01 1Colistimethate Sodium
02 1Colistin Sulfate
03 1Dihydrostreptomycin Sulphate
04 3Oxytetracycline Dihydrate
05 3Oxytetracycline Hydrochloride
06 1Spectinomycin
07 1Spectinomycin Dihydrochloride Pentahydrate
08 1Streptomycin
01 1Active
02 11Blank
01 11Valid
02 1Withdrawn by Holder
01 1222MF10078
02 1228MF10098
03 1229MF10076
04 1303MF10108
05 8Blank
01 12Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : Reviewed
Rev. Date : 2020-12-29
Pay. Date : 2020-09-10
DMF Number : 35177
Submission : 2020-09-22
Status : Active
Type : II
Certificate Number : CEP 2019-246 - Rev 02
Issue Date : 2024-04-12
Type : Chemical
Substance Number : 319
Status : Valid
Registration Number : 303MF10108
Registrant's Address : No. 50 Shengxue Road, Luncheng Shijiazhuang, Hebei Province, China
Initial Date of Registration : 2021-07-16
Latest Date of Registration :
NDC Package Code : 24507-005
Start Marketing Date : 2022-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Otran Korea Co., Ltd.
Registration Date : 2025-02-12
Registration Number : 20250212-210-J-1760
Manufacturer Name : Hebei Shengxue Dacheng Pharmaceutical Co., Ltd.
Manufacturer Address : No. 57 Zhangju Road, Luancheng District, Shijiazhuang City, Hebei Province, 051430, People's Republic of China
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2021-099 - Rev 01
Issue Date : 2022-06-28
Type : Chemical
Substance Number : 198
Status : Valid
Registration Number : 228MF10098
Registrant's Address : No. 50 Shengxue Road, Luncheng Shijiazhuang, Hebei Province, China
Initial Date of Registration : 2016-05-23
Latest Date of Registration :
NDC Package Code : 24507-003
Start Marketing Date : 2015-01-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 6070
Submission : 2014-05-02
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2013-090 - Rev 02
Issue Date : 2021-09-09
Type : Chemical
Substance Number : 198
Status : Valid
Registration Number : 222MF10078
Registrant's Address : No. 50 Shengxue Road, Luncheng Shijiazhuang, Hebei Province, China
Initial Date of Registration : 2010-03-09
Latest Date of Registration :
NDC Package Code : 24507-003
Start Marketing Date : 2015-01-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 6070
Submission : 2014-05-02
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2004-052 - Rev 03
Issue Date : 2021-09-09
Type : Chemical
Substance Number : 53
Status : Valid
Registration Number : 229MF10076
Registrant's Address : No. 50 Shengxue Road, Luncheng Shijiazhuang, Hebei Province, China
Initial Date of Registration : 2017-04-11
Latest Date of Registration :
NDC Package Code : 82403-003
Start Marketing Date : 2024-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1U/U)
Marketing Category : BULK INGREDIENT
VMF Number : 6518
Submission : 2023-04-19
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 2009-144 - Rev 01
Issue Date : 2019-02-21
Type : Chemical
Substance Number : 320
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2018-146 - Rev 03
Issue Date : 2024-09-02
Type : Chemical
Substance Number : 485
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2004-055 - Rev 03
Issue Date : 2024-10-09
Type : Chemical
Substance Number : 199
Status : Valid
NDC Package Code : 24507-001
Start Marketing Date : 2011-01-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 5975
Submission : 2021-06-06
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2017-258 - Rev 01
Issue Date : 2024-05-22
Type : Chemical
Substance Number : 199
Status : Valid
NDC Package Code : 24507-001
Start Marketing Date : 2011-01-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 5975
Submission : 2021-06-06
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R0-CEP 2021-031 - Rev 00
Issue Date : 2022-06-23
Type : Chemical
Substance Number : 199
Status : Valid
NDC Package Code : 24507-001
Start Marketing Date : 2011-01-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 5975
Submission : 2021-06-06
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2020-069 - Rev 01
Issue Date : 2024-05-06
Type : Chemical
Substance Number : 1658
Status : Valid
Hebei Shengxue Dacheng Pharmaceutical Co is a supplier offers 9 products (APIs, Excipients or Intermediates).
Find a price of Colistimethate Sodium bulk with DMF, CEP, JDMF offered by Hebei Shengxue Dacheng Pharmaceutical Co
Find a price of Oxytetracycline Hydrochloride bulk with CEP, JDMF offered by Hebei Shengxue Dacheng Pharmaceutical Co
Find a price of Streptomycin bulk with CEP, JDMF offered by Hebei Shengxue Dacheng Pharmaceutical Co
Find a price of Colistin Sulfate bulk with CEP offered by Hebei Shengxue Dacheng Pharmaceutical Co
Find a price of Dihydrostreptomycin Sulphate bulk with CEP offered by Hebei Shengxue Dacheng Pharmaceutical Co
Find a price of Oxytetracycline Dihydrate bulk with CEP offered by Hebei Shengxue Dacheng Pharmaceutical Co
Find a price of Spectinomycin bulk with CEP offered by Hebei Shengxue Dacheng Pharmaceutical Co
Find a price of Spectinomycin Dihydrochloride Pentahydrate bulk with CEP offered by Hebei Shengxue Dacheng Pharmaceutical Co
Find a price of Oxytetracycline Hydrochloride bulk offered by Hebei Shengxue Dacheng Pharmaceutical Co
