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Hydrochlorothiazide

CAS number: 58-93-5

Molecular formula: C7H8ClN3O4S2

molecular weight: 297.739

Chemical structure:

Producers shown on SFDA

(Record date:02/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Zhejiang Huahai Pharmaceutical Co., Ltd.

GMP
Valid till October 2021

Shanghai Jindi Jiuzhou Pharmaceutical (Anyang) Co., Ltd.,

GMP
Valid till October 2024

Yabao Pharmaceutical Group Co., Ltd. 

GMP
Valid till December 2017

Suzhou Lixin Pharmaceutical Co., Ltd.

GMP
Valid till June 2024

Changzhou Pharmaceutical Factory Co., Ltd.

GMP, DMF
Valid till July 2023


Producers shown on EP

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

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Hydrochlorothiazide
Posh Chemicals Private Limited IN 500 016 Hyderabad
  R0-CEP 2004-233-Rev 01
29/11/2013
EXPIRED
29/09/2014
Chemistry
Hydrochlorothiazide
SOUTHWEST SYNTHETIC PHARMACEUTICAL CORPORATION, LIMITED CN 400 025 Chongqing
  R0-CEP 2006-116-Rev 00
18/01/2008
EXPIRED
25/01/2013
Chemistry
Hydrochlorothiazide
AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad
  R1-CEP 2005-013-Rev 03
19/12/2017
VALID
/Chemistry
Hydrochlorothiazide
Unichem Laboratories Limited IN 400 102 Mumbai
  R1-CEP 2000-091-Rev 04
14/01/2020
VALID
/Chemistry
Hydrochlorothiazide Process I
IPCA Laboratories Limited IN 400 067 Mumbai
  R1-CEP 2004-013-Rev 04
27/07/2020
VALID
/Chemistry
Hydrochlorothiazide
ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai
  R1-CEP 2009-060-Rev 00
03/08/2015
VALID
/Chemistry
Hydrochlorothiazide
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
  R1-CEP 2004-149-Rev 05
13/01/2020
VALID
/Chemistry
Hydrochlorothiazide Process III
IPCA Laboratories Limited IN 400 067 Mumbai
  R1-CEP 2012-044-Rev 00
10/04/2017
VALID
/Chemistry
Hydrochlorothiazide
AREVIPHARMA GMBH DE 01445 Radebeul
  R1-CEP 2006-012-Rev 02
12/07/2017
VALID
/Chemistry
Hydrochlorothiazide
CTX LIFE SCIENCES PVT. LIMITED IN 394 230 Surat
  R1-CEP 2008-021-Rev 02
06/02/2017
VALID
/Chemistry
Hydrochlorothiazide
AMOLI ORGANICS PRIVATE LIMITED IN 400 021 Mumbai
  R0-CEP 2016-012-Rev 03
12/01/2021
VALID
/Chemistry
Hydrochlorothiazide 
ALEMBIC PHARMACEUTICALS LIMITED IN 390 003 Vadodara
  R1-CEP 2009-103-Rev 03
09/04/2020
VALID
/Chemistry
Hydrochlorothiazide Process II
IPCA Laboratories Limited IN 400 067 Mumbai
  R1-CEP 2006-100-Rev 00
16/01/2013
VALID
/Chemistry
Hydrochlorothiazide
SUZHOU LIXIN PHARMACEUTICAL CO., LTD. CN 215 151 Suzhou 
  R1-CEP 2012-250-Rev 00
22/07/2019
VALID
/Chemistry
Hydrochlorothiazide Process 2
Unichem Laboratories Limited IN 400 102 Mumbai
  R0-CEP 2020-017-Rev 00
28/04/2020
VALID
/Chemistry
Hydrochlorothiazide
Cambrex Profarmaco Milano S.r.l. IT 20067 Paullo
  R1-CEP 2004-307-Rev 04
07/03/2017
VALID
/Chemistry
Hydrochlorothiazide
Changzhou Pharmaceutical Factory CN 213 018 Jiangsu Province
  R1-CEP 2006-011-Rev 01
16/02/2018
VALID
/Chemistry
Hydrochlorothiazide
BLUE CIRCLE ORGANICS PRIVATE LIMITED IN 421 501 Ambernath West
  R0-CEP 2013-294-Rev 00
24/08/2015
EXPIRED
24/08/2020
Chemistry
Hydrochlorothiazide
FLAMMA S.P.A. IT 24040 Chignolo d'Isola
  R0-CEP 2014-276-Rev 00
07/06/2016
EXPIRED
07/06/2021
Chemistry
Hydrochlorothiazide
PHARMACEUTICAL WORKS POLPHARMA S.A. PL 83-200 Starogard Gdanski
  R1-CEP 2004-058-Rev 02
16/08/2019
VALID
/Chemistry
Hydrochlorothiazide
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
  R1-CEP 2001-304-Rev 10
09/12/2020
VALID
/Chemistry

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:Shanghai Jindi Jiuzhou Pharmaceutical (Anyang) Co., Ltd., formerly known as Anyang Jiuzhou Pharmaceutical Co., Ltd., is a backbone pharmaceutical enterprise in Anyang City, Henan Province. The company covers an area of 130 mu, with a registered capital of 80 million yuan, fixed assets of 220 million yuan and total assets of 250 million yuan.

Small volume injection: at present, there are three production lines in the small volume injection workshop, which have been approved for 75 months, with a monthly output of 90 million and an annual output of 1 billion. The company has four chemical synthetic medicine workshops and biological fermentation workshops, with a total volume of 856 cubic meters.

Staff size:100-199 persons

Registered capital:RMB 80 million


Producer:Yabao Pharmaceutical Group Co., Ltd. is a group company with a history of more than 40 years. It was listed on the Shanghai Stock Exchange in 2002. The company integrates the R & D, production, sales, logistics and planting of traditional Chinese medicine of drugs and great health products. It has 23 subsidiaries and nearly 6000 employees.

The company has 9 production bases, 4 research bases and 4 large and medium-sized medicinal material planting bases. Among them, 6 API production lines, 2 preparation production lines and 1 plastic bottle production line have passed the certification of developed countries such as the United States, Germany and Japan.

Staff size:About 6000 persons

Registered capital:RMB 770 million


Producer:Established in 2000, Suzhou Lixin Pharmaceutical Co., Ltd. has built a 12000m2 cGMP API production base in Suzhou high tech Zone, with multiple GMP workshops, chemical synthesis workshops and perfect supporting facilities. It has passed nmpa, FDA, EDQM and EMA certification for many times. The company has obtained 3 US DMF documents, 3 CEP certificates, 5 nmpa new drug certificates and 8 domestic GMP certificates. At the same time, more than 20 products are under project approval, R & D and registration at home and abroad.

Staff size:100-199 persons

Registered capital:RMB 20.78 million


Producer:Changzhou Pharmaceutical Factory Co., Ltd. is a state-owned core enterprise of Shanghai Pharmaceutical. It is a comprehensive pharmaceutical enterprise with equal emphasis on chemical raw materials and chemical preparations and all-round development of science, industry and trade.

The company produces more than 30 kinds of APIs and more than 150 varieties of needles, tablets and capsules throughout the year. In 2016, the company's rosuvastatin calcium tablets passed the on-site inspection of Anda in the United States. In November 2007, the company passed the EU GMP certification. It has become the second enterprise in Jiangsu and the seventh enterprise in China that has passed the EU GMP certification. In 2012, it passed the EU GMP certification again.

Staff size:800-899 persons

Registered capital:RMB 108 million


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