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Carvedilol

CAS number: 72956-09-3

Molecular formula: 406.48

molecular weight: C24H26N2O4

Chemical structure:

Producers shown on SFDA

(Record date:02/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Qilu Pharmaceutical Co., Ltd.

GMP
Valid till May 2022

Livzon Syntpharm Co., Ltd.(zhuhaiftz)

GMP
Valid till February 2019

Shenzhen Yuanxing Pharmaceutical Co., Ltd. 

GMP
/

Fu'an Pharmaceutical Group Ningbo Team Pharmaceutical Co., Ltd.

GMP
Valid till July 2023

PKU HealthCare Corp., Ltd.

GMP
Valid till March 2020


Producers shown on EP

(Quoted from EP website;record date:02/09/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Carvedilol
CTX LIFE SCIENCES PVT. LIMITED IN 394 230 Surat
  R1-CEP 2014-201-Rev 00
18/06/2021
VALID
/Chemistry
Carvedilol Synthetic route B
EGIS Pharmaceuticals PLC HU 1106 Budapest
  R0-CEP 2016-314-Rev 01
26/08/2020
VALID
/
Chemistry
Carvedilol
USV Limited IN 400 088 Mumbai
  R0-CEP 2004-071-Rev 00
13/05/2005
EXPIRED
13/05/2010
Chemistry
Carvedilol
EGIS Pharmaceuticals PLC HU 1106 Budapest
  R1-CEP 2003-042-Rev 03
20/02/2019
VALID
/
Chemistry
Carvedilol
F Hoffmann-La Roche Ltd. CH 4070 Basel
  R1-CEP 2002-001-Rev 03
25/07/2012
VALID
/
Chemistry
Carvedilol
QILU PHARMACEUTICAL CO., LTD. CN 250 100 Jinan
  R0-CEP 2013-204-Rev 00
19/09/2014
WITHDRAWN BY HOLDER
15/11/2018
Chemistry
Carvedilol
AREVIPHARMA GMBH DE 01445 Radebeul
  R1-CEP 2005-155-Rev 02
27/07/2012
VALID
/
Chemistry
Carvedilol Micronised
LUPIN LIMITED IN 400 055 Mumbai
  R1-CEP 2006-097-Rev 01
13/09/2016
WITHDRAWN BY HOLDER
27/07/2021
Chemistry
Carvedilol
SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai
  R1-CEP 2004-230-Rev 05
28/07/2015
VALID
/
Chemistry
Carvedilol
Urquima S.A. ES 08105 Sant Fost De Campsentelles
  R1-CEP 2003-248-Rev 00
21/04/2010
WITHDRAWN BY HOLDER
27/02/2012
Chemistry
Carvedilol
SHODHANA LABORATORIES LIMITED IN 500 055 Hyderabad
  R1-CEP 2008-259-Rev 00
06/02/2015
VALID
/
Chemistry
Carvedilol
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
  R1-CEP 2003-048-Rev 05
19/10/2020
VALID
/
Chemistry
Carvedilol
DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad
  R0-CEP 2009-228-Rev 01
08/10/2015
WITHDRAWN BY HOLDER
19/02/2018
Chemistry
Carvedilol
PharmaZell (India) Private Limited IN 600 045 Chennai
  R0-CEP 2010-236-Rev 01
05/04/2012
WITHDRAWN BY HOLDER
17/03/2016
Chemistry
Carvedilol
MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad
  R1-CEP 2005-267-Rev 06
25/02/2019
VALID
/
Chemistry
Carvedilol
ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai
  R1-CEP 2004-287-Rev 05
01/07/2021
VALID
/
Chemistry
Carvedilol
CADILA PHARMACEUTICALS LIMITED IN 393 002 Ankleshwar
  R1-CEP 2006-083-Rev 01
20/11/2013
VALID
/
Chemistry
Carvedilol
KRKA d.d. SI 8501 Novo Mesto
  R1-CEP 2001-294-Rev 04
28/01/2015
VALID
/
Chemistry
Carvedilol
PHARMACEUTICAL WORKS POLPHARMA S.A. PL 83-200 Starogard Gdanski
  R1-CEP 2002-258-Rev 07
22/01/2021
VALID
/
Chemistry
Carvedilol
AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad
  R1-CEP 2006-136-Rev 04
14/08/2019
VALID
/
Chemistry
Carvedilol
CIPLA LIMITED IN 400 013 Mumbai
  R1-CEP 2005-124-Rev 03
09/03/2018
VALID
/
Chemistry
Carvedilol
Moehs Iberica S.L. ES 08191 Rubi
  R1-CEP 2002-089-Rev 03
28/02/2019
VALID
/
Chemistry
Carvedilol
IPCA Laboratories Limited IN 400 067 Mumbai
  R1-CEP 2007-298-Rev 01
25/06/2019
VALID/
Chemistry
Carvedilol Site-II
AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad
  R0-CEP 2020-349-Rev 00
22/02/2021
VALID
/
Chemistry



Producer:Qilu Pharmaceutical Co., Ltd. is one of the first batch of GMP certified enterprises by the State Food and drug administration. Among them, non sterile APIs (fermentation, chemical synthesis), sterile APIs and various preparations have passed the certification of the US Food and Drug Administration (USFDA), the European Drug Quality Council (EDQM), the UK MHRA, the South African pharmaceutical Regulatory Commission (MCC) and other national drug regulatory agencies.

Qilu pharmaceutical has seven production bases including preparation, chemical synthesis and biotechnology and antibiotic fermentation, covering an area of 1.9 million square meters. The company's automatic production line and other main production equipment and testing instruments are purchased from major professional pharmaceutical equipment manufacturers in the world.

Staff size:7000-7999 persons

Registered capital:RMB 60 million


Producer:Livzon Syntpharm Co., Ltd.(zhuhaiftz), a wholly-owned subsidiary of Lizhu Pharmaceutical Group Co., Ltd., was established in 1993 and is located in Zhuhai Free Trade Zone, Guangdong Province. By the end of 2008, the company had invested more than 300 million yuan in fixed assets, covering an area of about 100000 square meters. It is a API base based on cephalosporin semi synthetic antibiotics built according to GMP standards. The production lines of the whole company have passed GMP certification.

The company has nearly 500 employees. Its main products include ceftriaxone sodium, cefuroxime sodium, cefdixone sodium, ceftazidime, cefepime hydrochloride and cefpirome sulfate. The total annual capacity is 680 tons. The production process and economic and technical indexes of all products have reached the domestic advanced level, and the product quality meets the CP and USP Pharmacopoeia standards.

Staff size:400-499 persons

Registered capital:RMB 128.28 million


Producer:Shenzhen Yuanxing Pharmaceutical Co., Ltd., established in 1997, is a wholly-owned subsidiary of Lizhu Pharmaceutical Group Co., Ltd. and has been cancelled.

Staff size:/

Registered capital:RMB 95 million


Producer:Fu'an Pharmaceutical Group Ningbo Team Pharmaceutical Co., Ltd., a subsidiary of Fu'an Pharmaceutical (Group) Co., Ltd., is the production base of antitumor API of the group. Founded in August 1992, Tianheng has been engaged in the pharmaceutical industry for more than 20 years and has fully passed the national GMP certification. The enterprise has national first-class medical science and technology strength and medical science and technology research center.

Staff size:400-499 persons

Registered capital:RMB 415 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