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Sailun Bio Receives Philippine GMP Compliance Certificate Covering Four Products Including Tetanus Antitoxin
Sailun Bio announced that the company has received a GMP Compliance Certificate issued by the Food and Drug Administration of the Department of Health of the Republic of the Philippines. The production address is located at 1288 Huaqing Road, Qingpu District, Shanghai. The certified dosage form is injection, covering tetanus antitoxin, equine tetanus immunoglobulin F(ab')2, antivenom serum, and anti-rabies serum, valid until October 24, 2028. The announcement shows that passing this certification and obtaining the certificate marks that the production quality management system for the relevant products meets the requirements of the Philippine FDA, establishing the basic conditions for drug registration and commercial launch in the Philippines. The company plans to initiate registration of the relevant products in the Philippines and subsequent market promotion work, and gradually expand into the Southeast Asian market. The company also cautioned that the products still need to complete the local drug registration approval process in the Philippines, and the registration cycle, approval results, and final launch timing all remain uncertain. There are certain risks regarding whether commercialization can be successfully achieved and expected returns obtained.
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688163.CG · Regulation · Positive Sailun Bio received Philippine FDA GMP compliance certification for four products, establishing conditions for registration and commercial launch in the Philippines.