Fluticasone propionate
CAS number： 80474-14-2
Molecular formula： C25H31F3O5S
molecular weight： 500.57
Chemical structure：
Producers shown on SFDA
(Record date:15/10/2021）
Producer | Documents | GMP Valid till(based on SFDA) |
| Tianjin Tianyao Pharmaceutical Co., Ltd. | GMP | Valid till January 2020 |
| :Lianyungang Runzhong Pharmaceutical Co., Ltd. | GMP | Valid till November 2021 |
Aurisco Pharmaceutical Co.,Ltd. | GMP | Valid till July 2022 |
Hubei Hengan Fulin Pharmaceutical Co., Ltd. | GMP | Valid till October 2024 |
Producers shown on EP
(Quoted from EP website；record date:15/10/2021）
| Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
| Fluticasone propionate | STERLING S.p.A. Solomeo Di Corciano IT | R1-CEP 2005-268 - Rev 02 | 02/02/2016 | Valid | / | Chemical |
| Fluticasone propionate | CIPLA LIMITED Mumbai IN | R1-CEP 2006-078 - Rev 02 | 29/02/2016 | Valid | / | Chemical |
| Fluticasone propionate Anti-solvent Crystallized Code 2000134 | STERLING S.p.A. Solomeo Di Corciano IT | R0-CEP 2014-352 - Rev 03 | 01/04/2016 | Expired | 20/02/2020 | Chemical |
| Fluticasone propionate Code 2000116 | STERLING S.p.A. Solomeo Di Corciano IT | R0-CEP 2013-014 - Rev 01 | 15/04/2016 | Expired | 17/05/2018 | Chemical |
| Fluticasone propionate | SANOFI CHIMIE Gentilly FR | R0-CEP 2013-158 - Rev 02 | 08/07/2016 | Expired | 17/04/2020 | Chemical |
| Fluticasone propionate | AARTI INDUSTRIES LIMITED Mulund (W), Mumbai IN | R1-CEP 2007-262 - Rev 02 | 26/10/2016 | Valid | / | Chemical |
| Fluticasone propionate Micronised (Grade 21) | Farmabios SpA Gropello Cairoli IT | R1-CEP 2008-117 - Rev 01 | 09/12/2016 | Valid | / | Chemical |
| Fluticasone propionate | MYLAN LABORATORIES LIMITED Hyderabad IN | R0-CEP 2014-134 - Rev 02 | 27/09/2017 | Withdrawn by Holder | 06/12/2019 | Chemical |
| Fluticasone propionate Anti-solvent Crystallized Code 2000111 | STERLING S.p.A. Solomeo Di Corciano IT | R1-CEP 2012-345 - Rev 01 | 09/03/2018 | Valid | / | Chemical |
| Fluticasone propionate Micronised, non-micronised | NEWCHEM S.p.A. Milano IT | R1-CEP 2006-093 - Rev 02 | 30/05/2018 | Valid | / | Chemical |
| Fluticasone propionate | Industriale Chimica S.R.L. Saronno IT | R1-CEP 2012-024 - Rev 00 | 11/02/2019 | Valid | / | Chemical |
| Fluticasone propionate | Hovione FarmaCiencia S.A. Loures PT | R1-CEP 2005-160 - Rev 02 | 27/02/2019 | Valid | / | Chemical |
| Fluticasone propionate | AURISCO PHARMACEUTICAL CO., LTD. Tiantai CN | R1-CEP 2007-060 - Rev 04 | 24/05/2019 | Valid | / | Chemical |
| Fluticasone propionate Process II, micronised, grades I and II | CIPLA LIMITED Mumbai IN | R1-CEP 2012-001 - Rev 01 | 07/08/2019 | Valid | / | Chemical |
| Fluticasone propionate Process III, micronised grade I, II, III | CIPLA LIMITED Mumbai IN | R1-CEP 2012-056 - Rev 02 | 05/12/2019 | Valid | / | Chemical |
| Fluticasone propionate | SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN | R1-CEP 2004-231 - Rev 04 | 12/12/2019 | Valid | / | Chemical |
| Fluticasone propionate Modified Process II | CIPLA LIMITED Mumbai IN | R0-CEP 2020-075 - Rev 00 | 17/08/2020 | Valid | / | Chemical |
| Fluticasone propionate | Coral Drugs Private Limited New Delhi IN | R1-CEP 2005-055 - Rev 03 | 25/09/2020 | Valid | / | Chemical |
| Fluticasone propionate Micronised | GlaxoSmithKline Research & Development Limited London GB | R0-CEP 2018-229 - Rev 01 | 07/12/2020 | Valid | / | Chemical |
| Fluticasone propionate Process I | Hovione FarmaCiencia S.A. Loures PT | R1-CEP 2011-103 - Rev 04 | 04/05/2021 | Valid | / | Chemical |
| Fluticasone propionate | TEVA PHARMACEUTICAL INDUSTRIES LTD. Petach Tikva IL | R1-CEP 2005-209 - Rev 02 | 10/06/2021 | Valid | / | Chemical |
| Fluticasone propionate | WAVELENGTH ENTERPRISES LTD. Petah Tikva IL | R1-CEP 2007-192 - Rev 07 | 18/06/2021 | Valid | / | Chemical |
| Fluticasone propionate Non-micronised, micronised | SANOFI CHIMIE Gentilly FR | R0-CEP 2018-040 - Rev 01 | 02/07/2021 | Valid | / | Chemical |
| Fluticasone propionate Micronised, non-micronised | FERMION OY Espoo FI | R0-CEP 2020-008 - Rev 00 | 05/08/2021 | Valid | / | Chemical |
| Fluticasone propionate | CURIA SPAIN S.A.U. Boecillo ES | R1-CEP 2013-315 - Rev 01 | 25/08/2021 | Valid | / | Chemical |
Producer:Tianjin Tianyao Pharmaceutical Co., Ltd., a wholly-owned subsidiary of Tianjin Jinyao Group Co., Ltd., is the first API production unit in Tianjin that has all passed the national GMP certification. It is the largest scientific research, production and export base of steroid corticosteroids in Asia. The company mainly produces more than 40 varieties of corticosteroid raw materials, cardiovascular and cerebrovascular raw materials, analgesic raw materials and preparation drugs, of which many products have passed the certification of FDA and European Pharmacopoeia Committee, and become a qualified supplier of Pfizer and other large multinational companies. The company's leading product dexamethasone (corticosteroid drugs) series technology and product quality have reached the international advanced level. Taking advantage of low cost and service advantages, the company has occupied the Asian market of dexamethasone and opened the European and American markets; The company's annual production capacity of corticosteroid APIs has reached more than 200 tons.
Staff size:About 3000 persons
Registered capital:RMB 1 billion 101 million
Producer:Lianyungang Runzhong Pharmaceutical Co., Ltd., a wholly-owned subsidiary and API production base of Zhengda Tianqing Pharmaceutical Group, was established in 2010, covering an area of 206 mu. In 2012, it was recognized as a high-tech enterprise, mainly engaged in the R & D, production and sales of various chemical APIs.
At present, the company has 7 product production workshops, 4 pilot workshops for new products, 1 product development center, and 2 drug inspection centers, power workshops and warehouses. There are 52 products approved for listing in China, of which 16 are listed as high-tech products in Jiangsu Province, involving liver disease, tumor, cardiovascular, respiratory and other fields, with an annual production capacity of more than 100 tons.
With the continuous increase of product types and production scale, the economic benefits of the company have also increased year by year. In 2020, the sales revenue will reach 3.5 billion yuan, including 10 API products such as arotinib hydrochloride, magnesium isoglycyrrhizinate and Diammonium Glycyrrhizinate, forming a "product group with sales of more than 100 million". The company has passed FDA certification for "zero defect" twice, and 14 products passed GMP on-site inspection in 2020, indicating that the company's quality management is at a high level in the industry.
Staff size:1000-1999 persons
Registered capital:RMB 103 million 528 thousand and 805
Producer:Aurisco Pharmaceutical Co.,Ltd. was founded in 1998. The company focuses on the R & D, production and sales of characteristic complex APIs and preparations. It is an international pharmaceutical enterprise with continuous innovation. At present, the company has passed the GMP certification of SFDA, and many products have passed the official FDA certification of the United States, the official GMP certification of Germany, the official MHRA GMP certification of the United Kingdom and the official GMP certification of Mexico.
Staff size:About 1000 persons
Registered capital:RMB 401 million
Producer:Hubei Hengan Fulin Pharmaceutical Co., Ltd. was established in 2001, Focusing on the development of drugs in the field of skin, the company has developed and launched a series of products covering the treatment of dermatitis, eczema, antifungal, antiviral and abnormal skin keratinization. It has become one of the professional preparation enterprises with many varieties, complete categories and high-end products at home and abroad.
The company has built various GMP production lines covering oral, external preparations, API and traditional Chinese medicine formula granules.
Registered capital:RMB 60 million
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