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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Withdrawn by Holder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