
Voriconazole
CAS number: 137234-62-9
Molecular formula: C16H14F3N5O
molecular weight: 349.31
Chemical structure:
Producers shown on SFDA
(Record date:30/08/2021)
Producer | Documents | GMP Valid till(based on SFDA) |
Venturepharm (Hainan) Co., Ltd. | GMP | Valid till July 2024 |
Chongqing Lummy Longyu Pharmaceutical Co., Ltd. | GMP | Valid till November 2022 |
Yangtze River Pharmaceutical Group Jiangsu Haici Biological Pharmaceutical Co., Ltd. | GMP | Valid till November 2024 |
Sichuan Medco Huakang Pharmaceutical Co., Ltd. | GMP | Valid till June 2021 |
Shenzhen Haibin Pharmaceutical Co., Ltd. | GMP | Valid till June 2019 |
Jincheng Haisi Pharmaceutical Co., Ltd. | GMP | Valid till March 2020 |
Zhuhai United Laboratories Co., Ltd. | GMP | Valid till December 2022 |
Zhejiang Huahai Pharmaceutical Co., Ltd. | GMP, DMF | Valid till October 2021 |
Chongqing Lummy Pharmaceutical Co.,Ltd | GMP | Valid till December 2017 |
Producers shown on EP
(Quoted from EP website;record date:30/08/2021)
Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
Voriconazole Process II | DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad | R1-CEP 2014-084-Rev 00 | 14/08/2019 | VALID | / | Chemistry |
Voriconazole | APOTEX PHARMACHEM INDIA PVT. LTD IN 560 099 Bangalore | R1-CEP 2013-289-Rev 00 | 06/07/2020 | VALID | / | Chemistry |
Voriconazole | DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad | R1-CEP 2012-081-Rev 00 | 03/01/2019 | VALID | / | Chemistry |
Voriconazole Form-I | HETERO LABS LIMITED IN 500 018 Hyderabad | R0-CEP 2018-184-Rev 00 | 06/11/2020 | VALID | / | Chemistry |
Voriconazole | MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad | R1-CEP 2011-298-Rev 02 | 25/05/2021 | VALID | / | Chemistry |
Voriconazole | GLENMARK LIFE SCIENCES LIMITED IN 400 099 Mumbai | R1-CEP 2012-102-Rev 01 | 28/02/2019 | VALID | / | Chemistry |
Voriconazole | Neuland Laboratories Limited IN 500 034 Hyderabad | R1-CEP 2013-203-Rev 00 | 19/12/2019 | VALID | / | Chemistry |
Voriconazole | SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai | R1-CEP 2013-057-Rev 00 | 07/10/2019 | VALID | / | Chemistry |
Voriconazole | APOTEX PHARMACHEM INDIA PVT. LTD IN 560 099 Bangalore | R0-CEP 2014-017-Rev 01 | 07/03/2017 | EXPIRED | 08/10/2020 | Chemistry |
Voriconazole | MEDICHEM MANUFACTURING (MALTA) LTD. MT BBG 3000 Hal Far | R1-CEP 2011-377-Rev 00 | 13/03/2018 | VALID | / | Chemistry |
Voriconazole | MSN LABORATORIES PRIVATE LIMITED IN 502 329 Rudraram Village | R1-CEP 2011-387-Rev 00 | 06/05/2019 | VALID | / | Chemistry |
Voriconazole | DONGKOOK PHARMACEUTICAL CO., LTD. KR 135-502 Seoul | R0-CEP 2013-008-Rev 00 | 08/06/2015 | EXPIRED | 08/06/2020 | Chemistry |
Voriconazole | CHROMO LABORATORIES INDIA PRIVATE LIMITED IN 502 307 Pashamylaram | R1-CEP 2013-171-Rev 00 | 13/03/2020 | VALID | / | Chemistry |
Voriconazole | LEE PHARMA LIMITED IN 500 037 Hyderabad | R1-CEP 2013-306-Rev 00 | 26/03/2021 | VALID | / | Chemistry |
Voriconazole | JUBILANT GENERICS LIMITED IN 571 302 Nanjangud | R1-CEP 2013-286-Rev 00 | 27/01/2020 | VALID | / | Chemistry |
Voriconazole | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai | R1-CEP 2011-365-Rev 01 | 20/10/2020 | VALID | / | Chemistry |
Producer:Venturepharm (Hainan) Co., Ltd.,is a group providing outsourced production service management for global pharmaceutical enterprises, which is authorized and managed by venturepharm Group Inc.
With 7 advanced API and preparation production bases in Asia, the company provides comprehensive production outsourcing services for global pharmaceutical enterprises. Customers can obtain professional support and services from the early stage of product development to large-scale production. All production bases of vante have passed GMP certification, and two API production bases have passed FDA certification.
Staff size:100-199 persons
Registered capital:RMB 194 million 870 thousand and 600
Producer:Chongqing Lummy Longyu Pharmaceutical Co., Ltd.As a wholly-owned subsidiary of Chongqing Lummy Pharmaceutical Co.,Ltd., the company was established on September 8, 2015. After six years of development, we have always provided customers with good product and technical support and perfect after-sales service. The company is mainly engaged in the production and sales of drugs; Sales: chemical raw materials and chemical products (excluding hazardous chemicals); Import and export of goods.
Producer:Yangtze River Pharmaceutical Group Jiangsu Haici Biological Pharmaceutical Co., Ltd.,a wholly-owned subsidiary invested and built by Yangtze River Pharmaceutical Group in 2004, is located in Binjiang Industrial Park, Taizhou pharmaceutical high tech Zone. It is the R & D, pilot test and production base of the group's chemical API. It covers a total area of more than 460 mu, with a total investment of 1.7 billion yuan and more than 700 employees. It is mainly committed to the technical research, production and sales of high value-added APIs and pharmaceutical intermediates, and widely carries out foreign cooperation in the fields of innovative drugs cdmo / CMO, drug agency sales and so on.
Staff size:700-799 persons
Registered capital:RMB 200 million
Producer:Sichuan Medco Huakang Pharmaceutical Co., Ltd. was founded in 1971. In 2012, the company invested 300 million in technical transformation and built a comprehensive pharmaceutical production plant of more than 40000 square meters according to the requirements of GMP 2010. All dosage forms of the company have passed GMP certification.
At present, there are more than 120 drug approval numbers, more than 70 national essential drug varieties and 12 new drug certificates (including three class I new drug certificates). The main varieties are mainly the production and sales of antibacterial drugs (anti bacteria, fungi and anaerobic bacteria), antiviral drugs, vitamins, antipyretic and analgesic drugs, especially the latest anti deep fungal infection drug voriconazole, Adefovir dipivoxil, a hepatitis B drug, plays a leading role in similar products in China.
Producer:Shenzhen Haibin Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Health Yuan Pharmaceutical Group Co., Ltd. It was established in 1989 and officially put into operation in 1992 with a registered capital of 700 million RMB. The factory covers an area of 16,000 square meters. 26,800 m2. The company is located in the national eco-environmental demonstration zone.The container port of the class --- Yantian Port, the route reaches more than 80 countries and regions.
The production capacity of powder injection injection is 80 million bottles, 100 million tablets, 100 million capsules and 30 tons of raw materials.
"Based on the domestic and the world" is a major strategic goal of Shenzhen Haibin Pharmaceutical Co., Ltd. Through unremitting efforts, the export of Meropenem raw materials in 2003 began, and in 2006, the export volume reached 1.3 tons. In just a few years, the drug product was ranked first in the world in terms of sales volume, and the products were exported. Southeast Asia, Africa, the Middle East, South America and other places. In 2006, imipenem cilastatin sodium API has also begun to export to countries such as India and Brazil. In December 2006, we signed a cooperation agreement with a German company on COS certification, which opened the curtain for entering the European and American market.
Staff size:500-599 persons
Registered capital:RMB 70 million
Producer:Jincheng Haisi Pharmaceutical Co., Ltd. (hereinafter referred to as the company) is a modern pharmaceutical enterprise based on the Chinese Academy of Preventive Medical Sciences and focusing on the development and production of new pharmaceutical products.
The company has a plant area of 22000 square meters and a construction area of 18000 square meters. There are five production workshops with a construction area, all of which have passed the national GMP certification, including the annual design capacity of biological agent workshop of 50 million tablets; The annual design capacity of the oral solid preparation workshop is 150 million capsules, 300 million tablets and 5 million bags of granules; The annual design capacity of injection workshop is 30 million; The design capacity of raw material workshop (traditional Chinese medicine extraction and chemical synthesis) is 25 tons per year; The annual design capacity of the water making workshop is 25000 tons.
Staff size:400-499 persons
Registered capital:RMB 113.7046 million
Producer:Zhuhai Rundu Pharmaceutical Co., Ltd. is a modern scientific and technological pharmaceutical enterprise integrating drug R & D, production and sales. It is located in Jinwan District, Zhuhai City, Guangdong Province. It was established in 1999. On January 5, 2018, the company was listed on Shenzhen Stock Exchange
The company has a sound quality management system and has established a drug production and manufacturing center in strict accordance with the national GMP requirements. The existing product production lines (including APIs, tablets, capsules, preparation intermediates (pellets), etc.) have passed the new national GMP certification, and some characteristic API products have passed the official certification of the World Health Organization, the European Union and Japan, Some products have passed the on-site inspection of FDA.
Staff size:2000 persons
Registered capital:RMB 185 million 700 thousand
Producer:Zhejiang Huahai Pharmaceutical Co., Ltd.was founded in 1989 and headquartered in Zhejiang, China. The company has nearly 7000 employees and more than 40 subsidiaries around the world (including China, the United States, Japan, Germany, etc.As a leading enterprise in the internationalization of Chinese medicine, Huahai pharmaceutical is the first pharmaceutical company in China to pass the FDA preparation quality certification and independently own the Anda document number. It is also the first Chinese pharmaceutical company to realize large-scale preparation sales in the United States. It has established China's pharmaceutical quality image in the world's high-end pharmaceutical market.
Staff size:About 7000 persons
Registered capital:RMB 1 billion 492 million
Producer:Chongqing Lummy Pharmaceutical Co.,Ltd.,was founded in 1999. In October 2009, the company was listed on the gem of Shenzhen Stock Exchange. It has many subsidiaries and more than 1500 employees.
Chongqing Lummy Pharmaceutical Co.,Ltdhas outstanding innovation ability, solid technical foundation, rich industrialization experience and strong marketing network. It is one of the first enterprises to pass GMP and GSP certification in China, and its new drug application volume ranks among the top in Chongqing.
Registered capital:RMB 1 billion 56 million
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