Ciprofloxacin HCl
CAS number： 86393-32-0
Molecular formula： 385.82
molecular weight： C17H18FN3O3.HCl.H2O
Chemical structure：
Producers shown on SFDA
(Record date:08/09/2021）
Producer | Documents | GMP Valid till(based on SFDA) |
Zhejiang Langhua Pharmaceutical Co., Ltd. | GMP | Valid till June 2026 |
Zhejiang Guobang Pharmaceutical Co., Ltd. | GMP, DMF | Valid till January 2026 |
Shangyu Jingxin Pharmaceutical Co., Ltd. | GMP | Valid till February 2024 |
Jiaozuo Kaisen Pharmaceutical Co., Ltd. | GMP | Valid till September 2021 |
Producers shown on EP
(Quoted from EP website；record date:08/09/2021）
| Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
| Ciprofloxacin Hydrochloride | DR. REDDY'S LABORATORIES LIMITED IN 500 016 Hyderabad | R0-CEP 2005-215-Rev 00 | 01/06/2007 | WITHDRAWN BY HOLDER | 12/08/2011 | Chemistry |
| Ciprofloxacin Hydrochloride | AARTI DRUGS LIMITED IN 400 022 Mumbai | R1-CEP 2005-119-Rev 04 | 23/10/2019 | VALID | / | Chemistry |
| Ciprofloxacin Hydrochloride | Smruthi Organics Limited IN 413 255 Solapur | R0-CEP 2011-051-Rev 00 | 10/12/2012 | WITHDRAWN BY EDQM | 13/12/2013 | Chemistry |
| Ciprofloxacin Hydrochloride | MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad | R1-CEP 2006-072-Rev 05 | 03/06/2019 | VALID | / | Chemistry |
| Ciprofloxacin Hydrochloride Process 105 | ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. CN 312 369 Shangyu | R0-CEP 2019-007-Rev 00 | 10/09/2020 | VALID | / | Chemistry |
| Ciprofloxacin Hydrochloride | BAYER AG DE 51373 Leverkusen | R1-CEP 1998-103-Rev 06 | 06/03/2017 | VALID | / | Chemistry |
| Ciprofloxacin Hydrochloride | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R1-CEP 2005-106-Rev 02 | 06/11/2017 | VALID | / | Chemistry |
| Ciprofloxacin Hydrochloride | HANGZHOU HUADONG MEDICINE GROUP ZHEJIANG HUAYI PHARMACEUTICAL CO.,LTD CN 322 002 Yiwu | R1-CEP 2006-045-Rev 01 | 11/01/2018 | VALID | / | Chemistry |
| Ciprofloxacin Hydrochloride | DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad | R1-CEP 2003-013-Rev 07 | 22/06/2018 | VALID | / | Chemistry |
| Ciprofloxacin Hydrochloride | KORES (INDIA) LIMITED IN 400 705 Navi Mumbai | R1-CEP 2005-045-Rev 00 | 19/09/2012 | WITHDRAWN BY HOLDER | 06/02/2014 | Chemistry |
| Ciprofloxacin Hydrochloride | INDOCO REMEDIES LIMITED IN 400 098 Mumbai | R0-CEP 2008-176-Rev 01 | 07/09/2011 | WITHDRAWN BY HOLDER | 06/02/2014 | Chemistry |
| Ciprofloxacin Hydrochloride | ZHEJIANG JINGXIN PHARMACEUTICAL CO., LTD. CN 312 500 Xinchang | R1-CEP 2005-262-Rev 00 | 12/05/2014 | WITHDRAWN BY HOLDER | 14/04/2015 | Chemistry |
| Ciprofloxacin Hydrochloride | CIPLA LIMITED IN 400 013 Mumbai | R1-CEP 2001-097-Rev 03 | 28/07/2014 | WITHDRAWN BY HOLDER | 17/08/2016 | Chemistry |
| Ciprofloxacin Hydrochloride | SREEPATHI PHARMACEUTICALS LIMITED IN 500 033 Hyderabad | R0-CEP 2008-241-Rev 00 | 10/05/2013 | EXPIRED | 23/05/2018 | Chemistry |
| Ciprofloxacin Hydrochloride Powder, compacted | Neuland Laboratories Limited IN 500 034 Hyderabad | R1-CEP 2000-405-Rev 11 | 03/07/2020 | VALID | / | Chemistry |
| Ciprofloxacin Hydrochloride | ZHEJIANG GUOBANG PHARMACEUTICAL CO., LTD. CN 312 369 Shangyu | R1-CEP 2010-099-Rev 01 | 01/02/2019 | VALID | / | Chemistry |
| Ciprofloxacin Hydrochloride | Quimica Sintetica S.A. ES 28805 Alcala De Henares | R1-CEP 1999-096-Rev 06 | 29/08/2017 | VALID | / | Chemistry |
| Ciprofloxacin Hydrochloride | Uquifa Mexico S.A. de C.V. MX 62578 Jiutepec | R1-CEP 2004-174-Rev 03 | 04/06/2021 | VALID | / | Chemistry |
| Ciprofloxacin Hydrochloride | SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai | R1-CEP 1998-090-Rev 09 | 29/09/2020 | VALID | / | Chemistry |
Producer:Zhejiang Langhua Pharmaceutical Co., Ltd., a subsidiary of Weiya biotechnology holding group, was founded in 1986.
Langhua pharmaceutical has three R & D centers in Shanghai, Taizhou and Ningbo. The production base has repeatedly passed the cGMP audit of global regulators, including FDA of the United States, EDQM of the European Union, nmpa of China, Ministry of health, labor and welfare of Japan, who, etc., as well as the EHS special audit and PSCI audit of international pharmaceutical companies.
Staff size:400-499 persons
Registered capital:RMB 120 million
Producer:Zhejiang Guobang Pharmaceutical Co., Ltd. is the core enterprise of Guobang enterprise group, mainly producing and operating pharmaceutical raw materials, chemical intermediates and veterinary drugs. The whole enterprise has passed ISO9001:2000 quality system and ISO14001 environmental quality system certification. All products are produced in strict accordance with ICH Q7A standards and have passed the domestic GMP certification. American DMF and European DMF, which have independently compiled drugs, have a production capacity and market share of more than 30% of similar products in China.
Staff size:1000-1999 persons
Registered capital:RMB 138.8 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:Jiaozuo Kaisen Pharmaceutical Co., Ltd. was founded in 2006, covering an area of more than 50000 square meters. It has newly built a powder injection production line, three water injection production lines, five solid production lines, two disinfectant production lines, doxycycline raw material production line and traditional Chinese medicine extraction production line. It will achieve an annual production capacity of 10 million bags of veterinary powder, 100 million pieces of water injection and powder injection, 500000 bottles of disinfectant and 450 tons of doxycycline API.
Staff size:/
Registered capital:RMB 15 million
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