese Medicine that has been processed to be ready for use. For more information, please visit www.sxtchina.com

Safe Harbor Statement

This press release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as "may, "will, "intend," "should," "believe," "expect," "anticipate," "project," "estimate" or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. Specifically, the Company's statements regarding the closing of the proposed private placement are forward-looking statements. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company's expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the following: the Company's goals and strategies; the Company's future business development; product and service demand and acceptance; changes in technology; the growth of the pharmaceutical market, particularly the Traditional Chinese Medicine Pieces ("TCMPs") market, in China; reputation and brand; the impact of competition and pricing; government regulations; fluctuations in general economic and business conditions in China and the international markets the Company serves and assumptions underlying or related to any of the foregoing and other risks contained in reports filed by the Company with the Securities and Exchange Commission. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company's filings with the U.S. Securities and Exchange Commission, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward - looking statements to reflect events or circumstances that arise after the date hereof.

For more information, please contact:

At the Company:
Mr. Feng Zhou, CEO
Email: fzhou@sxtchina.com or ir@sxtchina.com
Phone: 86-523-8629-9087

Cision View original content:https://www.prnewswire.com/news-releases/china-sxt-pharmaceuticals-inc-obtained-a-new-pharmaceutical-manufacturing-permit-and-passed-its-gmp-compliance-inspection-301401774.html

SOURCE China SXT Pharmaceuticals, Inc.

FAQ

What new permit did China SXT Pharmaceuticals receive on October 18, 2021?

China SXT Pharmaceuticals received a new Pharmaceutical Manufacturing Permit for lyophilization processing.

How does lyophilization processing benefit China SXT's products?

Lyophilization enhances product stability, solubility, and extends shelf life, crucial for temperature-sensitive components.

What is the significance of the GMP compliance-inspection passed by China SXT?

Passing the GMP compliance-inspection allows China SXT to manufacture Directly-Oral TCMPs in compliance with industry standards.

What is Luxuejing and how is it related to the new manufacturing permit?

Luxuejing is a Directly-Oral TCMP product that uses lyophilization processing to improve quality and efficacy for various health indications.

Is China SXT Pharmaceuticals expanding its market share?

Yes, the new permit is expected to accelerate R&D and expand market share for their Advanced TCMP products.

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