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Amisulpride

CAS number: 71675-85-9

Molecular formula: C17H27N3O4S

molecular weight: 369.48

Chemical structure:

Producers shown on SFDA

(Record date:07/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Qilu Antibiotics (Linyi) Pharmaceutical Co., Ltd.
GMP

Valid till November 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
Amisulpride
SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai
  R1-CEP 2009-246-Rev 01
01/07/2016
WITHDRAWN BY HOLDER
12/07/2021
Chemistry
Amisulpride
HUBEI HAOSUN PHARMACEUTICAL CO., LTD. CN 436 070 Ezhou
  R1-CEP 2009-342-Rev 03
31/01/2020
VALID
/Chemistry
Amisulpride
SANOFI CHIMIE FR 94250 Gentilly
  R1-CEP 2002-208-Rev 07
07/08/2019
VALID
/
Chemistry
Amisulpride Process-2
SYMED LABS LIMITED IN 500 034 Hyderabad
  R0-CEP 2019-147-Rev 00
15/10/2020
VALID
/
Chemistry
Amisulpride
SYMED LABS LIMITED IN 500 034 Hyderabad
  R1-CEP 2010-185-Rev 01
21/02/2019
VALID
/
Chemistry
Amisulpride Process II
SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai
  R0-CEP 2016-028-Rev 01
25/02/2019
VALID
/
Chemistry
Amisulpride
ICROM S.R.L. IT 20863 Concorezzo
  R1-CEP 2009-215-Rev 02
16/06/2021
VALID
/
Chemistry
Amisulpride Finorga S.A.S
SANOFI CHIMIE FR 94250 Gentilly
  R0-CEP 2019-265-Rev 00
26/03/2020
VALID
/
Chemistry
Amisulpride
Cosma S.p.A. IT 24040 Ciserano
  R1-CEP 2009-397-Rev 01
24/08/2017
VALID/
Chemistry
Amisulpride
Erregierre S.p.A. IT 24060 San Paolo D'Argon
  R1-CEP 2008-202-Rev 03
06/12/2017
VALID
/
Chemistry
Amisulpride
Laboratorios Espinos Y Bofill S.A. (LEBSA) ES 08940 Cornellà
  R1-CEP 2003-099-Rev 03
02/09/2019
VALID
/
Chemistry
Amisulpride
AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad
  R1-CEP 2010-005-Rev 03
24/07/2018
VALID
/
Chemistry
Amisulpride Process 2
ICROM S.R.L. IT 20863 Concorezzo
  R0-CEP 2019-051-Rev 02
30/03/2021
VALID
/
Chemistry


Producer:Shandong Anhong Pharmaceutical Co., Ltd. (formerly Qilu Antibiotics (Linyi) Pharmaceutical Co., Ltd.) was incorporated in 2009 and is a subsidiary of Shandong Qilu Pharmaceutical Group Co., Ltd.

At present, the company has formed four series of chemical API production bases of cephalosporins, penem, anticancer and general drugs. Many product technical levels are at the international advanced level, and have passed the official certification at home and abroad, such as China GMP, the United States FDA, Japan PMDA, Germany GMP, South Korea KFDA, etc.

Staff size:1000-1999 persons

Registered capital:RMB 30 million


For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978