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07 Jul 2020
// PRESS RELEASE
http://www.ausunpharm.com/news/zhong-mei-liang-guo-de-jiang-tang-yao-wu-shi-yong-zhuang-kuang-dui-bi-145.html

https://in.reuters.com/article/brief-zhejiang-ausun-pharmaceutical-aims-idUSP8N2CB03A

24 Apr 2020
// REUTERS
https://www.reuters.com/article/brief-zhejiang-ausun-pharmaceutical-aims/brief-zhejiang-ausun-pharmaceutical-aims-to-raise-350-mln-yuan-in-private-placement-of-shares-to-fund-project-idUSP8N2CB03A
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-08-07
Pay. Date : 2013-10-30
DMF Number : 25200
Submission : 2011-08-05
Status : Active
Type : II
Certificate Number : R1-CEP 2016-152 - Rev 00
Issue Date : 2022-06-27
Type : Chemical
Substance Number : 2815
Status : Valid
Registration Number : 227MF10302
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, China
Initial Date of Registration : 2015-12-28
Latest Date of Registration :
NDC Package Code : 76397-001
Start Marketing Date : 2015-02-22
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41866
Submission : 2025-06-28
Status : Active
Type : II
Certificate Number : CEP 2022-174 - Rev 00
Issue Date : 2023-10-23
Type : Chemical
Substance Number : 2230
Status : Valid
Registration Number : 307MF10092
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, China
Initial Date of Registration : 2025-07-30
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-11-29
Pay. Date : 2017-09-20
DMF Number : 32076
Submission : 2017-11-06
Status : Active
Type : II
Registration Number : 305MF10025
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, China
Initial Date of Registration : 2023-02-08
Latest Date of Registration :
NDC Package Code : 76397-006
Start Marketing Date : 2020-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-08-01
Pay. Date : 2015-09-21
DMF Number : 29716
Submission : 2015-09-22
Status : Active
Type : II
Registration Number : 303MF10011
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, China
Initial Date of Registration : 2021-01-20
Latest Date of Registration :
NDC Package Code : 76397-022
Start Marketing Date : 2020-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
Registrant Name : SK Chemical Co., Ltd.
Registration Date : 2025-03-17
Registration Number : Su703-8-ND
Manufacturer Name : Zhejiang Ausun Pharmaceutical Co., Ltd.
Manufacturer Address : No.5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, China 317015

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2025-09-04
Pay. Date : 2025-08-13
DMF Number : 41152
Submission : 2025-04-29
Status : Active
Type : II
Registration Number : 307MF10112
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, China
Initial Date of Registration : 2025-09-03
Latest Date of Registration :
NDC Package Code : 76397-044
Start Marketing Date : 2025-04-27
End Marketing Date : 2026-12-31
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 : 2016-04-13
Pay. Date : 2015-09-21
DMF Number : 29730
Submission : 2015-09-28
Status : Active
Type : II
Certificate Number : R0-CEP 2022-170 - Rev 00
Issue Date : 2022-12-09
Type : Chemical
Substance Number : 2775
Status : Valid
NDC Package Code : 76397-008
Start Marketing Date : 2020-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-11-29
Pay. Date : 2023-11-24
DMF Number : 38901
Submission : 2023-09-30
Status : Active
Type : II
Certificate Number : CEP 2023-367 - Rev 00
Issue Date : 2025-04-02
Type : Chemical
Substance Number : 633
Status : Valid
NDC Package Code : 76397-036
Start Marketing Date : 2023-09-26
End Marketing Date : 2026-12-31
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 : 2019-10-22
Pay. Date : 2019-08-16
DMF Number : 33719
Submission : 2019-08-31
Status : Active
Type : II
Registration Number : 303MF10095
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, China
Initial Date of Registration : 2021-06-15
Latest Date of Registration :
NDC Package Code : 76397-050
Start Marketing Date : 2025-11-27
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40808
Submission : 2024-12-09
Status : Active
Type : II
Registration Number : 228MF10177
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, China
Initial Date of Registration : 2016-08-29
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-12-14
Pay. Date : 2020-09-18
DMF Number : 35151
Submission : 2020-09-29
Status : Active
Type : II
Registration Number : 306MF10096
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, China
Initial Date of Registration : 2024-07-11
Latest Date of Registration :
NDC Package Code : 76397-034
Start Marketing Date : 2023-04-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2024-11-12
Registration Number : Su289-22-ND
Manufacturer Name : Zhejiang Ausun Pharmaceutical Co., Ltd.
Manufacturer Address : No.5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, China

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : Complete
Rev. Date : 2025-06-10
Pay. Date : 2025-04-23
DMF Number : 41803
Submission : 2025-04-30
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41921
Submission : 2025-05-15
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2017-11-29
Pay. Date : 2017-09-20
DMF Number : 32076
Submission : 2017-11-06
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2014-08-07
Pay. Date : 2013-10-30
DMF Number : 25200
Submission : 2011-08-05
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2017-08-01
Pay. Date : 2015-09-21
DMF Number : 29716
Submission : 2015-09-22
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41866
Submission : 2025-06-28
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-09-05
Pay. Date : 2025-08-13
DMF Number : 42077
Submission : 2025-08-07
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2016-10-06
Pay. Date : 2016-08-16
DMF Number : 30802
Submission : 2016-08-08
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42658
Submission : 2025-10-02
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-09-04
Pay. Date : 2025-08-13
DMF Number : 41152
Submission : 2025-04-29
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients
REF. STANDARDS & IMPURITIES
Inspections and registrations
Country : China
City/Region : Linhai, Zhejiang
Audit Date : 2025-07-15
Audit Type : On-Site
Country : China
City/Region : Linhai, Zhejiang
Audit Date : 2024-08-02
Audit Type : On-Site
Country : China
City/Region : Tiazhou Zhejiang
Audit Date : 2023-05-17
Audit Type : On-Site
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
Zhejiang Ausun Pharmaceutical is a supplier offers 101 products (APIs, Excipients or Intermediates).
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