Tadalafil
CAS number： 171596-29-5
Molecular formula： C22H19N3O4
molecular weight： 389.404
Chemical structure：
Producers shown on SFDA
(Record date:05/09/2021）
producer | Documents | GMP Valid till(based on SFDA) |
| Zhejiang Huahai Pharmaceutical Co., Ltd. | DMF | / |
Producers shown on EP
(Quoted from EP website；record date:05/09/2021）
| Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
| Tadalafil | MACLEODS PHARMACEUTICALS LIMITED IN 400 059 Mumbai | R0-CEP 2016-190-Rev 00 | 09/02/2018 | VALID | / | Chemistry |
| Tadalafil | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai | R1-CEP 2013-189-Rev 01 | 01/10/2020 | VALID | / | Chemistry |
| Tadalafil | TOPHARMAN SHANDONG CO., LTD. CN 262 123 Anqiu City, Weifang City | R0-CEP 2018-179-Rev 01 | 03/09/2020 | VALID | / | Chemistry |
| Tadalafil | HONOUR LAB LIMITED IN 500 018 Hyderabad | R0-CEP 2016-083-Rev 00 | 19/01/2017 | VALID | / | Chemistry |
| Tadalafil | SHANDONG ANXIN PHARMACEUTICAL CO., LTD. CN 250 105 Dongjia Town | R0-CEP 2016-001-Rev 01 | 15/01/2020 | VALID | / | Chemistry |
| Tadalafil | GLENMARK PHARMACEUTICALS LIMITED IN 400 099 Mumbai | R0-CEP 2012-103-Rev 01 | 29/06/2015 | WITHDRAWN BY HOLDER | 16/08/2018 | Chemistry |
| Tadalafil | AMI LIFESCIENCES PRIVATE LIMITED IN 390 020 Vadodara | R1-CEP 2014-339-Rev 00 | 02/03/2021 | VALID | / | Chemistry |
| Tadalafil | AMOLI ORGANICS PRIVATE LIMITED IN 400 021 Mumbai | R0-CEP 2016-183-Rev 01 | 16/11/2020 | VALID | / | Chemistry |
| Tadalafil Synthetic route code TP | MSN ORGANICS PRIVATE LIMITED IN 508 126 Bibinagar Village | R1-CEP 2013-147-Rev 00 | 18/06/2019 | VALID | / | Chemistry |
| Tadalafil | RAKSHIT PHARMACEUTICALS LIMITED IN 500 038 Hyderabad | R0-CEP 2016-317-Rev 00 | 06/09/2018 | VALID | / | Chemistry |
| Tadalafil | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R1-CEP 2012-232-Rev 00 | 01/08/2018 | VALID | / | Chemistry |
| Tadalafil | TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva | R1-CEP 2013-152-Rev 01 | 24/03/2021 | VALID | / | Chemistry |
| Tadalafil | HEC PHARM CO., LTD. CN 443 300 Yidu City | R0-CEP 2018-005-Rev 00 | 28/09/2018 | VALID | / | Chemistry |
| Tadalafil | PHARMACEUTICAL WORKS POLPHARMA S.A. PL 83-200 Starogard Gdanski | R1-CEP 2012-150-Rev 00 | 19/12/2019 | VALID | / | Chemistry |
| Tadalafil | SMS PHARMACEUTICALS LIMITED IN 500 034 Hyderabad | R1-CEP 2014-308-Rev 00 | 29/03/2021 | VALID | / | Chemistry |
| Tadalafil | PHALANX LABS PRIVATE LIMITED IN 500 034 Hyderabad | R0-CEP 2015-049-Rev 01 | 07/05/2019 | WITHDRAWN BY HOLDER | 17/03/2021 | Chemistry |
| Tadalafil | JUBILANT GENERICS LIMITED IN 571 302 Nanjangud | R1-CEP 2013-276-Rev 00 | 05/12/2019 | VALID | / | Chemistry |
| Tadalafil | ALEMBIC PHARMACEUTICALS LIMITED IN 390 003 Vadodara | R1-CEP 2011-316-Rev 00 | 06/09/2018 | VALID | / | Chemistry |
| Tadalafil | MSN ORGANICS PRIVATE LIMITED IN 508 126 Bibinagar Village | R1-CEP 2011-366-Rev 00 | 28/11/2018 | VALID | / | Chemistry |
| Tadalafil | MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad | R1-CEP 2012-021-Rev 02 | 02/08/2019 | VALID | / | Chemistry |
| Tadalafil Process II | MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad | R0-CEP 2019-201-Rev 00 | 20/12/2019 | VALID | / | Chemistry |
| Tadalafil D150 process | GLENMARK LIFE SCIENCES LIMITED IN 400 099 Mumbai | R0-CEP 2016-040-Rev 03 | 29/06/2020 | VALID | / | Chemistry |
| Tadalafil | Interquim, S.A. ES 08173 Sant Cugat Del Vallès | R1-CEP 2015-101-Rev 00 | 30/04/2021 | VALID | / | Chemistry |
| Tadalafil | Unichem Laboratories Limited IN 400 102 Mumbai | R1-CEP 2015-132-Rev 00 | 07/07/2021 | VALID | / | Chemistry |
Producer:Zhejiang Huahai Pharmaceutical Co., Ltd.was founded in 1989 and headquartered in Zhejiang, China. The company has nearly 7000 employees and more than 40 subsidiaries around the world (including China, the United States, Japan, Germany, etc.As a leading enterprise in the internationalization of Chinese medicine, Huahai pharmaceutical is the first pharmaceutical company in China to pass the FDA preparation quality certification and independently own the Anda document number. It is also the first Chinese pharmaceutical company to realize large-scale preparation sales in the United States. It has established China's pharmaceutical quality image in the world's high-end pharmaceutical market.
Staff size:About 7000 persons
Registered capital:RMB 1 billion 492 million
For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978
Tel: Cell/WhatsApp/WeChat: +86 18402846978
Email: paulzhang@yinuopharmchem.com
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