China is a major producer and exporter of APIs, with the continuous expansion of the pharmaceutical market, APIs as the basic raw materials for drug production, the market scale is increasing year by year, and the layout of related pharmaceutical companies in products is also accelerating
.
Recently, a number of pharmaceutical companies have received good news
that relevant API products have been approved at home and abroad.
Recently, Fuan Pharmaceutical announced that its wholly-owned subsidiary, Bosheng Pharmaceutical, recently received the approval notice of the marketing application of butorphanol tartrate chemical API issued by the State Food and Drug Administration
.
Butorphanol tartrate is a central inhibitory analgesic used to treat various cancerous pains and postoperative pain
.
According to the data platform of the State Food and Drug Administration, up to now, 6 companies have applied for marketing of the drug API, of which 2 have a registration status of "A
".
Prior to this, the registration and marketing authorization for domestic production of dydrogesterone APIs and tablets submitted by Auriscot has also been accepted
by the State Medical Products Administration.
On November 13, Aurisco said that "the GMP on-site inspection has been completed, the supplementary materials have been submitted, and it is currently waiting for the final approval results
of the State Medical Products Administration.
" At present, the production line has been built, and the production and sales can be started after the approval
.
”
It is worth noting that there are currently no generic dydrogesterone products on the market in China, so Aurisco's products are expected to break the monopoly of the original research and share the large market
.
It is worth mentioning that Aurisco has made sufficient preparations
for the production of this product in China.
According to the 2022 half-year report, the production line project of Yangzhou Auriscot with an annual output of 500 million solid form dydrogesterone/estradiol compound tablets has been filed, and the preparation of environmental impact assessment, safety assessment and occupational health assessment is underway, and the project construction
is scheduled to be completed in May 2023.
In addition, on November 4, Huaren Pharmaceutical also issued an announcement that its wholly-owned subsidiary, Anhui Xingxing Pharmaceutical's diquinonium chloride API, received the "Notice of Approval of Marketing Application for Chemical APIs"
approved and issued by the State Food and Drug Administration.
Huaren Pharmaceutical said that Anhui Xingxing Pharmaceutical has obtained the registration certificate of diquinonium chloride lozenges, and the approval of diquininium chloride API for marketing will realize the independent control of APIs, reduce the impact of API supply on the production of preparations, and on the other hand, reduce the cost
of preparations to a greater extent.
It is worth mentioning that in addition to continuous approval in China, domestic APIs are constantly coming with good news
overseas.
On November 10, Hanyu Pharmaceutical announced that the API DMF of ganirec acetate has been approved
by the FDA.
For the FDA approval of ganirec acetate (API), Hanyu Pharmaceutical said that it is to open up an access channel for the company's ganirec acetate (API) to enter the US market, which means that Galnirelic acetate will realize the commercial sales of the US market, which will have a positive impact on the overseas market of the company's APIs and help enhance the company's international brand influence
.
On the whole, the high prosperity of China's API industry is attracting a large number of enterprises to achieve economies of scale and improve the cost advantage and competitive advantage
of enterprises by further expanding the layout and capacity expansion of APIs and pharmaceutical excipients.
In this regard, the industry expects that in the future, with the transfer of overseas pharmaceutical R&D and production outsourcing industry and the bursting demand for innovation in China's pharmaceutical industry, the development trend of China's API industry will continue to improve
.
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