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Not Confirmed
11 May-15 November, 2026
DIA Global Annual Meet...DIA Global Annual Meeting
Industry Trade Show
Not Confirmed
14-18 June, 2026
Specialty & Agro Chemi...Specialty & Agro Chemical
Industry Trade Show
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16-18 June, 2026
Digital content

17 Jun 2025
// FDA
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zhejiang-huahai-pharmaceutical-co-ltd-707145-06062025

16 Apr 2025
// FDA

24 Aug 2022
// Kevin Dunleavy FIERCEPHARMA
https://www.fiercepharma.com/manufacturing/paxlovid-production-pfizer-partners-chinese-company-huahai-which-coming-fda-ban

23 Aug 2022
// BLOOMBERG
https://www.bnnbloomberg.ca/pfizer-picks-china-firm-involved-in-drug-recall-for-covid-pill-1.1809083

19 Nov 2021
// Angus Liu FIERCEPHARMA
https://www.fiercepharma.com/pharma-asia/biocon-viatris-insulin-biosimilar-astrazeneca-china-performance-huahai-fda-warning-lift

16 Nov 2021
// Angus Liu FIERCEPHARMA
https://www.fiercepharma.com/manufacturing/3-years-valsartan-recall-zhejiang-huahai-china-drug-manufacturer-fda-warning-letter
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-12-05
Pay. Date : 2012-11-23
DMF Number : 25455
Submission : 2011-10-21
Status : Active
Type : II
Certificate Number : CEP 2011-309 - Rev 05
Issue Date : 2024-09-09
Type : Chemical
Substance Number : 2573
Status : Valid
Registration Number : 304MF10122
Registrant's Address : Xunqiao, Linhai, Zhejiang 317024, China
Initial Date of Registration : 2022-08-17
Latest Date of Registration :
NDC Package Code : 64220-114
Start Marketing Date : 2011-02-09
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2024-07-25
Registration Number : 20200528-209-J-639(3)
Manufacturer Name : Zhejiang Huahai Pharmaceutical Co., Ltd. Ltd
Manufacturer Address : Xunqiao, Linhai, Zhejiang, 317024, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-07-10
Pay. Date : 2014-11-18
DMF Number : 14311
Submission : 1999-07-22
Status : Active
Type : II
Certificate Number : R1-CEP 1997-023 - Rev 10
Issue Date : 2020-10-19
Type : Chemical
Substance Number : 1079
Status : Valid
Registration Number : 227MF10237
Registrant's Address : Xunqiao, Linhai, Zhejiang 317024, China
Initial Date of Registration : 2015-09-24
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-12-11
Pay. Date : 2018-12-04
DMF Number : 14355
Submission : 1999-06-22
Status : Active
Type : II
Certificate Number : CEP 2000-053 - Rev 07
Issue Date : 2023-11-23
Type : Chemical
Substance Number : 1420
Status : Valid
Registration Number : 227MF10268
Registrant's Address : Xunqiao, Linhai, Zhejiang 317024, China
Initial Date of Registration : 2015-11-19
Latest Date of Registration :
NDC Package Code : 64220-143
Start Marketing Date : 2008-06-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2024-07-25
Registration Number : 20050831-12-B-51-08(4)
Manufacturer Name : Zhejiang Huahai Pharmaceutical Co., Ltd.
Manufacturer Address : Lizhuang, Xunqiao, Linhai, 317024, Zhejiang, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-06-17
Pay. Date : 2013-05-03
DMF Number : 20081
Submission : 2006-10-17
Status : Active
Type : II
Certificate Number : CEP 2016-178 - Rev 02
Issue Date : 2026-01-08
Type : Chemical
Substance Number : 2733
Status : Valid
Registration Number : 303MF10128
Registrant's Address : Xunqiao, Linhai, Zhejiang 317024, China
Initial Date of Registration : 2021-08-16
Latest Date of Registration :
NDC Package Code : 64220-109
Start Marketing Date : 2011-02-09
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Pharmapia Co., Ltd.
Registration Date : 2024-04-09
Registration Number : 20200221-209-J-422(3)
Manufacturer Name : Zhejiang Huahai Pharmaceutical Co., Ltd.
Manufacturer Address : Xunqiao, Linhai, Zhejiang, 317024, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-21
Pay. Date : 2013-05-14
DMF Number : 23853
Submission : 2010-06-02
Status : Active
Type : II
Certificate Number : CEP 2022-399 - Rev 01
Issue Date : 2024-08-19
Type : Chemical
Substance Number : 2535
Status : Valid
Registration Number : 301MF10091
Registrant's Address : Xunqiao, Linhai, Zhejiang 317024, China
Initial Date of Registration : 2019-11-15
Latest Date of Registration :
NDC Package Code : 64220-152
Start Marketing Date : 2011-02-09
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 : 2013-03-28
Pay. Date : 2013-03-19
DMF Number : 14801
Submission : 2000-03-24
Status : Active
Type : II
Certificate Number : CEP 2003-064 - Rev 06
Issue Date : 2024-07-19
Type : Chemical
Substance Number : 1120
Status : Valid
Registration Number : 219MF10148
Registrant's Address : Xunqiao, Linhai, Zhejiang 317024, China
Initial Date of Registration : 2007-04-27
Latest Date of Registration :
NDC Package Code : 64220-142
Start Marketing Date : 2010-09-01
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 : 2013-01-08
Pay. Date : 2012-12-07
DMF Number : 19712
Submission : 2006-08-11
Status : Active
Type : II
Certificate Number : R1-CEP 2016-153 - Rev 00
Issue Date : 2023-01-19
Type : Chemical
Substance Number : 2479
Status : Valid
Registration Number : 227MF10149
Registrant's Address : Xunqiao, Linhai, Zhejiang 317024, China
Initial Date of Registration : 2015-05-26
Latest Date of Registration :
NDC Package Code : 64220-102
Start Marketing Date : 2006-01-01
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 : 2014-06-23
Pay. Date : 2013-09-03
DMF Number : 25707
Submission : 2011-12-20
Status : Active
Type : II
Certificate Number : R1-CEP 2011-365 - Rev 01
Issue Date : 2020-10-20
Type : Chemical
Substance Number : 2576
Status : Valid
Registration Number : 306MF10092
Registrant's Address : Xunqiao, Linhai, Zhejiang 317024, China
Initial Date of Registration : 2024-07-03
Latest Date of Registration :
NDC Package Code : 64220-140
Start Marketing Date : 2006-01-01
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 : 22235
Submission : 2008-11-21
Status : Inactive
Type : II
Certificate Number : R1-CEP 2012-325 - Rev 00
Issue Date : 2019-02-20
Type : Chemical
Substance Number : 2535
Status : Valid
Registration Number : 306MF10094
Registrant's Address : Xunqiao, Linhai, Zhejiang 317024, China
Initial Date of Registration : 2024-07-11
Latest Date of Registration :
NDC Package Code : 64220-192
Start Marketing Date : 2015-12-16
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Gukjeon Co., Ltd.
Registration Date : 2012-10-12
Registration Number : 20121012-183-I-139-08
Manufacturer Name : Zhejiang Huahai Pharmaceutical Co., Ltd.
Manufacturer Address : Chuannan, Duqiao, Linhai, Zhejiang, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20716
Submission : 2007-04-25
Status : Inactive
Type : II
Certificate Number : R1-CEP 2010-139 - Rev 05
Issue Date : 2022-09-08
Type : Chemical
Substance Number : 2232
Status : Valid
Registration Number : 303MF10094
Registrant's Address : Xunqiao, Linhai, Zhejiang 317024, China
Initial Date of Registration : 2021-06-15
Latest Date of Registration :
NDC Package Code : 64220-164
Start Marketing Date : 2017-03-22
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Toru Co., Ltd.
Registration Date : 2022-05-11
Registration Number : 20100226-122-G-72-17(11)
Manufacturer Name : Zhejiang Huahai Pharmaceutical Co., Ltd.
Manufacturer Address : Chuannan, Duqiao, Linhai, Zhejiang, China

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26756
Submission : 2013-01-30
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2014-05-23
Pay. Date : 2013-09-27
DMF Number : 27505
Submission : 2013-09-30
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2015-07-14
Pay. Date : 2014-12-31
DMF Number : 28886
Submission : 2015-02-16
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2015-12-18
Pay. Date : 2015-09-25
DMF Number : 29667
Submission : 2015-09-02
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2017-09-14
Pay. Date : 2017-08-08
DMF Number : 31882
Submission : 2017-07-12
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2013-04-09
Pay. Date : 2012-11-23
DMF Number : 25685
Submission : 2011-12-20
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2020-01-17
Pay. Date : 2019-09-30
DMF Number : 33485
Submission : 2019-09-17
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-25
DMF Number : 17792
Submission : 2004-10-27
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2019-06-04
Pay. Date : 2019-04-26
DMF Number : 33810
Submission : 2019-04-25
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2022-10-27
Pay. Date : 2022-10-14
DMF Number : 37524
Submission : 2022-09-26
Status : Active
Type : II

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 : Chuannan, Duqiao, Linhai, Zhejiang Province
Audit Date : 2026-07-30
Audit Type : On-Site
Country : China
City/Region : Xunqiao, Linhai, Zhejiang Province
Audit Date : 2026-07-28
Audit Type : On-Site
Country : China
City/Region : Chuannan, Duqiao, Linhai, Zhejiang Province
Audit Date : 2025-07-17
Audit Type : On-Site
Country : China
City/Region : Xunqiao, Linhai, Zhejiang Province
Audit Date : 2025-05-09
Audit Type : On-Site
Country : China
City/Region : Xunqiao, Linhai, Zhejiang Province
Audit Date : 2024-08-27
Audit Type : On-Site
Country : China
City/Region : Linhai
Audit Date : Mar-26
Audit Type : On-Site
Country : China
City/Region : Linhai
Audit Date : Jul-24
Audit Type : On-Site
Country : China
City/Region : Linhai
Audit Date : Aug-24
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 Huahai Pharmaceutical is a supplier offers 135 products (APIs, Excipients or Intermediates).
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