Salmeterol Xinafoate
CAS number: 94749-08-3
Molecular formula: C25H37NO4.C11H8O3
molecular weight: 603.75
Chemical structure:
Producers shown on SFDA
(Record date:19/10/2021)
Producer | Documents | GMP Valid till(based on SFDA) |
Lianyungang Runzhong Pharmaceutical Co., Ltd. | GMP | Valid till February 2020 |
Jiangsu Hengrui Medicine Co.,Ltd. | GMP | Valid till November 2024 |
Lunan Better Pharmaceutical Co., Ltd. | GMP | Valid till August 2017 |
Producers shown on EP
(Quoted from EP website;record date:19/10/2021)
Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
Salmeterol xinafoate | Inke, S.A. Castellbisbal ES | R1-CEP 2007-127 - Rev 00 | 16/06/2014 | Valid | / | Chemical |
Salmeterol xinafoate | NATCO PHARMA LIMITED Hyderabad IN | R1-CEP 2009-013 - Rev 02 | 14/02/2017 | Valid | / | Chemical |
Salmeterol xinafoate | MYLAN LABORATORIES LIMITED Hyderabad IN | R1-CEP 2008-216 - Rev 01 | 25/09/2017 | Withdrawn by Holder | 29/10/2020 | Chemical |
Salmeterol xinafoate | MELODY HEALTHCARE PVT. LTD. Boisar IN | R1-CEP 2010-097 - Rev 01 | 07/02/2018 | Valid | / | Chemical |
Salmeterol xinafoate Process I | Hovione FarmaCiencia S.A. Loures PT | R0-CEP 2017-055 - Rev 01 | 07/03/2018 | Valid | / | Chemical |
Salmeterol xinafoate | MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN | R1-CEP 2011-183 - Rev 00 | 12/03/2018 | Valid | / | Chemical |
Salmeterol xinafoate Non-micronised and micronised | Vamsi Labs Limited Solapur IN | R1-CEP 2006-226 - Rev 01 | 05/06/2019 | Valid | / | Chemical |
Salmeterol xinafoate Process II | Hovione FarmaCiencia S.A. Loures PT | R0-CEP 2018-057 - Rev 02 | 05/07/2019 | Valid | / | Chemical |
Salmeterol xinafoate Micronised, grades I and II | CIPLA LIMITED Mumbai IN | R1-CEP 2006-296 - Rev 04 | 02/09/2019 | Valid | / | Chemical |
Salmeterol xinafoate | Industriale Chimica S.R.L. Saronno IT | R1-CEP 2013-107 - Rev 00 | 31/03/2020 | Valid | / | Chemical |
Salmeterol xinafoate Micronised | Farmabios SpA Gropello Cairoli IT | R0-CEP 2018-168 - Rev 00 | 12/06/2020 | Valid | / | Chemical |
Salmeterol xinafoate Route code XS | MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN | R0-CEP 2018-261 - Rev 00 | 07/06/2021 | Valid | / | Chemical |
Salmeterol xinafoate Micronised | FERMION OY Espoo FI | R0-CEP 2018-044 - Rev 02 | 28/06/2021 | Valid | / | Chemical |
Salmeterol xinafoate | AARTI INDUSTRIES LIMITED Mulund (W), Mumbai IN | R1-CEP 2008-239 - Rev 02 | 15/07/2021 | Valid | / | Chemical |
Salmeterol xinafoate Micronised | MELODY HEALTHCARE PVT. LTD. Boisar IN | R0-CEP 2020-070 - Rev 01 | 30/08/2021 | Valid | / | Chemical |
Salmeterol xinafoate | NEULAND LABORATORIES LIMITED Hyderabad IN | R1-CEP 2011-277 - Rev 02 | 07/09/2021 | Valid | / | Chemical |
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:Jiangsu Hengrui Medicine Co.,Ltd. is a pharmaceutical company engaged in the development and commercialization of innovative and high-quality drugs.
The company has 28000 employees globally, fifth R & D centers were built around the globe and several subsidiaries were established in the US, EU, and Japan.
The company has 10 manufacturing facilities and most of them maintain USP, EUP, and JP. We are the first Chinese company that exported injections on a large scale to the US, EU, and Japan markets. All dosage forms of the company have passed the national GMP certification, and ifosfamide, etoposide, mesilar and tiotepa have passed the verification of FDA.
Staff size:About 30000 persons
Registered capital:RMB 6 billion 397 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
For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978