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Ketoconazole

CAS number: 65277-42-1

Molecular formula: C26H28Cl2N4O4

molecular weight: 531.431

Chemical structure:

Producers shown on SFDA

(Record date:30/08/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Zhejiang East-Asia Pharmaceutical Co., Ltd.

GMP, DMFValid till January 2023

Nanjing Baijingyu Pharmaceutical Co., Ltd.

GMP
Valid till July 2019

Jiangsu Nhwa Pharmaceutical Co., Ltd.

GMP
Valid till February 2021

Guilin Huaxin Pharmaceutical Co., Ltd.

GMP
Valid till September 2023

Producers shown on EP

(Quoted from EP website;record date:30/08/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Ketoconazole
Janssen Pharmaceutical Ltd IE County Cork
  R0-CEP 1997-105-Rev 02
20/08/2003
WITHDRAWN BY HOLDER
13/05/2005
Chemistry
Ketoconazole
Choongwae Pharma Corporation 156-757 Seoul
  R0-CEP 2000-287-Rev 02
20/10/2004
EXPIRED
22/02/2007
Chemistry
Ketoconazole
Uquifa Mexico S.A. de C.V. MX 62578 Jiutepec
  R1-CEP 2005-138-Rev 04
21/04/2021
VALID
/Chemistry
Ketoconazole
JANSSEN PHARMACEUTICA NV BE 2340 Beerse
  R2-CEP 1995-009-Rev 04
08/03/2021
VALID
/Chemistry
Ketoconazole
PIRAMAL PHARMA LIMITED IN 500 063 Hyderabad
  R1-CEP 1999-049-Rev 09
27/01/2021
VALID
/Chemistry
Ketoconazole
DERIVADOS QUIMICOS, S.A.U. ES 30820 Alcantarilla
  R0-CEP 2016-102-Rev 02
23/04/2021
VALID
/Chemistry

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:Nanjing Baijingyu Pharmaceutical Co., Ltd. is a comprehensive pharmaceutical enterprise producing and selling chemical raw materials, preparations and traditional Chinese medicine. It originated from the "Baijingyu eye pharmaceutical factory" established in Nanjing with the approval of the national government on September 10, 1937. Its predecessor was the state-owned "Nanjing No. 2 pharmaceutical factory". At the end of 2003, it was restructured and established a multi-component mixed ownership company. The company has passed ISO9001 quality system certification, ISO14001 environmental management system certification and OHSAS18001 occupational health and safety management system certification. The company has nearly 50 APIs and pharmaceutical preparations listed on a large scale throughout the year, and many API and pharmaceutical preparations with product specifications are registered abroad. Production capacity: 6 billion tablets of solid tablets, 2 billion tablets of hormones, 1 million liters of tinctures, 40 thousand liters of lotions and 50 million pieces of ointments. In addition, they also produce gelatin, powder, paste and suspensions.

Staff size:400-499 persons

Registered capital:RMB 61.7764 million yuan


Producer:Jiangsu Nhwa Pharmaceutical Co., Ltd.  founded in 1978 and listed on Shenzhen Stock Exchange in 2008, is a pharmaceutical enterprise integrating science, industry and trade.

It has three large pharmaceutical GMP production bases for APIs and preparations, covering a total area of more than 900 mu. The enterprise has national certified workshops for APIs, solid preparations, water injections and lyophilized powder injections, and more than 10 automatic production lines for tablets, capsules, water injections and powder injections. At present, there are 39 kinds of APIs, 300 tons / year; More than 100 kinds of Western medicine preparations, 4 billion tablets (tablets) of solid preparations per year and 100 million injections per year.

According to the enterprise development strategy, we have made great efforts to save energy, reduce consumption and protect the environment, passed the international environmental certification (ISO14000), vigorously developed the export business of API, carried out EU edmf and FDA certification, and strive to gain a place in the international market.

Staff size:About 5000 persons

Registered capital:RMB 1 billion 8 million


Producer:Guilin Huaxin Pharmaceutical Co., Ltd., established in 2005, is a comprehensive pharmaceutical enterprise integrating product R & D, production and sales. Huaxin pharmaceutical has three workshops: API workshop, solid preparation workshop and external cream and ointment workshop, six dosage forms such as tablets, capsules, granules, external cream, ointment and API, and 17 product production approvals. In October 2013, Huaxin pharmaceutical passed the new national GMP certification. In April 2014, the lansoprazole raw materials produced by the company obtained the EU CEP certificate, making Huaxin pharmaceutical one of the few lansoprazole manufacturers in China to obtain this certification.

Staff size:300-399 persons

Registered capital:RMB 12.98 million


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