Sitagliptin
CAS number： 486460-32-6
Molecular formula： C16H15F6N5O
molecular weight： 407.32
Chemical structure：
Producer Documents Expiration DateZhejiang Huahai Pharmaceutical Co., Ltd. DMF /
Producers shown on EP
(Quoted from EP website；record date:30/08/2021）
| Substance | Certificate Holder | Certificate Number | Issue Date | Status | End date | Type |
| Sitagliptin phosphate monohydrate | HONOUR LAB LIMITED IN 500 018 Hyderabad | R0-CEP 2016-324-Rev 00 | 12/08/2019 | VALID | / | Chemistry |
| Sitagliptin phosphate monohydrate | MACLEODS PHARMACEUTICALS LIMITED IN 400 059 Mumbai | R0-CEP 2017-172-Rev 00 | 15/07/2019 | VALID | / | Chemistry |
| Sitagliptin phosphate monohydrate | HEC PHARM CO., LTD. CN 443 300 Yidu City | R1-CEP 2016-015-Rev 00 | 21/06/2021 | VALID | / | Chemistry |
| Sitagliptin phosphate monohydrate Route STP Process | MSN LIFE SCIENCES PRIVATE LIMITED IN 503 101 Bhiknoor Village | R0-CEP 2020-200-Rev 00 | 16/12/2020 | VALID | / | Chemistry |
| Sitagliptin phosphate monohydrate | Union Quimico Farmaceutica, S.A. (Uquifa S.A.) ES 08008 Barcelona | R0-CEP 2017-252-Rev 00 | 28/01/2021 | VALID | / | Chemistry |
| Sitagliptin phosphate monohydrate | MSN PHARMACHEM PRIVATE LIMITED IN 502 307 Pashamylaram Village | R0-CEP 2016-262-Rev 00 | 19/07/2018 | VALID | / | Chemistry |
| Sitagliptin phosphate monohydrate | ZHEJIANG TIANYU PHARMACEUTICAL CO., LTD. CN 318 020 Taizhou City | R0-CEP 2020-037-Rev 00 | 13/07/2021 | VALID | / | Chemistry |
| Sitagliptin phosphate monohydrate | MOREPEN LABORATORIES LIMITED IN 110 001 New Delhi | R0-CEP 2019-040-Rev 00 | 12/05/2020 | 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
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