Spike Another API Approved for Marketing
Release time:
2023-05-04
Peak Pharmaceutical's Fluprost API submitted its API registration information to the Drug Evaluation Center (CDE) of the State Drug Administration in February 2021, which was accepted and started the technical review in March of that year, and received a notice of issuance at the end of the year. In May 2022, the pharmaceutical company submitted supplementary research materials to the Drug Examination Center, and at the same time sent samples to Zhejiang Food and Drug Inspection Institute for partial quality standard review after the supplementary research. In September 2022, the Drug Review Center initiated the technical review of supplementary research data, and the final review results were in line with the relevant national technical standards for the review of APIs and approved for sale in the domestic market.
Tasfluprost is a prostaglandin analog. It is a selective prostaglandin receptor agonist. It can reduce intraocular pressure by increasing the outflow of aqueous humor through the uveoscleral route. It is used to reduce the increase of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Including Peak Pharmaceuticals, there are currently only two companies that have approved the listing of the API in China. The successful listing of the raw material drug of He Fluoroprost enriches the products of Peak Pharmaceuticals and helps to further expand the business areas of the company's pharmaceutical sector. (Xu Chunliu)
More information
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Spike Postdoctoral Research Papers on International Frontier Journals
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2022
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Daye Peak QC Achievements Won the Third Prize of Huangshi City
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06-01
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2022
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Cranberry extract combination identification detection method won the invention patent
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2022
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Daye Peak Manufacturing Department Won the Title of "Worker Pioneer" in Hubei Province
A few days ago, the manufacturing department of Daye Peak Cement Company was awarded the title of "Worker Pioneer" by the Hubei Provincial Federation of Trade Unions. Daye Jianfeng Manufacturing Department not only continued to actively explore and achieved good results in energy saving and consumption reduction, technological transformation, product quality process control, and economic responsibility system to guide management, but also improved Daye Jianfeng's overall operation level and won Huangshi City The seventh "Mayor Quality Award" created conditions and was fully affirmed by government departments at all levels.
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