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
Publicity of Environmental Protection Acceptance for Completion of Kiln End Flue Gas Desulfurization Project of daye peak cement co., ltd. According to the requirements of the Interim Measures for Environmental Protection Acceptance for Completion of Construction Projects (No.4 [2017] of the State Environmental Regulations) issued by the Ministry of Environmental Protection, the environmental protection acceptance information of "Kiln End Flue Gas Desulfurization Project" of daye peak cement co., ltd. is now publicized. Basic Information of 1. Project Project Name: Kiln End Flue Gas Desulfurization Project Construction Unit: daye Jianfeng Cement Co., Ltd. Project Construction Location: Yongguang Village, Baoan Town, daye city, nature of the project in the existing plant area of daye Jianfeng Cement Co., Ltd.: The construction content of the technological transformation project is: This technological transformation project is mainly to build a wet desulfurization system for kiln end gas of the company's existing 4000t cement clinker production line, adopting limestone-gypsum wet flue gas desulfurization process. The project covers a total area of 500 m2, with a new construction area of about 450 m2. It mainly builds desulfurization complex building, flue gas system, SO2 absorption system, limestone powder conveying and limestone slurry preparation system, process water system, gypsum dehydration system and supporting pipelines. Power supply, water supply, compressed air and other public works rely on the existing plant. Total investment and environmental protection investment: the total investment of the project is 10.37 million yuan, all of which are environmental protection investment. The project was entrusted to Huangshi Yangtze River Environmental Engineering Design and Research Institute to carry out environmental impact assessment in September 2017. On November 16, 2017, Daye Municipal Environmental Protection Bureau issued a reply with YEHAN [2017] No. 354. Implementation of 2. environmental protection measures The scope of this acceptance is the flue gas desulfurization system and supporting facilities at the end of the kiln. (1) Exhaust gas pollution
2020
07-31
Spike New Drug Approved for Registration
On April 16, Jianfeng Pharmaceutical Company received the approval and issuance of Olopatadine Hydrochloride Eye Drops "Drug Registration Approval" (approval number: 2019S00296) approved by the State Drug Administration. Olopatadine hydrochloride eye drops is mainly used to treat the signs and symptoms of allergic conjunctivitis. It is a mast cell stabilizer and a relatively selective histamine H1-receptor antagonist. It can inhibit type I immediate allergic reactions in vivo and in vitro experiments. At present, the product has been included in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2017 Edition)" and classified as Class B. According to the relevant data of IMS database, in 2018, the global sales of olopatadine hydrochloride eye drops were about 0.37 billion US dollars, and the sales in China were about 10.232 million US dollars. Spike Pharmaceuticals already has the corresponding production line, this time to obtain the registration approval, marking Spike Pharmaceuticals has the qualification to carry out the production and sales of olopatadine hydrochloride eye drops, will further enrich the product line of Spike Pharmaceuticals, help to enhance the competitiveness of the company's pharmaceutical business. (Xia Yingpin)
2020
07-31
Spike New Drug Approved for Registration
On April 16, Jianfeng Pharmaceutical Company received the approval and issuance of Olopatadine Hydrochloride Eye Drops "Drug Registration Approval" (approval number: 2019S00296) approved by the State Drug Administration. Olopatadine hydrochloride eye drops is mainly used to treat the signs and symptoms of allergic conjunctivitis. It is a mast cell stabilizer and a relatively selective histamine H1-receptor antagonist. It can inhibit type I immediate allergic reactions in vivo and in vitro experiments. At present, the product has been included in the "National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalog (2017 Edition)" and classified as Class B. According to the relevant data of IMS database, in 2018, the global sales of olopatadine hydrochloride eye drops were about 0.37 billion US dollars, and the sales in China were about 10.232 million US dollars. Spike Pharmaceuticals already has the corresponding production line, this time to obtain the registration approval, marking Spike Pharmaceuticals has the qualification to carry out the production and sales of olopatadine hydrochloride eye drops, will further enrich the product line of Spike Pharmaceuticals, help to enhance the competitiveness of the company's pharmaceutical business. (Xia Yingpin)
2020
07-31
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