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Azithromycin

CAS number: 83905-01-5

Molecular formula: C38H72N2O12

molecular weight: 748.984

Chemical structure:

Producers shown on SFDA

(Record date:25/08/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Qilu Pharmaceutical Co.,Ltd.

 GMP

Valid till October 2022
Shandong Dyne Marine Biological Pharmaceutical Co.,Ltd.GMPValid till  

May 2024

Shanghai Shyndec Pharmaceutical Co.,Ltd.

GMP, DMFValid till 

August 2022

Hebei Guolong Pharmaceutical Co., Ltd.

GMPValid till October 2024

Zhejiang Zhenyuan Pharmaceutical Co., Ltd. 

GMPValid till May 2017
Zhejiang Guobang pharmaceutical Co.,Ltd.GMP, DMF, CEPValid till November  2024

Zhejiang Yatai Pharmaceutical Co., Ltd.,

GMPValid till June 2020

Heze Fangming Pharmaceutical Co., Ltd.

GMPValid till July 2020

Zhejiang Nisikang Pharmaceutical Co., Ltd. 

GMPValid till November 2021

CSPC Ouyi Pharmaceutical Co., Ltd.

GMP
Valid till May 2022

Hainan Star Pharmaceutical Co., Ltd.

GMP
Valid till February 2021

HEC Pharmaceutical Co., Ltd. 

GMP, DMF

Valid till  December 2023

Shaoxing Xingya Pharmaceutical Co., Ltd.

GMP
Valid till December 2023

Ningxia Qiyuan Pharmaceutical Co., Ltd.

GMP, DMF
Valid till April 2023 

Tianjin Biochemical Pharmaceutical Co., Ltd.

GMP
Valid till November 2020

Hebei Dongfeng Pharmaceutical Co., Ltd.

GMP
Valid till November 2024

Hainan Hailing Chemipharma Corporation Ltd.

GMP
Valid till  July 2020

Zhejiang Jianfeng Pharmaceutical Co., Ltd.

GMP
Valid till September 2020

Jiangxi Gannan Haixin Pharmaceutical Co.,Ltd.

GMP
Valid till December 2015

Huangshi Shixing Pharmaceutical Co., Ltd.

GMP, DMF
Valid till September 2020

Harbin Pharmaceutical Group General Pharmaceutical Factory

GMP

Valid till  September 2024


Producers shown on EP

(Quoted from EP website;record date:25/08/2021

Substance
Certificate Holder
Certificate Number
Issue
Date
Status
End date
Type
Azithromycin Monohydrate
ALEMBIC PHARMACEUTICALS LIMITED IN 390 003 Vadodara
R1-CEP 2014-118-Rev 00
08/02/2021
VALID
/Chemistry
Azithromycin Monohydrate
PLIVA CROATIA LTD. HR 10000 Zagreb
R1-CEP 2010-131-Rev 01
23/08/2019
VALID
/Chemistry
Azithromycin Dihydrate
HEC PHARM CO., LTD. CN 443 300 Yidu City
R1-CEP 2007-230-Rev 03
02/05/2018
VALID
/Chemistry
Azithromycin Dihydrate
ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. CN 312 369 Shangyu
R1-CEP 2013-153-Rev 00
12/11/2019
VALID
/Chemistry
Azithromycin Dihydrate
JUBILANT GENERICS LIMITED IN 571 302 Nanjangud
R1-CEP 2007-119-Rev 05
10/08/2018
VALID
/Chemistry
Azithromycin Dihydrate
ALEMBIC PHARMACEUTICALS LIMITED IN 390 003 Vadodara
R1-CEP 2007-165-Rev 03
09/03/2018
VALID
/Chemistry
Azithromycin Monohydrate
Sandoz Industrial Products S.A. ES 08520 Les Franqueses Del Vallès
R1-CEP 2002-257-Rev 01
26/09/2012
VALID
/Chemistry
Azithromycin PII
HEC PHARM CO., LTD. CN 443 300 Yidu City
R0-CEP 2017-154-Rev 00
26/10/2017
VALID
/Chemistry
Azithromycin Dihydrate
ERCROS S.A. ES 28300 Aranjuez
R1-CEP 2007-206-Rev 02
19/08/2020
VALID
/Chemistry
Azithromycin Dihydrate
CSPC OUYI PHARMACEUTICAL CO., LTD. CN 052 160 Shijiazhuang
R1-CEP 2008-315-Rev 04
12/09/2019
VALID
/Chemistry
Azithromycin Dihydrate
Ningxia Qiyuan Pharmaceutical Co., Ltd. CN 750 101 Yinchuan City
R1-CEP 2012-212-Rev 00
14/12/2018
VALID/Chemistry
Azithromycin Monohydrate
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
R1-CEP 2004-181-Rev 03
03/02/2020
WITHDRAWN BY HOLDER
25/02/2021
Chemistry
Azithromycin Monohydrate
JUBILANT GENERICS LIMITED IN 571 302 Nanjangud
R1-CEP 2007-118-Rev 03
07/05/2018
VALID
/Chemistry
Azithromycin Monohydrate
HEC PHARM CO., LTD. CN 443 300 Yidu City R1-CEP 2014-185-Rev 00
28/08/2020
VALID
/Chemistry
Azithromycin Dihydrate
PLIVA CROATIA LTD. HR 10000 Zagreb
R1-CEP 2007-072-Rev 01
30/08/2018
VALID
/Chemistry
Azithromycin Dihydrate
JIANGSU WEIQIDA PHARMACEUTICAL CO., LTD. CN 226 133 Nantong CityR0-CEP 2016-070-Rev 02
19/04/2021
VALID
/Chemistry
Azithromycin Dihydrate
KOPRAN RESEARCH LABORATORIES LIMITED IN 400 018 Mumbai
 R1-CEP 2005-230-Rev 02
30/06/2020
VALID
/Chemistry

Producer:Qilu Pharmaceutical is one of the leading vertically integrated pharmaceutical companies in China focusing on the development, manufacturing and marketing of active pharmaceutical ingredients (APIs) & finished formulations. Qilu currently has 12 subsidiaries, 10 manufacturing sites and over 23000 employees worldwide, 70% of whom are with bachelor’s degree or above. It ranks No.8 in Chinese pharmaceutical industry by sales revenue in 2019. Dedicated to offering more affordable medicines to the world and improving people's well-being, Qilu has exported its products to over 70 countries.

Qilu Pharmaceutical has always committed itself to providing high-quality products to patients and the society. The company is the 1st Chinese company to obtain USFDA and EDQM approval for sterile APIs. Its finished formulations and APIs have been approved by USFDA, European Medicines Agency (EMA), Therapeutic Goods Administration (TGA) of Australia, Medicines and Healthcare products Regulatory Agency (MHRA) of UK, PMDA of Japan and other national regulatory authorities.

Staff size:About 8000 persons

Registered capital:RMB 60 million

Producer:Dyne pharmaceutical, the chairman unit of children's medication Professional Committee of China Pharmaceutical Enterprise Management Association, has always adhered to the corporate mission of "making millions of Chinese children healthy and strong", focusing on the R & D and production of products in the field of children's health.

The company's existing products mainly involve the fields of children's medicine and children's health care and nutritional food, forming a children's health industry layout with "children's health care and treatment field" as the core. The production base in Rongcheng, Shandong Province is designed and arranged in strict accordance with the production standards of professional children's drugs. The dosage forms include granules, dry suspensions, powders, oral liquid preparations, transdermal preparations, topical ointments and suppositories suitable for children. Equipped with world-class production and testing equipment, the production capacity ranks in the forefront of China's children's pharmaceutical industry. The company has established higher than legal internal control standards and strictly controlled the quality of all production links. Two special drug production lines for children have passed the Australian TGA certification and achieved the highest A1 level.

Staff size:About 1500 persons

Registered capital:RMB 62million


Producer:Shanghai Shyndec Pharmaceutical Co.,Ltd, which was established in 1996, is a high-tech enterprise in the pharmaceutical industry which is specialized in manufacturing new drug preparation products and founded by academician of Chinese Academy of Engineering. It was listed on Shanghai stock exchange on June 16, 2004 . In April 2010, it entered China National Pharmaceutical Group Corporation(SINOPHARM).

In 2016-2017, according to the integration strategy ofSINOPHARM, Shanghai Shyndec Pharmaceutical Co.,Ltd positioned itself as a pharmaceutical industry platform of SINOPHARM, have actively promoted major asset restructuring matters. The main business of the "new Shyndec " wholly-owned or holding subsidiary after the reorganization has achieved nearly 10 billion level of revenue, total profit has exceeded 1 billion yuan, and the number of enterprise members has reached 30, among which 17 are secondary enterprises, 13 are tertiary and four-level enterprises.

After the reorganization, the "New Shyndec" has integrated into many high-quality industrial product lines and enterprise assets of China National Pharmaceutical Group to create a more centralized resource allocation and a clearer main business market. Focusing on the "anti-infection, cardiovascular and cerebrovascular, anti-tumor, leptin drugs, metabolism and endocrine" five areas then has formed and strengthened the "5 + X" industrial chain system with the modern characteristics and core competitiveness of Chinese medicine. The product structure of the company will be richer, the R&D strength will be further strengthened, and the market position of the enterprise has been improved by leaps and bounds.

Staff size:About 600 persons

Registered capital:RMB 1 billion 56 million 226 thousand and 870


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:Zhejiang Zhenyuan Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of the Shenzhen listed company "Zhejiang Zhenyuan" and a national key high-tech enterprise. The company has a registered capital of 300 million yuan, covers an area of 345 mu, has more than 900 employees, and about half of them are junior college or above. With a construction area of 120000 square meters, the company has built seven API workshops and two preparation workshops, and has a comprehensive production capacity of API production by chemical synthesis and biological fermentation, oral solid preparations and small volume injections.

Staff size:About 900 persons

Registered capital:RMB 300 million


Producer:Guobang Pharmaceutical Group Co., Ltd. is a pharmaceutical manufacturing company facing the global market, with multiple varieties and the ability to produce a variety of key intermediates. It is an important participant in the global chemical manufacturing industry chain and one of the top 100 enterprises in China's pharmaceutical industry. The company is mainly engaged in the R & D, production and sales of related products in the field of medicine and animal health products. The pharmaceutical sector covers APIs, key pharmaceutical intermediates and preparations, and the animal health products sector covers animal protection APIs, animal protection additives and preparations.

Staff size:About 3000 persons

Registered capital:RMB 138.8 million


Producer:Heze Fangming Pharmaceutical Co., Ltd. is subordinate to Shandong Fangming Pharmaceutical Group Co., Ltd. the company mainly produces the second-generation macrolide antibiotics with advanced technology and excellent quality.

Staff size:About 100 persons

Registered capital:RMB 10 million


Producer:Zhejiang Nisikang Pharmaceutical Co., Ltd. was established in December 2002, with advanced manufacturing equipment and technology. The production plant is located in Linjiang Industrial Zone, Wucheng District, Jinhua City, Zhejiang Province, covering an area of 338 mu (252012 square meters). The registered capital of the company is 370 million yuan. It is a modern manufacturing enterprise mainly engaged in R & D, production and sales of APIs.

The company has obtained GMP certificates of azithromycin, clarithromycin, roxithromycin, benzhydrazine hydrochloride and fenofibrate respectively, and COS certificates of clarithromycin, fenofibrate and glimepiride. At the same time, clarithromycin was certified by PMDA of Japan.

Staff size:About 300 persons

Registered capital:RMB 374.438094 million 


Producer:CSPC Ouyi Pharmaceutical Co., Ltd. (formerly Shijiazhuang No. 1 pharmaceutical factory) of CSPC Pharmaceutical Group is a listed enterprise of Shijiazhuang Pharmaceutical Group. It was founded in 1938.
The annual production capacity is: 9 billion tablets, 400 million hard capsules, 400 million soft capsules, 600 million bags of granules, 600 million small volume injections, 300 million powder injections and 200 million bags of dry suspensions.
According to different requirements of customers, the product quality meets BP, USP, JP and EP standards respectively. The company has passed the national GMP quality certification, and the "zero defect project" has passed the FDA certification of the United States and the MCC quality certification of South Africa. Many varieties have obtained the EU CEP certification. It has become the designated manufacturer of well-known purchasers in the Netherlands, Denmark and other countries.

Staff size:4000-4999 persons

Registered capital:RMB 300 million 


Producer:Hainan Star Pharmaceutical Co., Ltd. is a comprehensive pharmaceutical enterprise integrating R & D, production and sales. It is a high-tech enterprise in Hainan Province. The company was established in August 1993. On February 15, 2006, Hainan Sida Pharmaceutical Co., Ltd. was successfully listed on the Singapore Stock Exchange, becoming the first pharmaceutical enterprise listed abroad in Hainan Province.

The company's production base is located in Qionghai City, Hainan Province. It is a garden type drug production base. The plant covers an area of 60000 square meters and has seven dosage form production lines, including powder injection, freeze-dried powder injection, water injection, tablet, capsule and granule. The company has more than 50 kinds of antibacterial, antiviral, cardiovascular and cerebrovascular diseases and other drugs. The whole factory has passed GMP certification.

Staff size:Hong Kong dollar 50 million

Registered capital:Hong Kong dollar 50 million


Producer:HEC Pharmaceutical Co., Ltd. formerly known as HEC Biochemical Pharmaceutical Co., Ltd., was established on January 12, 2004. It is a large-scale western medicine manufacturing and bioengineering enterprise mainly engaged in the R & D, production and sales of macrolide antibiotics, antiviral drugs, insulin and other drugs. At present, the company is the largest in the world It is a manufacturer of macrolide antibiotic API with the most advanced technology. Its main customers are pharmaceutical giants such as Abbott and Pfizer. It is also one of the earliest enterprises engaged in the R & D, registration and production of overseas generic drugs.

The company attaches great importance to the research and development of preparation technology, and has established a variety of preparation technology platforms such as slow and controlled release and transdermal technology. The company is also carrying out the layout of preparation products in Europe and America. At present, seven products have passed the EU cGMP certification, three products have passed the FDA certification, and macrolide APIs have passed the FDA cGMP certification.

Staff size:2000-2999 persons

Registered capital:RMB 813.368 million


Producer:Shaoxing Xingya Pharmaceutical Co., Ltd., established on August 29, 2017, is a wholly-owned subsidiary of Zhejiang Yatai Pharmaceutical Co., Ltd. Zhejiang Asia Pacific Pharmaceutical Co., Ltd. is a professional and large-scale national high-tech enterprise integrating scientific research, production and sales and a key high-tech enterprise of the national torch plan.

Staff size:50-99 persons

Registered capital:RMB 60 million


Producer:Ningxia Qiyuan Pharmaceutical Co., Ltd., established in January 2001, was restructured and merged by the former state-owned enterprise Ningxia pharmaceutical factory and Ningxia traditional Chinese medicine factory. After nearly 20 years of unremitting efforts, the company has developed into a modern large-scale comprehensive biopharmaceutical enterprise well-known at home and abroad. Relying on the regional advantages suitable for the development of biopharmaceutical in Ningxia, the company vigorously develops the R & D and production of antibiotic API, vitamin API and corn deep processing. The company's tetracycline API series products are the exclusive varieties in the world. Erythromycin API and its synthetic products are currently one of the three major suppliers in the world. Vitamin C series products occupy a place in the domestic and foreign markets with their scale and quality.

The company is listed as a national high-tech enterprise, and the company's technology center is a national enterprise technology center. Erythromycin and tetracycline hydrochloride APIs have passed FDA, cos and eugmp certification in Europe, as well as official quality audits in India, Japan and other countries. Vitamin C products of the company have passed international food certification, such as halal, kosher, etc. The company's products are sold to Europe, South America, Africa, Southeast Asia and other dozens of countries and regions.

Staff size:1000-1999 persons

Registered capital:RMB 2.91 million


Producer:Tianjin Biochemical Pharmaceutical Co., Ltd., formerly known as Tianjin biochemical pharmaceutical factory, was founded in 1943. It was one of the three major biochemical drug production bases in China planned by the former State Pharmaceutical Administration. Now it is a modern pharmaceutical enterprise developing and producing biological and chemical drug preparations.

The enterprise moved into the airport economic zone of Tianjin Free Trade Zone at the end of 2005, covering an area of 60 mu, a construction area of 15000 square meters and a total investment of 86 million yuan. The enterprise adopts domestic first-class equipment, complete supporting production facilities, has a research institute and central laboratory, a modern production workshop designed and built according to GMP standards, and seven high standard production lines (including hormones).

Staff size:200-299 persons

Registered capital:RMB 303 million 302 thousand and 800


Producer:Hebei Dongfeng Pharmaceutical Co., Ltd. is a famous modern large pharmaceutical enterprise in China. The API produced has passed the national GMP certification and EU cos certification, and is actively applying for FDA certification. Over the years, relying on strict GMP management, stable product quality and perfect marketing services, various products have been selling well in domestic and foreign markets. At the same time, Dongfeng pharmaceutical has also won a good reputation.

The annual production of doxycycline hydrochloride, the fist product of Dongfeng pharmaceutical, reaches 1000 tons, and the export volume occupies a leading position in the world. The company has increased its investment in azithromycin API, carried out a series of technical innovation and management upgrading, improved the quality day by day, and formed large-scale production, with an annual output of 120 tons. In order to make the products enter the international high-end market, the company has specially purchased the leading testing instruments from the United States, which has reached the quality standard of the 29th edition of the United States Pharmacopoeia.

Staff size:50-99 persons

Registered capital:RMB 50 million


Producer:Hainan Hailing Chemipharma Corporation Limited(Hailing Pharm) is one of the largest pharmaceutical companies integrating pharmaceutical product R&D, production and marketing activities in China.

Founded in 2004 and headquarter at the National High-Tech Industrial Development Zone in Haikou City, Hainan Province, Hailing Pharm is the No. 1 antibiotic manufacturer in China (covers 4,000+ hospitals in China) with existing assets of over 2 billion CNY and more than 600 employees. It occupies 3 modern manufacturing sites (2 DP manufacturing sites, 1 API site) in Haikou and Shanghai respectively.

Hailing Pharm is striving to be an internationalized pharmaceutical company. Our cGMP application for US FDA is under way. We have attempted to expand the global markets since 2017, and we are sparing no effort in exploring global markets.

Staff size:600-699 persons

Registered capital:RMB 116.669422 million


Producer:Zhejiang Jianfeng Pharmaceutical Co., Ltd., established on December 31, 1998, is a wholly-owned subsidiary of the listed company Zhejiang Jianfeng Group Co., Ltd. (Stock Code: 600668). The company has a registered capital of 298 million yuan and more than 1000 employees. By the end of 2019, the company has total assets of 1.526 billion yuan, sales revenue of 1.58 billion yuan and profit and tax of 95 million yuan.

The company has 5 wholly-owned, holding and joint-stock pharmaceutical production enterprises, 3 pharmaceutical trading enterprises, 3 National postdoctoral scientific research workstations and 2 provincial academician expert workstations. It has 52 international and domestic pharmaceutical invention patents, and the market share of leading products ranks among the top 3.

Staff size:400-499 persons

Registered capital:RMB 298.53 million


Producer:Haixin pharmaceutical was founded in December 2001. Its predecessor was Gannan pharmaceutical factory, an old state-owned enterprise with more than 30 years of pharmaceutical history. In August 2015, Haixin pharmaceutical was listed on the "new third board"

At the end of 2018, Haixin pharmaceutical's new modern plant with a total investment of 280 million yuan, covering an area of 120 mu and a construction area of more than 50000 square meters was completed and put into operation in Ganzhou economic and Technological Development Zone, a national development zone.

Haixin pharmaceutical has always practiced the core values of "integrity, responsibility, innovation and win-win", adhered to the corporate mission of "providing high-quality products and serving human health", and adhered to the corporate purpose of "quality first, user first, integrity-based and win-win cooperation". After decades of unremitting struggle, Haixin pharmaceutical has developed into a combination of drug R & D, production and sales, A modern pharmaceutical enterprise mainly engaged in chemical preparations, currently has seven series of more than 120 drug production approvals, including small volume injections, lyophilized powder injections, oral solutions, granules, dry suspensions, syrups and APIs, forming a pattern of specialized and special new products in the field of focus.

Staff size:About 300 persons

Registered capital:RMB 100 million


Producer:Huangshi Shixing Pharmaceutical Co., Ltd., established on June 16, 2004, is a private enterprise and other limited liability companies.

The company has focused on the R & D and production of chemical APIs for nearly 30 years, has production and inspection plants, equipment, instruments and supporting facilities in line with China's GMP standards, and has a perfect platform for API R & D and pilot test. Through independent research and development and industry university research cooperation, it has obtained a number of product core technologies, and the quality of its main products has reached the standards of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP).

The company is a national "high-tech enterprise", "AAA credit enterprise", a "science and technology small giant enterprise" in the subdivided field of pillar industries in Hubei Province, and a specialized and new "small giant" enterprise in Hubei Province. The company's technology center was recognized as the "provincial enterprise technology center" in 2019, with an average annual R & D cost of more than 10 million yuan. Now it has many invention patents and more than 130 R & D personnel. It has passed the three management system certification of ISO9001 quality, ISO14001 environment and iso45001 occupational health and safety, has the right of self import and export, and has obtained the registration certificate of customs declaration unit issued by China Customs.

Staff size:300-399 persons

Registered capital:RMB 250 million


Producer:Harbin Pharmaceutical Group General Pharmaceutical Factory belongs to Harbin Pharmaceutical Group Co., Ltd., which is a sino-foreign joint stock enterprise. It is a key antibiotic production base in China, a national large-scale first-level pharmaceutical enterprise, and one of the 500 large industrial enterprises in China.

Founded in 1958, the factory mainly produces penicillin and cephalosporin antibiotics, with a total of more than 30 kinds of apis and 18 kinds of dosage forms. It covers an area of 1.09 million square meters and has fixed assets of 2.156 billion yuan. It also has the production capacity of 1000 tons/year of 6-APA, 800 tons/year of 7-ACA, 4300 tons/year of antibiotic apis and intermediates and 3 billion doses of powder.

Staff size:3000-3999 persons

Registered capital:/


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