01 1Alkaloida Chemical Company Zrt
02 1Asia Pioneer Pharmaceuticals
03 1Biotechnica DWC
04 2Harman Finochem
05 1JPN Pharma
06 1Siegfried AG
07 2Yashiro Pharmaceutical Co Ltd
01 1Algeria
02 1Hungary
03 3India
04 1Switzerland
05 1U.S.A
06 2Blank
01 2Active
02 7Blank
01 1Valid
02 8Blank
01 1218MF10254
02 1227MF10203
03 7Blank
01 1WC-0044
02 1WC-0045nA2
03 7Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2020-03-31
Pay. Date : 2020-03-06
DMF Number : 34598
Submission : 2020-03-10
Status : Active
Type : II
Certificate Number : R0-CEP 2021-501 - Rev 00
Issue Date : 2023-04-04
Type : Chemical
Substance Number : 630
Status : Valid
NDC Package Code : 50095-003
Start Marketing Date : 2023-12-05
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31499
Submission : 2017-03-16
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-21
Written Confirmation Number : WC-0045nA2
Address of the Firm :
NDC Package Code : 66064-1017
Start Marketing Date : 2015-01-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-06-06
Valid Till : 2025-07-21
Written Confirmation Number : WC-0044
Address of the Firm :
NDC Package Code : 66064-1017
Start Marketing Date : 2015-01-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 0792-0004
Start Marketing Date : 1967-03-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 227MF10203
Registrant's Address : 10-2 Yoshida Shimojima, Higashiosaka City, Osaka Prefecture
Initial Date of Registration : 2015-08-10
Latest Date of Registration : --
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 218MF10254
Registrant's Address : 10-2 Yoshida Shimojima, Higashiosaka City, Osaka Prefecture
Initial Date of Registration : 2006-02-16
Latest Date of Registration : --
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