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01 2Evonik
02 1AMINO GmbH
03 1Bajaj Healthcare
04 1Mitsubishi Tanabe Pharma
05 1Qingdao Taidong Pharmaceutical
06 1SNJ Labs
07 1Sekisui Medical Co. Ltd
01 1China
02 3Germany
03 2India
04 2Japan
01 1Active
02 1Inactive
03 6Blank
01 4Valid
02 4Blank
01 1217MF10771
02 1219MF10244
03 6Blank
01 8Blank
Certificate Number : R1-CEP 2005-190 - Rev 04
Issue Date : 2023-08-24
Type : Chemical
Substance Number : 1027
Status : Valid
NDC Package Code : 16947-8201
Start Marketing Date : 2005-08-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Certificate Number : R1-CEP 2006-139 - Rev 06
Issue Date : 2023-08-24
Type : Chemical
Substance Number : 624
Status : Valid
NDC Package Code : 16947-8201
Start Marketing Date : 2005-08-31
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 : 38245
Submission : 2023-04-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1832
Submission : 1971-12-17
Status : Inactive
Type : II
Certificate Number : R1-CEP 2015-005 - Rev 00
Issue Date : 2021-12-07
Type : Chemical
Substance Number : 1027
Status : Valid
Certificate Number : R1-CEP 1999-136 - Rev 08
Issue Date : 2022-03-17
Type : Chemical
Substance Number : 1027
Status : Valid
Registration Number : 217MF10771
Registrant's Address : 3-13-5 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-20
Latest Date of Registration : --
NDC Package Code : 55152-002
Start Marketing Date : 1982-03-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registration Number : 219MF10244
Registrant's Address : No. 22, Huahai Road, Chengyang District, Qingdao City (Huanhai Economic Development Zone), Shandong Province, P. R China
Initial Date of Registration : 2007-07-17
Latest Date of Registration : --
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