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 Date | Status | 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