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Ensuring Supply: Hebei Provincial Drug Administration Approves Expansion of Production Capacity for the Company’s Anti-Epidemic Drug Abidor.

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Time：2020-01-29

On January 28, 2020, the Hebei Provincial Drug Administration approved an additional application submitted by Shijiazhuang Sihua Pharmaceutical Co., Ltd. to add a new active pharmaceutical ingredient supplier for its urgently needed antiviral drug, Abidol Hydrochloride Capsules.

Ensuring Supply: Hebei Provincial Drug Administration Approves Expansion of Production Capacity for the Company’s Anti-Epidemic Drug Abidor.

On January 28, 2020, the Hebei Provincial Drug Administration approved an additional application submitted by Shijiazhuang Sihua Pharmaceutical Co., Ltd. to add a new supplier of the active pharmaceutical ingredient for its urgently needed antiviral drug, abidol hydrochloride capsules.

Abidol hydrochloride has been included by the health commissions of multiple regions—including Shanghai, Chongqing, Guizhou Province, and Henan Province—in the “Initial List of Pharmaceutical Reserves for the Prevention and Control of Pneumonia Caused by Novel Coronavirus Infection.” It is also an antiviral drug clinically recommended for use in the “Guidelines for the Diagnosis and Treatment of Influenza (2019 Edition)” issued by the National Health Commission.

In response to epidemic prevention and control requirements, and addressing the issue of production constraints faced by Shijiazhuang Sihua Pharmaceutical Co., Ltd. due to insufficient supply of the active pharmaceutical ingredient for abidol hydrochloride capsules, on January 22, Xu Yanzeng, Director of the Hebei Provincial Drug Administration, convened a special meeting attended by drug regulators, drug registration personnel, technical review experts, and drug inspection experts. The meeting was aimed at helping the company develop and implement solutions. A dedicated team from the emergency approval group was assigned to liaise closely with the company, while the Chemical Drug Regulatory Division conducted in-depth, one-on-one technical assistance and provided guidance on relevant policies and regulations directly at the enterprise site.

Upon receiving samples of Abidol Hydrochloride capsules produced using a new active pharmaceutical ingredient, submitted by Shijiazhuang No. 4 Pharmaceutical Co., Ltd., the Provincial Institute for Drug Control immediately activated its emergency response plan, established a green inspection channel, and streamlined the submission procedures. The institute also worked overtime to carry out the testing. After continuous and uninterrupted testing, the examination was completed by noon on the 28th. The results showed that the Abidol Hydrochloride capsules produced using the new active pharmaceutical ingredient meet the national drug standards.

On the afternoon of January 28, after receiving the inspection report from the Provincial Drug Testing Institute, the Provincial Drug Administration immediately approved Shijiazhuang Sihua Pharmaceutical Co., Ltd.’s supplementary application to add a new raw-material supplier. Following the approval, Shijiazhuang Sihua Pharmaceutical will be able to produce up to 1 million abidol hydrochloride capsules per day, effectively ensuring the supply of clinical antiviral medications.

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