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Ketoprofen

CAS number: 22071-15-4

Molecular formula: C16H14O3

molecular weight: 254.2806

Chemical structure:

Producers shown on SFDA

(Record date:31/08/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Hubei Xunda Pharmaceutical Co., Ltd.

GMP, DMF
Valid till February 2021

Zhejiang Jiuzhou Pharmaceutical Co., Ltd.

GMP
Valid till December 2019

Zhejiang Raybow Pharmaceutical Co., Ltd.

GMP
Valid till February 2022

Huangshi Shixing Pharmaceutical Co., Ltd.

GMP
Valid till September 2020

PKU HealthCare Corp., Ltd.

GMP
Valid till March 2022



Producers shown on EP

(Quoted from EP website;record date:31/08/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Ketoprofen
MIDAS PHARMA GMBH DE 55218 Ingelheim am Rhein
  R0-CEP 2017-215-Rev 00
30/07/2018
VALID
/Chemistry
Ketoprofen
S.I.M.S. S.R.L. IT 50066 Reggello
  R1-CEP 2002-097-Rev 05
13/11/2018
VALID
/Chemistry
Ketoprofen
SANOFI CHIMIE FR 94250 Gentilly
  R2-CEP 1994-021-Rev 03
06/05/2010
WITHDRAWN BY HOLDER
12/03/2019
Chemistry
Ketoprofen
Cosma S.p.A. IT 24040 Ciserano
  R1-CEP 2007-053-Rev 03
21/04/2020
VALID
/Chemistry
Ketoprofen
BEC CHEMICALS PRIVATE LIMITED IN 400 059 Mumbai
  R1-CEP 2007-167-Rev 01
26/02/2018
VALID
/Chemistry
Ketoprofen
Yonezawa Hamari Chemicals, Ltd. JP 992-1128 Yonezawa City
  R0-CEP 2008-209-Rev 01
16/09/2010
EXPIRED
12/01/2015
Chemistry
Ketoprofen
DONG BANG FUTURE TECH & LIFE CO., LTD. KR 18622 Hwaseong-si
  R1-CEP 2008-120-Rev 01
19/12/2016
VALID
/Chemistry
Ketoprofen
Bidachem S.p.A. IT 24040 Fornovo San Giovanni
  R1-CEP 2002-010-Rev 02
08/07/2010
VALID
/Chemistry
Ketoprofen
SEQUENT SCIENTIFIC LIMITED IN 400 604 Thane
  R1-CEP 2010-063-Rev 02
19/01/2018
VALID
/Chemistry
Ketoprofen Process N
DONG BANG FUTURE TECH & LIFE CO., LTD. KR 18622 Hwaseong-si
  R0-CEP 2017-194-Rev 00
22/02/2019
VALID
/Chemistry
Ketoprofen
Oman Chemicals And Pharmaceuticals L.L.C. OM 512 Al Buraimi
  R1-CEP 2009-242-Rev 00
16/02/2018
WITHDRAWN BY EDQM
08/04/2021
Chemistry
Ketoprofen
SANOFI-AVENTIS DEUTSCHLAND GMBH DE 65926 Frankfurt am Main
  R1-CEP 2009-340-Rev 01
02/01/2020
VALID
/Chemistry
Ketoprofen
Zhejiang Jiuzhou Pharmaceutical Co., Ltd. CN 318 000 Taizhou City
  R1-CEP 2003-136-Rev 07
19/02/2021
VALID
/Chemistry



Producer:Hubei Xunda Pharmaceutical Co.,Ltd.is located in Wuxue city, Hubei province, which is close to the Yangtse River. It covers an area of more than 360,000m2, with 88,000m2 production zone. There are three production zones, which is for NSAIDs, Anti-biotic APIs and cardiovascular bulk drugs respectively, with thousand tons of production capacity,  advanced manufacturing facilities and analysis equipments.

The company strictly controls the product quality, adopts the international standards ISO9001, ISO14001 and OHSAS18001, implements total quality management according to the GMP specification, and the quality meets the world high-end pharmacopoeia standard. It has successively obtained the EU cos certification and the Japanese registration certificate. In particular, it passed the on-site inspection of the US official FDA last year, and the products sell well in the international high-end market.

Staff size:500-599 persons

Registered capital:RMB 46 million


Producer:Zhejiang Jiuzhou Pharmaceutical Co., Ltd.,  was formed in 1998. The company evolved out of the Dongshan Chemical Factory which dates back to 1973.

The company has a comprehensive and perfect cGMP quality management system and EHS management system. Following the purpose of "caring for life and maintaining health", the company provides customers with a high-standard quality management assurance system, and has successively passed the official Drug Administration inspection of China nmpa, US FDA, EU EDQM, Japan PMDA and other countries; According to the requirements of multinational pharmaceutical companies for upstream green supply chain, the company has established a set of EHS management system based on international best practices.

Staff size:About 4000 people

Registered capital:RMB 832 million 600 thousand


Producer:Zhejiang Raybow Pharmaceutical Co., Ltd.(cdmo division of Jiuzhou pharmaceutical industry) is a wholly-owned subsidiary of Zhejiang Jiuzhou Pharmaceutical Co., Ltd,   Over the past decade, it has provided comprehensive entrusted R & D and entrusted production services to global multinational pharmaceutical enterprises and new drug research and innovation companies.
Zhejiang Raybow Pharmaceutical Co., Ltd.is located in the coastal base of the National Chemical API Park, covering an area of about 210 mu. The company has 13 GMP,the total reaction volume of the production workshop is about 2500 m3. It has passed the official GMP audits of FDA, EU, Japan and China for many times, and has a world-class quality assurance system and quality management team. Ruibo pharmaceutical has established a leading EHS system in China   System, with wastewater, waste gas (VOC) and solid waste incineration treatment capacity. Passed iso140001 and oshas18000, and passed the EHS audit of multinational customers for many times. The company's EHS system has been rated as the top in the National Chemical API Park, and is moving towards a world-class EHS system. It provides a sustainable guarantee for customers' R & D and production projects.

Staff size:1000-1999 persons

Registered capital:RMB 311 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: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