Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
01 1Medichem S.A
02 2Neuland Laboratories
03 1Farmhispania
04 1Apotex Pharmachem
05 1ChemSource
06 1Esteve Quimica
07 1Gedeon Richter
08 2Krka
09 1Lek Pharmaceuticals
10 2Maprimed
11 1Merck & Co
12 1RANBAXY LABORATORIES LIMITED
13 1Wockhardt
14 1Zhejiang Huahai Pharmaceutical
01 9ENALAPRIL MALEATE
02 1ENALAPRIL MALEATE & DILTIAZEM ER TABLETS
03 1ENALAPRIL MALEATE DRUG SUBSTANCE
04 4ENALAPRIL MALEATE USP
05 1ENALAPRIL MALEATE, ACTIVE SUBSTANCE
06 1ENALAPRILA USP
01 2Argentina
02 1Canada
03 1China
04 1Hungary
05 4India
06 3Slovenia
07 3Spain
08 2U.S.A
01 5Active
02 12Inactive
01 2Complete
02 15Blank
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13055
Submission : 1998-06-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15434
Submission : 2001-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11525
Submission : 1995-05-19
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2016-06-28
Pay. Date : 2016-06-16
DMF Number : 19984
Submission : 2006-11-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11866
Submission : 1996-02-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12809
Submission : 1997-12-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11656
Submission : 1995-09-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11170
Submission : 1994-10-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12780
Submission : 1997-12-10
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-12-11
Pay. Date : 2018-12-04
DMF Number : 14355
Submission : 1999-06-22
Status : Active
Type : II
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