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Industry Trade Show
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22-25 February, 2026
Industry Trade Show
Not Confirmed
23-25 February, 2026
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Industry Trade Show
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24-25 February, 2026
Digital content

08 Jan 2026
// INDPHARMAPOST
https://www.indianpharmapost.com/news/wockhardt-files-marketing-authorisation-application-for-wck-5222-with-ema-18814

01 Dec 2025
// ECONOMICTIMES
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/usfda-accepts-wockhardts-nda-for-breakthrough-antibiotic-zaynich/articleshow/125696758.cms

17 Oct 2025
// PHARMABIZ

05 Oct 2025
// INDPHARMAPOST
https://www.indianpharmapost.com/drug-approval/wockhardt-submits-nda-to-usfda-for-zidebactam-cefepime-injection-17932

01 Oct 2025
// INDPHARMAPOST
https://www.indianpharmapost.com/drug-approval/wockhardt-submits-drug-application-to-fda-for-zidebactam-cefepime-for-treatment-of-serious-gram-negative-infections-17923

30 Sep 2025
// PHARMABIZ
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-16
Pay. Date : 2013-05-09
DMF Number : 11935
Submission : 1996-04-18
Status : Active
Type : II
Certificate Number : R1-CEP 1998-053 - Rev 04
Issue Date : 2017-03-21
Type : Chemical
Substance Number : 20
Status : Valid
Registration Number : 303MF10152
Registrant's Address : Wockhardt Towers, Bandra-kurla Complex, Bandra (East), Mumbai-400 051, Maharashtra, India
Initial Date of Registration : 2021-09-28
Latest Date of Registration :
Date of Issue : 2025-10-07
Valid Till : 2028-07-02
Written Confirmation Number : WC-0075
Address of the Firm :
Registrant Name : Hwail Pharmaceutical Co., Ltd.
Registration Date : 2022-01-27
Registration Number : 20210112-209-J-507(2)
Manufacturer Name : Wockhardt Ltd
Manufacturer Address : Plot No. 138, Ankleshwar-393 002, Dist. Bharuch, Gujarat State, India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-12-01
Pay. Date : 2015-11-23
DMF Number : 20071
Submission : 2007-05-15
Status : Active
Type : II
Certificate Number : R1-CEP 2008-258 - Rev 02
Issue Date : 2022-05-24
Type : Chemical
Substance Number : 1486
Status : Valid
Date of Issue : 2025-10-07
Valid Till : 2028-07-02
Written Confirmation Number : WC-0075
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20095
Submission : 2006-12-23
Status : Active
Type : II
Certificate Number : R1-CEP 2007-234 - Rev 00
Issue Date : 2014-03-07
Type : Chemical
Substance Number : 2131
Status : Valid
Date of Issue : 2025-10-07
Valid Till : 2028-07-02
Written Confirmation Number : WC-0075
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8028
Submission : 1989-04-24
Status : Active
Type : II
Certificate Number : R1-CEP 1998-052 - Rev 04
Issue Date : 2014-06-24
Type : Chemical
Substance Number : 1079
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16650
Submission : 2003-06-16
Status : Active
Type : II
Certificate Number : R1-CEP 2002-203 - Rev 01
Issue Date : 2011-05-23
Type : Chemical
Substance Number : 991
Status : Withdrawn by Holder

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15411
Submission : 2001-05-01
Status : Inactive
Type : II
Certificate Number : R1-CEP 2003-051 - Rev 01
Issue Date : 2009-12-17
Type : Chemical
Substance Number : 1300
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19385
Submission : 2006-03-01
Status : Active
Type : II
Certificate Number : R0-CEP 2011-211 - Rev 00
Issue Date : 2012-10-15
Type : Chemical
Substance Number : 2574
Status : Withdrawn by Holder

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24781
Submission : 2011-06-23
Status : Active
Type : II
Certificate Number : R0-CEP 2012-149 - Rev 00
Issue Date : 2014-07-15
Type : Chemical
Substance Number : 2416
Status : Withdrawn by Holder

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CEP/COS
Certificate Numbers : R1-CEP 2008-258 - Rev 02
Status : Valid
Issue Date : 2022-05-24
Type : Chemical
Substance Number : 1486

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CEP/COS
Certificate Numbers : R1-CEP 1998-052 - Rev 04
Status : Valid
Issue Date : 2014-06-24
Type : Chemical
Substance Number : 1079

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CEP/COS
Certificate Numbers : R1-CEP 2002-182 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2011-04-28
Type : Chemical
Substance Number : 989

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CEP/COS
Certificate Numbers : R1-CEP 2002-203 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2011-05-23
Type : Chemical
Substance Number : 991

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CEP/COS
Certificate Numbers : R1-CEP 2003-051 - Rev 01
Status : Valid
Issue Date : 2009-12-17
Type : Chemical
Substance Number : 1300

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CEP/COS
Certificate Numbers : R0-CEP 2003-236 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2006-07-07
Type : Chemical
Substance Number : 992

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Certificate Numbers : R1-CEP 1998-053 - Rev 04
Status : Valid
Issue Date : 2017-03-21
Type : Chemical
Substance Number : 20

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CEP/COS
Certificate Numbers : R1-CEP 1998-096 - Rev 02
Status : Withdrawn by Holder
Issue Date : 2010-07-12
Type : Chemical
Substance Number : 713

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CEP/COS
Certificate Numbers : R0-CEP 2001-062 - Rev 00
Status : Expired
Issue Date : 2005-01-17
Type : Chemical
Substance Number : 1420

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CEP/COS
Certificate Numbers : R0-CEP 2011-211 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2012-10-15
Type : Chemical
Substance Number : 2574

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Wockhardt Limited is a supplier offers 82 products (APIs, Excipients or Intermediates).
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