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Budesonide

CAS number: 51333-22-3

Molecular formula: C25H34O6

molecular weight: 430.53

Chemical structure:

Producers shown on SFDA

(Record date:14/10/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Hubei Gedian Humanwell Pharmaceutical Co., Ltd.

GMP
Valid till July 2022

Tianjin Tianyao Pharmaceutical Co., Ltd.

GMP
Valid till March 2022

Lunan Better Pharmaceutical Co., Ltd.

GMP
Valid till January 2020

Shanghai Sine Promod Pharmaceutical Co., Ltd.

GMP
Valid till February 2024

Lianyungang Runzhong Pharmaceutical Co., Ltd.

GMP
Valid till April 2024

Astrazeneca Pharmaceutical Co., Ltd.

GMP
Valid till October 2021


Producers shown on EP

(Quoted from EP website;record date:14/10/2021)

Substance
Certificate Holder
Certificate Number
Issue DateStatus
End date
Type
Budesonide micronised
Farmabios SpA Gropello Cairoli IT
  R1-CEP 2000-051 - Rev 02
04/05/2010
Valid
/Chemical
Budesonide
TIANJIN TIANYAO PHARMACEUTICALS CO., LTD. Tianjin CN
  R1-CEP 2000-038 - Rev 04
02/12/2011
Valid
/
Chemical
Budesonide
Industriale Chimica S.R.L. Saronno IT
  R1-CEP 2000-152 - Rev 04
16/03/2012
Valid
/
Chemical
Budesonide
CIPLA LIMITED Mumbai IN
  R1-CEP 2006-061 - Rev 01
28/07/2014
Valid
/
Chemical
Budesonide
STERLING S.p.A. Solomeo Di Corciano IT
  R1-CEP 2009-057 - Rev 00
07/10/2015
Valid
/
Chemical
Budesonide
NEWCHEM S.p.A. Milano IT
  R0-CEP 2016-104 - Rev 00
25/08/2016
Valid
/
Chemical
Budesonide Micronised, grades 21, 22 and 23
Farmabios SpA Gropello Cairoli IT
  R1-CEP 2005-174 - Rev 01
25/07/2017
Valid
/
Chemical
Budesonide
Coral Drugs Private Limited New Delhi IN
  R0-CEP 2016-020 - Rev 00
16/08/2017
Valid
/
Chemical
Budesonide
ASPEN OSS B.V. Oss NL
  R0-CEP 2016-043 - Rev 01
21/12/2017
Valid
/
Chemical
Budesonide
AARTI INDUSTRIES LIMITED Mulund (W), Mumbai IN
  R1-CEP 2006-295 - Rev 03
08/02/2018
Valid
/
Chemical
Budesonide
SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN
  R0-CEP 2018-064 - Rev 00
01/04/2019
Valid
/
Chemical
Budesonide T Process
TEVA PHARMACEUTICAL INDUSTRIES LTD. Petach Tikva IL  R1-CEP 2014-051 - Rev 00
24/04/2019
Valid
/
Chemical
Budesonide
TEVA PHARMACEUTICAL INDUSTRIES LTD. Petach Tikva IL
  R1-CEP 1997-067 - Rev 08
13/09/2019
Valid
/
Chemical
Budesonide Codes 201680 and 2016112 
STERLING S.p.A. Solomeo Di Corciano IT
  R0-CEP 2017-138 - Rev 02
09/10/2019
Valid
/
Chemical
Budesonide Micronised
NEWCHEM S.p.A. Milano IT
  R1-CEP 2009-185 - Rev 01
13/01/2020
Valid
/
Chemical
Budesonide
AVIK PHARMACEUTICAL LIMITED Vapi IN
  R0-CEP 2014-177 - Rev 01
10/02/2020
Valid
/
Chemical
Budesonide Micronised, non-micronised
MINAKEM Dunkerque FR
  R1-CEP 2010-190 - Rev 03
09/06/2020
Valid
/
Chemical
Budesonide Micronised
Hubei Gedian Humanwell Pharmaceutical Co., Ltd. E-Zhou CN
  R0-CEP 2019-295 - Rev 00
17/07/2020
Valid
/
Chemical
Budesonide
CURIA SPAIN S.A.U. Boecillo ES
  R1-CEP 2007-007 - Rev 02
24/08/2021
Valid
/
Chemical
Budesonide Sterile
CURIA SPAIN S.A.U. Boecillo ES
  R1-CEP 2009-037 - Rev 02
24/08/2021
Valid
/Chemical

Producer:Hubei Gedian Humanwell Pharmaceutical Co., Ltd. is a modern high-tech pharmaceutical enterprise invested and controlled by humanwell Pharmaceutical Group Co., Ltd. specializing in the R & D, production and sales of fertility regulating drugs and steroidal APIs.The company covers an area of 80000 square meters and a construction area of 15000 square meters.

Up to now, 6 workshops of the company have passed the national GMP certification; The new steroid hormone API workshop invested and built has passed the FDA certification.

Staff size:50-99 persons

Registered capital:RMB 128.255 million


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:Lunan Better Pharmaceutical Co., Ltd., a holding subsidiary of Lunan Pharmaceutical Group Co., Ltd., was established in 2003. The company produces 12 formulations including western medicine tablets, injections, sustained release tablets, large infusion, spray, capsule, granule, eye drops and so on. It mainly consists of Lunan Xin Kang tablets, Lunan Xin Kang sustained-release tablets, Nonan Bate tablets, Isosorbide Mononitrate Injection, Lunan Li Kang, Omeprazole Enteric-coated Tablets, cetirizine hydrochloride, sotalol hydrochloride and anisetam granules. 22 products, including aximus capsule, isoflurane anesthetic, salmeterol aerosol and ciprofloxacin hydrochloride eye drops, have all passed the national GMP verification in the production workshop.

Staff size:4000-4999 persons

Registered capital:RMB 115 million


Producer:Shanghai Sine Promod Pharmaceutical Co., Ltd. covers a total area of 100000 square meters, including 17000 square meters of building area and more than 40000 square meters of green and forest belt area.

The company has five workshops: Traditional Chinese medicine extraction workshop, tablet and capsule workshop, two chemical synthesis workshops (budesonide, moclobemide) and antibiotic workshop (cephalosporins). All five workshops have passed GMP certification (traditional Chinese medicine extraction workshop took the lead in passing GMP certification in Shanghai), with an annual production capacity of 1 billion tablets and an annual output of 400 million Ginkgo biloba preparations.

Staff size:100-199 persons

Registered capital:RMB 50 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:Astrazeneca Pharmaceutical Co., Ltd. is a global pharmaceutical company, founded in 1913, headquartered in London, UK and R & D headquarters in Sweden. There are 17 R & D institutions in 8 countries, with 13000 employees engaged in work related to new drug R & D.

Staff size:700-799 persons

Registered capital:USD 91.2 million


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