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Ensuring Supply: Hebei Provincial Drug Administration Approves Expansion of Production Capacity for the Antiviral Drug Arbidol
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发布时间：2020-01-29
【概要描述】
On January 28, 2020, the Hebei Provincial Drug Administration approved Shijiazhuang Sihua Pharmaceutical Co., Ltd.’s supplementary application to add an active pharmaceutical ingredient supplier for its urgently needed antiviral drug, Abidor Hydrochloride Capsules.
On January 28, 2020, the Hebei Provincial Drug Administration approved Shijiazhuang Sihua Pharmaceutical Co., Ltd.’s supplemental application to add an active pharmaceutical ingredient supplier for its urgently needed antiviral drug, Abidor Hydrochloride Capsules.
Abidor hydrochloride has been included by the health commissions of Shanghai Municipality, Chongqing Municipality, Guizhou Province, Henan Province, and other regions in the “First Batch of Drug Reserve List for the Prevention and Control of Pneumonia Caused by Novel Coronavirus Infection,” and is a clinically recommended antiviral agent for influenza in the National Health Commission’s “Diagnosis and Treatment Protocol for Influenza (2019 Edition).”
In response to epidemic prevention and control requirements and the production constraints faced by Shijiazhuang Sihua Pharmaceutical Co., Ltd. due to insufficient supply of the active pharmaceutical ingredient for abidor hydrochloride capsules, on January 22, Xu Yanzeng, Director of the Hebei Provincial Drug Administration, convened a special meeting bringing together drug regulatory personnel, drug registration staff, technical review experts, and pharmaceutical inspection experts to help the company develop and implement solutions. A dedicated liaison was assigned from the Emergency Approval Group to facilitate communication, while the Chemical Drug Regulatory Division dispatched personnel directly to the enterprise to provide tailored technical assistance and guidance on relevant policies and regulations.
Upon receipt of the abidor hydrochloride capsule samples manufactured using the new active pharmaceutical ingredient, submitted for testing by Shijiazhuang Sihua Pharmaceutical Co., Ltd., the Provincial Institute for Drug Control immediately activated its emergency response plan, established a green inspection channel, streamlined the sample submission procedures, and arranged for overtime work to expedite the testing. Following round-the-clock testing and analysis, the examination was completed at noon on the 28th. The results demonstrated that the abidor hydrochloride capsules produced with the new API comply with the national drug standards.
On the afternoon of January 28, upon receipt of the inspection report from the Provincial Drug Testing Institute, the Provincial Drug Administration promptly approved Shijiazhuang Sihua Pharmaceutical Co., Ltd.’s supplementary application to add an API supplier. Following approval, Shijiazhuang Sihua Pharmaceutical will be able to produce up to 1 million capsules of Arbidol Hydrochloride daily, thereby effectively ensuring the supply of antiviral medications for clinical use.
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