Apichope Pharmaceutical Group Co.,Ltd. (300723.SZ) announced that its wholly-owned subsidiary, Guangzhou Apichope Pharmaceutical Co., Ltd. ("Apichope Pharmaceutical"), recently received the "Drug Supplement Application Approval Notice" for Oseltamivir Phosphate Capsules issued by the National Medical Products Administration. Following review, the application met the relevant requirements for drug registration, and approval was granted to add the 45mg specification with the issuance of a drug approval number.
The following related supplement application items were also approved: 1) Changes to excipient amounts in the formulation; 2) Changes to packaging materials and containers; 3) Registration standard modifications. The revised production process and quality standards shall be implemented as attached, with a validity period of 12 months. The package insert and labeling shall be revised accordingly, while other aspects shall follow the originally approved information.
The company's newly obtained approval notice for the Oseltamivir Phosphate Capsules drug supplement application signifies that the company now has the qualification to market this specification of the drug in the domestic market. This will further enrich the company's product pipeline and product categories, having a positive impact on the company's sales.
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