Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
01 1Laboratorium Ofichem B.V
02 2Akzo Nobel Polymer Chem LLC
03 1Suven Pharmaceuticals
01 1DISSOLVINE E-CA-10 (EDETATE CALCIUM DISODIUM USP)
02 1DISSOLVINE NA-2-P (EDETATE DISODIUM USP)
03 1EDETATE CALCIUM DISODIUM
04 1EDETATE CALCIUM DISODIUM DIHYDRATE USP
01 1India
02 1Netherlands
03 2U.S.A
01 2Active
02 2Inactive
01 2Complete
02 2Blank
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
GDUFA
DMF Review : Complete
Rev. Date : 2022-08-30
Pay. Date : 2022-08-03
DMF Number : 36993
Submission : 2022-07-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10760
Submission : 1994-03-03
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10759
Submission : 1994-03-03
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-24
Pay. Date : 2020-10-22
DMF Number : 35275
Submission : 2020-10-01
Status : Active
Type : II
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