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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WITHDRAWN BY HOLDER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WITHDRAWN BY HOLDER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.

Staff size:About 4000 persons

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