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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.

GMPValid 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 DateStatus
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
07/10/2019VALID
/
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.

Staff size:50-99 persons
Registered capital:RMB 100 million

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.

Staff size:400-499 persons
Registered capital:RMB 100 million

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.

Staff size:About 1500 persons

Registered capital:RMB 1 billion 56 million


For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978