Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 1TAPI Technology & API Services
03 1ASAHI GLASS CO LTD
04 2Aesica Pharmaceuticals Limited
05 2Apotex Pharmachem
06 1Arch Pharmalabs
07 1Aurobindo Pharma Limited
08 2GSK
09 1ITF CHEMICAL LTDA
10 1Ipca Laboratories
11 1Jubilant Generics
12 1LONZEAL PHARMACEUTICALS CO LTD
13 1Orchid Pharma
14 1Recordati
15 1Signa S.A. de C.V.
16 1Sumitomo Chemical
17 1Sun Pharmaceutical Industries Limited
18 1Taizhou Highsun Pharmaceutical Co.,Ltd.
19 1Viatris
20 1Wanbury Limited
21 2Zhejiang Huahai Pharmaceutical
22 2Zydus Lifesciences
01 1PAROXETINE BASE (BULK)
02 4PAROXETINE HYDROCHLORIDE
03 1PAROXETINE HYDROCHLORIDE (ANHYDROUS)
04 1PAROXETINE HYDROCHLORIDE (HEMIHYDRATE) USP
05 1PAROXETINE HYDROCHLORIDE AMORPHOUS
06 1PAROXETINE HYDROCHLORIDE ANHYDRATE
07 1PAROXETINE HYDROCHLORIDE ANHYDROUS USP
08 8PAROXETINE HYDROCHLORIDE HEMIHYDRATE
09 4PAROXETINE HYDROCHLORIDE HEMIHYDRATE USP
10 2PAROXETINE HYDROCHLORIDE USP (HEMIHYDRATE)
11 1PAROXETINE HYDROCHLORIDE, ANHYDROUS
12 1PAROXETINE HYDROCHLORIDE-USP (HEMIHYDRATE)
13 1TTP.HCL / 4,5,6,7-TETRAHYDROTHIENO (3,2-C) PYRIDINE HYDROCHLORIDE
01 1Brazil
02 2Canada
03 4China
04 9India
05 1Israel
06 1Italy
07 2Japan
08 1Mexico
09 1Spain
10 1U.S.A
11 4United Kingdom
01 14Active
02 13Inactive
01 5Complete
02 22Blank
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-08
Pay. Date : 2015-09-14
DMF Number : 18052
Submission : 2005-02-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16416
Submission : 2003-02-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21440
Submission : 2008-03-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19152
Submission : 2006-01-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15039
Submission : 2000-09-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19751
Submission : 2006-09-11
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19178
Submission : 2006-02-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-05
Pay. Date : 2016-11-23
DMF Number : 20248
Submission : 2006-12-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-25
DMF Number : 19922
Submission : 2006-10-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16680
Submission : 2003-06-27
Status : Active
Type : II
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