
Moxifloxacin HCl
CAS number: 354812-41-2
Molecular formula: C21H24FN3O4·HCl
molecular weight: 437.9
Chemical structure:
Producers shown on SFDA
(Record date:28/08/2021)
Producer | Documents | GMP Valid till(based on SFDA) |
Shandong Qidu Pharmaceutical Co., Ltd. | GMP | Valid till December 2024 |
Zhejiang NHU Co., Ltd. | GMP | Valid till August 2023 |
Hebei Guolong Pharmaceutical Co., Ltd. | GMP | Valid till August 2024 |
Nanjing YOKO Pharmaceutical Co., Ltd. | GMP | Valid till May 2023 |
Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. | GMP | Valid till November 2023 |
Sichuan Gowell Pharmaceutical Co., Ltd. | GMP | Valid till November 2021 |
Sichuan Xicheng Pharmaceutical Co., Ltd. | GMP | Valid till February 2020 |
Chongqing Huapont Shengchem Pharmaceutical Co., Ltd. | GMP | Valid till February 2024 |
Yangtze River Pharmaceutical Group Jiangsu Haici Biological Pharmaceutical Co., Ltd. | GMP | Valid till March 2024 |
Producers shown on EP
(Quoted from EP website;record date:28/08/2021)
Substance | Certificate Holder | Certificate Holder | Issue Date | Status | End date | Type |
Moxifloxacin hydrochloride | SHAANXI DASHENG PHARMACEUTICAL TECH CO., LTD. CN 710 300 Xi’an | R0-CEP 2018-298-Rev 00 | 23/09/2020 | VALID | / | Chemistry |
Moxifloxacin hydrochloride Process II | DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad | R1-CEP 2013-078-Rev 00 | 22/01/2019 | VALID | / | Chemistry |
Moxifloxacin hydrochloride | MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad | R1-CEP 2013-201-Rev 00 | 02/09/2020 | VALID | / | Chemistry |
Moxifloxacin hydrochloride | CHROMO LABORATORIES INDIA PRIVATE LIMITED IN 502 307 Pashamylaram | R0-CEP 2016-327-Rev 01 | 30/04/2020 | VALID | / | Chemistry |
Moxifloxacin hydrochloride Monohydrate | MACLEODS PHARMACEUTICALS LIMITED IN 400 059 Mumbai | R0-CEP 2015-269-Rev 01 | 29/03/2021 | VALID | / | Chemistry |
Moxifloxacin hydrochloride Route code MP | MSN PHARMACHEM PRIVATE LIMITED IN 502 307 Pashamylaram Village | R1-CEP 2015-360-Rev 00 | 22/03/2021 | VALID | / | Chemistry |
Moxifloxacin hydrochloride | HISUN PHARMACEUTICAL (NANTONG) CO., LTD. CN 226 407 Nantong City | R0-CEP 2018-266-Rev 00 | 16/07/2020 | VALID | / | Chemistry |
Moxifloxacin hydrochloride | HEC PHARM GMBH DE 10963 Berlin | R1-CEP 2013-225-Rev 01 | 26/08/2021 | VALID | / | Chemistry |
Moxifloxacin hydrochloride | OLON S.P.A. IT 20053 Rodano | R1-CEP 2010-148-Rev 01 | 02/07/2019 | WITHDRAWN BY HOLDER | 08/07/2019 | Chemistry |
Moxifloxacin hydrochloride | DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad | R1-CEP 2008-113-Rev 01 | 22/06/2018 | WITHDRAWN BY HOLDER | 06/11/2019 | Chemistry |
Moxifloxacin hydrochloride Site 2 | RUYUAN HEC PHARM CO., LTD. CN 512 721 Shaoguan | R0-CEP 2020-402-Rev 00 | 01/03/2021 | VALID | / | Chemistry |
Moxifloxacin hydrochloride | NOSCH LABS PRIVATE LIMITED IN 500 072 Hyderabad | R0-CEP 2015-316-Rev 00 | 23/05/2017 | VALID | / | Chemistry |
Moxifloxacin hydrochloride | HETERO DRUGS LIMITED IN 500 018 Hyderabad | R0-CEP 2017-113-Rev 01 | 12/11/2019 | VALID | / | Chemistry |
Moxifloxacin hydrochloride | MSN PHARMACHEM PRIVATE LIMITED IN 502 307 Pashamylaram Village | R1-CEP 2007-355-Rev 03 | R1-CEP 2007-355-Rev 03 | VALID | / | Chemistry |
Moxifloxacin hydrochloride For use in the manufacture of parenteral preparations | BAYER AG DE 51373 Leverkusen | R1-CEP 2008-066-Rev 02 | 15/01/2020 | VALID | / | Chemistry |
Moxifloxacin hydrochloride | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R1-CEP 2011-257-Rev 01 | 08/01/2021 | VALID | / | Chemistry |
Moxifloxacin hydrochloride | BAYER AG DE 51373 Leverkusen | R1-CEP 2008-067-Rev 02 | 15/01/2020 | VALID | / | Chemistry |
Moxifloxacin hydrochloride Monohydrate | ARAGEN LIFE SCIENCES PRIVATE LIMITED IN 500 076 Hyderabad | R1-CEP 2014-101-Rev 00 | 27/07/2021 | VALID | / | Chemistry |
Producer:Shandong Qidu Pharmaceutical Co., Ltd. is located in Linzi District, Zibo City, the former capital of the state of Qi, a famous historical and cultural city. There are more than 3800 employees, covering an area of more than 600 mu and a total asset of nearly 3 billion yuan.
Qidu Pharmaceutical Co., Ltd. is a comprehensive research-oriented pharmaceutical production enterprise focusing on injections with oral preparations and APIs. Its products mainly involve basic infusion, intravenous nutrition, plasma substitutes, anti infection, anti-tumor, cardio cerebrovascular, endocrine, pharmaceutical packaging materials and medical consumables, and has more than 170 drug production approval numbers.
The company has passed ISO9001 international quality management system certification, ISO14001 international environmental management system certification and national intellectual property management system certification.
Staff size:3000-3999 persons
Registered capital:RMB 90 million
Producer:Founded in 1999,Zhejiang NHU Co., Ltd. was listed on Shenzhen Stock Exchange in 2004 as the first stock of SME board (code: 002001). The company has total assets of 21.9 billion yuan and has four modern production bases in Xinchang, Shangyu, Weifang and Suihua.
The company's leading products are ve, VA, VH, VD3 and carotenoids, with a market share in the forefront of the world. Relying on continuous technological progress, improving quality and reducing cost, relying on global marketing network and good service, the company has become one of the most important vitamin manufacturers in the world.
Staff size:About 10000 persons
Registered capital:RMB 2 billion 578 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:Nanjing YOKO Pharmaceutical Co., Ltd. is subordinate to Nanjing Youke biomedical Co., Ltd , Nanjing Youke Pharmaceutical Co., Ltd. is the main production platform. At present, the company has five production workshops that have passed the 2010 GMP certification, including small volume injection workshop, lyophilized powder injection workshop, ordinary solid workshop, aseptic sub packaging (cephalosporin) workshop, etc.
Staff size:300-399 persons
Registered capital:RMB 61 million
Producer:Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd. is a comprehensive foreign-funded holding enterprise integrating drug R & D, production and operation, which is jointly established by the world's top 500 Zhengda Group (Zhengda pharmaceutical) and Jiangsu Nongken group.
Zhengda Fenghai preparation and raw material workshop have all passed the national GMP certification, doxycycline raw material series have passed the European cos certification and the quality audit of Pfizer, dextran 40 API has passed the quality audit of Baxter, and the quality of fructose API is excellent, which is supplied to many domestic manufacturers.
Staff size:1000-1999 persons
Registered capital:USD 29.6 million
Producer:Sichuan Guowei Pharmaceutical Co., Ltd., a subsidiary of Guowei Pharmaceutical Group, was established in 2005. Headquartered in Chengdu high tech Zone, Sichuan.
It has always been committed to technological innovation, high-level quality control and professional marketing. It has continued to invest in R & D and innovation and promote marketing expansion in many fields. It has completed the application of more than 30 new drugs, high-end generic drugs and omega-3 series products, and has obtained more than 30 issued patent authorizations. It is one of the few enterprises that can produce omega-3 series products with high purity, In the future, many heavy new products will continue to be approved for listing every year.
Staff size:100-199 persons
Registered capital:RMB 50 million
Producer:Sichuan Xicheng Pharmaceutical Co., Ltd. has been renamed Youhua Pharmaceutical (Leshan) Co., Ltd., formerly known as the original Sichuan Leshan pharmaceutical factory founded in 1939. Its registered address is No. 2, Linjiang North Road, Leshan high tech Zone, Sichuan Province, with a registered capital of 91 million yuan.
The company now has GMP certification of xanthine series API, preparation GMP certification, sublimated sulfur API and linezolid API issued by the State Food and drug administration. At the same time, the company actively expands its overseas business, exports APIs to the United States, the European Union and Southeast Asia, and has also completed international certification of corresponding quality systems, including ISO9000, ISO14000, ISO22000, halal & kosher and SQF.
At present, the company has 130 national drug approved varieties (including raw material varieties), 1 food additive variety and 1 medical device product. It is the only designated manufacturer of caffeine drugs and food additives in Southwest China and the only manufacturer of medical masks in Leshan. The preparation includes seven dosage forms: tablets, capsules, rods, granules, powders, ointments and creams. The annual production capacity of the preparation is 3 billion tablets, 1 billion capsules, 2.4 million boxes of rods, 1 billion bags of granules and 100 million creams, 2000 tons of traditional Chinese medicine and 1000 tons of raw materials.
Staff size:100-199 persons
Registered capital:RMB 91 million
Producer:Chongqing Huapont Shengchem Pharm Co., Ltd. (Hereafter called Huapont Pharm.) is a leading dermatological drug manufacturer in China. Huapont Pharm was established in 1992 by Dr Songshan Zhang, now he is a member of of Huapont Life Science Co., Ltd. which is a non-state owned public company listed in Shenzhen Stock Exchange since 2004.
With over 25 years’ development, Huapont Pharm rely on science and technology, continually provide the highly effective medicines and service to patients and society. From a leading manufacturer of dermatological drugs and gradually expand the product mix to respiratory system drugs, drugs for tumors, drugs for TB and drugs treating cardio-cerebrovascular diseases, etc. Both the finished dosage forms (FDFs) and active pharmaceutical ingredients (APIs) are manufactured and supplied to the domestic and international market.
The API facility of Huapont Pharm has become an exporting base of APIs, where of GMP has inspected and approved by US-FDA, MEDSAFE, COFEPRIS, other countries authorities and number of customers.
Staff size:300-399 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
For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978