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Lincomycin

CAS number: 154-21-2

Molecular formula: C18H34N2O6S

molecular weight: 406.54

Chemical structure:

Producers shown on SFDA

(Record date:27/08/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Anhui Wanbei Pharmaceutical Co., Ltd.
GMPValid till February 2019

Xinyu Pharmaceutical Co., Ltd.

GMP
Valid till December 2020

Henan Xinxiang Huaxing Pharmaceutical Co., Ltd.

GMP
Valid January 2021

Jiangsu Hibroad Bio-pharnaceutical Co., Ltd.

GMP
Valid till April 2021

North China Pharmaceutical Group Hualuan Co., Ltd. 

GMP
Valid till December 2018

Jiangxi Guoyao Pharmaceutical Co., Ltd

GMP
Valid till May 2024

Harbin Pharmaceutical Group General Pharmaceutical Factory

GMP
Valid till September 2019

Topfond Pharmaceutical Co., Ltd.

GMP, DMF
Valid till November 2024

Huazhong Pharmaceutical Co., Ltd. 

GMP

Valid till February 2021


Producers shown on EP

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

SubstanceCertificate Holder
Certificate Number
Issue Date
Status
End date
Type
Lincomycin hydrochloride
Pfizer Inc US 07977 Peapack
R1-CEP 2005-284-Rev 00
07/06/2012
WITHDRAWN BY EDQM
20/12/2013Chemistry
Lincomycin hydrochloride
TOPFOND PHARMACEUTICAL CO., LTD. CN 463 000 Zhumadian
R1-CEP 2008-225-Rev 01
20/03/2017
VALID
/Chemistry
Lincomycin hydrochloride
HEC PHARM CO., LTD. CN 443 300 Yidu City
R0-CEP 2018-038-Rev 00
30/01/2019
VALID
/Chemistry
Lincomycin hydrochloride
NANYANG PUKANG PHARMACEUTICAL CO., LTD. CN 474 250 Nanyang
R0-CEP 2013-114-Rev 00
01/10/2015
WITHDRAWN BY EDQM
29/11/2017
Chemistry
Lincomycin hydrochloride
JIANGXI GUOYAO PHARMACEUTICAL LIMITED LIABILITY COMPANY CN 330 052 Nanchang
R1-CEP 2007-135-Rev 00
10/02/2014
VALID
/Chemistry
Lincomycin hydrochloride
JIANGSU HIBROAD BIO-PHARMACEUTICAL CO., LTD. CN 224 555 Binhai
R0-CEP 2014-133-Rev 00
20/10/2015
EXPIRED
20/10/2020/
Chemistry
Lincomycin hydrochloride
NORTH CHINA PHARMACEUTICAL GROUP HUALUAN CO., LTD. CN 051 430 Shijiazhuang City
R1-CEP 2007-295-Rev 01
13/04/2017
VALID
/Chemistry
Lincomycin hydrochloride
NINGXIA TAIYICIN BIOTECH CO., LTD. CN 750 205 Yinchuan City
R0-CEP 2017-155-Rev 00
29/01/2019
VALID
/Chemistry
Lincomycin hydrochloride
XINYU PHARMACEUTICAL CO., LTD. CN 234 000 Suzhou City
R0-CEP 2017-168-Rev 01
03/11/2020
VALID
/Chemistry
Lincomycin hydrochloride
LIVZON GROUP (NINGXIA) PHARMACEUTICAL CO., LTD. CN 753 400 Pingluo
R0-CEP 2018-090-Rev 01
27/10/2020
VALID
/Chemistry
Lincomycin hydrochloride Process III, code C20103
HEC PHARM CO., LTD. CN 443 300 Yidu City
R0-CEP 2019-136-Rev 01
02/07/2020
VALID
/Chemistry
Lincomycin hydrochloride Alternative process
XINYU PHARMACEUTICAL CO., LTD. CN 234 000 Suzhou City
R0-CEP 2020-105-Rev 00
10/07/2020
VALID
/Chemistry

Producer:Anhui Wanbei Pharmaceutical Co., LtdThe company has changed its name to Xinyu Pharmaceutical Co., Ltd.

Staff size:About 700 persons

Registered capital:RMB 90 million 


Producer:Xinyu Pharmaceutical Co., Ltd. (formerly Anhui Wanbei Pharmaceutical Co., Ltd.) was founded in 1988, with total assets of 305 million yuan and an area of more than 200000 square meters.

The company has many production lines for APIs (medical and veterinary), injections, tablets, granules and capsules, and all production lines have passed GMP certification. Lincomycin hydrochloride raw material production line has passed FDA certification in the United States, GMP certification in Germany, registration in Spain, Canada, Japan and other countries; Lincomycin hydrochloride and clindamycin phosphate obtained CEP certificate.

Staff size:About 700 persons

Registered capital:RMB 90 million 


Producer:Henan Xinxiang Huaxing Pharmaceutical Factory is located in the Central Plains. It is close to Beijing Guangzhou railway in the West and national highway 107 in the East. The transportation is very convenient. The factory covers an area of more than 300000 square meters, with a construction area of more than 130000 square meters, and has a group of high and intermediate technical teams and management personnel. The annual production of inosine is more than 200 tons, penicillin is more than 1000 tons, 6-APA, ampicillin, ampicillin sodium, erythromycin and penicillin powder injection are 600 million, and commodity hall powder is 20000 tons. The production of dipyridamole, ofloxacin, jiemycin, n-butanol, acetone, ethanol, butyl acetate, ethyl acetate and other products. Huaxing Pharmaceutical Factory has established a perfect quality control and quality assurance system, and has advanced testing instruments at home and abroad. Its products are sold at home and abroad and are praised by our customers. Huaxing Pharmaceutical Factory is one of China's large inosine and antibiotic manufacturers. Party and state leaders Jiang Zemin and Li Peng visited and spoke highly of it.

Staff size:100-199 persons

Registered capital: RMB 799 million


Producer:Jiangsu Hibroad Bio-pharnaceutical Co., Ltd., whose office address is located at No. 6, Zhongshan Road, coastal industrial park, Jiangsu Binhai Economic Development Zone, Yancheng, the traditional Jiangnan culture and land of fish and rice, was registered with Binhai County market supervision and Administration Bureau on April 28, 2011, with a registered capital of 40 million yuan. In the 10 years of development and growth of the company, We always provide customers with good product and technical support and sound after-sales service. Our company is mainly engaged in drug production {raw material drug [lincomycin hydrochloride, lincomycin hydrochloride (for injection)]} and chemical product production (vancomycin hydrochloride, teicoplanin, daptomycin and acarbose).
Staff size:About 50 persons

Registered capital:RMB 463 million


Producer:North China Pharmaceutical Group Hualuan Co., Ltd. was completed and put into operation in September 1986. It is the largest antibiotic production base in China and the holding subsidiary of North China Pharmaceutical Group. The company covers an area of 200000 square meters, has fixed assets of 200 million yuan, and has nearly 1000 employees, of which 25% are professional technicians. It mainly produces lincomycin hydrochloride API, gentamicin sulfate API, vitamin B12 API and vitamin B12 feed additives, with a fermentation capacity of 3200 tons. The production technology level and production cost are the advanced level of the same industry in China, and the environmental protection treatment has reached the standard in 2000. The company takes "quality is always the first, human health is supreme" as its purpose, and adopts internationally advanced production equipment and technology. A sound quality assurance system ensures the full implementation of GMP. The product quality adopts international advanced quality standards. The products are exported to Europe, the United States and other places, and the export volume accounts for 80% of the total output.

Staff size:50-99 persons
Registered capital:RMB 11.46 million


Producer:Jiangxi Guoyao Pharmaceutical Limited Liability Company,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


Producer:Harbin Pharmaceutical Group General Pharmaceutical Factory belongs to Harbin Pharmaceutical Group Co., Ltd., which is a sino-foreign joint stock enterprise. It is a key antibiotic production base in China, a national large-scale first-level pharmaceutical enterprise, and one of the 500 large industrial enterprises in China.

Founded in 1958, the factory mainly produces penicillin and cephalosporin antibiotics, with a total of more than 30 kinds of apis and 18 kinds of dosage forms. It covers an area of 1.09 million square meters and has fixed assets of 2.156 billion yuan. It also has the production capacity of 1000 tons/year of 6-APA, 800 tons/year of 7-ACA, 4300 tons/year of antibiotic apis and intermediates and 3 billion doses of powder.

Staff size:3000-3999 persons

Registered capital:---


Producer:Topfond Pharmaceutical Co., Ltd.is a large-scale large-scale enterprise integrating the production and sales of finished products, chemical synthesis raw materials and biological fermentation raw materials, and pharmaceutical management. Comprehensive pharmaceutical company.

Topfond Pharmaceutical was founded in 1969. In December 2000, the A shares of Topfond  Pharmaceutical was listed on the Shanghai Stock Exchange. After more than 40 years of hard work, the company has grown from small to large, from weak to strong, and has now developed into a large pharmaceutical group with 5 subsidiaries, 4 production plants and 1 national technology development center. It has 4000 employees. There are more than 4 people with total assets of more than 4 billion yuan. The company's production scale of finished preparations and fermentation tonnage of antibiotic raw materials are among the best in the industry in the country. Joined China General Technology Group in August 2008. In July 2013, it successfully realized the merger and absorption of shares exchange with China National Pharmaceutical and Health Industry Co., Ltd., and was officially included in China Pharmaceutical Management.

Topfond Pharmaceutical produces and reserves more than 10 types and nearly 600 varieties and specifications of products. It has an oral solid preparation workshop with an annual production capacity of nearly 6 billion tablets (tablets), the scale is among the forefront of the industry; the antibiotic fermentation tonnage is 12,000m³. The raw materials and some preparation products are exported to more than 20 countries and regions including Western Europe, Southeast Asia, the Middle East, North Africa, India, etc., and an international marketing network is initially formed.

Staff size:2000-2999 persons

Registered capital:RMB 420 million


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