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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.

GMPValid 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WITHDRAWN BY HOLDER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WITHDRAWN BY HOLDER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
08/01/2021VALID
/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