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Betamethasone Valerate

CAS number: 2152-44-5

Molecular formula: C27H37FO6

molecular weight: 476.585

Chemical structure:

Producers shown on SFDA

(Record date:31/08/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Zhejiang Xianju Xianle Pharmaceutical Co., Ltd.

GMP, DMF
Valid till November 2024

Shanghai New Hualian Pharmaceutical Co., Ltd.

GMP
Valid till December 2019

Zhejiang Xianju Pharmaceutical Co., Ltd.

 GMP

Valid till May 2022

Producers shown on EP

(Quoted from EP website;record date:31/08/2021)

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 valerate
Pharmacia & Upjohn Company US 49001 Kalamazoo
  R0-CEP 2001-307-Rev 00
29/07/2002
EXPIRED
29/07/2007
TSE
Betamethasone valerate Micronised
Farmabios SpA IT 27027 Gropello Cairoli
  R1-CEP 2002-078-Rev 03
22/03/2021
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 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WITHDRAWN BY HOLDER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 valerate
CURIA SPAIN S.A.U. ES 47151 Boecillo
  R1-CEP 2003-022-Rev 02
24/08/2021
VALID
/Chemistry
Betamethasone valerate
SYMBIOTICA SPECIALITY INGREDIENTS SDN. BHD. MY 13700 Perai
  R1-CEP 2008-215-Rev 00
26/06/2015
VALID
/Chemistry
Betamethasone valerate
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
  R1-CEP 2003-095-Rev 03
17/08/2018
VALID
/Chemistry
Betamethasone valerate Micronised
GlaxoSmithKline Research & Development Limited GB TW8 9GS London
  R1-CEP 2002-219-Rev 07
30/01/2020
VALID
/Chemistry


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: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: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


For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978