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PEGS Boston SummitPEGS Boston Summit
Industry Trade Show
Not Confirmed
11 May-15 November, 2026
STLE Annual MeetingSTLE Annual Meeting
Industry Trade Show
Not Confirmed
17-21 May, 2026
Biogas AmericasBiogas Americas
Industry Trade Show
Not Confirmed
18-21 May, 2026
Digital content

30 Mar 2022
// FDA
https://www.pharmacompass.com/pdf/news/fda-issues-form-483-to-zhejiang-hisun-pharmaceuticals-1648618859.pdf
![FDA Issues Form 483 to Zhejiang Hisun Pharmaceuticals [8.11.17 483]](https://www.pharmacompass.com/image/vb/caution.png)
30 Mar 2022
// FDA
https://www.pharmacompass.com/pdf/news/fda-issues-form-483-to-zhejiang-hisun-pharmaceuticals-81117-483-1648619084.pdf

30 Jun 2020
// PRNEWSWIRE
https://www.prnewswire.com/news-releases/zhejiang-hisun-pharmaceutical-co-ltd-free-of-covid-19-governments-suggest-favipiravir-301086032.html

26 Jun 2020
// BUSINESSWIRE

26 Jun 2020
// BUSINESSWIRE

26 Jun 2020
// PRNEWSWIRE
https://www.prnewswire.com/news-releases/zhejiang-hisun-pharmaceutical-co-ltd-free-of-covid-19-governments-suggest-favipiravir-301084393.html
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-23
Pay. Date : 2012-11-15
DMF Number : 19069
Submission : 2005-12-14
Status : Active
Type : II
Certificate Number : CEP 2006-144 - Rev 02
Issue Date : 2025-06-11
Type : Chemical
Substance Number : 2089
Status : Valid
Registration Number : 218MF10411
Registrant's Address : 46 Waisha Road, Jiaojiang District, Taizhou City, Zhejiang Province, P. R. China 318000
Initial Date of Registration : 2006-04-14
Latest Date of Registration :
NDC Package Code : 58623-0022
Start Marketing Date : 2008-05-07
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 : 2013-03-07
Pay. Date : 2012-12-18
DMF Number : 13773
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 2013-262 - Rev 02
Issue Date : 2024-10-09
Type : Chemical
Substance Number : 714
Status : Valid
Registration Number : 226MF10124
Registrant's Address : 46 Waisha Road, Jiaojiang District, Taizhou City, Zhejiang Province, P. R. China 318000
Initial Date of Registration : 2014-07-01
Latest Date of Registration :
NDC Package Code : 58623-0119
Start Marketing Date : 2019-09-05
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 : 2014-02-08
Pay. Date : 2012-12-18
DMF Number : 21624
Submission : 2008-05-08
Status : Active
Type : II
Certificate Number : CEP 1999-176 - Rev 06
Issue Date : 2025-01-10
Type : Chemical
Substance Number : 1336
Status : Valid
Registration Number : 304MF10048
Registrant's Address : 46 Waisha Road, Jiaojiang District, Taizhou City, Zhejiang Province, P. R. China 318000
Initial Date of Registration : 2022-03-02
Latest Date of Registration :
NDC Package Code : 58623-0047
Start Marketing Date : 2014-10-24
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2025-02-21
Registration Number : 20250221-211-J-1776
Manufacturer Name : Zhejiang Hisun Pharmaceutical Co., Ltd.
Manufacturer Address : 56 Binhai Road, Jiaojiang District, Taizhou City, Zhejiang Province, People's Republic of China
VMF Number : 5553
Submission : 1995-12-14
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-18
Pay. Date : 2012-12-18
DMF Number : 13775
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : CEP 2012-380 - Rev 03
Issue Date : 2026-01-30
Type : Chemical
Substance Number : 662
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-12
Pay. Date : 2013-07-24
DMF Number : 27311
Submission : 2013-09-09
Status : Active
Type : II
Certificate Number : CEP 1999-151 - Rev 09
Issue Date : 2024-10-15
Type : Chemical
Substance Number : 714
Status : Valid
NDC Package Code : 58623-0029
Start Marketing Date : 1996-09-12
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 : 2015-02-13
Pay. Date : 2014-12-24
DMF Number : 28923
Submission : 2014-12-25
Status : Active
Type : II
Certificate Number : CEP 2024-020 - Rev 00
Issue Date : 2026-02-19
Type : Chemical
Substance Number : 3087
Status : Valid
NDC Package Code : 58623-0131
Start Marketing Date : 2018-10-12
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 : 2013-08-18
Pay. Date : 2012-11-15
DMF Number : 26311
Submission : 2012-09-04
Status : Active
Type : II
Certificate Number : CEP 2024-176 - Rev 01
Issue Date : 2025-11-06
Type : Chemical
Substance Number : 2825
Status : Valid
NDC Package Code : 58623-0048
Start Marketing Date : 2018-01-18
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Penmix Co., Ltd.
Registration Date : 2016-01-25
Registration Number : Number 4766-6-ND(1)
Manufacturer Name : Zhejiang Hisun Pharmaceutical Co., Ltd.
Manufacturer Address : No.56, Binhai Road, Jiaojiang District, Taizhou city, Zhejiang China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-18
Pay. Date : 2012-12-18
DMF Number : 16205
Submission : 2002-10-22
Status : Active
Type : II
Certificate Number : R0-CEP 2012-132 - Rev 00
Issue Date : 2014-10-29
Type : Chemical
Substance Number : 2174
Status : Withdrawn by Holder
NDC Package Code : 58623-0037
Start Marketing Date : 2004-04-22
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 : Reviewed
Rev. Date : 2013-01-18
Pay. Date : 2012-12-18
DMF Number : 15178
Submission : 2000-12-01
Status : Active
Type : II
Certificate Number : R1-CEP 2005-279 - Rev 01
Issue Date : 2016-06-30
Type : Chemical
Substance Number : 711
Status : Withdrawn by Holder
NDC Package Code : 58623-0024
Start Marketing Date : 2009-03-12
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 : 2013-01-18
Pay. Date : 2012-12-18
DMF Number : 15959
Submission : 2002-04-28
Status : Active
Type : II
Certificate Number : R1-CEP 2001-390 - Rev 03
Issue Date : 2016-08-02
Type : Chemical
Substance Number : 760
Status : Withdrawn by Holder
NDC Package Code : 58623-0026
Start Marketing Date : 2004-01-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
REF. STANDARDS & IMPURITIES
Inspections and registrations
Country : China
City/Region : Nantong
Audit Date : 2024-08-05
Audit Type : On-Site
Country : China
City/Region : Taizhou City, Jiaojiang District
Audit Date : Sep-26
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 Hisun Pharmaceutical is a supplier offers 108 products (APIs, Excipients or Intermediates).
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