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30 Jan 2026
// EMA
https://eudragmdp.ema.europa.eu/inspections/gmpc/searchGMPNonCompliance.do;jsessionid=N0cxzXLHEV6L7KfIaPrMD3QEjaqFdI1jJiztF-BrBNXilAR-_Wzk!-520925219?ctrl=searchGMPNCResultControlList&action=Drilldown¶m=182734
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 : Suspended by EDQM G...
Registration Number : 303MF10108
Registrant's Address : No. 50 Shengxue Road, Luancheng 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 : 2026-12-31
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 : CEP 2021-099 - Rev 02
Issue Date : 2026-01-20
Type : Chemical
Substance Number : 198
Status : Valid
Registration Number : 228MF10098
Registrant's Address : No. 50 Shengxue Road, Luancheng Shijiazhuang, Hebei Province, China
Initial Date of Registration : 2016-05-23
Latest Date of Registration :
NDC Package Code : 24507-004
Start Marketing Date : 2022-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 6436
Submission : 2021-07-07
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, Luancheng 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 : 2026-12-31
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
GDUFA
DMF Review : Reviewed
Rev. Date : 2026-02-10
Pay. Date : 2025-09-26
DMF Number : 42636
Submission : 2025-09-24
Status : Active
Type : II
Certificate Number : CEP 2024-389 - Rev 00
Issue Date : 2025-09-03
Type : Chemical
Substance Number : 203
Status : Valid
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, Luancheng Shijiazhuang, Hebei Province, China
Initial Date of Registration : 2017-04-11
Latest Date of Registration :
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 : R0-CEP 2021-031 - Rev 00
Issue Date : 2022-06-23
Type : Chemical
Substance Number : 199
Status : Valid
NDC Package Code : 24507-002
Start Marketing Date : 2019-12-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 6433
Submission : 2021-06-06
Status : Active
Type : II
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 : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 6073
Submission : 2014-06-03
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
VMF Number : 5975
Submission : 2010-01-14
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2020-069 - Rev 02
Issue Date : 2025-09-18
Type : Chemical
Substance Number : 1658
Status : Valid
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Inspections and registrations
ABOUT THIS PAGE
Hebei Shengxue Dacheng Pharmaceutical is a supplier offers 13 products (APIs, Excipients or Intermediates).
Find a price of Colistimethate Sodium bulk with DMF, JDMF offered by Hebei Shengxue Dacheng Pharmaceutical
Find a price of Oxytetracycline Hydrochloride bulk with CEP, JDMF offered by Hebei Shengxue Dacheng Pharmaceutical
Find a price of Polymyxin B Sulfate bulk with DMF, CEP offered by Hebei Shengxue Dacheng Pharmaceutical
Find a price of Streptomycin bulk with CEP, JDMF offered by Hebei Shengxue Dacheng Pharmaceutical
Find a price of Colistin Sulfate bulk with CEP offered by Hebei Shengxue Dacheng Pharmaceutical
Find a price of Oxytetracycline Dihydrate bulk with CEP offered by Hebei Shengxue Dacheng Pharmaceutical
Find a price of Spectinomycin bulk with CEP offered by Hebei Shengxue Dacheng Pharmaceutical
Find a price of Spectinomycin Dihydrochloride Pentahydrate bulk with CEP offered by Hebei Shengxue Dacheng Pharmaceutical
Find a price of Dihydrostreptomycin Sulphate bulk offered by Hebei Shengxue Dacheng Pharmaceutical
Find a price of Oxytetracycline Hydrochloride bulk offered by Hebei Shengxue Dacheng Pharmaceutical
Find a price of Chlortetracycline bulk offered by Hebei Shengxue Dacheng Pharmaceutical
Find a price of Colistimethate Sodium bulk offered by Hebei Shengxue Dacheng Pharmaceutical
Find a price of Spectinomycin HCl bulk offered by Hebei Shengxue Dacheng Pharmaceutical
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