Chengdu Easton Biopharmaceuticals subsidiary Shuode Pharmaceutical passed the on-site inspection by the US FDA.

date
18:05 27/11/2025
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GMT Eight
Yuandong Biology (688513.SH) announced that its wholly-owned subsidiary Chengdu Suode Pharmaceutical Co., Ltd. (referred to as "Suode Pharmaceutical") underwent current Good Manufacturing Practice (cGMP) inspections and Bioresearch Monitoring Program (BIMO) inspections by the U.S. Food and Drug Administration (FDA) from May 6 to 9, 2025 and from May 16 to 22, 2025, respectively, for the approval inspection of naloxone hydrochloride nasal spray. Recently, Suode Pharmaceutical received two Establishment Inspection Reports (EIR) issued by the U.S. FDA, and Suode Pharmaceutical passed the above-mentioned inspections with zero defects (no 483).
Chengdu Easton Biopharmaceuticals (688513.SH) announced that its wholly-owned subsidiary, Chengdu Shuode Pharmaceuticals Co., Ltd.(referred to as "Shuode Pharmaceuticals"), underwent Current Good Manufacturing Practice (cGMP) inspections and Bioresearch Monitoring (BIMO) inspections by the U.S. Food and Drug Administration (FDA) from May 6th to 9th and May 16th to 22nd, 2025. These inspections were conducted for the approval of naloxone hydrochloride nasal spray. Recently, Shuode Pharmaceuticals received two Establishment Inspection Reports (EIR) from the U.S. FDA, indicating that Shuode Pharmaceuticals passed both inspections with no deficiencies (no 483).