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 CN 024 001 Chifeng | R1-CEP 2002-118-Rev 00 | 12/05/2009 | WITHDRAWN BY HOLDER | 17/09/2013 | Chemistry |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 CN 255000 Zibo City | R0-CEP 2008-165-Rev 00 | 12/05/2010 | WITHDRAWN BY HOLDER | 01/06/2012 | Chemistry |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 CN 051 430 Shijiazhuang City | R0-CEP 2009-145-Rev 00 | 08/09/2010 | WITHDRAWN BY HOLDER | 10/08/2015 | Chemistry |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
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