The reporter actually explored the first Azf's raw medicine producer!What is the quality of the product?Can it meet the supply demand?One article understands ｜ Extremely engraved

Dahecai Cube "Extreme Carrier" No. 769

Dahecai Cube "Extreme Carrier" team reporter Wang Leibinwen

Ran Heng Photography

On July 25, the State Drug Administration had the conditions to approve Henan True Biotechnology Co., Ltd. (hereinafter referred to as real creatures) Azf fixed chip to increase the application for the treatment of new coronary virus pneumonia.

This drug is the first oral small molecular new coronary virus pneumonia therapy drug independently developed in my country. It will play an important role in fighting against the global new crown pneumonia epidemic and promoting the development of Henan and China's biomedical industry.

After being allowed to register, production and sales have become an important thing that Azf is facing. So, where does Azf set to produce? What is the production process? Where does the raw medicine come from?

On July 30, a reporter from the Dahe Daily · Dahe Cai Cube entered Xinxiang, Henan to explore the first Azf's raw material drug producer -Henan Listed Company Takinxin Pharmaceutical subsidiary Xinxiang Pharmaceutical Co., Ltd. (hereinafter referred to as Xinxiang Pharmaceutical Pharmaceutical ), Azf's ingredients produced by the company, as the main active ingredients of active drugs and preparations, will play a key role in treating new coronary virus pneumonia.

Field visit

The first Azoff Simplica Pharmaceutical Manufacturer is located in Xinxiang, Henan

July 30, Saturday.

Xinxiang Pharmaceutical Co., Ltd., which is located in Yanjin County, Xinxiang City, is still busy.

Recently, due to the approval of the first oral small -molecular new coronary virus pneumonia's treatment drugs independently developed in my country, the first Azf's raw material drug producer has also attracted much attention.

It is understood that the main business of Xinxiang Pharmaceuticals is the production and sales of the intermediates of the pharmaceutical and medicine, which is mainly used in the field of antiviral and nervous system. At this stage, the main products include myososide, Libavarin, sodium cell phosphate sodium, and alchemine, and cicada. Luo Wei, Azfdin and other raw medicines.

For the newly put into production of the Azf Style Pharmaceutical Production Line, He Bin, deputy general manager of Xinxiang Pharmaceutical Co., Ltd., told reporters that compared with other production lines, the production line has increased the investment in equipment automation. The main purpose is to improve production efficiency , Reduce labor intensity and production and operation costs, and optimize the production environment and conditions.

"At the same time, in order to improve product quality stability and reliability, the company has systematically trained and manage the relevant personnel of the production line, and strengthens the entire process control of the production of raw medicine." He Bin said.

On July 20, 2021, the State Drug Administration attached a condition to approve an innovative medicine Azf's setting. This medicine is the world's first AIDS reversal recording enzyme and auxiliary protein VIF dual target inhibitory drug, which is the first in China A anti -AIDS oral drug with independent intellectual property rights.

On July 21, 2021, the official website of the State Drug Administration (CDE) official website shows that Xinxiang Pharmaceutical is an unit associated with the preparation enterprise. manufacturer.

Technology leading in China

Product quality is higher than national standards

According to the reporter, to become a producer of Azf's raw medicine, not only must he be a leading technical level, but also the product quality must pass, but more importantly, it must also have production qualifications.

Xinxiang Pharmaceutical's Azf Stand -up Materials Production Line passed the on -site inspection of the Food and Drug Review and Inspection Center in Henan Province in April this year, and officially obtained production qualifications.

"After the above work is completed, it has entered the production preparation procedure, such as the procurement of raw materials, auxiliary materials, personnel configuration, production scheduling, finished product inspection, environmental protection, and other tasks. Increased revenue and output consolidation foundation; in addition, strengthen the training of operating employees to ensure that production equipment can be correct and skilled, and production is strictly produced in accordance with GMP requirements to ensure product quality. After ready, production can be produced. "He Bin said.

According to reports, Azf's raw medicine is also a new type of medicine, without similar generic drugs, unparalleled. According to the registration of the State Drug Administration, the level of process organization and production technology is in China. The quality of the product can meet the quality standards of the approval of the State Drug Administration.

"Azf's production technology and optimization of the upstream intermediate also have certain technical barriers, including the company's application of intellectual property and non -patented technologies." He Bin said that Azf's raw drugs have been synthesized and synthesized by the raw medicine medicines and medicines. Refined craftsmanship is finally prepared, and the production process is relatively complicated. In the production of preparations, as an active drug ingredient, the raw medicine is the main active ingredient of the preparation and plays a therapeutic role.

Production capacity can meet market demand

The production rhythm will be adjusted according to market conditions

In Azf's dry leak room, the workers are busy using polyethylene, aluminum foil and other packaging Azf to fix the raw materials. Every 5 kg is a pack. After the packaging, it is closed and packed into a dedicated storage barrel, and then enters the finished warehouse. In the finished product warehouse, the reporter saw that Azf's raw materials that had been produced were neatly placed, waiting for the finished product production factory that transported to Azf's medicine. The reporter learned that Azf's raw materials need to be stored in a dedicated warehouse below 25 ° C, so that it will not affect the stability of the medicine. According to He Bin, at present, Takuki Pharmaceutical subsidiary Xinxiang Pharmaceutical Co., Ltd. Azf Fixed Material Production Line has all the conditions for mass production and can continue to produce, which can meet market demand. In the future, the rhythm of production will be adjusted according to market conditions.

He Bin said that in the future, Tuoxin Pharmaceutical and Xinxiang Pharmaceutical will continue to work closely with real creatures in terms of business and technology. According to market demand, high -quality products will be provided on time and quantities to meet the raw materials of preparation manufacturers Demand for medicines contributes to the "Xinxiang Power" for the prevention and treatment of the new crown epidemic cause.

Interview with He Bin, deputy general manager of Xinxiang Pharmaceutical Co., Ltd.:

It has all the conditions for the production of Azf's fixing raw materials, which can meet market demand

Dahe Cai Cube: What are the main business of Xinxiang Pharmaceutical Co., Ltd.? In combination with this new production line, what improvements and innovations are there in technology and management?

He Bin: At present, the main business of Xinxiang Pharmaceutical Co., Ltd. of Tuoxin Pharmaceuticals is the production and sales of raw materials and pharmaceutical intermediates. It is mainly used in the field of antiviral and nervous system. At this stage Weilin, sodium phosphate choline sodium, Agelovirville, Azfdin and other raw medicines. Reserve products include alcohol hydrochloride, monocular phosphate adenosine and other raw medicines. Symbolic acid medicines such as Siidi. In this new production line, the company has increased investment in equipment automation, improves labor production efficiency, reduces labor intensity and production operation costs, and optimizes the production environment and conditions. Stability and reliability have strengthened the entire process control of raw drug production.

Dahecai Cube: After the National Drug Administration officially approved the Azf fixed tablet to increase the treatment of the new coronary virus, does it have started large -scale production? Can it meet the supply demand?

He Bin: On July 25, 2022, the State Drug Administration Emergency Conditions approved the application of Henan Real Biotechnology Co., Ltd. Azf's fixed chip to increase the application of new crown virus pneumonia.

At present, the Takura Pharmaceutical subsidiary Xinxiang Pharmaceutical Co., Ltd. Azf Fixed Material Production Line has all the conditions for mass production and can continue to produce and can meet market demand. In the future, the rhythm of production will be adjusted according to market conditions.

Dahe Cai Cube: What are the preparations for large -scale production after the production license is obtained by the production permit for the new raw material pharmaceutical production line of Xinxiang Pharmaceutical Co., Ltd.?

He Bin: In April 2022, passed the on -site inspection through the Provincial Food and Drug Review and Inspection Center, and issued the "Decision on Administrative Licensing Decision" issued by the Henan Provincial Drug Administration. The address was changed from No. 515 Cologne Avenue, Hongqi District, Xinxiang City to No. 16 Jianwen Road, Beibei District, Yanjin County, Xinxiang City. The new raw material pharmaceutical production line passed the GMP compliance inspection (number HNGMP22078X). After the above work is completed, it has entered the production preparation procedure, such as the procurement of raw materials, auxiliary materials, personnel configuration, production scheduling, finished product inspection, environmental protection, and other tasks. Increased the foundation of rates and yields; in addition, strengthen training for operating employees, ensure that production equipment can be correct and proficient, and strictly produced in accordance with GMP requirements to ensure product quality. You can produce after you are ready.

Dahe Cai Cube: In contrast, is the production process of Azf's raw medicine drug complicated? What role does the raw medicine play in the production of preparations?

He Bin: The production of Azf's raw medicine requires the approval of the State Drug Administration, Takura Xinxiang Pharmaceutical Co., Ltd. Xinxiang Pharmaceutical Co., Ltd. Azf Standard Pharmaceutical has passed the associated review with Azf's customizer, Xinxiang Pharmaceutical Co., Ltd. has corresponding production qualifications. There are also certain technical barriers to the production technology and optimization of Azf's raw materials and upstream intermediates, including the company's intellectual property and non -patented technologies applied for. After many steps of synthesis and refining processes, Azf's raw medicine is finally prepared, and the production process is relatively complicated. In the production of preparations, as an active drug ingredient, the raw medicine is the main active component of the preparation, which plays a therapeutic role.

Dahecai Cube: What is the technical level and product quality of Azf's raw medicine?

He Bin: On July 20, 2021, the State Drug Administration has the conditions to approve an innovative medicine Azf to be listed. This medicine is the world's first AIDS reversal recording enzyme and auxiliary protein VIF dual target inhibitory drug. The first domestic anti -AIDS oral drug with independent intellectual property rights. On July 25, 2022, the State Drug Administration Emergency Conditions approved Henan True Biotechnology Co., Ltd. Azf Fixed Pixel to increase the application for the treatment of new coronary virus pneumonia. Similarly, Azf's raw medicine is also a new type of medicine, without similar generic drugs, unparalleled. According to the registration process of the State Drug Administration, the technical level is leading in China. The quality of the product can meet the quality standards of the approval of the State Drug Administration. Dahecai Cube: As the only ingredients in Henan Province to provide manufacturers, how to strengthen cooperation with real creatures in the next step?

He Bin: On July 21, 2021, the official website of the Drug Review Center of the State Drug Administration (CDE) shows that the company's subsidiary Xinxiang Pharmaceutical is a unit associated with preparation enterprises. In the future, we will continue to cooperate with real creatures in terms of business, technology and other aspects, and exchange opinions. According to market demand, high -quality products will be provided on time and guarantee, and the demand for the raw and drugs of preparation manufacturers will contribute to the prevention and treatment of the new crown pneumonia. "Henan Power".

Responsible editor: Wang Shidan | Audit: Li Zhen | Director: Wan Junwei

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