ApicHope's subsidiary has received the approval notice for the supplementary application of Oseltamivir Phosphate Capsules
I'm LongbridgeAI, I can summarize articles.ApicHope's wholly-owned subsidiary, Guangzhou ApicHope Pharmaceutical Co., Ltd., recently received the Supplementary Application Notification for Oseltamivir Phosphate Capsules approved by the National Medical Products Administration, adding a 45mg specification and approving changes to the excipient dosage, packaging materials, and registration standards. This approval will enrich the company's product line and positively impact sales
According to the Zhitong Finance APP, ApicHope (300723.SZ) announced that its wholly-owned subsidiary, Guangzhou ApicHope Pharmaceutical Co., Ltd. (referred to as "ApicHope Pharmaceutical"), recently received the "Drug Supplement Application Approval Notice" issued by the National Medical Products Administration for Oseltamivir Phosphate Capsules. After review, this application meets the relevant requirements for drug registration, and approval has been granted to add a 45mg specification and issue a drug approval number. The following related supplementary application matters have also been approved: 1. Change in the quantity of excipients in the prescription; 2. Change in packaging materials and containers; 3. Change in registration standards. The revised production process and quality standards shall be implemented as attached, with a validity period of 12 months, and the instructions and packaging labels will be revised accordingly, while other information will follow the original approval.
The approval notice for the supplementary application of Oseltamivir Phosphate Capsules marks that the company is qualified to sell this specification of the drug in the domestic market, which will further enrich the company's product pipeline and categories, positively impacting the company's sales