Anhui Zhongwang obtains drug production license
Release time:
2020-07-22
Anhui Zhongwang Obmed Drug Production License
News 11# August 25 , Anhui Zhongwang Pharmaceutical Co., Ltd. successfully obtained drug production license and successfully transformed from a pharmaceutical intermediate production enterprise to a drug production enterprise.
Starting from 2018 9 , Anhui Zhongwang Pharmaceutical has planned the company's organizational structure in strict accordance with GMP standard management requirements, established GMP document system, and compiled and perfected more than 24 technical standards, management standards and working standard documents 1100 , and completed the purified water system, air conditioning purification system, nitrogen system and production equipment and inspection equipment and other types of verification, a total of more than 100 ; on the basis of the original pharmaceutical intermediate production facilities and equipment, according to GMP requirements of the plant facilities and equipment have been upgraded, adding gas chromatograph, high performance liquid chromatograph, infrared spectrometer, drug stability test box, drug ultraviolet strong light irradiation test box and other inspection equipment; A new raw material medicine fine baking workshop and microbiology laboratory, as well as a purified water system and an air-conditioning purification system have been built, and the storage facilities and storage environment of the warehouse have been upgraded and improved.
By integrating the teams of Shanghai Beika and Zhongwang Pharmaceutical QA and QC , Anhui Zhongwang Company has basically met the personnel requirements of quality management and quality inspection required for the application of Drug Production License, and has established a personnel training management system, respectively compiled the company-level annual training plan and the department-level annual training plan, which are organized and implemented monthly as planned, focus on strengthening the training of relevant laws and regulations on drug production and GMP specification for personnel in key positions such as QA , QC , air conditioning purification system, purified water system, fine drying package workshop and warehouse, so as to improve the overall quality of personnel.
When the new "Drug Administration Law" is about to be implemented, the transformation and upgrading of Zhongwang Pharmaceuticals has laid a more solid foundation for the construction of the API base in the peak pharmaceutical sector. (Chen Lidong)
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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