Fosun Pharma (SHSE: 600196) has announced that its controlling subsidiary, Shanghai Henlius Biopharmaceutical Co., Ltd., recently received a "Drug GMP Compliance Inspection Notification Letter" from the Shanghai Drug Administration.
The notification confirms that the subsidiary's production base in Songjiang District, Shanghai, has passed a Good Manufacturing Practice compliance inspection for Pertuzumab Injection (marketed in China under the brand name Hanbeiyou®).
The scope of the inspection covered the Drug Substance production East Line, the Drug Product production line, and the packaging line.
Passing this GMP compliance inspection signifies that the related production facilities for Pertuzumab Injection now meet the standards outlined in the Good Manufacturing Practice for Drugs, laying a foundation for the commercial production and supply of this drug within China.
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