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
Peak natural products among the top 20 scientific and technological innovation in TEDA
A few days ago, Tianjin Jianfeng Natural products Research and Development Co., Ltd. stood out among nearly 35000 enterprises in Tianjin Development Zone and won the honor of "Top 20 Scientific and technological Innovation Enterprises of 2015. The selection criteria for the top 20 scientific and technological innovation enterprises in Tianjin Economic and Technological Development Zone mainly include: they have won science and technology awards or patent awards in 2015, as well as other awards above the provincial level; they have obtained the qualification certification or approval of research and development institutions above the provincial level; in 2015, the number of invention and utility model patent applications and authorizations was large, totaling more than 15; in 2015, they were supported by national or Tianjin key science and technology plans; scientific research achievements have made significant progress and technology. According to the above standards, Jianfeng Natural Products Company has not only won the second prize of Tianjin Science and Technology Innovation Project Award for the achievements of "Tianjin Plant Waste Reutilization Technology Engineering Center Construction", but also completed the process research of grape seed extract and ginsenoside to pesticide residues, and formulated the international business standard of grape seed extract (grape seed oligomeric proanthocyanidins). In order to better carry out the pilot experiment, large-scale technical transformation was carried out on the second workshop, and the process optimization of extracting anthocyanins from blueberries has been carried out. At the same time, the main business income, operating profit, tax revenue and other economic indicators of peak natural products company in 2015 have increased significantly year-on-year. Relying on the advantages of excellent quality, good efficiency, great contribution, safety and environmental protection, and good social responsibility, Jianfeng Natural Products Company successfully passed the review and became one of the "Top 20 Scientific and Technological Innovation Enterprises in 2015" in Tianjin Development Zone. (
2020
07-31
Peak natural products among the top 20 scientific and technological innovation in TEDA
A few days ago, Tianjin Jianfeng Natural products Research and Development Co., Ltd. stood out among nearly 35000 enterprises in Tianjin Development Zone and won the honor of "Top 20 Scientific and technological Innovation Enterprises of 2015. The selection criteria for the top 20 scientific and technological innovation enterprises in Tianjin Economic and Technological Development Zone mainly include: they have won science and technology awards or patent awards in 2015, as well as other awards above the provincial level; they have obtained the qualification certification or approval of research and development institutions above the provincial level; in 2015, the number of invention and utility model patent applications and authorizations was large, totaling more than 15; in 2015, they were supported by national or Tianjin key science and technology plans; scientific research achievements have made significant progress and technology. According to the above standards, Jianfeng Natural Products Company has not only won the second prize of Tianjin Science and Technology Innovation Project Award for the achievements of "Tianjin Plant Waste Reutilization Technology Engineering Center Construction", but also completed the process research of grape seed extract and ginsenoside to pesticide residues, and formulated the international business standard of grape seed extract (grape seed oligomeric proanthocyanidins). In order to better carry out the pilot experiment, large-scale technical transformation was carried out on the second workshop, and the process optimization of extracting anthocyanins from blueberries has been carried out. At the same time, the main business income, operating profit, tax revenue and other economic indicators of peak natural products company in 2015 have increased significantly year-on-year. Relying on the advantages of excellent quality, good efficiency, great contribution, safety and environmental protection, and good social responsibility, Jianfeng Natural Products Company successfully passed the review and became one of the "Top 20 Scientific and Technological Innovation Enterprises in 2015" in Tianjin Development Zone. (
2020
07-30
Peak pharmaceutical "enterprise information construction project" through the acceptance
The "Enterprise Informatization Construction Project" of Jianfeng Pharmaceutical Company was included in the list of key projects of "Integration of Industrialization and Industrialization" (high-level and in-depth combination of informatization and industrialization) in Jinhua City in 2015, and successfully passed the on-site acceptance of the expert group on the morning of May 18. The main contents of the "enterprise information construction project" of the pharmaceutical company include: the tank farm control system, which solves the problem of closed metering and transportation of organic solvents between the tank farm and the production area, can automatically realize the terminal metering setting, and effectively ensure the safety and environmental protection requirements of the tank farm operation; The air conditioning automatic control system realizes the control of the temperature, humidity and room pressure difference in the air conditioning area through the PLC digital-to-analog conversion of the upper computer and lower computer and the terminal actuator regulator, ensure the cleanliness requirements of the production area environment; The online particle monitoring software system automatically adjusts to the standard flow through the upper computer, vacuum system, laser sensor and isodynamic sampling probe, etc. through the flow detector device and key orifice plate inside each sensor, monitors the temperature, humidity, particles, planktonian bacteria, room pressure difference, etc., implements dynamic management, and realizes visual monitoring of the production process environment. MRP production management system, it makes it easier for the warehouse, workshop, and management personnel to obtain information about the flow of materials in the production process, the implementation of production plans, and product inventory. During the on-site acceptance on the 18th, the acceptance team composed of the Information Department of the Municipal Economic and Information Commission, the Economic and Development Bureau of the Development Zone, the Municipal Information Promotion Association and professors of Zhejiang Normal University checked the contracts of each system software, purchase and transfer records, training records, and problem records in project implementation,
2020
07-31
Peak natural products among the top 20 scientific and technological innovation in TEDA
A few days ago, Tianjin Jianfeng Natural products Research and Development Co., Ltd. stood out among nearly 35000 enterprises in Tianjin Development Zone and won the honor of "Top 20 Scientific and technological Innovation Enterprises of 2015. The selection criteria for the top 20 scientific and technological innovation enterprises in Tianjin Economic and Technological Development Zone mainly include: they have won science and technology awards or patent awards in 2015, as well as other awards above the provincial level; they have obtained the qualification certification or approval of research and development institutions above the provincial level; in 2015, the number of invention and utility model patent applications and authorizations was large, totaling more than 15; in 2015, they were supported by national or Tianjin key science and technology plans; scientific research achievements have made significant progress and technology. According to the above standards, Jianfeng Natural Products Company has not only won the second prize of Tianjin Science and Technology Innovation Project Award for the achievements of "Tianjin Plant Waste Reutilization Technology Engineering Center Construction", but also completed the process research of grape seed extract and ginsenoside to pesticide residues, and formulated the international business standard of grape seed extract (grape seed oligomeric proanthocyanidins). In order to better carry out the pilot experiment, large-scale technical transformation was carried out on the second workshop, and the process optimization of extracting anthocyanins from blueberries has been carried out. At the same time, the main business income, operating profit, tax revenue and other economic indicators of peak natural products company in 2015 have increased significantly year-on-year. Relying on the advantages of excellent quality, good efficiency, great contribution, safety and environmental protection, and good social responsibility, Jianfeng Natural Products Company successfully passed the review and became one of the "Top 20 Scientific and Technological Innovation Enterprises in 2015" in Tianjin Development Zone. (
2020
07-31