Axplora- The partner of choice for complex APIs.
01 1Axplora
02 1Ajinomoto Company
03 1Apotex Pharmachem
04 1Kyowa Hakko Bio
05 1Mitsubishi Tanabe Pharma
06 1Nanjing Joyin Pharmachem Co, ltd
07 1Nihon Rikagaku
08 2Nippon Protein Co Ltd
09 1Nippon Rikagaku Yakuhin
10 1Taenaka Kogyo
01 1Canada
02 1China
03 1Germany
04 8Japan
01 2Active
02 3Inactive
03 6Blank
01 1Valid
02 10Blank
01 1217MF10553
02 1219MF10005
03 1220MF10016
04 1220MF10229
05 7Blank
01 1WC-0102
02 10Blank
Axplora- The partner of choice for complex APIs.
Certificate Number : R1-CEP 1997-014 - Rev 03
Issue Date : 2014-04-24
Type : Chemical
Substance Number : 895
Status : Valid
Date of Issue : 2022-06-24
Valid Till : 2025-07-02
Written Confirmation Number : WC-0102
Address of the Firm :
| Available Reg Filing : EU |
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-10-27
Pay. Date : 2017-03-14
DMF Number : 8866
Submission : 1990-11-30
Status : Active
Type : II
Registration Number : 220MF10229
Registrant's Address : 452 Oshiba, Mobara City, Chiba Prefecture
Initial Date of Registration : 2008-11-17
Latest Date of Registration : --
NDC Package Code : 53884-1013
Start Marketing Date : 2023-01-27
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 : 2018-08-14
Pay. Date : 2018-07-02
DMF Number : 21364
Submission : 2008-02-26
Status : Active
Type : II
Registration Number : 220MF10016
Registrant's Address : 575 Shimada-cho, Ashikaga City, Tochigi Prefecture
Initial Date of Registration : 2008-01-09
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2753
Submission : 1976-10-15
Status : Inactive
Type : II
NDC Package Code : 12497-1013
Start Marketing Date : 1978-03-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10741
Submission : 1994-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1930
Submission : 1972-05-09
Status : Inactive
Type : II
Registration Number : 217MF10553
Registrant's Address : 575 Shimada-cho, Ashikaga City, Tochigi Prefecture
Initial Date of Registration : 2005-09-09
Latest Date of Registration : --
NDC Package Code : 17333-909
Start Marketing Date : 2008-06-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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