
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.
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.
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