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Doxycycline

CAS number: 564-25-0

Molecular formula: C22H24N2O8

molecular weight: 444.435

Chemical structure:

Producers shown on SFDA

(Record date:26/08/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Yancheng Suhai Pharmaceutical Co., Ltd.

GMPValid till March 2020

Kunshan Oriental Pharmaceutical Co., Ltd.

GMP
Valid till April 2020

Kaifeng Pharmaceutical (Group) Co., Ltd.

GMP
Valid till January 2021

Hebei Dongfeng Pharmaceutical Co., Ltd.

GMP, DMF
Valid till January 2024

Yangzhou Pharmaceutical Co., Ltd.

GMP
Valid till April 2024

Shandong Lukang Pharmaceutical Co.,Ltd.

GMPValid till April 2024


Producers shown on EP

(Quoted from EP website;record date:26/08/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Doxycycline hyclate
Shanghai International Pharmaceutical Co., Ltd. CN 200 051 Shanghai
R2-CEP 1992-018-Rev 00
19/02/2004
WITHDRAWN BY EDQM
22/10/2010
Chemistry
Doxycycline hyclate
KUNSHAN CHEMICAL AND PHARMACEUTICAL FACTORY CN 215 337 Kunshan City
R0-CEP 2003-225-Rev 00
15/04/2005
WITHDRAWN BY EDQM
02/07/2008
Chemistry
Doxycycline monohydrate
KUNSHAN CHEMICAL AND PHARMACEUTICAL FACTORY CN 215 337 Kunshan City
R0-CEP 2003-226-Rev 00
27/04/2005
WITHDRAWN BY EDQM
02/07/2008
Chemistry
Doxycycline hyclate
Ranbaxy Laboratories Limited IN 122 015 Gurgaon
R1-CEP 1997-002-Rev 04
14/11/2014
WITHDRAWN BY HOLDER
24/03/2015
Chemistry
Doxycycline monohydrate
YANCHENG SUHAI PHARMACEUTICAL CO., LTD. CN 224 100 Dafeng District, Yancheng City
R1-CEP 1999-157-Rev 04
28/09/2015
VALID
/Chemistry
Doxycycline monohydrate
Ranbaxy Laboratories Limited IN 122 015 Gurgaon
R1-CEP 1997-072-Rev 03
17/03/2008
WITHDRAWN BY HOLDER
24/03/2015
Chemistry
Doxycycline hyclate
Hebei Dongfeng Pharmaceutical Co., Ltd CN 057 150 Handan City
R1-CEP 2004-163-Rev 00
01/06/2011
WITHDRAWN BY HOLDER
27/06/2016
Chemistry
Doxycycline monohydrate
Shanghai International Pharmaceutical Co., Ltd. CN 200 052 Shanghai
R1-CEP 1996-064-Rev 04
01/06/2007
WITHDRAWN BY HOLDER
22/10/2010
Chemistry
Doxycycline hyclate
RAKS PHARMA PVT. LTD. IN 531 021 Visakhapatnam
R0-CEP 2014-175-Rev 02
18/08/2020
VALID
/Chemistry
Doxycycline hyclate
Hovione PharmaScience Limited MO Taipa
 R1-CEP 1996-066-Rev 06
05/10/2020
VALID
/Chemistry
Doxycycline monohydrate
Hebei Dongfeng Pharmaceutical Co., Ltd CN 057 150 Handan City
R1-CEP 2004-162-Rev 00
01/06/2011
WITHDRAWN BY HOLDER
27/06/2016
Chemistry
Doxycycline monohydrate
Hovione PharmaScience Limited MO Taipa
R1-CEP 1997-115-Rev 06
10/11/2015
VALID
/Chemistry
Doxycycline monohydrate
YANGZHOU LIBERTY PHARMACEUTICAL CO., LTD. CN 225 127 Yangzhou
R1-CEP 2013-052-Rev 00
12/02/2019
VALID
/Chemistry
Doxycycline monohydrate
KAIFENG PHARMACEUTICAL (GROUP) CO., LTD. CN 475 003 Kaifeng
 R1-CEP 2012-243-Rev 00
28/01/2019
VALID
/Chemistry
Doxycycline hyclateKAIFENG PHARMACEUTICAL (GROUP) CO., LTD. CN 475 003 Kaifeng
R1-CEP 2001-038-Rev 02
19/03/2015
VALID
/Chemistry
Doxycycline hyclate
YANGZHOU LIBERTY PHARMACEUTICAL CO., LTD. CN 225 127 Yangzhou
R1-CEP 2000-165-Rev 06
26/04/2019
VALID
/Chemistry
Doxycycline hyclate
YANCHENG SUHAI PHARMACEUTICAL CO., LTD. CN 224 100 Dafeng District, Yancheng City
R1-CEP 1999-100-Rev 04
25/06/2018
VALID
/Chemistry

Producer:Yancheng Suhai Pharmaceutical Co., Ltd., established in April 1990, is located in Dafenggang Petrochemical new material industrial park, Dafeng District, Yancheng City, Jiangsu Province. It has total assets of 180 million yuan and covers an area of 55570 square meters, including a construction area of 12013 square meters; There are more than 140 employees, including 36 with college degree or above. The company is an enterprise specializing in the production of doxycycline hydrochloride (also known as doxycycline) and doxycycline monohydrate, with an annual output of 1000 tons of doxycycline. The company's products are mainly used for drugs for people at home and abroad, and are mainly exported to Europe and the United States and other regulatory markets.

The company has complete administrative licensing procedures for safety, environmental protection and fire protection. In 2015, doxycycline hydrochloride API produced by the company passed the review of China food and Drug Administration and obtained GMP certificate. Doxycycline hydrochloride and doxycycline monohydrate also hold the cos (drug applicability) certificate issued by the European drug quality administration. It passed the on-site inspection of the U.S. Food and Drug Administration (FDA) twice in 2015 and 2019 respectively. We are promoting the GMP declaration of fructose, allantoin, dextran and other products to adapt to the market innovation and operation of diversified and differentiated products.

Staff size:100-199 persons
Registered capital:RMB 28.88 million


Producer:Kunshan Oriental Pharmaceutical Co., Ltd. is a modern synthetic API enterprise integrating pharmaceutical R & D, production and self export. It has been renamed Kunshan HuaSu Biotechnology Co., Ltd. since 1981. It has been renamed to specializing in the production of doxycycline series products for nearly 40 years. We are a new chemical production base integrating pharmaceutical R & D, production and export according to the requirements of modern pharmaceutical enterprises. The company has more than 400 employees, of which professional and technical personnel account for about 25%. The factory has a large-scale workshop, advanced equipment, modern office management system, perfect quality inspection system, water supply system, power supply system, fire protection system, sewage treatment system, etc. The enterprise has an independent R & D laboratory and maintains a good cooperative relationship with a number of science and technology colleges, providing a strong guarantee for the enterprise's new product R & D and process improvement.

In December 1999, doxycycline monohydrate produced by us passed FDA certification, and passed reexamination in 2002. Obtained the European cos Certificate in April 2005. In June 2012, it obtained the GMP certificate from the Ministry of agriculture of China.

Staff size:About 50 persons

Registered capital:RMB 6.18 million


Producer:Kaifeng Pharmaceutical (Group) Co., Ltd. (hereinafter referred to as "Kaifeng Pharmaceutical Group") was founded in May 1949. Its predecessor is Kaifeng Pharmaceutical Factory in Henan Province, a national comprehensive large class II pharmaceutical enterprise.

The company covers an area of 400000 square meters, a construction area of 170000 square meters, and more than 3000 large and medium-sized advanced production equipment. The production equipment of the enterprise is advanced and perfect, and has fully passed GMP certification and relevant acceptance. Kaiyao group is a high-tech enterprise in Henan Province, with perfect quality assurance system and quality detection and control instruments, and reliable product quality. All kinds of products produced have been spot checked by national, provincial and municipal quality supervision departments, and the qualified rate has been 100% for 23 consecutive years. The product quality meets the standards of Chinese Pharmacopoeia, British Pharmacopoeia, European Pharmacopoeia and American Pharmacopoeia. It is the first self-supporting import and export enterprise in the pharmaceutical system of Henan Province approved by the Ministry of foreign economic relations and trade.

Staff size:900-999 persons
Registered capital:RMB 204 million 568 thousand and 562

Producer:Hebei Dongfeng Pharmaceutical Co., Ltd. is a famous modern large pharmaceutical enterprise in China. The API produced has passed the national GMP certification and EU cos certification, and is actively applying for FDA certification. Over the years, relying on strict GMP management, stable product quality and perfect marketing services, various products have been selling well in domestic and foreign markets. At the same time, Dongfeng pharmaceutical has also won a good reputation.

The annual production of doxycycline hydrochloride, the fist product of Dongfeng pharmaceutical, reaches 1000 tons, and the export volume occupies a leading position in the world. The company has increased its investment in azithromycin API, carried out a series of technical innovation and management upgrading, improved the quality day by day, and formed large-scale production, with an annual output of 120 tons. In order to make the products enter the international high-end market, the company has specially purchased the leading testing instruments from the United States, which has reached the quality standard of the 29th edition of the United States Pharmacopoeia.

Staff size:50-99 persons

Registered capital:RMB 50 million


Producer:Yangzhou Pharmaceutical Co., Ltd. is a national medium-sized pharmaceutical industrial enterprise controlled by Jiangsu Lianhuan Pharmaceutical Group. The company covers an area of 120000 m2, has a registered capital of 22 million yuan, and has nearly 700 employees, of which more than 30% are professional and technical personnel. The enterprise has four API production workshops, one preparation production workshop, and a thermal power station with a power generation of 4500kw. The enterprise has its own import and export right, with an annual export volume of more than US $15 million.

As the backbone enterprise of Jiangsu Lianhuan Pharmaceutical Group, Yangzhou Pharmaceutical Co., Ltd. has been committed to the production of more than 100 varieties, specifications and chemical pharmaceutical products in four categories: chemical synthetic drugs, antibiotics, water needle preparations, various pharmaceutical accessories and chemical pharmaceutical intermediates. The products sell well in more than 40 countries in Europe, America and Asia. The main products are hydrocortisone, hydrocortisone acetate Doxycycline hydrochloride and doxycycline monohydrate have passed the inspection and approval of FDA. Cortical steroids such as hydrocortisone and hydrocortisone acetate are mainly exported to the United States, accounting for more than 30% of the same products in China; Doxycycline hydrochloride, doxycycline monohydrate and oxytetracycline hydrochloride are mainly exported to Europe, North America and Southeast Asia. Doxycycline hydrochloride has obtained the certificate of applicability (COS) from the European Drug Quality Committee (GDQM); Levonorgestrel, felodipine and oxytetracycline hydrochloride have been successfully registered in the United States. Levonorgestrel and levonorgestrel are free assistance projects of the United Nations Population Fund (UNFPA), with annual sales accounting for 50% of the same industry in China.

All API production varieties and water injection preparation production lines of the company have passed the cGMP certificate issued by the State Food and drug administration.

Staff size:500-999 persons

Registered capital:RMB 104.187 million


Producer:Shandong Lukang Pharmaceutical Co., Ltd. is the first large joint-stock enterprise in the pharmaceutical industry of Shandong Province, and the controlling shareholder is Shandong Lukang Pharmaceutical Group Co., Ltd. Lukang Pharmaceutical is a national large-scale first-class enterprise and the most complete variety of domestic pharmaceutical enterprises that have passed GMP certification, and is the first enterprise in the national western medicine system to pass ISO9001 quality system certification and ISO14001 environmental system certification“ The trademark of "Lukang brand" has been officially recognized as a well-known trademark in China by the Trademark Office of the State Administration for Industry and commerce. It is one of the five international well-known brands cultivated in Shandong Province. As of December 31, 2006, the total assets of the company reached 2.43 billion yuan.

All production workshops of the company have successfully passed GMP certification; Domestic sales are distributed in East China, North China, South China, northeast, northwest and southwest, and exported to Europe, North America and Southeast Asia. The company has actively adjusted the product layout and optimized the product structure, and has formed three series of product chains with 6-APA, 7-ACA and 7-ADCA as the parent core, realizing the successful leap from traditional antibiotic production to semi synthetic antibiotic production.

Staff size:6000 persons

Registered capital:RMB 880 million 200 thousand


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