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 1Brenntag
03 1Helsinn Advanced Synthesis
04 1MSN Laboratories
05 1Nitika Pharmaceutical Specialities
06 1SAFC
07 1Valaji PharmaChem
08 1Wuhan Biet
01 1China
02 3India
03 1Netherlands
04 2Switzerland
05 1U.S.A
01 2Active
02 1Inactive
03 5Blank
01 1Valid
02 7Blank
01 8Blank
01 8Blank
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-08-17
Pay. Date : 2017-08-01
DMF Number : 31238
Submission : 2016-12-28
Status : Active
Type : II
NDC Package Code : 69766-028
Start Marketing Date : 2016-12-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-04-27
Pay. Date : 2014-11-05
DMF Number : 27608
Submission : 2013-09-30
Status : Active
Type : II
Certificate Number : R1-CEP 2016-144 - Rev 00
Issue Date : 2022-01-06
Type : Chemical
Substance Number : 123
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19426
Submission : 2006-05-12
Status : Inactive
Type : II
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