Recently, the drug regulatory department carried out an inspection on GSK's Avodart capsules, and found that the enterprise did not carry out batch by batch and full item inspection for the products exported to China according to the registration standards, and there were deficiencies in the prevention and control of microbial pollution risks. It was comprehensively assessed that the production quality management of this variety did not meet the requirements of China's Good Manufacturing Practice (revised in 2010).
On October 31, 2022, the State Drug Administration issued an announcement to suspend the import, sale and use of this product from now on. The drug regulatory department at each drug import port shall suspend the issuance of the import customs clearance form for the above products.
In addition, according to the news of the State Organization Drug Joint Procurement Office on October 31, in accordance with the spirit of the Opinions of the General Office of the State Council on Promoting the Normalization and Institutionalization of Centralized Drug Procurement in Volume (GBF [2021] No. 2), and after collective deliberation by relevant members of the State Organization Drug Joint Procurement Office, the enterprise violated the commitments made in the application materials and the relevant provisions of the National Centralized Drug Procurement Document (GY-YD2021-2), The Joint Procurement Office decided to cancel the qualification of GlaxoSmithKline for the selection of Dutasteride capsules, and at the same time included GlaxoSmithKline in the list of violations, suspended the application qualification of the enterprise to participate in the national centralized drug procurement activities from October 31, 2022 to April 29, 2024.
The State Organization Drug Joint Procurement Office said that the selection results of the fifth batch of national organization drug centralized procurement had been launched in October 2021. Since the procurement cycle of Avodart ended at the end of October this year, no replacement procedure will be started, please pay attention to the supply of this drug in the follow-up work after the procurement cycle expires, and do a good job of linking up to ensure stable drug supply.
Background of the punished company
It is understood that GlaxoSmithKline (GSK) was formed by the merger of a series of old pharmaceutical companies, such as Glaxo, Wellcome, SmithKline, and Bicheng, and it will be a multinational pharmaceutical company headquartered in the United Kingdom. In 2021, the company's operating income will be 43.732 billion dollars, and its profit will be 7.373 billion dollars. The total number of employees once exceeded 110000, and the founding history of the subsidiary Allen&Hanbury can be traced back to 1715. In the 1940s, Schneider was already an amazing pharmaceutical enterprise in the United States, and also the first company to use modern methods to screen drugs.
However, according to the information on the Internet, this year is a year of frequent changes for GlaxoSmithKline. On July 18 this year, GlaxoSmithKline officially completed the separation of its consumer health business and began trading on the London Exchange, becoming the largest IPO in Europe in more than a decade. Haleon, the new company, will have the largest independent consumer health business in the world. Its brands include Comfortable Toothpaste, Advil Analgesics, Fenbid, Contac, etc.
What is the punished product used for?
Duetasteride capsule is a drug for the treatment of prostate enlargement, seborrheic alopecia and other diseases
Comparison of the effects of dutasteride and finasteride?
The effect of Dutasteride raw material is better than that of Finasteride Raw powder. Both drugs are selective 5 α Reductase inhibitors play a role mainly by inhibiting the conversion of testosterone into active dihydrotestosterone in vivo. Inside the human body 5 α Reductase can be divided into type 1, type 2 and type 3. Finasteride mainly inhibits the activity of type 2 and type 3 reductase in vivo, while Dutasteride powder can inhibit the activity of three types of reductase. Therefore, its drug effect is better than finasteride capsules. These two kinds of drugs are mainly used for male androgen alopecia and prostate hyperplasia in elderly men. Before using these drugs, patients need to see a doctor in time, make a clear diagnosis, and take appropriate drug dosage.
For prostate hyperplasia in elderly patients, both drugs can be used. Duetasteride has a better effect, which can completely inhibit the role of androgens in the body, thereby inhibiting prostate hyperplasia and improving the symptoms of dysuria caused by prostate hyperplasia; However, for androgenic alopecia in young adults, Finasteride Powder is more effective. It can inhibit testosterone transformation in hair follicles and androgenic alopecia. At the same time, it basically does not affect the testosterone level in patients, so as not to excessively reduce the sexual desire and erectile function of patients. It is a better choice for young patients. Therefore, when patients need to use these two drugs to treat related diseases, they need to seek medical advice and choose the appropriate type under the guidance of doctors to achieve better treatment effect and reduce the occurrence of adverse reactions as much as possible.
Our comments and suggestions
On the whole, the punishment is a little heavy. If the documents provided for this product are not very standard, just declare the bidding result invalid, and directly put the whole company on the negative list, which shows that the Chinese government is becoming more and more serious about this industry, even if you have old qualifications. At the same time, it also shows that this kind of product is saturated in the Chinese market, and there are many substitutes with appropriate prices. The market fluctuations are just rumors. If you are interested, please contact us, and we will give you more help!
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