Since 2023, news from the API industry has continued to come, including the approval of APIs by pharmaceutical companies, the production plan of APIs, and export plans
.
Approved
Since 2023, a number of pharmaceutical companies in the API industry have announced the approval of their APIs, including Tonghe Pharmaceutical and Southern Pharmaceutical Company
.
For example, Nuotech Biotech announced on January 11 that the company's registered application of semeglutide API has been accepted by the Drug Evaluation Center of the State Food and Drug Administration, and there is uncertainty
in the approval of the review.
At present, the company's semeglutide API mainly supplies the generic drug research and development needs
of overseas and domestic customers.
Tianyu Co.
, Ltd.
announced on January 10 that the company's sitagliptin phosphate API recently passed the technical review
of the Center for Drug Evaluation of the National Medical Products Administration (hereinafter referred to as "CDE").
The announcement shows that sitagliptin phosphate is used to treat type II diabetes
.
On January 6, Tonghe Pharmaceutical issued an announcement that the company recently inquired from the "API Medicine, Pharmaceutical Excipients and Pharmaceutical Packaging Materials Registration Information Publicity" platform of the Drug Evaluation Center (CDE) of the State Medical Products Administration that the "vildagliptin" API submitted by the company passed the CDE approval
.
According to reports, vildagliptin is an orally administered DPP-IV inhibitor that is clinically used to treat type 2 diabetes
.
News on January 4, Southern Pharmaceutical's chemical API azacitidine successfully passed the technical review of the Drug Evaluation Center (CDE) of the National Medical Products Administration and was approved for production
.
According to the data, the API is mainly used for the treatment of five subtypes of myelodysplastic syndrome, such as refractory anemia and chronic myelomonocytes leukemia
.
.
.
.
.
.
.
.
It is understood that for pharmaceutical companies, the company's API has passed the CDE approval, indicating that the API meets the relevant technical standards for drug evaluation in China and has been approved for use in domestic marketing preparations, which is generally conducive to the company's expansion of product sales in the domestic market and forms a good pattern
of synchronous sales in domestic and foreign markets.
Production
Kunlun Pharmaceutical replied to investors on the interactive platform on January 13, saying that according to the overall plan, Kunlun Pharmaceutical is expected to complete the on-site verification of some API drugs in the first quarter of 2023, and after the drug regulatory department passes the review, it can officially put some API drugs into production
.
Changshan Pharmaceutical said on the interactive platform on January 4 that the company will adhere to the established development strategy, expand API production capacity and export business scale, and the 35-ton heparin API project will accelerate follow-up work, strive to officially put into production as soon as possible, and gradually release production capacity
according to market demand and the actual situation of the company.
It is reported that the 35-ton heparin series API product project is a key construction project of Changshan Pharmaceutical in 2022, and it was originally planned to be put into production
before the end of 2022.
Changshan Pharmaceutical said at the performance briefing that after the completion of the 35-ton heparin API expansion project, it can greatly increase the production capacity of the company's heparin APIs, especially low molecular weight heparin APIs, which will positively promote the expansion of the company's export business
.
outlet
Fengyuan Pharmaceutical said on the investor interactive platform on January 13 that the company's paracetamol API actively expands its export business
while meeting the needs of the domestic market.
Recently, Fengyuan Pharmaceutical also said on the interactive platform that with the recent increase in market demand, the price of Likang Pharmaceutical's paracetamol API has increased to a certain extent, which has a positive impact
on the current profitability of the company and its subsidiaries.
It is understood that the paracetamol API produced by Likang Pharmaceutical, a subsidiary of Fengyuan Pharmaceutical, is the main ingredient
for antipyretic and analgesic preparations.
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