Duloxetine HCl
CAS number： 136434-34-9
Molecular formula： C18H19NOS·HCl
molecular weight： 333.88
Chemical structure：
Producers shown on SFDA
(Record date:07/09/2021）
Producer Documents GMP Valid till(based on SFDA) Zhejiang Huahai Pharmaceutical Co., Ltd. Zhejiang Liaoyuan Pharmaceutical Co., Ltd. Shanghai Wonder Pharmaceutical Co., Ltd. Jiangsu Nhwa Pharmaceutical Co., Ltd.GMP, DMF GMP GMP GMP
Producers shown on EP
(Quoted from EP website；record date:07/09/2021）
| Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
| Duloxetine hydrochloride | HETERO DRUGS LIMITED IN 500 018 Hyderabad | R1-CEP 2012-305-Rev 01 | 22/04/2021 | VALID | / | Chemistry |
| Duloxetine hydrochloride | AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad | R1-CEP 2013-061-Rev 00 | 05/04/2019 | VALID | / | Chemistry |
| Duloxetine hydrochloride | ALEMBIC PHARMACEUTICALS LIMITED IN 390 003 Vadodara | R1-CEP 2012-118-Rev 01 | 08/06/2020 | VALID | / | Chemistry |
| Duloxetine hydrochloride | SHODHANA LABORATORIES LIMITED IN 500 055 Hyderabad | R1-CEP 2013-340-Rev 00 | 03/11/2020 | VALID | / | Chemistry |
| Duloxetine hydrochloride | CADILA HEALTHCARE LIMITED IN 391 440 Dabhasa Village | R0-CEP 2015-369-Rev 02 | 18/12/2019 | VALID | / | Chemistry |
| Duloxetine hydrochloride | SCI PHARMTECH, INC. TW 33856 Taoyuan City | R1-CEP 2012-217-Rev 00 | 24/04/2019 | VALID | / | Chemistry |
| Duloxetine hydrochloride | Zhejiang Liaoyuan Pharmaceutical Co., Ltd. CN 317 016 Duqiao Town | R1-CEP 2014-239-Rev 00 | 28/08/2020 | VALID | / | Chemistry |
| Duloxetine hydrochloride | NOSCH LABS PRIVATE LIMITED IN 500 072 Hyderabad | R1-CEP 2012-247-Rev 00 | 09/04/2018 | VALID | / | Chemistry |
| Duloxetine hydrochloride | ESTEVE QUIMICA S.A. ES 08038 Barcelona | R1-CEP 2013-016-Rev 02 | 26/07/2021 | VALID | / | Chemistry |
| Duloxetine hydrochloride | QILU PHARMACEUTICAL CO., LTD. CN 250 100 Jinan | R0-CEP 2013-197-Rev 00 | 01/12/2014 | WITHDRAWN BY HOLDER | 15/11/2018 | Chemistry |
| Duloxetine hydrochloride | LUPIN LIMITED IN 400 055 Mumbai | R0-CEP 2015-144-Rev 00 | 02/12/2016 | VALID | / | Chemistry |
| Duloxetine hydrochloride | ZHEJIANG YONGTAI PHARMACEUTICAL CO., LTD. CN 317 016 Duqiao | R0-CEP 2016-142-Rev 01 | 05/12/2019 | VALID | / | Chemistry |
| Duloxetine hydrochloride | ALEMBIC PHARMACEUTICALS LIMITED IN 390 003 Vadodara | R0-CEP 2016-185-Rev 00 | 16/01/2017 | VALID | / | Chemistry |
| Duloxetine hydrochloride | JUBILANT GENERICS LIMITED IN 571 302 Nanjangud | R1-CEP 2014-012-Rev 00 | 14/02/2020 | VALID | / | Chemistry |
| Duloxetine hydrochloride | SANECA PHARMACEUTICALS A.S. SK 920 27 Hlohovec | R1-CEP 2014-297-Rev 00 | 05/08/2021 | VALID | / | Chemistry |
| Duloxetine hydrochloride | HANGZHOU HUADONG MEDICINE GROUP ZHEJIANG HUAYI PHARMACEUTICAL CO.,LTD CN 322 002 Yiwu | R0-CEP 2015-155-Rev 02 | 25/02/2019 | VALID | / | Chemistry |
| Duloxetine hydrochloride | Union Quimico Farmaceutica, S.A. (Uquifa S.A.) ES 08008 Barcelona | R0-CEP 2015-130-Rev 01 | 12/02/2019 | VALID | / | Chemistry |
| Duloxetine hydrochloride | Zhejiang Jiuzhou Pharmaceutical Co., Ltd. CN 318 000 Taizhou City | R0-CEP 2012-187-Rev 00 | 20/05/2014 | EXPIRED | 20/05/2019 | Chemistry |
| Duloxetine hydrochloride | MACLEODS PHARMACEUTICALS LIMITED IN 400 059 Mumbai | R0-CEP 2015-166-Rev 00 | 29/06/2016 | VALID | / | Chemistry |
| Duloxetine hydrochloride | KRKA d.d. SI 8501 Novo Mesto | R0-CEP 2015-246-Rev 01 | 17/07/2017 | VALID | / | Chemistry |
| Duloxetine hydrochloride | MSN LABORATORIES PRIVATE LIMITED IN 502 329 Rudraram Village | R1-CEP 2012-368-Rev 00 | 30/04/2019 | VALID | / | Chemistry |
| Duloxetine hydrochloride | ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai | R1-CEP 2012-220-Rev 01 | 10/02/2021 | VALID | / | Chemistry |
| Duloxetine hydrochloride | MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad | R1-CEP 2012-203-Rev 02 | 01/09/2021 | VALID | / | Chemistry |
| Duloxetine hydrochloride Milled, micronised | Moehs Iberica S.L. ES 08191 Rubi | R1-CEP 2012-319-Rev 00 | 22/10/2019 | VALID | / | Chemistry |
| Duloxetine hydrochloride | TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva | R1-CEP 2012-311-Rev 00 | 08/07/2020 | 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
Producer:Zhejiang Liaoyuan Pharmaceutical Co., Ltd. is now a holding subsidiary of Ningbo Minova Pharmaceutical Co., Ltd. The registered capital of the company is 28.109 million yuan, covering an area of about 186 Mu and a construction area of about 41000 square meters. It is an enterprise mainly engaged in the production of intermediates and APIs of anticoagulant, antidepressant and cardiovascular and cerebrovascular drugs. Its products are mainly sold to Europe, America, Japan, India, South America and other countries and regions. It is a well-known manufacturer of thiophene derivatives in the international market. The company has European cGMP certificate and is an enterprise with three system certification of FDA, GMP and ISO.
Staff size:About 500 persons
Registered capital:RMB 28 million 109 thousand and 620
Producer:Shanghai Wonder Pharmaceutical Co., Ltd. was founded in 1989 and merged with Shanghai Wandai Pharmaceutical Co., Ltd. in October 2016. The combined production plant covers an area of 15100 square meters, a workshop building area of 10030 square meters, a warehouse building area of 2700 square meters, an office building area of 2900 square meters, a greening area of 5920 square meters, and the plant environment is standardized and clean.
Wonder pharmaceutical is a GMP factory specializing in the production of API. It is managed in strict accordance with GMP procedures and has passed FDA audit for several times. It is a qualified supplier of several multinational companies.
Staff size:50-99 persons
Registered capital:RMB 59 million
Producer:Jiangsu Nhwa Pharmaceutical Co., Ltd. founded in 1978 and listed on Shenzhen Stock Exchange in 2008, is a pharmaceutical enterprise integrating science, industry and trade.
It has three large pharmaceutical GMP production bases for APIs and preparations, covering a total area of more than 900 mu. The enterprise has national certified workshops for APIs, solid preparations, water injections and lyophilized powder injections, and more than 10 automatic production lines for tablets, capsules, water injections and powder injections. At present, there are 39 kinds of APIs, 300 tons / year; More than 100 kinds of Western medicine preparations, 4 billion tablets (tablets) of solid preparations per year and 100 million injections per year.
According to the enterprise development strategy, we have made great efforts to save energy, reduce consumption and protect the environment, passed the international environmental certification (ISO14000), vigorously developed the export business of API, carried out EU edmf and FDA certification, and strive to gain a place in the international market.
Staff size:About 5000 persons
Registered capital:RMB 1 billion 8 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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