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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218083
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-21
Pay. Date : 2013-09-11
DMF Number : 18063
Submission : 2005-02-08
Status : Active
Type : II
Certificate Number : R1-CEP 2004-062 - Rev 04
Issue Date : 2020-09-24
Type : Chemical
Substance Number : 353
Status : Valid
Registration Number : 302MF10041
Registrant's Address : No. 1 Xianyao Road, Xianju, Zhejiang, China
Initial Date of Registration : 2020-04-02
Latest Date of Registration :
NDC Package Code : 60722-3001
Start Marketing Date : 2020-08-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2017-09-12
Registration Number : 20050831-71-B-193-01(5)
Manufacturer Name : Zhejiang Xianju Pharmaceutical Co.,Ltd.
Manufacturer Address : No.1 Xianyao Road, Xianju, Zhejiang, China 317300
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-12-12
Pay. Date : 2023-06-13
DMF Number : 30230
Submission : 2016-01-21
Status : Active
Type : II
Certificate Number : CEP 2024-440 - Rev 00
Issue Date : 2025-02-04
Type : Chemical
Substance Number : 335
Status : Valid
NDC Package Code : 60722-1001
Start Marketing Date : 2016-01-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2018-02-05
Registration Number : 20180205-209-J-16
Manufacturer Name : Zhejiang Xianju Pharmaceutical Co., Ltd.
Manufacturer Address : No.3 Donghai 4th Avenue, Zhejiang Toumen Port Economic Development Zone, Linhai, Zhejiang, China
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-01-26
Pay. Date : 2023-11-07
DMF Number : 24592
Submission : 2011-01-31
Status : Active
Type : II
Certificate Number : CEP 2012-010 - Rev 04
Issue Date : 2024-11-19
Type : Chemical
Substance Number : 1593
Status : Valid
NDC Package Code : 60722-1009
Start Marketing Date : 2023-06-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2020-03-03
Registration Number : 20200303-211-J-361
Manufacturer Name : Zhejiang Xianju Pharmaceutical Co., Ltd
Manufacturer Address : No.3 Donghai Fourth Avenue, Zhejiang Toumen Port Economic Development Zone, Linhai, Taizhou, Zhejiang, China
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-03-02
Pay. Date : 2020-02-26
DMF Number : 25067
Submission : 2011-06-18
Status : Active
Type : II
Certificate Number : R1-CEP 2011-027 - Rev 01
Issue Date : 2021-03-22
Type : Chemical
Substance Number : 561
Status : Valid
NDC Package Code : 60722-1003
Start Marketing Date : 2016-01-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2022-10-24
Registration Number : 20221024-209-J-1384
Manufacturer Name : Zhejiang Xianju Pharmaceutical Co., Ltd.
Manufacturer Address : No.3 Donghai Fourth Avenue, Zhejiang Toumen Port Economic Development Zone, Linhai, Taizhou, Zhejiang, China
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-07-05
Pay. Date : 2016-03-16
DMF Number : 30194
Submission : 2015-12-24
Status : Active
Type : II
Certificate Number : CEP 2018-027 - Rev 02
Issue Date : 2024-04-02
Type : Chemical
Substance Number : 354
Status : Valid
NDC Package Code : 60722-1002
Start Marketing Date : 2016-01-06
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-01-26
Pay. Date : 2021-10-22
DMF Number : 23942
Submission : 2010-06-29
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-09
Pay. Date : 2013-09-25
DMF Number : 19433
Submission : 2006-05-10
Status : Active
Type : II
NDC Package Code : 60722-1006
Start Marketing Date : 2017-01-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-11-16
Pay. Date : 2017-08-21
DMF Number : 31873
Submission : 2017-07-20
Status : Active
Type : II
NDC Package Code : 60722-3002
Start Marketing Date : 2020-10-23
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-06-04
Pay. Date : 2024-04-16
DMF Number : 30741
Submission : 2016-07-11
Status : Active
Type : II
NDC Package Code : 60722-3016
Start Marketing Date : 2022-07-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-07-01
Pay. Date : 2013-07-18
DMF Number : 23934
Submission : 2010-06-28
Status : Active
Type : II
NDC Package Code : 60722-3007
Start Marketing Date : 2020-11-05
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38063
Submission : 2023-08-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39854
Submission : 2024-04-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40994
Submission : 2024-12-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2022-01-26
Pay. Date : 2021-10-22
DMF Number : 23942
Submission : 2010-06-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-12
Pay. Date : 2023-06-13
DMF Number : 30230
Submission : 2016-01-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-12-09
Pay. Date : 2013-09-25
DMF Number : 19433
Submission : 2006-05-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-01-26
Pay. Date : 2023-11-07
DMF Number : 24592
Submission : 2011-01-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-03-02
Pay. Date : 2020-02-26
DMF Number : 25067
Submission : 2011-06-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-11-16
Pay. Date : 2017-08-21
DMF Number : 31873
Submission : 2017-07-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-21
Pay. Date : 2013-09-11
DMF Number : 18063
Submission : 2005-02-08
Status : Active
Type : II
CEP/COS
Zhejiang Xianju Pharmaceutical Co. Ltd
Certificate Numbers : R1-CEP 2003-109 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2011-09-26
Type : Chemical
Substance Number : 1094
CEP/COS
Zhejiang Xianju Pharmaceutical Co. Ltd
Certificate Numbers : CEP 2023-187 - Rev 00
Status : Valid
Issue Date : 2023-09-15
Type : Chemical
Substance Number : 1094
CEP/COS
Zhejiang Xianju Pharmaceutical Co. Ltd
Certificate Numbers : R1-CEP 2015-328 - Rev 00
Status : Valid
Issue Date : 2022-10-05
Type : Chemical
Substance Number : 2765
Zhejiang Xianju Pharmaceutical Co. Ltd
Certificate Numbers : CEP 2022-220 - Rev 01
Status : Valid
Issue Date : 2024-06-25
Type : Chemical
Substance Number : 821
CEP/COS
Zhejiang Xianju Pharmaceutical Co. Ltd
Certificate Numbers : R1-CEP 2012-112 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2018-06-29
Type : Chemical
Substance Number : 140
Zhejiang Xianju Pharmaceutical Co. Ltd
Certificate Numbers : R0-CEP 2020-326 - Rev 00
Status : Valid
Issue Date : 2021-04-26
Type : Chemical
Substance Number : 140
CEP/COS
Zhejiang Xianju Pharmaceutical Co. Ltd
Certificate Numbers : CEP 2018-239 - Rev 02
Status : Valid
Issue Date : 2024-09-25
Type : Chemical
Substance Number : 335
Zhejiang Xianju Pharmaceutical Co. Ltd
Certificate Numbers : CEP 2024-440 - Rev 00
Status : Valid
Issue Date : 2025-02-04
Type : Chemical
Substance Number : 335
CEP/COS
Zhejiang Xianju Pharmaceutical Co. Ltd
Certificate Numbers : CEP 2012-010 - Rev 04
Status : Valid
Issue Date : 2024-11-19
Type : Chemical
Substance Number : 1593
CEP/COS
Zhejiang Xianju Pharmaceutical Co. Ltd
Certificate Numbers : R1-CEP 2011-027 - Rev 01
Status : Valid
Issue Date : 2021-03-22
Type : Chemical
Substance Number : 561
JDMF
Zhejiang Xianju Pharmaceutical Co. Ltd
Registration Number : 223MF10037
Registrant's Address : No. 1 Xianyao Road, Xianju, Zhejiang, China
Initial Date of Registration : 2011-03-10
Latest Date of Registration : 2013-02-06
JDMF
Zhejiang Xianju Pharmaceutical Co. Ltd
Registration Number : 302MF10041
Registrant's Address : No. 1 Xianyao Road, Xianju, Zhejiang, China
Initial Date of Registration : 2020-04-02
Latest Date of Registration : 2020-04-02
JDMF
Zhejiang Xianju Pharmaceutical Co. Ltd
Registration Number : 304MF10022
Registrant's Address : No. 1 Xianyao Road, Xianju, Zhejiang, China
Initial Date of Registration : 2022-01-26
Latest Date of Registration : 2023-03-15
JDMF
Zhejiang Xianju Pharmaceutical Co. Ltd
Registration Number : 227MF10269
Registrant's Address : No. 1 Xianyao Road, Xianju, Zhejiang, China
Initial Date of Registration : 2015-11-19
Latest Date of Registration : 2015-11-19
Zhejiang Xianju Pharmaceutical Co. Ltd
Registrant Name : Hiple Co., Ltd.
Registration Date : 2025-01-24
Registration Number : 20250124-209-J-1751
Manufacturer Name : Zhejiang Xianju Pharmaceutical...
Manufacturer Address : No. 15 West Fengxi Road, Modern Industrial Park, Xianju, Taizhou, Zhejiang, China
Zhejiang Xianju Pharmaceutical Co. Ltd
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2018-02-05
Registration Number : 20180205-209-J-16
Manufacturer Name : Zhejiang Xianju Pharmaceutical...
Manufacturer Address : No.3 Donghai 4th Avenue, Zhejiang Toumen Port Economic Development Zone, Linhai, Zhej...
Zhejiang Xianju Pharmaceutical Co. Ltd
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2020-03-03
Registration Number : 20200303-211-J-361
Manufacturer Name : Zhejiang Xianju Pharmaceutical...
Manufacturer Address : No.3 Donghai Fourth Avenue, Zhejiang Toumen Port Economic Development Zone, Linhai, T...
Zhejiang Xianju Pharmaceutical Co. Ltd
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2018-01-16
Registration Number : 20180116-209-J-2
Manufacturer Name : Zhejiang Xianju Pharmaceutical...
Manufacturer Address : No.3 Donghai Fourth Avenue, Zhejiang Toumen Port Economic Development Zone, Linhai, T...
Zhejiang Xianju Pharmaceutical Co. Ltd
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2022-10-24
Registration Number : 20221024-209-J-1384
Manufacturer Name : Zhejiang Xianju Pharmaceutical...
Manufacturer Address : No.3 Donghai Fourth Avenue, Zhejiang Toumen Port Economic Development Zone, Linhai, T...
Zhejiang Xianju Pharmaceutical Co. Ltd
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2021-02-09
Registration Number : 20210209-211-J-835
Manufacturer Name : Zhejiang Xianju Pharmaceutical...
Manufacturer Address : 15 West Fengxi Road, Modern Industrial Park, Xianju, Taizhou, Zhejiang, China
Zhejiang Xianju Pharmaceutical Co. Ltd
Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2012-01-13
Registration Number : 20050831-71-B-193-01(3)
Manufacturer Name : Zhejiang xianju Pharmaceutical...
Manufacturer Address : No. 1 Xianyao Road, Xianju, Zhejiang, China 317300
Zhejiang Xianju Pharmaceutical Co. Ltd
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2013-05-08
Registration Number : 20050831-71-B-193-01(4)
Manufacturer Name : Zhejiang Xianju Pharmaceutical...
Manufacturer Address : No.1 Xianyao Road, Xianju, Zhejiang, China 317300
Zhejiang Xianju Pharmaceutical Co. Ltd
Registrant Name : Wooshin Labotech Co., Ltd.
Registration Date : 2017-09-12
Registration Number : 20050831-71-B-193-01(5)
Manufacturer Name : Zhejiang Xianju Pharmaceutical...
Manufacturer Address : No.1 Xianyao Road, Xianju, Zhejiang, China 317300
Zhejiang Xianju Pharmaceutical Co. Ltd
Registrant Name : Hanlim Pharmaceutical Co., Ltd.
Registration Date : 2011-11-18
Registration Number : 20050831-71-B-193-01(2)
Manufacturer Name : Zhejiang Xianju Pharmaceutical...
Manufacturer Address : No. 1 Xianyao Road, Xianju, Zhejiang, China 317300
Zhejiang Xianju Pharmaceutical Co. Ltd
About the Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedicated to scientific research since ...
Zhejiang Xianju Pharmaceutical Co. Ltd
About the Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedicated to scientific research since ...
Zhejiang Xianju Pharmaceutical Co. Ltd
About the Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedicated to scientific research since ...
Zhejiang Xianju Pharmaceutical Co. Ltd
About the Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedicated to scientific research since ...
Zhejiang Xianju Pharmaceutical Co. Ltd
About the Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedicated to scientific research since ...
Zhejiang Xianju Pharmaceutical Co. Ltd
About the Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedicated to scientific research since ...
Zhejiang Xianju Pharmaceutical Co. Ltd
About the Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedicated to scientific research since ...
Zhejiang Xianju Pharmaceutical Co. Ltd
About the Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedicated to scientific research since ...
Zhejiang Xianju Pharmaceutical Co. Ltd
About the Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedicated to scientific research since ...
Zhejiang Xianju Pharmaceutical Co. Ltd
About the Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedicated to scientific research since ...
Inspections and registrations
ABOUT THIS PAGE
Zhejiang Xianju Pharmaceutical Co. Ltd is a supplier offers 61 products (APIs, Excipients or Intermediates).
Find a price of Prednisolone bulk with DMF, CEP, JDMF offered by Zhejiang Xianju Pharmaceutical Co. Ltd
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