Montelukast sodium
CAS number： 151767-02-1
Molecular formula： C35H35ClNNaO3S
molecular weight： 608.17
Chemical structure：
Producers shown on SFDA
(Record date:07/09/2021）
Producer | Documents | GMP Valid till(based on SFDA) |
Lunan Bettter Pharmaceutical Co., Ltd. | GMP, DMF | Valid till September 2023 |
Zhejiang Tianyu Pharmaceutical Co., Ltd. | GMP, DMF | Valid till March 2023 |
Mudanjiang Hengyuan Pharmaceutical Co., Ltd. | GMP | Valid till October 2020 |
Producers shown on EP
(Quoted from EP website；record date:07/09/2021）
| Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
| Montelukast sodium Milled and micronised | MOREPEN LABORATORIES LIMITED IN 110 001 New Delhi | R1-CEP 2012-003-Rev 00 | 17/12/2018 | VALID | / | Chemistry |
| Montelukast sodium | Laurus Labs Private Limited IN 500 034 Hyderabad | R0-CEP 2012-169-Rev 00 | 29/10/2013 | WITHDRAWN BY HOLDER | 07/09/2015 | Chemistry |
| Montelukast sodium | DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad | R1-CEP 2012-115-Rev 01 | 08/10/2020 | VALID | / | Chemistry |
| Montelukast sodium ID 6177 | TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva | R0-CEP 2017-131-Rev 01 | 28/02/2020 | VALID | / | Chemistry |
| Montelukast sodium Alternate process | LAURUS LABS LIMITED IN 500 034 Hyderabad | R1-CEP 2013-311-Rev 00 | 17/05/2019 | VALID | / | Chemistry |
| Montelukast sodium Process II | MELODY HEALTHCARE PVT. LTD. IN 401 506 Boisar | R0-CEP 2013-303-Rev 01 | 07/02/2018 | EXPIRED | 15/12/2020 | Chemistry |
| Montelukast sodium Process B | UNIMARK REMEDIES LIMITED IN 400 099 Mumbai | R0-CEP 2012-331-Rev 00 | 23/01/2015 | EXPIRED | 23/01/2020 | Chemistry |
| Montelukast sodium | MELODY HEALTHCARE PVT. LTD. IN 401 506 Boisar | R1-CEP 2011-319-Rev 01 | 10/09/2020 | VALID | / | Chemistry |
| Montelukast sodium | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R1-CEP 2012-186-Rev 00 | 26/02/2019 | VALID | / | Chemistry |
| Montelukast sodium | ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. CN 318 020 Taizhou City | R1-CEP 2014-115-Rev 01 | 16/07/2021 | VALID | / | Chemistry |
| Montelukast sodium | MSN PHARMACHEM PRIVATE LIMITED IN 502 307 Pashamylaram Village | R1-CEP 2012-091-Rev 00 | 13/09/2019 | VALID | / | Chemistry |
| Montelukast sodium MK | MSN PHARMACHEM PRIVATE LIMITED IN 502 307 Pashamylaram Village | R1-CEP 2015-038-Rev 00 | 07/05/2020 | VALID | / | Chemistry |
| Montelukast sodium | MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad | R1-CEP 2011-245-Rev 01 | 01/09/2021 | VALID | / | Chemistry |
| Montelukast sodium | FORMOSA LABORATORIES, INC. TW 33842 Taoyuan | R1-CEP 2013-278-Rev 00 | 23/07/2021 | VALID | / | Chemistry |
| Montelukast sodium | MACLEODS PHARMACEUTICALS LIMITED IN 400 059 Mumbai | R0-CEP 2015-135-Rev 01 | 06/07/2017 | VALID | / | Chemistry |
| Montelukast sodium | TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva | R1-CEP 2011-131-Rev 01 | 27/06/2019 | VALID | / | Chemistry |
| Montelukast sodium | HETERO DRUGS LIMITED IN 500 018 Hyderabad | R1-CEP 2012-318-Rev 00 | 11/10/2019 | VALID | / | Chemistry |
| Montelukast sodium | UNIMARK REMEDIES LIMITED IN 400 062 Mumbai | R1-CEP 2012-288-Rev 00 | 07/07/2021 | VALID | / | Chemistry |
Producer:Lunan Bettter Pharmaceutical Co., Ltd., a holding subsidiary of Lunan Pharmaceutical Group Co., Ltd., was established on December 16, 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:Zhejiang Tianyu Pharmaceutical Co., Ltd. founded in 2003, is headquartered in Taizhou, Zhejiang, with a registered capital of more than 180 million yuan. It has six wholly-owned subsidiaries and more than 3800 employees. Tianyu Co., Ltd. is a joint-stock pharmaceutical enterprise specializing in R & D, manufacturing and sales of APIs and advanced pharmaceutical intermediates. It was successfully listed on Shenzhen Stock Exchange on September 19, 2017 (Stock Code: 300702). The company is a national high-tech enterprise, an innovative pilot enterprise in Zhejiang Province and a patent demonstration enterprise in Zhejiang Province. It has established a provincial enterprise research institute, a provincial high-tech enterprise research and development center, a provincial innovation carrier, a provincial enterprise technology center and a provincial postdoctoral research workstation. The company's main products include antihypertensive, hypoglycemic, antithrombotic and antiasthmatic drug raw materials and intermediates. It is one of the world's major manufacturers of cardiovascular raw materials, and its products sell well in markets at home and abroad.
Staff size:About 3800 persons
Registered capital:RMB 180 million
Producer:Mudanjiang Hengyuan Pharmaceutical Co., Ltd., established in 2004, covers an area of 70000 square meters. It is the largest production base of montelukast sodium, an asthma API in China. The company's montelukast sodium API has independent intellectual property rights and has passed GMP certification. The company has built a modern drug R & D laboratory, laboratory, drug synthesis workshop and API GMP workshop.
Staff size:100-199 persons
Tel: Cell/WhatsApp/WeChat: +86 18402846978
Email: paulzhang@yinuopharmchem.com
SKYPE