
Paclitaxel
CAS number: 33069-62-4
Molecular formula: C47H51NO14
molecular weight: 853.91
Chemical structure:
Producers shown on SFDA
(Record date:06/09/2021)
Producer | Documents | GMP Valid till(based on SFDA) |
Haikou Pharmaceutical Factory Co., Ltd. | GMP | Valid till March 2023 |
Xichang Kaiyuankang Pharmaceutical Co., Ltd. | GMP | Valid till September 2017 |
Shanghai Zhongxi Sunve Pharmaceutical Co., Ltd. | GMP | Valid till December 2019 |
Fujian South Pharmaceutical Co.,Ltd. | GMP | Valid till September 2023 |
Hainan Yew Pharmaceutical Co., Ltd. | GMP | Valid till December 2021 |
Zhejiang Hisun Pharmaceutical Co., Ltd. | GMP | Valid till May 2022 |
Yunnan Hande Bio-Tech Co., Ltd. | GMP | Valid till June 2018 |
Shanghai Jinhe Bio-Pharmaceutical Co., Ltd. | GMP | Valid till January 2022 |
Chongqing Beisheng Pharmaceutical Co., Ltd. | GMP | Valid till March 2023 |
Gulin Huiang Biochemistry Pharmaceutical Co., Ltd. | GMP | Valid till February 2024 |
Shanghai Acebright Pharmaceuticals Co., Ltd. | GMP | Valid till November 2021 |
Chongqing Taihao Pharmaceutical Co., Ltd. | GMP | Valid till April 2024 |
Ningbo Green-Health Pharmaceutical Co., Ltd. | GMP | Valid till July 2020 |
Wuxi Taxus Pharmaceutical Co., Ltd. | GMP | Valid till October 2019 |
Producers shown on EP
(Quoted from EP website;record date:06/09/2021)
Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
Paclitaxel Isolated from natural sources | CENWAY PHARMACEUTICALS CO., LTD. CN 300480 Tianjin | R0-CEP 2009-064-Rev 00 | 22/11/2010 | WITHDRAWN BY HOLDER | 23/07/2013 | Chemistry |
Paclitaxel Produced by a semi-synthetic process, product code SPT 1308 | SCINOPHARM TAIWAN, LTD. TW 74144 Shan-Hua | R0-CEP 2015-278-Rev 01 | 25/06/2020 | VALID | / | Chemistry |
Paclitaxel Produced by a semi-synthetic process | SERIPHARM S.A.S. FR 72000 Le Mans | R1-CEP 2008-327-Rev 00 | 02/09/2014 | VALID | / | Chemistry |
Paclitaxel Produced by a semi-synthetic process – Process II | INDENA S.P.A. IT 20139 Milano | R0-CEP 2019-346-Rev 02 | 23/02/2021 | VALID | / | Chemistry |
Paclitaxel isolated from natural source: roots of Taxus x media | INDENA S.P.A. IT 20139 Milano | R1-CEP 2006-319-Rev 00 | 26/03/2013 | VALID | / | Chemistry |
Paclitaxel produced by semi-synthetic process | INDENA S.P.A. IT 20139 Milano | R1-CEP 2008-102-Rev 02 | 25/08/2020 | VALID | / | Chemistry |
Paclitaxel Semi synthetic process | PHYTON BIOTECH LLC CA V3M 6P7 Delta | R1-CEP 2008-077-Rev 02 | 30/10/2018 | VALID | / | Chemistry |
Paclitaxel Isolated from natural sources | YUNNAN HANDE BIO-TECH CO., LTD. CN 650 301 Taiping Town | R1-CEP 2008-031-Rev 02 | 18/08/2020 | VALID | / | Chemistry |
Paclitaxel Isolated from natural sources | TEVA CZECH INDUSTRIES S.R.O. CZ 747 70 Opava | R1-CEP 2007-212-Rev 00 | 18/10/2013 | VALID | / | Chemistry |
Paclitaxel Produced by semi-synthetic process | INTAS PHARMACEUTICALS LIMITED GB HA1 4HF North Harrow | R1-CEP 2012-385-Rev 00 | 14/03/2019 | VALID | / | Chemistry |
Paclitaxel Isolated from natural source: whole plant of Taxus x media | INDENA S.P.A. IT 20139 Milano | R1-CEP 2006-320-Rev 02 | 19/11/2020 | VALID | / | Chemistry |
Paclitaxel Isolated from natural sources | TAIHUA NATURAL PLANT PHARMACEUTICAL CO., LTD. CN 726 100 Shangzhou | R0-CEP 2008-005-Rev 00 | 24/09/2009 | WITHDRAWN BY EDQM | 15/09/2011 | Chemistry |
Paclitaxel Produced by a semi-synthetic process | POLYMED THERAPEUTICS, INC. US 77036 Houston | R1-CEP 2014-192-Rev 00 | 29/06/2021 | VALID | / | Chemistry |
Paclitaxel Produced by a semi-synthetic process | SAMYANG BIOPHARMACEUTICALS CORPORATION KR 306-230 Daejeon | R0-CEP 2014-061-Rev 00 | 14/01/2016 | EXPIRED | 14/01/2021 | Chemistry |
Paclitaxel Semi-synthetic process | FRESENIUS KABI ONCOLOGY LIMITED IN 741 235 Kalyani | R1-CEP 2008-181-Rev 07 | 28/04/2020 | VALID | / | Chemistry |
Paclitaxel isolated from natural sources | POLYMED THERAPEUTICS, INC. US 77036 Houston | R1-CEP 2010-143-Rev 01 | 17/04/2019 | VALID | / | Chemistry |
Paclitaxel Produced by fermentation | SAMYANG HOLDINGS CORPORATION KR 13488 Gyeonggi-do | R1-CEP 2009-255-Rev 02 | 12/08/2021 | VALID | / | Chemistry |
Paclitaxel produced by a semi-synthetic process | WUHAN CALMLAND PHARMACEUTICALS CO., LTD. CN 430 075 Wuhan | R0-CEP 2018-004-Rev 00 | 25/06/2019 | VALID | / | Chemistry |
Paclitaxel Produced by fermentation | PHYTON BIOTECH LLC CA V3M 6P7 Delta | R1-CEP 2011-324-Rev 01 | 20/11/2018 | VALID | / | ChemistryV |
Paclitaxel Produced by a semi-synthetic process | MSN LABORATORIES PRIVATE LIMITED IN 502 300 Kardanur Village | R0-CEP 2020-038-Rev 00 | 20/08/2021 | VALID | / | Chemistry |
Paclitaxel Produced by semi-synthetic process | TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva | R1-CEP 2009-236-Rev 02 | 06/02/2020 | VALID | / | Chemistry |
Paclitaxel Produced by semi-synthetic process | YUNNAN HANDE BIO-TECH CO., LTD. CN 650 033 Kunming | R1-CEP 2010-091-Rev 01 | 03/02/2017 | VALID | / | Chemistry |
Paclitaxel Produced by a semi-synthetic process | Fujian South Pharmaceutical Co., Ltd. CN 365 200 Sanming City | R0-CEP 2019-110-Rev 01 | 08/04/2021 | VALID | / | Chemistry |
Paclitaxel Produced by a semi-synthetic process | SCINOPHARM TAIWAN, LTD. TW 74144 Shan-Hua | R1-CEP 2009-209-Rev 01 | 17/05/2019 | VALID | / | Chemistry |
Paclitaxel Produced by a semi-synthetic process | CORDEN PHARMA BOULDER, INC. US 80301 Boulder | R1-CEP 2009-126-Rev 01 | 05/02/2021 | VALID | / | Chemistry |
Producer:Haikou Pharmaceutical Factory Co., Ltd. is subordinate to Hainan Haiyao Co., Ltd.
Hainan Haiyao Co., Ltd. was founded in 1965 and listed on Shenzhen Stock Exchange in 1994. The company's main products cover intermediates, APIs, chemical innovative drugs, modern traditional Chinese medicine, biological drugs, cellular immunity, high-end medical devices and other fields. It has established intermediates and APIs bases in Chongqing and Jiangsu, and preparation production bases in Tianjin and Hainan. It has the advantages of the whole industrial chain of characteristic antibiotics, focusing on high value-added generic drugs and characteristic drugs, The core varieties have high popularity in the industry.
Staff size:1000-1999 persons
Registered capital:RMB 562 million 352 thousand and 31
Producer:Xichang Kaiyuankang Pharmaceutical Co., Ltd., established in 2012, belongs to the pharmaceutical manufacturing industry. Its business scope includes the production and sales of API (paclitaxel, calcium acetate, ferrous fumarate, prasug hydrobromide and febuxostat).
Staff size:About 50 persons
Registered capital:RMB 8 million
Producer:Shanghai Zhongxi Sunve Pharmaceutical Co., Ltd. was jointly established by Shanghai Zhongxi Pharmaceutical Co., Ltd. and Shanghai Sunv Pharmaceutical Co., Ltd. in 2010. The company now has APIs, preparations, pharmaceutical intermediates and other products. Some APIs have successively passed FDA certification and successful registration of edmf documents.
The company has three production bases: Spark base, a large-scale Ted API production base in line with international and domestic cGMP and EHS standards, and also a flashy base for the research industry; Waigang base, a preparation production base in line with domestic GMP standards; Jinhe base is a plant-derived antitumor API production base in line with the international and domestic cGMP level.
Staff size:200-299 persons
Registered capital:RMB 545.8 million
Producer:Fujian South Pharmaceutical Co.,Ltd. , established in September 2001, is committed to the R & D and production of antitumor drugs represented by paclitaxel API.
Its Xuefeng and Hanxian plants cover an area of 131000 square meters, with 4000 mu of preferred Southern yew planting base. The company's quality management meets international standards. Now it has passed the on-site inspection of EU EDQM, China GMP and US FDA, and obtained China GMP、EU-GMP and US-FDA EIRcertificates.
Staff size:300-399 persons
Registered capital:RMB 105.5 million
Producer:Hainan Yew Pharmaceutical Co., Ltd., established in April 2009, is subordinate to Fujian Sansan Pharmaceutical Co., Ltd.
At present, the company has two production lines of API (paclitaxel) and small volume injection (including anti-tumor), and the annual production capacity of API (paclitaxel) is 360kg.
Staff size:About 50 persons
Registered capital:RMB 60 million
Producer:Zhejiang Hisun Pharmaceutical Co., Ltd. was founded in 1956. In 2000, Hisun issued A-shares in Shanghai stock exchange, but it continues to remain a state-owned enterprise. Hisun is one of the largest antibiotics and anti-tumor drug production bases in the country. It has won several titles, including first batch of innovative enterprises, national technology innovation demonstration enterprises, and "National Industrial Brand Demonstration Enterprise” of the Chinese Ministry of Industry and Information Technology.
Hisun began as a small chemical factory and entered the pharmaceutical field in the early 1970s. Since its founding over 60 years ago in 1956, Hisun has amassed a total asset worth of 21.8 billion RMB. While Hisun is primarily engaged in the R&D, manufacturing, and sales and marking of API and final dosage forms of chemical and biological drugs, its core business has extended to include branded generic drugs, biosimilarst and other innovative drugs.
Staff size:About 9000 persns
Registered capital:RMB 1 billion 169 million
Producer:Yunnan Hande Bio-Tech Co., Ltd.is the merely one who had approved by USFDA,EU EDQM, TGA and CFDA. Also national regulatory agencies of India, Japan and other approved us extract anticancer drug paclitaxel API as an independent manufacturers.
The new manufacture base is located in Taiping town, 10km west of Kunming City. It covers an area of 20 acres with over 10,000 square meters of factory buildings.
Staff size:50-99 persons
Registered capital:RMB 4711.643961 million
Producer:Shanghai Jinhe Bio-Pharmaceutical Co., Ltd. is a pharmaceutical enterprise specializing in the research, production and sales of antitumor APIs and intermediates. Founded in March 2002, the company began to undertake international paclitaxel API processing business based on the scientific research achievements of Fudan University. In January 2017, the company successfully passed the GMP certification of API (paclitaxel, docetaxel). Now the company has all product lines of taxanes and has become the largest enterprise in China's yew branch and leaf processing.
Staff size:100-199 persons
Registered capital:RMB 3.4 million
Producer:Chongqing Beisheng Pharmaceutical Co., Ltd.was established in June 2009. At present, the company has built a 3500 square meter R & D center in Chongqing Liangjiang New Area Water and soil high tech park. The production base is located in Sansheng Town, Beibei District, Chongqing. At present, it has built a multi-functional chemical synthesis workshop, biological fermentation workshop and natural product extraction and purification workshop, with about 320 sets of production equipment, The production lines of synthesis, fermentation and preparation are under construction. The 10000 mu yew planting project of the company is located in Qingfeng mountain, Sansheng Town, Beibei District, with an altitude of 800-1040m. The climate, soil and other conditions are suitable for the growth of Taxus mandia. The company carries out artificial cultivation of Taxus mandii in strict accordance with gap specifications. So far, more than 10000 mu of Taxus mandii has been planted, with an annual seedling raising capacity of more than 10 million plants. It has become one of the largest Taxus mandii cultivation and planting parks in China.
Staff size:100-199 persons
Registered capital:RMB 132 million
Producer:Gulin Huiang Biochemistry Pharmaceutical Co., Ltd., founded in July 1998, is a professional manufacturer of paclitaxel API, with a production scale of 400kg / year. The company's production technology of natural paclitaxel API and semi synthetic paclitaxel API has reached the domestic leading level and international advanced level respectively. The products have obtained the national drug registration approval and GMP certificate. Paclitaxel API has obtained the DMF number of FDA.
Staff size:50-99 persons
Registered capital:RMB 38.911 million
Producer:Shanghai Chuang Nuo Pharmaceutical Co., Ltd. is subordinate to Shanghai Chuang Nuo Pharmaceutical Group. The company has established a high standard GMP quality specification system. Take compliance with cGMP, EU GMP and GMP certification as standards, improve management level and continuous improvement, and the quality of similar products meets international standards.
Staff size:200-299 persons
Registered capital:RMB 61 million 211 thousand and 95
Producer:Chongqing Taihao Pharmaceutical Co., Ltd. was established in 2004. The company fully implemented and strictly followed cGMP guidelines (ICH Q7A), gradually introduced ICH Q8, Q9 and Q10, and established a good quality assurance system. At present, many API products of Taihao pharmaceutical have passed the on-site GMP inspection of the US Food and Drug Administration (FDA), the European Drug Quality Council (EDQM), the Japan drug and medical device administration (PMDA), the China food and Drug Administration (CFDA), the French national safety administration of medicine and health products (ansm) and other drug administration departments.
Staff size:100-199 persons
Registered capital:RMB 15 million
Producer:Ningbo Green-Health Pharmaceutical Co., Ltd.has successively passed the GMP certification of the State Food and drug administration. In 2007, the company has successively passed ISO9001, ISO14001, ISO18001, HACCP certification and NSF certification in the United States.
The company has an extraction workshop mainly producing natural plant extracts and effective components of traditional Chinese medicine, and a preparation workshop mainly producing solid preparations such as tablets, granules, capsules and pills.
Staff size:300-399 persons
Registered capital:USD 2.5 million
Producer:Wuxi Taxus Pharmaceutical Co., Ltd. (formerly Jiangsu yew Pharmaceutical Co., Ltd.) was established in 2004. It is a pharmaceutical enterprise subordinate to Hongdou Group in the field of big health industry,.
The API factory has built a standard workshop of 28800 square meters according to GMP standards, has advanced automatic production lines at home and abroad, and is equipped with a full set of raw material processing equipment, advanced testing instruments and supporting sewage treatment system. A complete set of processing technology from paclitaxel crude products to high-quality products has been formed, and more than 300 kg of paclitaxel finished products can be extracted every year. The preparation factory adopts advanced and standardized GMP design concept, selects international production equipment and testing instruments, and can produce various specifications of anti-tumor drug injection and freeze-dried powder injection, with an annual production of 6 million anti-tumor drug injections.
Staff size:100-199 persons
Registered capital:RMB 80 million
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