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联环药业(600513.SH):收到药品GMP符合性检查结果

Jiangsu Lianhuan Pharmaceutical (600513.SH): received the Pharmaceutical GMP compliance inspection results.

Gelonghui Finance ·  Dec 23, 2024 03:52

On December 23, Gelonghui reported that Jiangsu Lianhuan Pharmaceutical (600513.SH) announced, based on information from the Jiangsu Provincial Drug Administration website, the "Pharmaceutical GMP Compliance Inspection Result Notification", with the inspection scope including: Active Pharmaceutical Ingredient [sacubitril/valsartan sodium, Production Workshop 2, C7-H1 production line (hydrogenation), C5-H1 production line (esterification), C5-H2 production line (acylation), No. 8 precision drying pack (cocrystal)]; oral solution [Production Workshop 3, No. 2 production line (oral solution)]; tablets [anti-cancer drug, Production Workshop 3, tablet (anti-cancer) production line]. According to the relevant provisions of the "Pharmaceutical Administration Law" and the "Measures for the Supervision and Administration of Pharmaceutical Production", Jiangsu Lianhuan Pharmaceutical Co., Ltd. underwent compliance inspection and evaluation for the "Pharmaceutical Production Quality Management Standards", and the results met the requirements.

This time, the Active Pharmaceutical Ingredient sacubitril/valsartan sodium, oral solution, and tablets (anti-cancer drugs) all passed the GMP compliance inspection for the first time. The investment in the oral solution production line was approximately 4.436 million yuan, and the Active Pharmaceutical Ingredient sacubitril/valsartan sodium and tablet abiraterone acetate were produced on the same line as other varieties. The investment in the Active Pharmaceutical Ingredient sacubitril/valsartan sodium production line was approximately 0.65 million yuan, and the investment in the tablet abiraterone acetate line was approximately 0.27 million yuan (the above data is not audited).

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