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Oxytetracycline Hydrochloride

CAS number: 2058-46-0

Molecular formula: C22H24N2O9·HCl

molecular weight: 496.89

Chemical structure:

Producers shown on SFDA

(Record date:27/08/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Yancheng Dafeng Area Tiansheng Joint Pharmaceutical Co., Ltd.

GMP
Valid till May 2023

Hebei Shengxue Dacheng Pharmaceutical Co., Ltd. 

GMP
Valid till August 2024

Jiangxi Guoyao Pharmaceutical Co., Ltd.

GMP
Valid till May 2024

Producers shown on EP

(Quoted from EP website;record date:27/08/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Oxytetracycline hydrochloride
CHIFENG PHARMACEUTICAL CO., LTD. CN 024 001 Chifeng
R1-CEP 2002-118-Rev 00
12/05/2009
WITHDRAWN BY HOLDER
17/09/2013
Chemistry
Oxytetracycline hydrochloride
YANGZHOU LIBERTY PHARMACEUTICAL CO., LTD. CN 225 127 Yangzhou
 R1-CEP 2010-080-Rev 03
09/05/2019
VALID
/Chemistry
Oxytetracycline hydrochloride
SHANDONG JINYANG PHARMACEUTICAL CO., LTD. CN 255000 Zibo City
R0-CEP 2008-165-Rev 00
12/05/2010
WITHDRAWN BY HOLDER
01/06/2012
Chemistry
Oxytetracycline hydrochloride
Hebei Shengxue Dacheng Pharmaceutical Co., Ltd. CN 051 430 Shijiazhuang City
  R0-CEP 2009-145-Rev 00
08/09/2010
WITHDRAWN BY HOLDER
10/08/2015
Chemistry
Oxytetracycline hydrochloride
JIANGXI GUOYAO PHARMACEUTICAL LIMITED LIABILITY COMPANY CN 330 052 Nanchang
 R1-CEP 2001-125-Rev 02
14/08/2018
VALID
/Chemistry
Oxytetracycline hydrochloride
HEBEI JIANMIN STARCH GLUCOSE CO., LTD. CN 055 550 Ningjin
 R1-CEP 2013-200-Rev 00
09/04/2019
VALID
/Chemistry
Oxytetracycline hydrochloride
Norbrook Laboratories LIMITED IE BT35 6JP Newry
 R1-CEP 1999-162-Rev 06
19/04/2017
VALID
/Chemistry
Oxytetracycline hydrochloride Process B - Micronised, non-micronised
Hebei Shengxue Dacheng Pharmaceutical Co., Ltd. CN 051 430 Shijiazhuang City
 R1-CEP 2013-090-Rev 01
10/08/2020
VALID
/Chemistry
Oxytetracycline hydrochloride
YANCHENG DAFENG AREA TIANSHENG JOINT PHARMACEUTICAL CO., LTD CN 224 145 Yancheng City
R1-CEP 2002-070-Rev 01
23/06/2021
VALID
/Chemistry
Oxytetracycline hydrochloride For use in the manufacture of parenteral preparations
YANGZHOU LIBERTY PHARMACEUTICAL CO., LTD. CN 225 127 Yangzhou
R0-CEP 2018-119-Rev 01
05/06/2020
VALID
/Chemistry


Producer:Yancheng Dafeng Area Tiansheng Joint Pharmaceutical Co., Ltd.The company covers an area of about 50000 square meters. The design, construction, installation and production processes of the main production plants meet the requirements of GMP. The company is a high-tech enterprise in Jiangsu Province. It is a comprehensive pharmaceutical manufacturer integrating chemical APIs, pharmaceutical intermediates and chemical products. The company organizes production in strict accordance with CP2005, ep5, USP28 and other quality standards, and self exports to dozens of countries and regions in Europe, America, Africa and Southeast Asia.

Staff size:100-199 persons

Registered capital:RMB 50 million


Producer:Hebei Shengxue Dacheng Pharmaceutical Co., Ltd. (hereinafter referred to as "the company"), founded in 1997, is a modern pharmaceutical enterprise controlled by China Nuclear uranium industry Co., Ltd. and headquartered in Luancheng District, Shijiazhuang city. After more than 20 years of development, Dacheng pharmaceutical has two wholly-owned subsidiaries, one holding company and four production bases, covering a total area of about 1600 mu. It is an important manufacturer of colistin sulfate and streptomycin sulfate at home and abroad, and its production scale ranks in the forefront of the same industry.

The company's main products have passed the national GMP certification and EU CEP certification, colistin sulfate has passed the German eu-gmp certification, oxytetracycline series products have passed the U.S. FDA certification, and dihydrostreptomycin has passed the aseptic CEP certification. The company is the only state-owned enterprise in the competition of similar products, with a total production capacity of more than 10000 tons. Its products sell well all over the country and are exported to Europe, America, Southeast Asia, the Middle East, India, North Africa, South America and other dozens of countries and regions, of which colistin sulfate accounts for more than 70% of the global market; Streptomycin sulfate accounts for about 60% of the global market share; Oxytetracycline series products occupy the main international high-end market share.

Staff size:500-599 persons

Registered capital:RMB 46.995196 million


Producer:Jiangxi Guoyao Pharmaceutical Co., Ltd.has strong pharmaceutical industry strength, with more than 200 professional and technical personnel, covering an area of 350000 square meters and a construction area of 182000 square meters. There are more than 3300 fixed assets equipment, of which the total volume of fermentation equipment is 2100m3.

The company has two national silver products, three ministerial products and eight provincial products. In particular, Lincomycin Hydrochloride and oxytetracycline hydrochloride have passed the FDA certification. Fermented Cordyceps sinensis powder (CS-4) is the first class of new traditional Chinese medicine in China, which can "win with quality" in the international market. The company's small volume injection, Lincomycin Hydrochloride and oxytetracycline hydrochloride have passed the national GMP certification.

Staff size:200-299 persons
Registered capital:RMB 183 million 601 thousand and 910


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