01 1Chemische Fabrik Berg
02 1Malladi Drugs & Pharmaceuticals Limited
03 1Moehs Iberica
04 1Biotechnica DWC
05 1Cambrex Corporation
06 1Cody Laboratories, Inc.
07 1Gyma Laboratories of America
08 1Olon S.p.A
09 1Pisgah Labs
10 1Siegfried AG
11 1Sun Pharmaceutical Industries Limited
12 1Symed Labs
13 1Zydus Lifesciences
14 1Blank
01 1Algeria
02 1Germany
03 4India
04 1Italy
05 1Spain
06 1Switzerland
07 4U.S.A
08 1Blank
01 6Active
02 5Inactive
03 3Blank
01 14Blank
01 14Blank
01 1WC-0072
02 1WC-0159
03 12Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-27
Pay. Date : 2014-08-20
DMF Number : 15442
Submission : 2001-05-14
Status : Active
Type : II
NDC Package Code : 65319-1452
Start Marketing Date : 2019-01-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea BMI Co., Ltd.
Registration Date : 2013-07-15
Registration Number : 20080331-98-E-32-03(5)
Manufacturer Name : chemical factory berg GmbH
Manufacturer Address : Mainthalstrasse 3 D-06749 Bitterfeld
Malladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38657
Submission : 2023-11-08
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-24
Pay. Date : 2012-12-03
DMF Number : 3432
Submission : 1979-01-09
Status : Active
Type : II
NDC Package Code : 0792-0344
Start Marketing Date : 1979-01-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-23
Pay. Date : 2012-12-21
DMF Number : 15289
Submission : 2001-02-15
Status : Active
Type : II
NDC Package Code : 17337-0030
Start Marketing Date : 2012-12-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2020-07-08
Registration Number : 20080204-98-E-40-02(1)
Manufacturer Name : Olon SpA
Manufacturer Address : Via Milano, 186 20024 garbagnate Milanese (MI), Italy
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24856
Submission : 2011-04-12
Status : Active
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-09-08
Written Confirmation Number : WC-0072
Address of the Firm :
NDC Package Code : 66022-0112
Start Marketing Date : 1997-05-30
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 : 15940
Submission : 2002-04-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2144
Submission : 1973-08-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15461
Submission : 2001-05-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17039
Submission : 2003-12-17
Status : Inactive
Type : II
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