Home>APIs>

Betamethasone Dipropionate

CAS number: 5593-20-4

Molecular formula: C28H37FO7

molecular weight: 504.59

Chemical structure:

Producers shown on SFDA

(Record date:20/10/2021)

Producer   

Documents

GMP Valid till(based on SFDA)

Zhejiang Xianju Xianle Pharmaceutical Co., Ltd.

GMP
Valid till February 2020

Zhejiang Xianju Pharmaceutical Co., Ltd.

GMP
Valid till October 2020

Chongqing Huapont Shengchem Pharm Co., Ltd.

GMP
Valid till June 2023



Producers shown on EP

(Quoted from EP website;record date:20/10/2021)

Substance
Certificate Holder
Certificate Number
Issue Date
Status
End date
Type
Betamethasone dipropionate
SYMBIOTICA SPECIALITY INGREDIENTS SDN. BHD. Perai MY
  R1-CEP 2011-005 - Rev 01
12/12/2017
Valid

Chemical
Betamethasone dipropionate
SYMBIOTEC PHARMALAB PRIVATE LIMITED Indore IN
  R1-CEP 2012-079 - Rev 00
19/02/2018
Valid

Chemical
Betamethasone dipropionate
Farmabios SpA Gropello Cairoli IT
  R1-CEP 2003-232 - Rev 02
27/02/2018
Valid

Chemical
Betamethasone dipropionate
TARO PHARMACEUTICAL INDUSTRIES, LTD. Haifa Bay IL
  R0-CEP 2018-018 - Rev 01
16/01/2020
Valid

Chemical
Betamethasone dipropionate
CURIA SPAIN S.A.U. Boecillo ES
  R1-CEP 2002-031 - Rev 03
24/08/2021
Valid

Chemical
Betamethasone dipropionate
TEVA PHARMACEUTICAL INDUSTRIES LTD. Petach Tikva IL
  R1-CEP 2000-223 - Rev 06
16/09/2021
Valid

Chemical

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: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: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


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