LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
01 1LGM Pharma
02 1Laboratorium Ofichem B.V
03 1Apicore LLC
04 1CHEMO
05 1CordenPharma
06 1Industriale Chimica
07 1Jiangsu Lianhuan Pharmaceutical
08 1Reliable Biopharmaceutical Corporation
09 1Shouyuan Chemical
10 1Viatris
01 2China
02 1Germany
03 1India
04 1Italy
05 1Netherlands
06 1Spain
07 3U.S.A
01 5Active
02 1Inactive
03 4Blank
01 1Valid
02 9Blank
01 10Blank
01 1WC-0110n
02 9Blank
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Laboratorium Ofichem, offering a flexible, high-tech environment to produce broad range of APIs for Human & Vet pharmaceutical markets.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39578
Submission : 2024-03-05
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-10
Pay. Date : 2012-12-21
DMF Number : 16428
Submission : 2003-02-13
Status : Active
Type : II
Certificate Number : R1-CEP 2001-442 - Rev 02
Issue Date : 2010-12-03
Type : Chemical
Substance Number : 1138
Status : Valid
NDC Package Code : 63190-0090
Start Marketing Date : 2003-02-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12260
Submission : 1996-12-11
Status : Active
Type : II
NDC Package Code : 59605-2260
Start Marketing Date : 1996-12-11
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-28
Pay. Date : 2014-06-12
DMF Number : 28193
Submission : 2014-06-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39948
Submission : 2024-06-07
Status : Active
Type : II
Date of Issue : 2022-07-15
Valid Till : 2025-07-02
Written Confirmation Number : WC-0110n
Address of the Firm :
NDC Package Code : 42973-194
Start Marketing Date : 2012-09-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11936
Submission : 1996-04-19
Status : Inactive
Type : II
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