Chinanews.com, Guangzhou, December 21 (Cai Minjie Liang Lijun) "Kach, click, click..." On the 21st, the tablet press machine in the pharmaceutical production workshop of Guangdong Yili Pharmaceutical Co., Ltd. was running at full capacity.
The relevant person in charge of the company said: "The green channel opened by the Guangdong Provincial Drug Administration has allowed the company to quickly complete the procurement approval of caffeine, the raw material for epidemic prevention and control drugs. It is estimated that the caffeine raw material purchased this time can meet 750 million tablets of compound cold spirit Tablets, 40 million Ammonia Huangmin Capsules and 125 million bags of Ganmaoling Granules."
Caffeine is a xanthine alkaloid compound, and it is an important raw material for the production of compound Ganmaoling tablets, Ankahuangmin capsules, compound acetaminophen tablets, compound aspirin tablets, phenol coffee tablets and other epidemic prevention and control drugs. It is addictive and must be approved by the local provincial drug regulatory department before purchasing.
To this end, the Guangdong Provincial Drug Administration made emergency deployments to provide green channels for the approval of drugs for epidemic prevention and control.
Since December 5, a total of 8,700 kilograms of caffeine APIs have been approved, which is expected to guarantee the production of 1.5 billion tablets (bags) of cold medicines.
On December 15, Guangzhou Wondfo Biotechnology Co., Ltd. received the Guangdong Provincial Drug Administration's approval for the change of its new crown antigen production license. At this time, it was only 31 hours before they submitted the materials for acceptance.
The person in charge of Wondfo’s COVID-19 special class said that thanks to the rapid review and approval process launched by the Guangdong Provincial Drug Administration, a dedicated person will guide and provide a green channel for the expansion of the company’s new crown antigen production site throughout the process. The company is currently making every effort to increase production capacity. , multi-production lines run day and night, and do a good job in emergency supply of new crown antigen products.
Starting from the beginning of December, the Guangdong Provincial Drug Administration, under the premise of ensuring the quality and safety of medical devices, has adopted special channels, special guidance, and dedicated services to support priority in the registration of medical devices for epidemic prevention and control.
Changes in the registration of the increase in packaging specifications and resumption of production of epidemic prevention and control drugs in Guangdong Province, as well as the provincial preliminary examination of the registration of new crown antigens and nucleic acid detection reagents, will be handled immediately, and will be completed within 24 hours.
Submitted to the State Food and Drug Administration overnight the application for the adjustment of the demand plan for poppy shells in Guangdong, and urgently added a demand plan for the use of 50 tons of poppy shells, which can guarantee the subsequent production of 450 million tablets of cough medicines.
At present, a total of 6 companies in Guangdong Province have obtained the registration certificate of the new coronavirus antigen detection kit, and the daily production capacity of antigen detection reagents for the domestic market and export can reach 30 million copies, and 7 products are in the technical review process of the State Drug Administration. 13 A product is in the acceptance stage of the State Drug Administration; the number of ventilators, medical masks, and infrared thermometers that have been approved for registration in the province ranks first in the country.
In addition, the Guangdong Provincial Institute for Drug Control has completed a total of 328 batches of new crown vaccine batch release inspections this year (137 million doses), 46 batches of cold drug registration inspections, and 3,202 batches of cough medicine import inspections; The Evaluation and Certification Center has dispatched 291 inspectors to carry out on-site inspections and registration system inspections of epidemic prevention and control medical devices to ensure the quality, safety and production supply of epidemic prevention and control drugs and medical devices.
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