BTBP: Intravenous immunoglobulin has received approval for a supplemental drug application
BTBP announced that its subsidiary Chengdu Rongsheng Pharmaceutical Co., Ltd. recently received the "Drug Supplement Application Approval Notice" issued by the National Medical Products Administration. The 2.5g/bottle specification of "Intravenous Immunoglobulin" developed by Chengdu Rongsheng meets the relevant requirements for drug registration. The indications for this product include the treatment of primary immunoglobulin G deficiency, secondary immunoglobulin G deficiency diseases, and autoimmune diseases, among others. The main approval procedures that need to be fulfilled before production and market sales include passing the GMP compliance inspection and obtaining the "Drug GMP Compliance Inspection Notification" issued by the Sichuan Provincial Drug Administration. There are currently no 2.5g/bottle specification "Intravenous Immunoglobulin" products available in the domestic market
