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INTERVIEW #SpeakPharma
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04 Jan 2025
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16 Dec 2024
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20 Nov 2024
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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 : 2019-07-22
Valid Till : 2022-07-21
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 : 2019-07-22
Valid Till : 2022-07-21
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 : 2019-07-22
Valid Till : 2022-07-21
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
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16119
Submission : 2002-08-27
Status : Active
Type : II
Date of Issue : 2019-07-22
Valid Till : 2022-07-21
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 : 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 : 21923
Submission : 2008-08-29
Status : Active
Type : II
Date of Issue : 2020-10-16
Valid Till : 2022-07-21
Written Confirmation Number : WC-0075a3
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 : 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 : 21213
Submission : 2007-12-31
Status : Active
Type : II
Date of Issue : 2020-10-16
Valid Till : 2022-07-21
Written Confirmation Number : WC-0075a3
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 : 21211
Submission : 2007-12-31
Status : Active
Type : II
Date of Issue : 2019-07-22
Valid Till : 2022-07-21
Written Confirmation Number : WC-0075
Address of the Firm :
Regulatory Info : RX
Registration Country : USA
Dosage Form : TABLET;ORAL
Brand Name : ABIRATERONE ACETATE
Dosage Strength : 250MG
Packaging :
Approval Date : 2019-02-27
Application Number : 208380
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Dosage Form : SOLUTION;INTRAVENOUS
Brand Name : ACETAMINOPHEN
Dosage Strength : 1GM/100ML (10MG/ML)
Packaging :
Approval Date : 2023-04-18
Application Number : 205746
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE
Dosage Form : TABLET;ORAL
Brand Name : PROPOXYPHENE NAPSYLATE AN...
Dosage Strength : 325MG;50MG
Packaging :
Approval Date : 2007-03-16
Application Number : 77677
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE
Dosage Form : TABLET;ORAL
Brand Name : PROPOXYPHENE NAPSYLATE AN...
Dosage Strength : 650MG;100MG
Packaging :
Approval Date : 2007-03-16
Application Number : 77677
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
ACETIC ACID, GLACIAL; HYDROCORTISONE
Dosage Form : SOLUTION/DROPS;OTIC
Brand Name : HYDROCORTISONE AND ACETIC...
Dosage Strength : 2%;1%
Packaging :
Approval Date : 1996-08-30
Application Number : 40168
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : India
Dosage Form : Vial
Brand Name :
Dosage Strength : 3MG/ML
Packaging : 10 ML, 6 Pack Size
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : India
Dosage Form : Vial
Brand Name :
Dosage Strength : 3MG/ML
Packaging : 2 ML, 6 Pack Size
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Regulatory Info :
Registration Country : USA
Dosage Form : INJECTABLE; INJECTION
Brand Name : ADENOSINE
Dosage Strength : 3MG/ML
Packaging :
Approval Date :
Application Number : 79147
Regulatory Info :
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : INJECTABLE;INJECTION
Brand Name : ADENOSINE
Dosage Strength : 3MG/ML
Packaging :
Approval Date : 2009-07-20
Application Number : 90220
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Dosage Form : SOLUTION;INHALATION
Brand Name : ALBUTEROL SULFATE
Dosage Strength : EQ 0.083% BASE
Packaging :
Approval Date : 1999-11-22
Application Number : 75394
Regulatory Info : DISCN
Registration Country : USA
Inspections and registrations
ABOUT THIS PAGE
WOCKHARDT LTD is a supplier offers 80 products (APIs, Excipients or Intermediates).
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