
Clindamycin Phosphate
CAS number: 24729-96-2
Molecular formula: C18H34ClN2O8PS
molecular weight: 504.96
Chemical structure:
Producers shown on SFDA
(Record date:26/08/2021)
Producer | Documents | GMP Valid till(based on SFDA) |
Zhejiang Xianju Pharmaceutical Co., Ltd. | GMP | Valid till December 2022 |
Hubei Yitai Pharmaceutical Co., LTD. | GMP | Valid till December 2022 |
Xinyu Pharmaceutical Co., Ltd. | GMP, DMF | Valid till September 2024 |
Zhejiang Tiantai Pharmaceutical Co., Ltd. | GMP | Valid till November 2024 |
Nanyang Pukang Pharmaceutical Co., Ltd. | GMP | Valid till November 2024 |
Fuan Pharmaceutical Group Chongqing Bosen Pharmaceutical Co., Ltd. | GMP | Valid till March 2022 |
Zhejiang Hisoar Pharmaceutical Co.,Ltd. | GMP, DMF | Valid till January 2022 |
North China Pharmaceutical Huasheng Co., Ltd. | GMP | Valid till May 2019 |
Chongqing Carelife Pharmaceutical Co., Ltd. | GMP | Valid till November 2020 |
Topfond Pharmaceutical Co., Ltd. | GMP | December 2020 |
Producers shown on EP
(Quoted from EP website;record date:26/08/2021)
Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
Clindamycin phosphate | Zhejiang Candorly pharmaceutical Co., Ltd. CN 317 500 Taiping, Wenling City | R0-CEP 2007-299-Rev 01 | 08/03/2012 | WITHDRAWN BY HOLDER | 20/03/2015 | Chemistry |
Clindamycin phosphate | ACS DOBFAR S.P.A. IT 20067 Tribiano | R1-CEP 1999-025-Rev 01 | 15/06/2007 | WITHDRAWN BY HOLDER | 16/01/2012 | Chemistry |
Clindamycin phosphate Albano plant | ACS DOBFAR S.P.A. IT 20067 Tribiano | R1-CEP 2006-033-Rev 03 | 16/03/2020 | VALID | / | Chemistry |
Clindamycin phosphate Product code number 60960 | Union Quimico Farmaceutica, S.A. (Uquifa S.A.) ES 08008 Barcelona | R0-CEP 2003-177-Rev 01 | 14/01/2010 | EXPIRED | 13/05/2010 | Chemistry |
Clindamycin phosphate BTC process | ZHEJIANG HISOAR PHARMACEUTICAL CO., LTD. CN 318 000 Taizhou | R1-CEP 2013-178-Rev 01 | 25/11/2020 | VALID | / | Chemistry |
Clindamycin phosphate | Suzhou No.4 Pharmaceutical Factory CN 215 008 Suzhou | R0-CEP 2007-250-Rev 01 | 07/07/2009 | WITHDRAWN BY EDQM | 20/12/2013 | Chemistry |
Clindamycin phosphate | XINYU PHARMACEUTICAL CO., LTD. CN 234 000 Suzhou City | R1-CEP 2011-019-Rev 01 | 13/06/2018 | VALID | / | Chemistry |
Clindamycin phosphate | ZHEJIANG HISOAR PHARMACEUTICAL CO., LTD. CN 318 000 Taizhou | R1-CEP 2000-256-Rev 05 | 31/01/2019 | VALID | / | Chemistry |
Clindamycin phosphate | Union Quimico Farmaceutica, S.A. (Uquifa S.A.) ES 08008 Barcelona | R1-CEP 2000-097-Rev 03 | 22/07/2020 | VALID | / | Chemistry |
Clindamycin phosphate Alternative process | Chongqing Carelife Pharmaceutical Co. Ltd. CN 401 254 Chongqing | R1-CEP 2009-398-Rev 03 | 21/01/2021 | VALID | / | Chemistry |
Clindamycin phosphate | Chongqing Carelife Pharmaceutical Co. Ltd. CN 401 254 Chongqing | R1-CEP 2005-033-Rev 02 | 03/02/2015 | VALID | / | Chemistry |
Clindamycin phosphate | ZHEJIANG TIANTAI PHARMACEUTICAL CO., LTD. CN 317 200 Taizhou, Tiantai County | R1-CEP 2003-060-Rev 05 | 28/03/2019 | VALID | / | Chemistry |
Producer:Zhejiang Xianju Pharmaceutical Co., Ltd., formerly known as Xianju pharmaceutical factory, was founded in 1972. It is a professional manufacturer of steroids in China, a designated manufacturer of national family planning drugs, a key high-tech enterprise of the national torch plan, a national contract abiding and trustworthy enterprise, etc. The total share capital of the company is 916.2166 million yuan, covering an area of 650 mu. At present, the company has more than 3900 employees, including 15% technical personnel and 35% sales personnel. It is a comprehensive manufacturer of APIs and preparations.
The company's products are unique, and its main business is the development, production and sales of steroidal APIs and preparations. It mainly produces corticosteroids, sex hormones (gynecological and family planning drugs) and anesthetics and muscle pines. There are nearly 200 varieties, with a production capacity of 300 tons of API, 10 billion tablets, 500 million capsules, 500 million water needles, 20 million lyophilized powder injections, 35 million creams and 60 million bags of granules.
At present, all products of the company have passed the national GMP certification. 13 products such as vecuronium, prednisone acetate, prednisolone and medroxyprogesterone acetate have been certified by FDA; Nine products including cyproterone acetate, prednisolone and norethisterone have obtained the EU CEP certificate; Prednisolone, betamethasone dipropionate and betamethasone valerate have passed the KFDA certification in Korea; Small volume injection production line and comprehensive solid preparation production line (I) have passed the invima certification in Colombia.
Staff size:About 4000 persons
Registered capital:RMB 989 million 200 thousand
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: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:Fuan Pharmaceutical Group Chongqing Bosen Pharmaceutical Co., Ltd.was spun off from the group company to become a wholly-owned holding subsidiary on September 1, 2016. It has more than 600 employees, of which personnel with bachelor's degree or above account for 1 / 3 of the company, mainly engaged in the production and sales of APIs and preparations. At present, it mainly involves the fields of anti infection, anti-tumor, mental nervous system, cardiovascular and cerebrovascular system, digestive system, endocrine and metabolism, bone and muscle system and so on.
Staff size:600 persons
Registered capital:RMB 10 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: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.
Staff size:900-999 persons
Registered capital:RMB 237 million 475 thousand and 100
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: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