Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Fermion Oy
03 1SCI Pharmtech
04 1Cambrex Corporation
05 1Changzhou Ruiming Pharmaceutical
06 1Emcure Pharmaceuticals
07 1Erregierre SpA
08 1ORGAMOL PHARMA SOLUTIONS SA
09 1Procos
10 1Siegfried AG
11 1Tianish Laboratories
12 1Trimax Bio Sciences
13 3Viatris
14 1Zydus Lifesciences
01 1China
02 1Finland
03 1Germany
04 4India
05 2Italy
06 2Switzerland
07 1Taiwan
08 4U.S.A
01 8Active
02 4Inactive
03 4Blank
01 4Valid
02 12Blank
01 1217MF11295
02 1224MF10096
03 14Blank
01 1WC-0015
02 1WC-0102
03 2WC-0117
04 1WC-0226
05 11Blank
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-07
Pay. Date : 2013-02-15
DMF Number : 10641
Submission : 1993-12-16
Status : Active
Type : II
Certificate Number : R1-CEP 2005-236 - Rev 03
Issue Date : 2018-06-08
Type : Chemical
Substance Number : 2103
Status : Valid
Date of Issue : 2022-06-24
Valid Till : 2025-07-02
Written Confirmation Number : WC-0102
Address of the Firm :
NDC Package Code : 12598-6216
Start Marketing Date : 1992-12-16
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1h/kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Registrant Name : Abbott Korea Ltd.
Registration Date : 2022-01-24
Registration Number : 20220124-209-J-1222
Manufacturer Name : PharmaZell GmbH
Manufacturer Address : Rosenheimer Straße 43 83064 Raubling Germany
Available Reg Filing : EU, CA, BR, TH, ID |
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-23
Pay. Date : 2014-05-14
DMF Number : 11568
Submission : 1995-06-29
Status : Active
Type : II
Certificate Number : R1-CEP 2012-297 - Rev 00
Issue Date : 2019-05-02
Type : Chemical
Substance Number : 2103
Status : Valid
NDC Package Code : 12780-4900
Start Marketing Date : 1995-06-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-04
Pay. Date : 2013-08-28
DMF Number : 23537
Submission : 2010-02-04
Status : Active
Type : II
Certificate Number : R1-CEP 2010-183 - Rev 01
Issue Date : 2019-04-09
Type : Chemical
Substance Number : 2103
Status : Valid
Registration Number : 224MF10096
Registrant's Address : No. 61, Ln. 309, Haihu N. Rd. , Luzhu Dist. , Taoyuan City 33856, Taiwan
Initial Date of Registration : 2012-05-08
Latest Date of Registration : --
NDC Package Code : 68108-0340
Start Marketing Date : 2012-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2021-03-16
Registration Number : 20210316-209-J-662
Manufacturer Name : SCI Pharmtech, Inc
Manufacturer Address : No.61, Ln.309, Haihu N. Rd., Luzhu Dist. Taoyuan City 33856, Taiwan
Available Reg Filing : CA, CN |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37964
Submission : 2023-02-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25588
Submission : 2012-03-20
Status : Active
Type : II
Date of Issue : 2019-10-07
Valid Till : 2022-07-02
Written Confirmation Number : WC-0226
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-01-04
Pay. Date : 2017-01-20
DMF Number : 13010
Submission : 1998-06-01
Status : Active
Type : II
NDC Package Code : 49706-0201
Start Marketing Date : 2010-01-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-24
Pay. Date : 2013-06-18
DMF Number : 11426
Submission : 1995-04-03
Status : Active
Type : II
Registration Number : 217MF11295
Registrant's Address : Via Matteotti 249,28062 CAMERI(NOVARA)/ITALY
Initial Date of Registration : 2005-12-22
Latest Date of Registration : --
NDC Package Code : 46016-0320
Start Marketing Date : 2006-07-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12691
Submission : 1997-10-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8311
Submission : 1989-11-27
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20418
Submission : 2007-03-15
Status : Inactive
Type : II
Date of Issue : 2022-06-22
Valid Till : 2025-07-28
Written Confirmation Number : WC-0117
Address of the Firm :
NDC Package Code : 65015-671
Start Marketing Date : 2015-02-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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