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Metronidazole

CAS number: 443-48-1

Molecular formula: C6H9N3O3

molecular weight: 171.154

Chemical structure:

Producers shown on SFDA

(Record date:27/08/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Huanggang Yinhe Aarti Pharmaceutical Co., Ltd.

GMP
Valid till August 2021

YiChang HEC ChangJiang Pharmaceutical Co., Ltd.

GMP
Valid till August 2017

Hubei Hongyuan Pharmaceutical technology Co.,Ltd. 

GMP, DMF
Valid till July 2023

Guangxi Jinxing Industrial Co., Ltd.

GMP
Valid till August 2022

Hebei Guolong Pharmaceutical Co., Ltd.

GMP
Valid till July 2023

Tianjin Zhongan Pharmaceutical Co., Ltd.

GMP
Valid till January 2021

Wuhan Wuyao Pharmaceutical Co., Ltd.

GMP, DMF
Valid till November 2023

Huanggang Saikang Pharmaceutical Co., Ltd.

GMP
Valid till May 2021

Hebei Guangxiang Pharmaceutical Co., Ltd.

GMP
Valid till September 2024

Hubei Hope Pharmaceutical Co., Ltd.

GMP
Valid till December 2018

Jinzhou Jiutai Pharmaceutical Co., Ltd. 

GMP
Valid till May 2022

Donggang Hongda Pharmaceutical Co., Ltd.

GMP
Valid till December 2020

Shanxi Tongji Pharmaceutical Co., Ltd.

GMP
Valid till March 2021

Suzhou Homesun Pharmaceutical Co., Ltd.

GMP
Valid till February 2022

Jiangsu Hanstone Pharmaceutical Co., Ltd.

GMP
Valid till May 2024



Producers shown on EP

(Quoted from EP website;record date:27/08/2021)

Substance
Certificate Holder
Certificate Number
Issu Date
Status
End date
Type
Metronidazole
HEC PHARM CO CN 443 300 Yidu
R1-CEP 2005-002-Rev 00
01/06/2011
WITHDRAWN BY HOLDER
10/08/2016
Chemistry
Metronidazole
CORDEN PHARMA BERGAMO S.P.A. IT 24047 Treviglio
R2-CEP 1995-052-Rev 02
25/04/2018
VALID
/Chemistry
Metronidazole
Unique Chemicals (A Division of J.B. Chemicals & Pharmaceuticals Ltd.) IN 400 030 Mumbai
R1-CEP 1997-083-Rev 02
07/07/2008
WITHDRAWN BY HOLDER
30/01/2012
Chemistry
Metronidazole
Tianjin Zhongan Pharmaceutical Co Ltd CN 300 384 Tianjin
R1-CEP 2002-119-Rev 00
02/03/2009
WITHDRAWN BY EDQM
14/01/2013
Chemistry
Metronidazole
AARTI DRUGS LIMITED IN 400 022 Mumbai
R1-CEP 2000-035-Rev 01
23/10/2006
WITHDRAWN BY HOLDER
10/07/2012
Chemistry
MetronidazoleHUBEI HONGYUAN PHARMACEUTICAL TECHNOLOGY CO., LTD. CN 438 600 Fengshan Town
R1-CEP 2007-309-Rev 02
08/06/2018
VALID
/Chemistry
Metronidazole benzoate
CORDEN PHARMA BERGAMO S.P.A. IT 24047 Treviglio
R1-CEP 1996-067-Rev 04
31/05/2018
VALID
/Chemistry
Metronidazole
Unichem Laboratories Limited IN 400 102 Mumbai
R1-CEP 2001-450-Rev 05
05/02/2016
VALID
/Chemistry
Metronidazole benzoate
ACHARYA CHEMICALS IN 421 204 Dombivli (East)
R1-CEP 2007-056-Rev 02
26/09/2019
SUSPENDED
21/11/2019
Chemistry
Metronidazole
WUHAN WUYAO PHARMACEUTICAL CO., LTD. CN 430 032 Wuhan
 R1-CEP 2007-083-Rev 03
17/01/2020
VALID
/Chemistry
Metronidazole Process II
HUBEI HONGYUAN PHARMACEUTICAL TECHNOLOGY CO., LTD. CN 438 600 Fengshan Town
R0-CEP 2018-264-Rev 01
02/07/2020
VALID
/Chemistry

Producer:Huanggang Yinhe Aarti Pharmaceutical Co., Ltd.(formerly Huanggang Hongya Pharmaceutical Co., Ltd.) is a modern Sino foreign joint venture producing pharmaceutical chemical raw materials, pharmaceutical intermediates and fine chemical products. The company was founded in 2006 with a registered capital of RMB 11.2 million and an investment of RMB 26 million in the first phase. The plant is designed in strict accordance with the requirements of GMP and has a complete and sound quality inspection system. The company mainly produces metronidazole and other series products, and the output of metronidazole ranks second in the world. The company has self operated import and export rights. All products are exported to Europe, America, Southeast Asia, India and other countries.

Staff size:200-299 persons

Registered capital:RMB 11.2 million


Producer:Yichang Changjiang Pharmaceutical Co., Ltd., now renamed YiChang HEC ChangJiang Pharmaceutical Co., Ltd., is the production base of synthetic API and domestic preparation products of dongyangguang Pharmaceutical Group. The company has more than ten kinds of API products approved by China's State Food and drug administration. The annual production capacity of metronidazole is 500 tons, which is one of the main domestic production enterprises.

In January 2005, dongyangguang submitted the main registration document of metronidazole to European EDQM and received feedback from EDQM. In April 2006, dongyangguang will submit the main document of metronidazole registration to FDA and complete the GMP transformation of metronidazole production and quality management system in Europe and America. Yichang Changjiang pharmaceutical now has a series of preparation product production lines, such as solid preparation, water injection, freeze-dried powder injection and so on. Nearly 30 kinds of preparation products have been approved by the State Food and Drug Administration of China. By the end of 2006, it is estimated that up to 50 kinds of preparation products have been approved for marketing.

Staff size:2000 persons

Registered capital:RMB 879 million 967 thousand and 700


Producer:Hubei Hongyuan Pharmaceutical technology Co.,Ltd. is located in Luotian County at the southern foot of Dabie Mountain. Founded in 2002, the company has a registered capital of 352,749,600 Yuan, a total asset of 1.7 billion Yuan, an area of 600,000 square meters, annual sales revenue of 1.6 billion Yuan, export earnings of 35 million U.S. dollars. In 2014, the company was listed on the stock transfer system of national small and medium-sized enterprises .

The company has passed GMP, ISO9001, ISO14001, ISO22000, IATF16949, KOSHER, HALAL and European COS certification and REACH registration, has obtained the self-import and export rights, the products sell well in more than 30 provinces and cities in China and more than 50 countries and regions in the world.

Staff size:About 1300 persons

Registered capital:RMB 352.7496 million


Producer:Guangxi Jinxing industrial Co., Ltd. is integrated and established by Hechi Jinxing Biotechnology Co., Ltd. and Guangxi Hechi chemical pharmaceutical factory with registered capital   50 million yuan. It mainly produces three series of products, including pharmaceutical raw materials, pharmaceutical intermediates, finished drugs and natural food additives. The fist product "Jingui brand" metronidazole has won the Hundred Flowers Award for new products in Guangxi and the title of high-quality products in Guangxi. It sells well in more than 20 provinces and cities in China and all over Western Europe, the Middle East and Southeast Asia.

Company in   two thousand and fourteen   year   In May, the technical transformation project of metronidazole series products was built in Daren Industrial Park, covering an area of 174 mu with a total investment of 610 million yuan. The project is implemented in two phases, with an investment of 210 million yuan in the first phase, producing 1800 tons / year of metronidazole, 2200 tons / year of dimethyl imidazole and 2200 tons / year of 2-methyl-5-nitroimidazole, with an annual output value of 250 million yuan. The investment of 210 million yuan has been completed, phase I has been officially put into operation in August 2017, and phase II is under construction.

Staff size:50-99 persons

Registered capital:RMB 50 million


Producer:Hebei Guolong Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Shijiazhuang No. 4 pharmaceutical group, is located in Shijiazhuang Economic and Technological Development Zone. It is a professional pharmaceutical API manufacturing enterprise with advanced technology and excellent management. There are dozens of API product codes produced and developed by the company.Hebei Guolong Pharmaceutical Co., Ltd. has first-class production facilities and plants in the world. It has established and improved the quality management system in strict accordance with the new national GMP standard. Relying on the company's Drug Research Institute, united with domestic universities and research institutes and many other institutions to carry out technological innovation, its production process level and product quality have been kept at the first level in the same industry in China, It can meet the various needs of customers at home and abroad. At present, the company has passed IS0, kosher and other international certification

Staff size:About 3800 persons

Registered capital:RMB 180 million


Producer:Tianjin Zhongan Pharmaceutical Co., Ltd., founded in 1988, covers an area of 82000 square meters, mainly produces 10 kinds of chemical synthetic APIs, with an annual production capacity of 4000 tons and a sales revenue of nearly 250 million yuan.

The company has its own import and export rights. More than 90% of its products are exported to the international market, of which 60% are directly sold to internationally famous large pharmaceutical companies and beverage companies. Its sales network covers more than 30 countries and regions such as Europe, America, Hong Kong, Macao, Taiwan, Southeast Asia, central and Western Asia and Russia.

Since 2000, the company has passed the national GMP, ISO9001:2008 and FDA certification. And won the title of Tianjin high-tech enterprise and Tianjin Municipal Technology Center. Caffeine and metronidazole, the two flagship products, have obtained the EU cos certificate and the DMF registration of the US FDA. Caffeine has passed the on-site inspection of the US FDA, obtained the "certificate of foreign manufacturer" from the Ministry of health and welfare of Japan, and carried out the international food safety certification of BRC, kof-k, halal, etc.

Staff size:About 50 persons

Registered capital:RMB 11.088 million


Producer:Wuhan Wuyao Pharmaceutical Co., Ltd. is a holding subsidiary invested by Broad (China) Co., Ltd. (formerly Wuhan Pharmaceutical Factory) in 2002. It is a well-known enterprise in the production and operation of specialty drug substances in China. The company passed the acceptance of "secondary enterprise of safety production standardization"; in the same year, it was rated as "high-tech enterprise" in Hubei Province; the annual sales income is 600 million yuan, and the products are exported to more than 40 countries and regions such as Europe and the United States, and the total annual export value $ 50 million.

According to the Opinions of the People's Government of Wuhan City on Accelerating the Relocation and Remediation of Chemical Production Enterprises in the Third Ring Road of the City (Wuzheng [2008] No. 50) and the overall plan, Wuhan Wuyao Pharmaceutical Co., Ltd. was relocated to Yangxin County, Huangshi City, Hubei Province. Chemical Industrial Park of Fuchi Town. The company currently has 820 employees and 500 technical and management personnel with college education or above. With a registered capital of 61 million yuan, the company is a high-tech enterprise engaged in the production and operation of bulk drugs.

Staff size:800-899 persons

Registered capital:RMB 61 million 


Producer:Huanggang Saikang Pharmaceutical Co., Ltd.founded in 2005, is a manufacturer of APIs. Its license number of medicine manufacturing is E20110076, and its products are metronidazole, secnidazole, anethole trithione, piribedil, tauroursodeoxycholic acid, melatonin and tadalafil. Metronidazole, secnidazole and anethole trithione passed the GMP inspection on 13 April 2009, the GMP certificate number is EK0382. Piribedil, tauroursodeoxycholic acid, melatonin and tadalafil were licensed on 21 June 2012, and now these products are in the process of registration. It is the only licensed manufacturer of melatonin.

Huanggang Saikang Pharmaceutical Co., Ltd., locates in Zhongyi town of Macheng (it is the old revolutionary base area of Dabieshan), at the exits of Daguang expressway and Hurong expressway, and is about 70 km away from the Wuhan airport. Its total area is 16625 m2, in which the production area 16415 m2; the building area is 5500 m2, in which the warehouse area is 368 m2, the storage area for the liquid materials is 380 m2; the production workshop area of melatonin is 976 m2, the packaging area of melatonin is 28 m2.

Staff size:About 50 persons

Registered capital: RMB 3 million


Producer:Hebei Guangxiang Pharmaceutical Co., Ltd., established in February 2017, is located in Huanghua Lingang Economic and Technological Development Zone, Cangzhou City, Hebei Province, covering a total area of 489.2 Mu and a total construction area of 250000 square meters. At present, it has a registered capital of 670 million yuan and is a subsidiary of Shisi Pharmaceutical Group. Shisiyao is one of the leading manufacturers in China's pharmaceutical industry. For many consecutive years, it has ranked among the top 100 enterprises in China's pharmaceutical industry, the top 10 excellent enterprise brands for the export of preparations in China's chemical pharmaceutical industry, and the national demonstration enterprise of technological innovation. With national enterprise technology center, national and local joint engineering laboratories and other national platforms, it has strong R & D strength.

Staff size:400-499 persons

Registered capital:RMB 670 million


Producer:Hubei Hope Pharmaceutical Co., Ltd., established in 2002, is a modern pharmaceutical enterprise specializing in the development, production and sales of antibiotics, antiviral drugs, digestive drugs, antipyretic and analgesic drugs and disinfection products. The company covers an area of 45000 square meters, with a registered capital of 30 million yuan and total assets of more than 100 million yuan
At present, the company has chemical synthesis production line, general API production line, sterile API production line, sterile lyophilized preparation production line, sterile powder injection production line, disinfectant production workshop and disinfection equipment production workshop in line with the national GMP specification. More than 20 kinds of products are produced throughout the year, which are sold all over the country and have been highly praised by consumers.
Staff size:About 50-99 persons
Registered capital:RMB 30 million


Producer:Jinzhou Jiutai Pharmaceutical Co., Ltd. is a comprehensive pharmaceutical enterprise with a production history of more than 60 years. The predecessor of Jinzhou No. 1 pharmaceutical factory was founded in 1951 and restructured into Jinzhou Jiutai Pharmaceutical Co., Ltd. in 1998. In recent years, various economic indicators have been among the top 100 pharmaceutical production enterprises in China. It is one of the key pharmaceutical enterprises in Liaoning Province.

The company covers an area of 58000 square meters, has a registered capital of 40.46 million yuan and has 1250 employees, including 310 engineering and technical personnel; It has 5 production workshops, 1 R & D center and 1 holding pharmaceutical commercial company. The company produces nearly 100 varieties, with reasonable product structure and good economic operation. Advanced production technology, mature process route, complete quality monitoring system and stable and reliable product quality.

Staff size:About 1250 persons

Registered capital:RMB 40.46 million 


Producer:Donggang Hongda Pharmaceutical Co., Ltd. is the only high-tech enterprise specializing in the production of API in Dandong. It passed the national GMP certification in August 2004, in which metronidazole and promethazine hydrochloride were rated as high-tech products by Dandong science and Technology Bureau.

The plant layout of the company is reasonable. The plant is a brick concrete frame structure. Two 300000 grade fine drying bags are newly built according to the requirements of GMP specification. The company's products have reliable quality and complete inspection means. The products sell well in more than 30 provinces and cities across the country, and are exported to Japan, India, Brazil, Thailand, Taiwan and other countries and regions. The Product Executive Standards: CP2005, bp2005 and USP28. The production equipment and public facilities can meet the production requirements of chemical APIs. Based on the principle of mutual benefit and common development, Always adhere to the purpose of product quality first, user interests first and enterprise honor first.

Staff size:50-99 persons

Registered capital:RMB 16 million


Producer:Shanxi Tongji Pharmaceutical Co., Ltd., established in April 2005, is an enterprise specializing in the production of API. The company integrates scientific research, pilot test and production, and has strong scientific research and development and achievement transformation ability. The company's advanced production equipment provides a solid material foundation for the synthesis of high-quality and efficient API; Perfect testing equipment; It has professional scientific research and technical personnel and rich pharmaceutical expert resources. The production management, quality control and quality inspection personnel have relevant professional skills and knowledge. At the same time, the production personnel are trained in production skills and quality control regularly or irregularly, so as to provide a reliable guarantee for the quality of drugs! Strictly control the product quality according to the enterprise's internal control standards, and prevent unqualified products from leaving the factory.

Staff size:About 50 persons

Registered capital:RMB 83.1 million


Producer:Suzhou Homesun Pharmaceutical Co., Ltd. was established on April 17, 2009, production address: Jiangsu Taicang Port Development Zone, petrochemical zone GCL Road on the 12th, registered capital of 98 million yuan, 2.3 million yuan in fixed assets, covers an area of 4.3 million square meters, construction area of 2.5 million square meters.

Company's main products include pharmaceutical intermediates, pharmaceutical raw materials (including sterile APIs), frozen dried powder injection, small volume injection, oral solid dosage forms (tablets and capsules) and inhalation solution. Currently has 17 APIs and small capacity injection workshop, tablets, hard capsule agent through the national GMP certification, with an annual output of: 350 tons of raw material medicine (fine baked package), 1 billion ampoules of small volume injections, 15 million tablets, 1 million capsules agent, product coverage of antitumor, antiviral, central nervous, anti infective, cardiovascular, digestive, antipyretic analgesic class.

Staff size:About 150 persons

Registered capital:RMB98 million 


Producer:Jiangsu HanStone Pharmaceutical Co., Ltd. is a modern API pharmaceutical enterprise completed and put into operation in 2005, and has become a high-tech enterprise in Jiangsu Province.

The two plant areas of the company cover an area of about 70 mu, and the investment in the new plant area is more than 60 million yuan. It mainly produces and operates chemical synthetic APIs and sterile APIs. According to the latest relevant national laws and regulations, the workshop shall be constructed according to GMP standards. Since its establishment, it has experienced more than ten domestic and international GMP certification of API. At the end of 2013, all sterile APIs of the company passed the GMP certification of 2010 version, and at the end of 2015, all non sterile APIs of the company passed the GMP certification of 2010 version, laying a good foundation for the next development of the company. The main product ranitidine hydrochloride quality and sales volume in China. It was registered by Japan DMF in November 2006 and became a qualified foreign manufacturer of Japanese API. After receiving the strict inspection of the Japanese government, the company successfully passed the GMP inspection of PMDA of Japan's Ministry of health, labor and welfare, marking that ranitidine hydrochloride of our company has become a product successfully exported to the Japanese market, paving the way for large-scale sales in the Japanese market.

Staff size:50-99 persons

Registered capital:RMB 20.36 million


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