Home>APIs>

Candesartan Cilexetil

CAS number: 145040-37-5

Molecular formula: C33H34N6O6

molecular weight: 610.66

Chemical structure:

Producers shown on SFDA

(Record date:01/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Zhejiang Tianyu Pharmaceutical Co., Ltd.

GMP
Valid till November 2024

Zhejiang Kinglyuan Pharmaceutical Co., Ltd.

GMP
Valid till August 2023

Tiandi Hinye Pharmaceutical Co., Ltd.

GMP
Valid till October 2020

Fuzhou Jinshan Biological Pharmaceutical Co., Ltd.

GMP
Valid till February 2021

Weihai Disu Pharmaceutical Co., Ltd.

GMP
Valid till January 2022

Shanxi Huangcheng Xiangfu Pharmaceutical Co., Ltd.

GMP
Valid till December 2019

Zhejiang Yongning Pharmaceutical Co., Ltd.

GMP
Valid till November 2024

Chongqing Shenghuaxi Pharmaceutical Co., Ltd.

GMP
Valid till June 2024

Zhejiang Huahai Pharmaceutical Co., Ltd.

GMP, DMF
Valid till September 2019

Tipr Pharmaceutical Co., Ltd.

GMP
Valid till January 2021

Producers shown on EP

(Quoted from EP website;record date:01/09/2021

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Candesartan cilexetil
JUBILANT GENERICS LIMITED IN 571 302 Nanjangud
  R1-CEP 2011-204-Rev 01
13/03/2018
WITHDRAWN BY HOLDER
28/08/2019
Chemistry
Candesartan cilexetil
SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai
  R1-CEP 2012-110-Rev 01
04/04/2019
VALID
/Chemistry
Candesartan cilexetil
AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad
  R0-CEP 2011-280-Rev 02
18/12/2017
WITHDRAWN BY HOLDER
30/01/2018
Chemistry
Candesartan cilexetil
CHROMO LABORATORIES INDIA PRIVATE LIMITED IN 502 307 Pashamylaram
  R1-CEP 2011-367-Rev 00
11/12/2019
VALID
/Chemistry
Candesartan cilexetil Process-2
AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad
  R0-CEP 2015-179-Rev 01
18/12/2017
WITHDRAWN BY HOLDER
30/07/2019
Chemistry
Candesartan cilexetil
HETERO LABS LIMITED IN 500 018 Hyderabad
  R0-CEP 2016-110-Rev 00
26/01/2018
WITHDRAWN BY HOLDER
30/07/2019
Chemistry
Candesartan cilexetil
ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. CN 318 020 Taizhou City
  R1-CEP 2013-256-Rev 02
10/09/2020
VALID
/Chemistry
Candesartan cilexetil
MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad
  R1-CEP 2011-259-Rev 04
29/11/2019
VALID
/Chemistry
Candesartan cilexetil
Quimica Sintetica S.A. ES 28805 Alcala De Henares
  R1-CEP 2013-228-Rev 02
11/06/2020
VALID
/
Chemistry
Candesartan cilexetil
DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad
  R1-CEP 2012-100-Rev 01
19/12/2019
VALID
/
Chemistry
Candesartan cilexetil -
Zhejiang Kinglyuan Pharmaceutical Co., Ltd. CN 312 369 Shangyu
  R0-CEP 2012-279-Rev 00
03/03/2014
EXPIRED
03/03/2019
Chemistry
Candesartan cilexetil
ZHUHAI RUNDU PHARMACEUTICAL CO., LTD. CN 519 041 Sanzao
  R1-CEP 2013-314-Rev 01
25/01/2021
VALID
/
Chemistry
Candesartan cilexetil
KRKA d.d. SI 8501 Novo Mesto
  R0-CEP 2016-132-Rev 04
06/02/2020
VALID
/
Chemistry
Candesartan cilexetil Process II
MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad
  R0-CEP 2019-303-Rev 00
02/04/2020
VALID
/
Chemistry
Candesartan cilexetil
MACLEODS PHARMACEUTICALS LIMITED IN 400 059 Mumbai
  R1-CEP 2014-042-Rev 00
22/01/2021
VALID
/
Chemistry
Candesartan cilexetil Form I
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
  R1-CEP 2011-248-Rev 01
21/11/2019
VALID
/
Chemistry
Candesartan cilexetil Process-IV
SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai
  R0-CEP 2019-297-Rev 01
09/10/2020
VALID
/
Chemistry
Candesartan cilexetil Process II
CADILA HEALTHCARE LIMITED IN 393 002 Ankleshwar
  R1-CEP 2012-130-Rev 01
03/10/2019
VALID
/
Chemistry
Candesartan cilexetil Form I - process 2
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
  R0-CEP 2020-164-Rev 00
10/11/2020
VALID
/
Chemistry
Candesartan cilexetil
Jiangxi Synergy Pharmaceutical Co., Ltd. CN 330 700 Fengxin
  R1-CEP 2013-007-Rev 01
24/11/2020
VALID
/
Chemistry
Candesartan cilexetil
ALEMBIC PHARMACEUTICALS LIMITED IN 390 003 Vadodara
  R1-CEP 2011-266-Rev 03
26/11/2020
VALID
/Chemistry
Candesartan cilexetil
ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai
  R1-CEP 2011-309-Rev 03
31/03/2021
VALID
/
Chemistry

Producer:Zhejiang Tianyu Pharmaceutical Co., Ltd., founded in 2003, is headquartered in Taizhou, Zhejiang, with a registered capital of more than 180 million yuan. It has six wholly-owned subsidiaries and more than 3800 employees. Tianyu Co., Ltd. is a joint-stock pharmaceutical enterprise specializing in R & D, manufacturing and sales of APIs and advanced pharmaceutical intermediates. It was successfully listed on Shenzhen Stock Exchange on September 19, 2017.

The company's main products include antihypertensive, hypoglycemic, antithrombotic and antiasthmatic drug raw materials and intermediates. It is one of the world's major manufacturers of cardiovascular raw materials, and its products sell well in markets at home and abroad.

Staff size:About 4000 persons

Registered capital:RMB 348 million


Producer:Zhejiang Kinglyuan Pharmaceutical Co., Ltd.is located on the Bank of Hangzhou Bay, Zhejiang Province, with beautiful scenery, pleasant climate and superior geographical location. The company covers an area of 180000 square meters, has assets of 680 million yuan, and has 560 employees, including 32 with senior professional titles, and intermediate and other relevant technicians account for 42% of the total number of employees. After more than ten years of development, the company has become a comprehensive pharmaceutical enterprise integrating R & D, production and service.

Staff size:About 560 persons

Registered capital:RMB 68.2 million


Producer:Tiandi Hinye Pharmaceutical Co., Ltd. was established in 2006. The company covers an area of 60 mu. The first phase of the project has built a 4000 square meter frame structure plant and supporting facilities including four solid preparation production lines.

The company's products include Chinese patent medicine, chemical medicine and API. There are more than 100 drug R & D projects under research and declared to the State Drug Administration, including generic and innovative drugs of Chinese patent medicine and chemical medicine.

Staff size:600-699 persons

Registered capital:RMB 112 million


Producer:Fuzhou Jinshan Biological Pharmaceutical Co., Ltd., covering a total area of about 40000 square meters, was built in 1999. It is a leading enterprise under Fujian Jinshan Pharmaceutical Industry Group Co., Ltd.

At present, it has a small volume injection workshop, external ointment workshop and chemical API workshop, all of which have passed the national GMP certification. The company has advanced technical equipment, perfect detection system, unique process technology and scientific management system. It is engaged in the production of more than ten kinds of high-tech products in three dosage forms: injection, software paste and patch of biochemical immune function drugs, antifungal drugs, analgesics, antitumor drugs and antibiotics.

Staff size:February 2021

Registered capital:RMB 45.29 million


Producer:The company is now deregistered

Weihai Disu Pharmaceutical Co., Ltd., established in May 2005, is a subsidiary of Disha Pharmaceutical Group. It is a national high-tech enterprise integrating R & D, production and sales of chemical APIs, veterinary drugs, marine biological new materials and their intermediates.

Staff size:RMB 40 million

Registered capital:January 2022


Producer:Shanxi Huangcheng Xiangfu Pharmaceutical Co., Ltd., a subsidiary of Huangcheng Xiangfu group, is a modern pharmaceutical enterprise integrating scientific research, development and production. Founded in 2001, the company is located in Jincheng Economic and Technological Development Zone.

The business scope of Shanxi Huangcheng Xiangfu Pharmaceutical Co., Ltd. includes the production of API, tablet, hard capsule, granule, powder, dry suspension, membrane and health food; Traditional Chinese medicine extraction.

Staff size:About 500 persons

Registered capital:RMB 84 million 300 thousand


Producer:Zhejiang Yongning Pharmaceutical Co., Ltd., located in Taizhou, Zhejiang Province, has more than 100 product varieties in five categories, including chemical agents, chemical pharmaceutical intermediates, APIs, Chinese patent medicines and health products.   The company has fully passed the new national GMP certification, and some products have passed the certification of FDA, PMDA of Japan and KFDA of Korea, among which cefotiam hydrochloride is the standard of USP.
Staff size:900-999 persons

Registered capital:RMB 153.125 million


Producer:Chongqing Shenghuaxi Pharmaceutical Co., Ltd. was established in 1998 and officially restructured into a joint stock limited company in 2010; At present, the company has more than 900 employees. After more than ten years of development, it has been established   Jingjing is a high-tech API and pharmaceutical preparation enterprise integrating R & D, production and sales.

Taking new drug R & D as the core competitiveness of the enterprise, the company has built a large-scale scientific research system, with more than 200 full-time scientific and technological developers; The company invests more than 12% of its sales revenue into new drug research and development every year. The company has three production bases, with more than ten fully sterile API and non sterile API production workshops, fine, drying and charter workshops, as well as a number of pharmaceutical preparation workshops; It has an annual production capacity of more than one billion yuan for APIs and pharmaceutical preparations.

Staff size:About 800 persons

Registered capital:RMB 66 million


Producer:Zhejiang Huahai Pharmaceutical Co., Ltd.was founded in 1989 and headquartered in Zhejiang, China. The company has nearly 7000 employees and more than 40 subsidiaries around the world (including China, the United States, Japan, Germany, etc.As a leading enterprise in the internationalization of Chinese medicine, Huahai pharmaceutical is the first pharmaceutical company in China to pass the FDA preparation quality certification and independently own the Anda document number. It is also the first Chinese pharmaceutical company to realize large-scale preparation sales in the United States. It has established China's pharmaceutical quality image in the world's high-end pharmaceutical market.

Staff size:About 7000 persons

Registered capital:RMB 1 billion 492 million


Producer:Tipr Pharmaceutical Co., Ltd.Research Institute was formerly directly under the State Food and drug administration. The pharmaceutical products produced by the company mainly involve antipsychotics, non steroidal anti-inflammatory, analgesia and detoxification, hypoglycemic, antiviral, cardio cerebrovascular and other fields. The dosage forms include small volume injection, tablet, granule, hard capsule, oral liquid and API. All dosage forms have passed GMP certification. It is a designated production unit of national psychotropic drugs and a comprehensive high-tech enterprise.
Staff size:300-399 persons

Registered capital:RMB 50 million


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