Home>APIs>

Clindamycin Hydrochloride

CAS number: 21462-39-5

Molecular formula: C18H34Cl2N2O5S

molecular weight: 461.444

Chemical structure:

Producers shown on SFDA

(Record date:26/08/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Changzhou Minbang Pharmaceutical Co., Ltd.

GMP
Valid till January 2023

Hainan Haishen Tongzhou Pharmaceutical Co., Ltd.

GMP
Valid till March 2019

Hubei Yitai Pharmaceutical Co., Ltd. 

GMP, DMF
Valid till December 2020

 Chongqing Land Tower Pharmaceutical Co., Ltd.

GMP
Valid till June 2023

Zhejiang Hisoar Pharmaceutical Co.,Ltd. 

GMP, DMF
Valid till December 2018

Zhejiang Hisoar Chuannan Pharmaceutical Co., Ltd.

GMP
Valid till January 2022

Xinyu Pharmaceutical Co., Ltd. 

GMPValid till September 2024

Zhejiang Tiantai Pharmaceutical Co., Ltd.

GMP
Valid till November 2024

Nanyang Pukang Pharmaceutical Co.

GMP
Valid till November 2024

Chongqing Angelisun Pharmaceutical Co., Ltd.

GMPValid till August 2022

Suzhou No.4 Pharmaceutical Factory Co., Ltd.

GMP
Valid till February 2018

Chongqing Carelife Pharmaceutical Co., Ltd.

GMP
Valid till November 2022

Changzhou Lanling Pharmaceutical Co., Ltd.

GMPValid till July 2020

PKU HealthCare Corp., Ltd.

GMP
Valid till March 2022

Huabei pharmaceutical Huasheng Co., Ltd.

GMP
Valid till November 2019

Topfond Pharmaceutical Co., Ltd.

GMP
Valid till January 2023

Huazhong Pharmaceutical Co., Ltd.

GMP
Valid till February 2021


Producers shown on EP

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

Substance
Certificate Holder
Certificate Number
Issu  Date
Status
End  dateType
Clindamycin hydrochloride
Suzhou No.4 Pharmaceutical Factory CN 215 008 Suzhou
 R0-CEP 2005-287-Rev 00
28/07/2008
WITHDRAWN BY EDQM
20/12/2013
Chemistry
Clindamycin hydrochloride BTC Process
ZHEJIANG HISOAR PHARMACEUTICAL CO., LTD. CN 318 000 Taizhou
R1-CEP 2013-190-Rev 01
30/11/2020
VALID
/Chemistry
Clindamycin hydrochloride
Union Quimico Farmaceutica, S.A. (Uquifa S.A.) ES 08008 Barcelona
R1-CEP 2000-041-Rev 08
19/06/2020
VALID
/Chemistry
Clindamycin hydrochloride
Chongqing Carelife Pharmaceutical Co. Ltd. CN 401 254 Chongqing
 R1-CEP 2000-210-Rev 08
10/03/2021
VALID
/Chemistry
Clindamycin hydrochloride
ZHEJIANG TIANTAI PHARMACEUTICAL CO., LTD. CN 317 200 Taizhou, Tiantai County
R1-CEP 2010-281-Rev 02
28/03/2019
VALID
/Chemistry
Clindamycin hydrochloride
ACS DOBFAR S.P.A. IT 20067 Tribiano
R1-CEP 2002-132-Rev 03
13/04/2018
VALID/Chemistry
Clindamycin hydrochloride
ZHEJIANG HISOAR PHARMACEUTICAL CO., LTD. CN 318 000 Taizhou
R1-CEP 2000-255-Rev 01
06/04/2018
WITHDRAWN BY HOLDER
08/09/2020
Chemistry

Producer:Changzhou Minbang Pharmaceutical Co., Ltd. is the subsidiary company of Zhuhai Ebang Pharmaceutical Co., Ltd., it is established in May, 2012, the total area is 39093 M2. It is located in the Binjiang economic development zone, Xinbei district, Changzhou city, Jiangsu province, It is an area of chemical production which planned by Changzhou government, approved by Jiangsu province government and announced by NDRC. Our site is near with the high-speed rail and highway, the transportation is convenient. To changzhou north railway station is 18km, to Huning highway is 8km. The total employees are about 70, 25% staff are college or above. Our site has 1 synthesis workshop and 1 cleaning workshop which is include non-sterile API production line and sterile API production line. In the future, 1 pilot workshop and 1 API production workshop will be built. The main products: clindamycin hydrochloride, clindamycin phosphate and quetiapine fumarate, all passed the CFDA GMP inspection. 

Staff size:About 50 persons

Registered capital:RMB 40 million


Producer:Hainan Haishen Tongzhou Pharmaceutical Co., Ltd.is the production base of solid, capsule, ointment suppository and API of the group company, with solid workshop, soft capsule workshop, ointment suppository workshop and raw material workshop. The main dosage forms include cream, suppository, tablet, capsule (soft capsule), granule, powder and dry suspension. The company has passed the national GMP certification in 2002. Sertaconazole nitrate cream (lilingqi), compound glutamine granules (SELAN), ofloxacin suppository and Loratadine Tablets (Shetai), the national class II antifungal drugs exclusively produced in China, have been vigorously promoted in all provinces, cities and counties across the country, and dozens of new varieties such as soft capsules and solid preparations have been continuously listed.

Staff size:2000-2999 persons

Registered capital:RMB 10.5 million


Producer:Hubei Yitai Pharmaceutical Co., Ltd. is a professional APIs  and food additives manufacturer. The company was founded in 2000 with a registered capital of 99.9 million RMB. After more than ten years of development, the total assets have reached to 400 million RMB. The total number of employees is 600. Among them, more than 30% are technicians from more than 10 provinces and cities. The company covers an area of 333000 m2, and the green area accounts for more than 35% of the total area.

Staff size:About 600 persons

Registered capital:RMB 106.566666 million 


Producer:Chongqing Land Tower Pharmaceutical Co., Ltd., established on April 21, 2010, is located at No. 4, Huanan 1st Road, Yanjia chemical park, Changshou District, Chongqing. Chongqing langtian pharmaceutical is committed to taking high technology and internationalization as the company's strategic goal, focusing on the development of characteristic APIs and innovative drug intermediates; Through 3-5 years of efforts, the company's leading products have passed the quality certification of FDA, EDQM in Europe and SFDA in China, and entered the international mainstream drug markets such as Europe and the United States; Chongqing langtian pharmaceutical will build the company into a world-class R & D and production enterprise of characteristic APIs and innovative drug intermediates.

Staff size:100-199 persons

Registered capital:RMB 40 million


Producer:Zhejiang Hisoar Pharmaceutical Co.,Ltd. located in Taizhou, Zhejiang Province, is a listed company controlled by Donggang group, which mainly produces characteristic APIs, preparations, fine chemicals, dyes and dye intermediates.

The company's main products are antibiotics, cardiovascular, hypoglycemic and other APIs, fine chemicals, preparations, dyes and intermediates. More than 70% of pharmaceutical products are exported, and the output of clindamycin series is firmly in the leading position in the world. The company attaches great importance to the construction of EHS and GMP system. Dozens of products have registered with the US FDA, obtained the EU CEP (COS) certificate, passed the Japanese GMP certification and domestic GMP certification. Dye products are exported to more than 30 countries and regions such as Europe, America and Asia. The leading product reactive brilliant blue KN-R accounts for more than 60% of the global market share. It is in a leading position in the industry in terms of industrial scale, technical quality and product application“ "Dye eight brand" reactive dyes are rated as China's famous brand products and national excellent torch plan projects. They are one of the three famous brand dyes in China.

Staff size:500 persons

Registered capital:RMB 1 billion 618 million 715 thousand and 253 


Producer:Zhejiang Haixiang Chuannan Pharmaceutical Co., Ltd. is a wholly-owned subsidiary of Zhejiang Haixiang Pharmaceutical Co., Ltd., which was listed and invested in November 2005. It produces pharmaceutical intermediates and APIs. Its main products include antibiotics, fine chemicals, antiviral, cardiovascular, insect repellent, hypoglycemic, etc. Among the products, the output of clindamycin series, thiamphenicol series, nicotinic acid series, bit and biphenyl diester ranks first in China.

Staff size:1000-1999 persons

Registered capital:RMB 640 million


Producer:Xinyu Pharmaceutical Co., Ltd. is a comprehensive pharmaceutical enterprise based on research and development and production of microbiological drugs, the National High-tech Enterprise, Anhui Province's first batch of technology innovation enterprises, Anhui Province's production, education and research demonstration enterprises, Anhui Province AAA credit enterprises. The company covers an area of 500 mu, with the total assets of 1 billion yuan.

The company has established a sound quality assurance system, all production lines have passed the national GMP certification. The company is set up as the pharmaceutical GMP practice training base by Anhui Provincial Food and Drug Administration. Lincomycin hydrochloride production line has passed America FDA certification, German GMP certification, Spain, Canada, Japan and other countries registered. Lincomycin hydrochloride, clindamycin phosphate obtained CEP certificate. 

Staff size:About 700 persons

Registered capital:RMB 90 million 


Producer:Zhejiang Tiantai Pharmaceutical Co., Ltd., established in June 1998, is a pharmaceutical enterprise specializing in the production of antibiotic and antifungal series APIs such as clindamycin hydrochloride and clindamycin phosphate. The company covers an area of more than 40000 square meters and a construction area of 15000 square meters. It is located in Tiantai County, the "source of Buddhism and Taoism and the beauty of mountains and rivers". It is adjacent to national highway 104 in the west, and Shanghai Hangzhou Expressway goes directly to Tiantai. The company has nearly 400 employees and an excellent professional R & D team; D technical team to provide solid guarantee for meeting customers' various needs for products. The subsidiary Hangzhou Tianze biomedical Co., Ltd. is mainly engaged in technology development and research.

The company's products clindamycin hydrochloride and clindamycin phosphate have obtained the GMP certification of national drug raw materials, and have been registered in Europe, the United States, Australia, Brazil, India and other countries. Before and after passing the official on-site inspection of EDQM, USFDA and Anvisa, the company has obtained relevant qualifications and certificates such as eugmp, CEP and eir. The company's products are exported to overseas markets with excellent quality and good service.
The company attaches great importance to environmental protection, follows the EHS policy, strengthens the whole process prevention principle, prevents the occurrence of environmental pollution and health hazard accidents, and has passed the ISO14001 environmental management system and OHSAS18001 occupational health and safety management system certification, ensuring the company's safe, efficient, sustainable and stable supply strength.

Staff size:300-399 persons

Registered capital:RMB 77.4 million


Producer:Nanyang Pukang Pharmaceutical Co., Ltd. is a national large class I enterprise, a key supporting enterprise in bioengineering and new pharmaceutical industry in Henan Province, and one of the 50 key enterprises in Henan Province. In February 2008, new health (China) Lim itemed Xinkang China Co., Ltd. wholly acquired Nanyang Pukang Pharmaceutical Co., Ltd. and Nanyang Pukang group Hengyi Pharmaceutical Co., Ltd. and the two companies were restructured into foreign companies. New health (China) Limited Xinkang China Co., Ltd. wholly acquired Nanyang Pukang Pharmaceutical Co., Ltd. and Nanyang Pukang group Hengyi Pharmaceutical Co., Ltd, The two companies were restructured into wholly foreign-owned enterprises.

Nanyang Pukang Pharmaceutical Co., Ltd. has more than 1700 employees, covering an area of 160000 square meters. The company has two production bases in Nanyang city and Zhenping county, a total of 12 production units and a provincial technical center. It has formed a GMP standard production base and a wholly-owned enterprise integrating antibiotics, biological and biochemical drugs and preparations. Nanyang Pukang Pharmaceutical Co., Ltd. currently has more than 1700 employees and covers an area of 160000 square meters. The company has two production bases in Nanyang city and Zhenping county, a total of 12 production units and a provincial technical center. It has formed a GMP standard production base integrating antibiotics, biological and biochemical drugs and preparations.

Staff size:500 persons

Registered capital:RMB 132 million


Producer:Established in 2008, Chongqing Angelisun Pharmaceutical Co., Ltd.has become a high-tech group company integrating R & D, production, sales, export and internet medical services. The company is committed to becoming an innovative enterprise in the pharmaceutical and health industry and providing high-quality products and services for human health. At present, it has a professional innovation team led by many postdoctors and senior engineers, and maintains a good cooperation mechanism with first-class R & D institutions and expert teams at home and abroad.

Staff size:50-99 persons

Registered capital:RMB 42 million


Producer:Suzhou No. 4 Pharmaceutical Factory Co., Ltd., founded in 1952, specializes in the production, R & D of APIs and preparations, and is committed to providing high-quality pharmaceutical products for human healthy life.

Suzhou No. 4 Pharmaceutical Factory Co., Ltd. has strong production and R & D capacity and perfect quality assurance and service system. All products have passed the GMP certification of the State Food and drug administration. Three varieties of the company have passed the FDA certification and obtained the European CEP certificate, making the company a qualified supplier for many well-known multinational companies such as Abbott and Pfizer. Its products are exported to more than 20 countries such as the United States, Western Europe and Southeast Asia.

Staff size:50-99 persons
Registered capital:RMB 78 million


Producer:Chongqing Carelife Pharmaceutical Co., Ltd. is an export-oriented API manufacturer under Chongqing Yaoyou Pharmaceutical Co., Ltd. Located in Chongqing Changshou chemical industry park, the company has a modern API production base that meets the current international and domestic drug production quality management standards. The company has established a strict quality assurance system with international advanced level. Its products have passed the U.S. Food and Drug Administration (FDA), European Drug Quality Management Council (EDQM) and Japan's drug and medical device administration (PMDA) and India's Ministry of health have been certified and approved.

Carelife pharmaceutical has long been committed to the development of international and domestic markets, especially the international regulatory market. Clindamycin hydrochloride series products have the first market share in the United States, and has established a long-term and stable cooperative relationship with international famous multinational pharmaceutical enterprises.

Staff size:300-399 persons

Registered capital:RMB 16 million 85 thousand and 667


Producer:Changzhou Lanling Pharmaceutical Co., LTD. (changzhou No.2 Pharmaceutical Factory), founded in 1962, is a comprehensive pharmaceutical enterprise specializing in the production of chemical synthetic bulk drugs, small volume injections, capsules, tablets, granules and other preparations. Jiangsu province is the backbone of the pharmaceutical industry, national high-tech enterprises. The company is a foreign-funded enterprise fully invested by Hong Kong Jiaao Co., LTD., located in the southeast economic Development Zone of Changzhou city in the Yangtze River Delta Economic zone, where the city has complete water, land and air transportation facilities, education, science and technology, talent, information and other resources developed, so as to provide a good resource guarantee for the long-term and stable development of the enterprise.

Staff size:200-299 persons

Registered capital:RMB 25 million


Producer:PKU HealthCare Corp., Ltd.is a core member enterprise of Founder group medical and pharmaceutical industry - Peking University medical industry group. It has more than 50 years of pharmaceutical manufacturing history and a national technology center. It is a key backbone enterprise of Chinese medicine, a national innovative pilot enterprise and a key high-tech enterprise of the national torch plan.

Peking University Pharmaceutical has a pharmaceutical manufacturing base built according to international cGMP in Liangjiang New Area, Chongqing. Its products cover more than 10 categories and more than 100 varieties, such as anti-tumor, psychoneurological, cardiovascular, immunosuppressive, anti microbial, antipyretic and analgesic. The company has a perfect quality assurance system, which has passed the FDA and EU GMP certification.

Staff size:About 800 persons

Registered capital:RMB 596 million


Producer:Huabei pharmaceutical Huasheng Co., Ltd. is a Sino foreign joint venture controlled by Huabei Pharmaceutical Co., Ltd. and jointly invested and built with Hong Kong Changying Finance Co., Ltd. and American Yongsheng International Co., Ltd. in 1995. Taking "human health first, quality first forever" as the guideline and international standards as the guidance, Huasheng Company has established a perfect quality management system and passed the GMP certification in 2001. With the development of the enterprise, the company has continuously improved its quality management concept and brought its quality management system into line with international standards. It has successively accepted the on-site review of EDQM and who officials, the pre audit of FDA customers and the customer audit of Pfizer, which have been highly praised.

After nearly ten years of operation and development, Huasheng Company has become a pharmaceutical enterprise with multi variety production. Its main products include streptomycin sulfate, dihydrostreptomycin API and its series products, amphotericin B, vancomycin, spectinomycin hydrochloride, chunleimycin hydrochloride, capreomycin sulfate, bacitracin, bacitracin zinc, etc. Its production management and main technical indicators are in a leading position at home and abroad. Huasheng Pharmaceutical Co., Ltd. has an annual output of 1200 tons of streptomycin, accounting for 75% of the total output in Asia and 60% of the world. It is the largest streptomycin production company in Asia and the world.

Staff size:900-999 persons

Registered capital:RMB 237 million 475 thousand and 100


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


Producer:Huazhong Pharmaceutical Co., Ltd. is subordinate to China Ordnance Equipment Group Corporation. It is located in Xiangyang City, an important town in Northwest Hubei Province with beautiful scenery and rich resources. It covers an area of 700000 square meters. It is a modern comprehensive pharmaceutical enterprise integrating R & D, production and sales of pharmaceutical products. The company has strong technical force, complete quality testing equipment and quality assurance system, advanced production technology and equipment, and has passed GMP, fami-qs, HACCP, ISO9001, ISO22000, kosher, halal and other certifications.

Subsidiaries of Huazhong Pharmaceutical Co., Ltd.: Hubei 295 Technology Co., Ltd. and Xiangfan 295 Pharmaceutical Trading Co., Ltd. We are the earliest manufacturer of vitamin B1 raw materials in China and the largest in the world. The product quality meets the quality standards of CP, BP, USP, EP and JP. At the same time, we have also developed VB1 Granule Series and VB1 derivative series products.

Staff size:600-699 persons

Registered capital:RMB 245 million 148 thousand and 515


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