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01 1Baricitinib
02 1Clevidipine
03 1Degarelix Acetate
04 1Levamisole
05 2Pemetrexed Disodium
06 1Sermorelin Acetate
07 1Trepibutone
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01 2Active
02 6Blank
01 1Valid
02 7Blank
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01 8Blank
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01 8Blank
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01 1No. 5991-1-ND(1)
02 1Su5991-1-ND
03 6Blank
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01 170155-022
02 170155-608
03 6Blank
01 8Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37244
Submission : 2022-08-04
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-04-28
Pay. Date : 2025-02-18
DMF Number : 37767
Submission : 2022-12-22
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2013-154 - Rev 01
Issue Date : 2022-06-23
Type : Chemical
Substance Number : 726
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 70155-022
Start Marketing Date : 2016-08-24
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registrant Name : Kosha Bio Co., Ltd.
Registration Date : 2019-01-24
Registration Number : No. 5991-1-ND(1)
Manufacturer Name : Nanjing Asia-East Sunrise Pharmaceutical Co., Ltd
Manufacturer Address : Nanjing Taiwanese Industrial Park (Guabu, Luhe), Nanjing City, China
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registrant Name : SG Biochem Co., Ltd.
Registration Date : 2015-02-24
Registration Number : Su5991-1-ND
Manufacturer Name : Nanjing Asia-East Sunrise Pharmaceutical Co., Ltd_x000D_
Manufacturer Address : Nanjing Taiwanese Industrial Park (Guabu, Luhe), Nanjing City, China_x000D_
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 70155-608
Start Marketing Date : 2017-12-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR ...
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Nanjing Pharmaceutical is a supplier offers 7 products (APIs, Excipients or Intermediates).
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