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Ofloxacin

CAS number: 82419-36-1

Molecular formula: C18H20FN3O4

molecular weight: 361.368

Chemical structure:

Producers shown on SFDA

(Record date:27/08/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Zhejiang Starry Pharmaceutical Co., Ltd.

GMPValid till September 2024

Donggang Hongda Pharmaceutical Co., Ltd.

GMP
Valid till April 2018
Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
GMP
Valid till November 2024

Zhejiang Xianfeng Technology Co., Ltd. 

GMP
Valid till January 2023

Shangyu Jingxin Pharmaceutical Co., Ltd. 

GMP
Valid till January 2022

Zhejiang Langhua Pharmaceutical Co., Ltd.

GMP
Valid till March 2020

Jiangxi Dadi Pharmaceutical Co., Ltd.

GMPValid till July 2021

Zhejiang East-Asia Pharmaceutical Co., Ltd.

GMP, DMFValid till August 2021

Zhejiang Medicine Co., Ltd.

GMPValid till July 2020

Liu'an Huayuan Pharmaceutical Co., Ltd.

GMPValid till February 2022
Kaifeng Pharmaceutical (Group) Co., Ltd.
GMPValid till September 2024

Henan Lantu Pharmaceutical Co., Ltd.

GMPValid till January 2021

Topfond Pharmaceutical Co., Ltd.

GMPValid till December 2020

 Jincheng Haisi Pharmaceutical Co., Ltd.

GMP
Valid till November 2020

Liaoyuan City Baikang Pharmaceutical Co., Ltd.

GMPValid till July 2020

Suzhou Homesun Pharmaceutical Co., Ltd.

GMP
Valid till September 2017

PKU HealthCare Corp., Ltd.

GMP
Valid till  May 2019



Producers shown on EP

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

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Ofloxacin
DAIICHI SANKYO CO., LTD. JP 103-8426 Tokyo
R1-CEP 2003-210-Rev 03
04/08/2015
VALID
/Chemistry
Ofloxacin
Cambrex Charles City, Inc. US 50616 Charles City
R0-CEP 2002-029-Rev 01
13/10/2004
EXPIRED
04/11/2008
Chemistry
Ofloxacin
Calao s.r.l. IT 20157 Milano
R0-CEP 2001-436-Rev 02
24/03/2005
WITHDRAWN BY HOLDER
28/08/2008
Chemistry
OfloxacinSUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai
R1-CEP 2000-106-Rev 08
29/07/2021
VALID
/Chemistry
Ofloxacin
Quimica Sintetica S.A. ES 28805 Alcala De Henares
R1-CEP 2000-134-Rev 05
09/04/2020
VALID
/Chemistry
Ofloxacin
ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO., LTD. CN 322 118 Hengdian
R1-CEP 2002-146-Rev 02
07/02/2011
VALID
/Chemistry
Levofloxacin hemihydrate
ZHEJIANG LANGHUA PHARMACEUTICAL CO., LTD. CN 317 016 Linhai
R0-CEP 2019-111-Rev 00
11/06/2020
VALID
/Chemistry
Levofloxacin hemihydrate
Neuland Laboratories Limited IN 500 034 Hyderabad
 R0-CEP 2019-023-Rev 01
16/02/2021
VALID
/Chemistry
Levofloxacin hemihydrate
ZHEJIANG APELOA KANGYU PHARMACEUTICAL CO., LTD. CN 322 118 Hengdian
 R0-CEP 2020-128-Rev 00
16/07/2021
VALID
/Chemistry
Levofloxacin hemihydrate
SHANGYU JINGXIN PHARMACEUTICAL CO., LTD. CN 312 369 Shangyu
 R0-CEP 2020-041-Rev 00
16/06/2021
VALID/Chemistry
Levofloxacin hemihydrateDR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad
R0-CEP 2019-059-Rev 00
31/03/2020
VALID
/Chemistry
Levofloxacin hemihydrate
MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad
 R0-CEP 2019-161-Rev 00
15/02/2021
VALID
/Chemistry
Levofloxacin hemihydrate
Quimica Sintetica S.A. ES 28805 Alcala De Henares
 R0-CEP 2019-165-Rev 00
06/04/2021
VALID
/Chemistry

Producer:Zhejiang Starry Pharmaceutical Co., Ltd., established in 1997, is a high-tech enterprise specializing in R & D, production and sales of X-CT non-ionic contrast agent series and quinolone series APIs and intermediates. It is the largest and most complete factory of contrast agent generic pharmaceutical products in China. On March 9, 2016, the company was listed on Shanghai Stock Exchange.

In the past 20 years, the company has always maintained a good and stable development momentum and has become a leading enterprise in China for X-CT non-ionic contrast agent raw materials. Among them, the production capacity and output of iohexol API rank first in China. The company's product quality is stable and has obtained certification from many developed countries. The raw materials produced by the company, including iohexol, iodopanol, iodixanol, levofloxacin and levofloxacin hydrochloride, have obtained the national GMP certificate; The raw materials iohexol and iodopanol have obtained the EU CEP certificate; The raw materials iohexol, iodopanol, iodixanol, levofloxacin and levofloxacin hydrochloride have obtained domestic registration approval documents; The bulk drugs iohexol, iodopanol, iodixanol and levofloxacin were registered in India; The raw materials iohexol, iodopanol, levofloxacin, loxoprofen sodium and the intermediate levofloxacin were registered in Japan. At present, there are four global iohexol API manufacturers that have obtained the EU CEP certificate, and there is only one Stellite (including Haishen pharmaceutical) in China; There are four global iohexol API manufacturers with Japanese registration certificate, and Stellite (including Poseidon pharmaceutical) is also one of them.

Staff size:About1800 persons

Registered capital:RMB 244 million 900 thousand


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:Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd. is subordinate to Apeloa Pharmaceutical Co., Ltd. Apeloa Pharmaceutical Co., Ltd. is a state-level key high-tech enterprise and key enterprise in pharmaceutical industry in Zhejiang Province  .The company is engaged in the research and development, production and sales of pharmaceutical products. The main business is in crude drug (API), contract R & D, production service (CDMO) and preparation (FDF) business. 

 In order to improve market competition, our company build core competitiveness continuesly in quality, EHS and technology . Five of the API plants were certified by GMP, four by FDA, three by PMDA, three by CE in EU, one by WHO, one by KFDA, one by Germany GMP, and all of preparation factory were certified by GMP. In addition to the safety and occupational health management system certification, API plants continue to be audited by EHS audits from international pharmaceutical companies or third parties.

Staff size:1000-1999 persons

Registered capital:RMB 83.75 million


Producer:Zhejiang Xianfeng Technology Co., Ltd. is an industrial manufacturing enterprise specializing in the R & D and production of pharmaceutical intermediates with self-supporting import and export rights. Founded in 2002, the company is located in Linhai, a famous national historical and cultural city. The company now covers an area of about 120 mu. In 2014, the sales volume was nearly 450 million yuan. The company has more than 500 employees, with various technical personnel composed of doctors, masters and senior engineers. The company has been awarded "Zhejiang science and technology small and medium-sized enterprise" and "Zhejiang high-tech enterprise" by the Department of science and technology of Zhejiang Province; For long-term development, the company has invested and established a wholly-owned subsidiary "Zhejiang Weifeng Pharmaceutical Co., Ltd." in Linhai national pharmaceutical and chemical park. The subsidiary covers an area of nearly 200 mu, which has laid a solid foundation for the future development of pioneer technology. The company has passed ISO90001, ISO14001 and ISO18001 system certification. The company was listed on the National SME transfer system (new third board) on January 27, 2015.

Staff size:About 500 persons

Registered capital:RMB 85 million


Producer:Shangyu Jingxin Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Zhejiang Jingxin Pharmaceutical Co., Ltd. Zhejiang Jingxin Pharmaceutical Co., Ltd. is one of the top 100 pharmaceutical enterprises in China and a listed pharmaceutical company. The company is located in the West Zone of Shangyu Industrial Park, Hangzhou Bay, Zhejiang Province. Its products are mainly the production of APIs. It is one of the largest production bases of quinolone APIs in China“ Cyclopropyl hydrochloride and levofloxacin hydrochloride occupy a large market share in China. API products sell well in Southeast Asia, South Asia, Latin America, Europe and other international markets.

The company has fully passed the national GMP certification, ISO14001 certification, simvastatin has obtained cos certificate, ciprofloxacin hydrochloride has obtained cos certificate, French GMP certificate, EU GMP certificate and KFDA registration certificate.

Staff size:500-599 persons

Registered capital:RMB 150 million


Producer:Zhejiang Langhua Pharmaceutical Co., Ltd. is a subsidiary of Weiya biotechnology holding group, a leading enterprise in the field of innovative drug discovery. As a rapidly developing cdmo enterprise, Langhua pharmaceutical is committed to providing global innovative drug partners with efficient, flexible and high-quality one-stop CMC (Chemistry, production and control) solutions for small molecule APIs and preparations from preclinical to commercialization.

 Langhua pharmaceutical has three R & D centers in Shanghai, Taizhou and Ningbo. The R & D leaders in various fields are returned overseas doctors who have worked in multinational pharmaceutical enterprises for many years, and have rich experience in process R & D, scale-up production and application of innovative drug APIs and preparations. The production base in Taizhou, Zhejiang Province has passed cGMP audits by global regulators for many times, including FDA of the United States, EDQM of the European Union, nmpa of China, Ministry of health, labor and welfare of Japan, who, etc., and has passed EHS special audit and PSCI audit of international pharmaceutical companies for many times.

Staff size:400-499 persons

Registered capital:RMB 120 million


Producer:Jiangxi Dadi Pharmaceutical Co., Ltd., established in December 2000, is headquartered in Lianhua County Industrial Park, Pingxiang City, Jiangxi Province. With a registered capital of 89 million yuan, the company has established production bases in Pingxiang, Jiangxi and Yancheng, Jiangsu, covering a total area of nearly 400 mu and total assets of more than 250 million yuan.

The company is mainly engaged in raw materials and intermediates such as levofloxacin hydrochloride, levofloxacin lactate, ciprofloxacin hydrochloride and simvastatin, various dosage forms of Chinese patent medicines, chemical raw materials and products. It has a number of drug number approvals. The raw materials products have fully passed the national GMP certification, and the products are sold to all parts of the motherland, Europe, America, India and other countries and regions.

Staff size:About 4000 persons

Registered capital:RMB 198 million yuan


Producer:Zhejiang East-Asia Pharmaceutical Co., Ltd., founded in 1998 and headquartered in Taizhou City, Zhejiang Province, has more than 1000 employees and a total assets of 1.3 billion yuan. It has successively won the titles of "national high-tech enterprise", "Zhejiang Patent Demonstration Enterprise" and "Taizhou top ten enterprises in management innovation".

Many products of the company have passed the new version of cGMP certification, European Union (EDQM) certification and Japan's Ministry of health and welfare (PMDA) certification. It has established long-term cooperative relations with customers in Europe, America, Southeast Asia and other more than ten countries and regions, and its product sales network covers more than 50 countries and regions around the world.

Staff size:About 1000 persons

Registered capital:RMB 113.6 million


Producer:Zhejiang Medicine Co., Ltd. is a large-scale joint-stock pharmaceutical company established in May 1997.After receiving approval by the China Securities Regulatory Commission in August 1999, the company issued 58 million A shares on the open market. In October, the company's shares were then listed on the Shanghai Stock Exchange. As of the end of 2018, the company had 980 million yuan in registered capital and total assets of 10 billion yuan.

The company has first-class chemical pharmaceutical, microbial pharmaceutical and preparation production facilities that meet GMP requirements, and also produces natural drugs, food additives and feed additives. It is an important production base of vitamins, antibiotics and fluoroquinolones in China. The leading products are synthetic vitamin E, accounting for 25% of the global output; Natural vitamin E is the largest producer in China and the third largest producer in the world; Biotin accounts for more than 60% of the global output; Levofloxacin lactate injection (lailixin), accounting for 20% of the country; Coenzyme Q10 accounts for 20% of the world; Vancomycin hydrochloride accounts for 30% of the world; Teicoplanin accounts for 100% of the country and 30% of the world.

Staff size:About 3000 persons

Registered capital:RMB 980 million


Producer:Liu'an Huayuan Pharmaceutical Co., Ltd. is subordinate to Shanghai Huayuan Changfu (Group) Co., Ltd. in China. It is the only comprehensive chemical pharmaceutical enterprise integrating API and preparation in Lu'an City. It holds a controlling stake in Jiangyuan pharmaceutical company and shares in Anhui Huayuan Guangsheng Pharmaceutical Co., Ltd. The company is located in Chengbei Industrial Zone, Lu'an City, Anhui Province, covering an area of 120000 square meters and total assets of 100.11 million yuan. There are 900 employees and 160 professional technicians. The company has 7 APIs and 42 preparation varieties, with a total of 118 national drug approval numbers; Have self operated import and export rights. First class production equipment, advanced testing means and scientific and effective management ensure product quality and enhance market competitiveness.

Staff size:About 300 persons

Registered capital:200 million yuan


Producer:Kaifeng Pharmaceutical (Group) Co., Ltd. (hereinafter referred to as "Kaifeng Pharmaceutical Group") was founded in May 1949. Its predecessor is Kaifeng Pharmaceutical Factory in Henan Province, a national comprehensive large class II pharmaceutical enterprise.

The company covers an area of 400000 square meters, a construction area of 170000 square meters, and more than 3000 large and medium-sized advanced production equipment. The production equipment of the enterprise is advanced and perfect, and has fully passed GMP certification and relevant acceptance. Kaiyao group is a high-tech enterprise in Henan Province, with perfect quality assurance system and quality detection and control instruments, and reliable product quality. All kinds of products produced have been spot checked by national, provincial and municipal quality supervision departments, and the qualified rate has been 100% for 23 consecutive years. The product quality meets the standards of Chinese Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia and American Pharmacopoeia. It is the first self-supporting import and export enterprise in the pharmaceutical system of Henan Province approved by the Ministry of foreign economic relations and trade.

Staff size:900-999 persons
Registered capital:RMB 204 million 568 thousand and 562


Producer:Henan Lantu Pharmaceutical Co., Ltd.is a key pharmaceutical enterprise in Henan Province. The company is located in Nanyang, a famous historical and cultural city, covering an area of 108.43 Mu and a construction area of 68000 square meters. It has nearly 300 million yuan of fixed assets and 190 employees, including 106 professional technicians above college level. It has oral solid preparations, chemical synthetic APIs, microbial fermentation, food and health products There are 5 production lines of agricultural enzyme preparations, with 60 drug numbers.

Staff size:About 200 persons

Registered capital:RMB 17.25 million


Producer:Topfond Pharmaceutical Co., Ltd.is a large-scale large-scale enterprise integrating the production and sales of finished products, chemical synthesis raw materials and biological fermentation raw materials, and pharmaceutical management. Comprehensive pharmaceutical company.

Topfond Pharmaceutical was founded in 1969. In December 2000, the A shares of Topfond  Pharmaceutical was listed on the Shanghai Stock Exchange. After more than 40 years of hard work, the company has grown from small to large, from weak to strong, and has now developed into a large pharmaceutical group with 5 subsidiaries, 4 production plants and 1 national technology development center. It has 4000 employees. There are more than 4 people with total assets of more than 4 billion yuan. The company's production scale of finished preparations and fermentation tonnage of antibiotic raw materials are among the best in the industry in the country. Joined China General Technology Group in August 2008. In July 2013, it successfully realized the merger and absorption of shares exchange with China National Pharmaceutical and Health Industry Co., Ltd., and was officially included in China Pharmaceutical Management.

Topfond Pharmaceutical produces and reserves more than 10 types and nearly 600 varieties and specifications of products. It has an oral solid preparation workshop with an annual production capacity of nearly 6 billion tablets (tablets), the scale is among the forefront of the industry; the antibiotic fermentation tonnage is 12,000m³. The raw materials and some preparation products are exported to more than 20 countries and regions including Western Europe, Southeast Asia, the Middle East, North Africa, India, etc., and an international marketing network is initially formed.

Staff size:2000-2999 persons

Registered capital:RMB 420 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:Liaoyuan Baikang Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Chongqing Sansheng Industrial Co., Ltd. Its predecessor, Liaoyuan No. 1 pharmaceutical factory, was founded in 1958.

After more than 50 years of accumulation and development, the company now has 104 drug production approval numbers, including 20 APIs and 84 preparations. The leading varieties of API are acetaminophen, chlorpipetin hydrochloride, nefopam hydrochloride, procaine hydrochloride, diphenhydramine hydrochloride, famotidine, dioxpromazine hydrochloride and levofloxacin mesylate. The annual output of preparations is more than 2 billion tablets, mainly including chlorpipetin hydrochloride tablets and compound paracetamol diphenhydramine tablets. The company has import and export rights, and its products are mainly exported to India, Hong Kong, Macao, Taiwan and other countries and regions. The company has passed GMP certification and COS certification, and is applying for FDA certification to obtain a pass for products to enter the European and American markets.

Staff size:About 400 persons

Registered capital:RMB 50 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:PKU HealthCare Corp., Ltd.is a core member enterprise of Founder group medical and pharmaceutical industry - Peking University medical industry group. It has more than 50 years of pharmaceutical manufacturing history and a national technology center. It is a key backbone enterprise of Chinese medicine, a national innovative pilot enterprise and a key high-tech enterprise of the national torch plan.

Peking University Pharmaceutical has a pharmaceutical manufacturing base built according to international cGMP in Liangjiang New Area, Chongqing. Its products cover more than 10 categories and more than 100 varieties, such as anti-tumor, psychoneurological, cardiovascular, immunosuppressive, anti microbial, antipyretic and analgesic. The company has a perfect quality assurance system, which has passed the FDA and EU GMP certification.

Staff size:About 800 persons

Registered capital:RMB 596 million


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