
Betamethasone
CAS number: 378-44-9
Molecular formula: C22H28FNa2O8P/C22H29O5F
molecular weight: 392.4641
Chemical structure:
Producers shown on SFDA
(Record date:30/08/2021)
Producer | Documents | GMP Valid till(based on SFDA) |
Zhejiang Xianju Xianle Pharmaceutical Co., Ltd. | GMP, DMF | Valid till November 2024 |
Henan Lihua Pharmaceutical Co., Ltd. | GMP | Valid till February 2019 |
Shanghai New Hualian Pharmaceutical Co., Ltd. | GMP | Valid till February 2022 |
Xi'an Guokang Ruijin Pharmaceutical Co., Ltd. | GMP | Valid till March 2021 |
Chongqing Huapont Shengchem Pharm Co., Ltd. | GMP | Valid till April 2023 |
Zhejiang Xianju Pharmaceutical Co., Ltd. | GMP | Valid till August 2024 |
Tianjin Tianyao Pharmaceutical Co., Ltd. | GMP | Valid till January 2020 |
Producers shown on EP
(Quoted from EP website;record date:30/08/2021)
Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
Betamethasone valerate | SM BIOMED SDN BHD MY 08000 Sungai Petani | R1-CEP 1999-118-Rev 00 | 12/08/2009 | VALID | / | Chemistry |
Betamethasone Triene (Betamethasone 6/6 BMS) | Pharmacia & Upjohn Company US 49001 Kalamazoo | R0-CEP 2000-407-Rev 00 | 07/12/2001 | WITHDRAWN BY HOLDER | 06/12/2006 | TSE |
Betamethasone valerate | Pharmacia & Upjohn Company US 49001 Kalamazoo | R0-CEP 2001-307-Rev 00 | 29/07/2002 | EXPIRED | 29/07/2007 | TSE |
Betamethasone dipropionate | SYMBIOTICA SPECIALITY INGREDIENTS SDN. BHD. MY 13700 Perai | R1-CEP 2011-005-Rev 01 | 12/12/2017 | VALID | / | Chemistry |
Betamethasone valerate Micronised | Farmabios SpA IT 27027 Gropello Cairoli | R1-CEP 2002-078-Rev 03 | 22/03/2021VALID | VALID | / | Chemistry |
Betamethasone | TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva | R1-CEP 2010-365-Rev 00 | 16/08/2018 | VALID | / | Chemistry |
Betamethasone Micronised | SYMBIOTEC PHARMALAB PRIVATE LIMITED IN 453 331 Indore | R1-CEP 2011-285-Rev 01 | 23/11/2017 | VALID | / | Chemistry |
Betamethasone valerate Micronised | SYMBIOTEC PHARMALAB PRIVATE LIMITED IN 453 331 Indore | R1-CEP 2008-307-Rev 00 | 08/04/2016 | VALID | / | Chemistry |
Betamethasone dipropionate | CURIA SPAIN S.A.U. ES 47151 Boecillo | R1-CEP 2002-031-Rev 03 | 24/08/2021 | VALID | / | Chemistry |
Betamethasone valerate Micronised | GlaxoSmithKline Research & Development Limited GB TW8 9GS London | R1-CEP 2005-254-Rev 02 | 06/08/2013 | WITHDRAWN BY HOLDER | 04/06/2015 | Chemistry |
Betamethasone sodium phosphate | CURIA SPAIN S.A.U. ES 47151 Boecillo | R1-CEP 2002-032-Rev 01 | 24/08/2021 | VALID | / | Chemistry |
Betamethasone valerate | CURIA SPAIN S.A.U. ES 47151 Boecillo | R1-CEP 2003-022-Rev 02 | 24/08/2021 | VALID | / | Chemistry |
Betamethasone dipropionate Micronised | Farmabios SpA IT 27027 Gropello Cairoli | R1-CEP 2003-232-Rev 02 | 27/02/2018 | VALID | / | Chemistry |
Betamethasone valerate | SYMBIOTICA SPECIALITY INGREDIENTS SDN. BHD. MY 13700 Perai | R1-CEP 2008-215-Rev 00 | 26/06/2015 | VALID | / | Chemistry |
Betamethasone dipropionate Micronised | SYMBIOTEC PHARMALAB PRIVATE LIMITED IN 453 331 Indore | R1-CEP 2012-079-Rev 00 | 19/02/2018 | VALID | / | Chemistry |
Betamethasone sodium phosphate | SYMBIOTICA SPECIALITY INGREDIENTS SDN. BHD. MY 13700 Perai | R1-CEP 2013-326-Rev 00 | 27/10/2020 | VALID | / | Chemistry |
Betamethasone valerate | TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva | R1-CEP 2003-095-Rev 03 | 17/08/2018 | VALID | / | Chemistry |
Betamethasone Micronised | Merck Sharp & Dohme (Europe) Inc. BE 1200 Brussels | R1-CEP 2012-214-Rev 00 | 27/01/2020 | VALID | / | Chemistry |
Betamethasone | Merck Sharp & Dohme (Europe) Inc. BE 1200 Brussels | R0-CEP 2017-092-Rev 00 | 16/10/2017 | VALID | / | Chemistry |
Betamethasone dipropionate | TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva | R1-CEP 2000-223-Rev 05 | 22/02/2018 | VALID | / | Chemistry |
Betamethasone valerate Micronised | GlaxoSmithKline Research & Development Limited GB TW8 9GS London | R1-CEP 2002-219-Rev 07 | 30/01/2020 | VALID | / | Chemistry |
Betamethasone dipropionate Micronised | TARO PHARMACEUTICAL INDUSTRIES, LTD. IL 2624761 Haifa Bay | R0-CEP 2018-018-Rev 01 | 16/01/2020 | VALID | / | Chemistry |
Producer:Zhejiang Xianju Xianle Pharmaceutical Co., Ltd., founded in November 1995 and located in the South Industrial Zone of Xianju Chengguan, is a professional manufacturer of steroids with self-supporting import and export rights. The plant covers an area of about 30000m2, with total assets of more than 65 million yuan, and technicians account for about 40% of the total number of employees. The company is a key backbone (2112) enterprise in the county and a provincial high-tech enterprise. It is a "contract abiding and trustworthy" unit in Zhejiang Province and a provincial AAA industrial and commercial credit enterprise. The company's main products are: betamethasone series, dexamethasone series, cyproterone series and more than 20 intermediates. In February 2007, the company passed the GMP certification of the State Food and Drug Administration of the people's Republic of China. At present, FDA and COS certification of relevant products of the company is in progress. The company has won wide praise for organizing production and continuously improving EHS system in strict accordance with drug production quality management specifications. The product quality conforms to bp2007, USP30, ep5, CP2005 and other Pharmacopoeia standards at home and abroad. The products are mainly sold to Europe, America, Southeast Asia, the Middle East, India and other countries and regions.
Staff size:100-199 persons
Registered capital:RMB 10 million
Producer:Henan Lihua Pharmaceutical Co., Ltd. is located in the middle of Huanghe Avenue, Wenfeng District (high tech Industrial Development Zone), Anyang City, Henan Province. Founded in 1994, the company has also deeply cooperated with the Institute of process engineering of the Chinese Academy of Sciences to develop a series of green solvents - ionic liquids, which are at the forefront of the world and have broad industrial development prospects. Adhering to the core values of "customer first, technology-based, integrity and pragmatism, harmony and win-win", the company carries out production and management in strict accordance with ichq7, cGMP and other norms and standards. The company's products meet the latest Pharmacopoeia standards of EP, BP, USP, JP, IP and CHP, and sell well in more than 60 countries and regions such as Europe, the United States, Asia and Africa. The company has successively passed the GMP certification and re certification of the state, Henan food and Drug Administration and the food and Drug Administration of the German government, passed the on-site inspection of the US FDA, South Korea MFDs, EDQM and EU authorities (Finland), and obtained the EDQM inspection certificate and eugmp certificate. Prednisolone, prednisone, prednisolone acetate and prednisolone sodium phosphate have obtained CEP certificate. Hydrocortisone sodium succinate, prednisolone, prednisone, hydrocortisone, hydrocortisone acetate, prednisolone acetate and betamethasone have obtained Indian registration form 41.
Staff size:400-499 persons
Registered capital:RMB 8.35 million
Producer:Shanghai New Hualian Pharmaceutical Co., Ltd. is a national high-tech enterprise. Its predecessor is New Hualian pharmaceutical factory of Shanghai Pharmaceutical (Group) Co., Ltd. It has a pharmaceutical history of 80 years since its establishment in 1939. The company is located at No. 217, Minle Road, Xinghuo Development Zone, Fengxian District, Shanghai, covering an area of 341 Mu and a construction area of 67000 square meters. At present, it has 40 drug approvals and 18 GMP workshops. Among them, mifepristone and other products have passed the U.S. FDA, isotretinoin and other products have obtained the CEP certificate issued by European EDQM, and many products have passed certification and registration in many countries and regions. The company has professional R & D and industrialization capabilities of pharmaceutical products, standardized GMP management system, advanced drug testing instruments and production equipment, and a stable professional team.
Staff size:200-299 persons
Registered capital:RMB 107 million 636 thousand and 649
Producer:Xi'an Guokang Ruijin Pharmaceutical Co., Ltd. is a steroid hormone pharmaceutical enterprise invested by Guokang biomedical (Shenzhen) Co., Ltd. in Xi'an. The company is located in Jinghe Industrial Park, Xi'an, covering an area of about 100 mu, with more than 80 employees and about 20 middle and senior technicians; The company has advanced production facilities and testing equipment, and professional synthesis, refining and fermentation production lines. The main products are hormone products: dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate and betamethasone. These varieties have passed the national GMP certification and have a perfect GMP management system. At present, dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate and betamethasone have obtained the Indian registration certificate.
Staff size:50-99 persons
Registered capital:RMB 50 million
Producer:Chongqing Huapont Shengchem Pharm Co., Ltd. (Hereafter called Huapont Pharm.) is a leading dermatological drug manufacturer in China. Huapont Pharm was established in 1992 by Dr Songshan Zhang, now he is a member of of Huapont Life Science Co., Ltd. which is a non-state owned public company listed in Shenzhen Stock Exchange since 2004.
With over 25 years’ development, Huapont Pharm rely on science and technology, continually provide the highly effective medicines and service to patients and society. From a leading manufacturer of dermatological drugs and gradually expand the product mix to respiratory system drugs, drugs for tumors, drugs for TB and drugs treating cardio-cerebrovascular diseases, etc. Both the finished dosage forms (FDFs) and active pharmaceutical ingredients (APIs) are manufactured and supplied to the domestic and international market.
The API facility of Huapont Pharm has become an exporting base of APIs, where of GMP has inspected and approved by US-FDA, MEDSAFE, COFEPRIS, other countries authorities and number of customers.
Staff size:300-399 persons
Registered capital:RMB 100 million
Producer:Zhejiang Xianju Pharmaceutical Co., Ltd., formerly known as Xianju pharmaceutical factory, was founded in 1972. It is a professional manufacturer of steroidal drugs in China. The total share capital of the company is 916212166 yuan, covering an area of 650 mu. At present, it has more than 3900 employees, including 15 technical personnel and 35 sales personnel. It is a comprehensive manufacturer of APIs and preparations.
The company has nearly 200 varieties and has 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.
Registered capital:RMB 989 million 200 thousand
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
For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978