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10 Mar 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/zentiva-takes-legal-action-and-challenges-urban-wastewater-treatment-directive-to-protect-access-to-affordable-healthcare-for-millions-of-people-in-europe-302396932.html
17 Dec 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/zentiva-hosted-the-european-health-check-302333887.html
09 Dec 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/zentiva-completes-voluntary-public-purchase-offer-for-apontis-pharma-ag-302326002.html
26 Nov 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/zentiva-secures-approx-85-27-of-apontis-pharma-ag-voting-rights-in-the-context-of-its-public-purchase-offer-302316398.html
21 Nov 2024
// PHARMAWEB
https://www.pharmiweb.com/press-release/2024-11-21/apontis-pharma-ag-condition-of-minimum-acceptance-in-zentiva-s-voluntary-public-purchase-offer-waiv
05 Nov 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/zentiva-raises-alarm-about-eus-urban-waste-water-treatment-directive-302296640.html
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-31
Pay. Date : 2013-01-03
DMF Number : 20287
Submission : 2007-02-20
Status : Active
Type : II
Certificate Number : R1-CEP 2002-060 - Rev 07
Issue Date : 2022-05-17
Type : Chemical
Substance Number : 1688
Status : Valid
Date of Issue : 2020-10-15
Valid Till : 2023-10-14
Written Confirmation Number : WC-0133
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 : 18018
Submission : 2005-01-21
Status : Active
Type : II
Certificate Number : R1-CEP 2003-223 - Rev 07
Issue Date : 2022-02-08
Type : Chemical
Substance Number : 718
Status : Valid
Date of Issue : 2020-10-15
Valid Till : 2023-10-14
Written Confirmation Number : WC-0133
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 : 10374
Submission : 1993-07-21
Status : Inactive
Type : II
Certificate Number : R1-CEP 2008-012 - Rev 04
Issue Date : 2022-05-06
Type : Chemical
Substance Number : 851
Status : Valid
Date of Issue : 2020-10-15
Valid Till : 2023-10-14
Written Confirmation Number : WC-0133
Address of the Firm :
Registrant Name : Handok Co., Ltd.
Registration Date : 2021-04-16
Registration Number : 20210416-209-J-939
Manufacturer Name : Zentiva Private Limited@BAKUL PHARMA PRIVATE LIMITED@Bajaj Healthcare Limited (Unit-2)
Manufacturer Address : Plot No. 3501 to 3515, 6301 to 6313 & 16 meter road/c, GIDC Estate, Ankleshwar – 393 002, Dist. Bharuch, Gujarat State, India@Plot No. 6202, GIDC, City : Ankleshwar-393 002, Dist : Bharuch, Gujarat state, India@Block No. 588, Savli Karachia Road, At & Post - Gothada, Tal-Savli, Dist - Vadodara - 391 776, India
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18186
Submission : 2005-03-14
Status : Inactive
Type : II
Certificate Number : R1-CEP 2009-121 - Rev 02
Issue Date : 2021-12-14
Type : Chemical
Substance Number : 2131
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2023-124 - Rev 00
Issue Date : 2024-12-18
Type : Chemical
Substance Number : 2020
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2023-469 - Rev 00
Issue Date : 2024-04-25
Type : Chemical
Substance Number : 2131
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16530
Submission : 2003-04-08
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11637
Submission : 1995-08-28
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11600
Submission : 1995-08-15
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15191
Submission : 2000-12-15
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-31
Pay. Date : 2013-01-03
DMF Number : 20287
Submission : 2007-02-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16530
Submission : 2003-04-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11637
Submission : 1995-08-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18018
Submission : 2005-01-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11600
Submission : 1995-08-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10374
Submission : 1993-07-21
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18186
Submission : 2005-03-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15191
Submission : 2000-12-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12404
Submission : 1997-02-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16624
Submission : 2003-06-02
Status : Inactive
Type : II
Details:
Raltegravir is an approved, small molecule, HIV-1 integrase inhibitor, available as a film coated tablet for the treatment of HIV in adult and paediatric patients weighing at least 40kg.
Lead Product(s): Raltegravir Potassium
Therapeutic Area: Infections and Infectious Diseases Brand Name: Raltegravir-Generic
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Lupin Ltd
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 22, 2024
Lead Product(s) : Raltegravir Potassium
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Recipient : Lupin Ltd
Deal Size : Not Applicable
Deal Type : Not Applicable
Generic HIV raltegravir medicines approved
Details : Raltegravir is an approved, small molecule, HIV-1 integrase inhibitor, available as a film coated tablet for the treatment of HIV in adult and paediatric patients weighing at least 40kg.
Product Name : Raltegravir-Generic
Product Type : Small molecule
Upfront Cash : Not Applicable
July 22, 2024
Details:
Liraglutide-Generic is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is indicated for the treatment of patients with type 2 diabetes mellitus.
Lead Product(s): Liraglutide
Therapeutic Area: Endocrinology Brand Name: Liraglutide-Generic
Study Phase: ApprovedProduct Type: Peptide
Recipient: Biocon
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2024
Lead Product(s) : Liraglutide
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Recipient : Biocon
Deal Size : Not Applicable
Deal Type : Not Applicable
Biocon to Obtain Approval for Diabetes Drug, Liraglutide in UK
Details : Liraglutide-Generic is a glucagon-like peptide-1 (GLP-1) receptor agonist, which is indicated for the treatment of patients with type 2 diabetes mellitus.
Product Name : Liraglutide-Generic
Product Type : Peptide
Upfront Cash : Not Applicable
March 28, 2024
Details:
Under the terms of collaboration, Zentiva will complement their product offering with the support of longstanding partners Adalvo with new molecules in a variety of therapeutical areas like Respiratory, CNS and Dermatology.
Lead Product(s): Undisclosed
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Undisclosed
Recipient: Adalvo
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Expanded Collaboration January 09, 2023
Lead Product(s) : Undisclosed
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Undisclosed
Recipient : Adalvo
Deal Size : Undisclosed
Deal Type : Expanded Collaboration
Details : Under the terms of collaboration, Zentiva will complement their product offering with the support of longstanding partners Adalvo with new molecules in a variety of therapeutical areas like Respiratory, CNS and Dermatology.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Undisclosed
January 09, 2023
Details:
Through this acquisition, Zentiva will significantly increase its position in the Hospital sector and more specifically in the Oncology area with some value-added 16 products complementing the products recently launched.
Lead Product(s): Undisclosed
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Undisclosed
Recipient: Tillomed Laboratories Ltd
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition December 16, 2022
Lead Product(s) : Undisclosed
Therapeutic Area : Oncology
Highest Development Status : Undisclosed
Recipient : Tillomed Laboratories Ltd
Deal Size : Undisclosed
Deal Type : Acquisition
Zentiva Completes Major Product Acquisition from Tillomed Spain
Details : Through this acquisition, Zentiva will significantly increase its position in the Hospital sector and more specifically in the Oncology area with some value-added 16 products complementing the products recently launched.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Undisclosed
December 16, 2022
Details:
Under the terms of this agreement Biocon will be responsible for the manufacturing and supply of Liraglutide to Zentiva, for its commercialization across 30 countries in Europe.
Lead Product(s): Liraglutide
Therapeutic Area: Endocrinology Brand Name: Liraglutide-Generic
Study Phase: UndisclosedProduct Type: Peptide
Recipient: Biocon
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 23, 2022
Lead Product(s) : Liraglutide
Therapeutic Area : Endocrinology
Highest Development Status : Undisclosed
Recipient : Biocon
Deal Size : Undisclosed
Deal Type : Agreement
Biocon Limited Enters Into a Commercialization Agreement With Zentiva in Europe
Details : Under the terms of this agreement Biocon will be responsible for the manufacturing and supply of Liraglutide to Zentiva, for its commercialization across 30 countries in Europe.
Product Name : Liraglutide-Generic
Product Type : Peptide
Upfront Cash : Undisclosed
November 23, 2022
Details:
Alymsys (bevacizumab-maly) is a vascular endothelial growth factor inhibitor for the treatment of metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first or second-line treatment.
Lead Product(s): Bevacizumab-maly,Fluorouracil,Calcium Folinate
Therapeutic Area: Oncology Brand Name: Alymsys
Study Phase: ApprovedProduct Type: Large molecule
Recipient: Mabxience
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 09, 2021
Lead Product(s) : Bevacizumab-maly,Fluorouracil,Calcium Folinate
Therapeutic Area : Oncology
Highest Development Status : Approved
Recipient : Mabxience
Deal Size : Undisclosed
Deal Type : Collaboration
Zentiva Continues Its Expansion in Oncology with The Launch of Alymsys® (Bevacizumab) in 21 Count...
Details : Alymsys (bevacizumab-maly) is a vascular endothelial growth factor inhibitor for the treatment of metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first or second-line treatment.
Product Name : Alymsys
Product Type : Large molecule
Upfront Cash : Undisclosed
April 09, 2021
Details:
Mithra grants license to Zentiva for commercialization of its vaginal contraceptive ring in three key European markets.
Lead Product(s): Etonogestrel,Ethinyl Estradiol
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Myring
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Mithra Pharmaceuticals
Deal Size: $2.2 million Upfront Cash: Undisclosed
Deal Type: Agreement July 06, 2020
Lead Product(s) : Etonogestrel,Ethinyl Estradiol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved
Recipient : Mithra Pharmaceuticals
Deal Size : $2.2 million
Deal Type : Agreement
Mithra to Commercialize Myring In France, Poland And UK
Details : Mithra grants license to Zentiva for commercialization of its vaginal contraceptive ring in three key European markets.
Product Name : Myring
Product Type : Small molecule
Upfront Cash : Undisclosed
July 06, 2020
Regulatory Info :
Registration Country : Czech Republic
Dosage Form : Film Coated Tablet
Brand Name :
Dosage Strength : 600MG; 300MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Czech Republic
Regulatory Info :
Registration Country : Czech Republic
Dosage Form : Film Coated Tablet
Brand Name :
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Czech Republic
Regulatory Info :
Registration Country : Czech Republic
Dosage Form : Tablet
Brand Name :
Dosage Strength : 1000MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Czech Republic
Regulatory Info :
Registration Country : Czech Republic
Acetaminophen/Paracetamol; Tramadol Hydrochloride
Dosage Form : Tablet
Brand Name :
Dosage Strength : 325MG; 37.5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Czech Republic
Regulatory Info :
Registration Country : Italy
Dosage Form : Gastro-Resistant Tablets
Brand Name : ACETYLSALICYLIC ACID ZENT...
Dosage Strength : 100 mg
Packaging : 30 UNITS 100 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Tablets
Brand Name : ACICLOVIR ZENTIVA ITALY
Dosage Strength : 400 mg
Packaging : 25 UNITS 400 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Tablets
Brand Name : ACICLOVIR ZENTIVA ITALY
Dosage Strength : 200 mg
Packaging : 25 UNITS 200 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Tablets
Brand Name : ACICLOVIR ZENTIVA ITALY
Dosage Strength : 800 mg
Packaging : 35 UNITS 800 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Alendronic Acid 70Mg 4 U...
Brand Name : Alendronic Acid
Dosage Strength : 4 CPR 70 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Tablets
Brand Name : ALENDRONIC ACID ZENTIVA
Dosage Strength : 70 mg
Packaging : 4 UNITS 70 MG - ORAL USE
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Inspections and registrations
Type : GMP Certificates
Number : sukls61217/...
EudraGMDP Key : 151259
Country : India
Issue Date : 2022-08-12
Post Code : 393002
NCA Ref : IN-A-ZENO01
City : Ankleshwar
Type : GMP Certificates
Number : DE_HE_01_GM...
EudraGMDP Key : 147384
Country : Germany
Issue Date : 2022-05-10
Post Code : 65926
NCA Ref : 165234707397...
City : Frankfurt Am Main
Type : GMP Certificates
Number : DE_HE_01_GM...
EudraGMDP Key : 142107
Country : Germany
Issue Date : 2021-11-29
Post Code : 65926
NCA Ref : 00021354
City : Frankfurt am Main
Type : GMP Certificates based on a Distant Assessment
Number : DE_HE_01_GM...
EudraGMDP Key : 131243
Country : India
Issue Date : 2021-06-29
Post Code : District Bharuch,
NCA Ref : 00051568
City : IN-393002, Gujarat
Type : GMP Certificates
Number : UK MIA 1778...
EudraGMDP Key : 53431
Country : United Kingdom
Issue Date : 2019-03-27
Post Code : GU1 4YS
NCA Ref : 41093-ZENTIV...
City : GUILDFORD
Type : GMP Certificates
Number : 036/2018/RO
EudraGMDP Key : 51669
Country : Romania
Issue Date : 2018-09-19
Post Code : cod 032266
NCA Ref : Z1-3
City : Bucure?ti
Type : GMP Certificates
Number : 018/2018/RO
EudraGMDP Key : 51663
Country : Romania
Issue Date : 2018-05-18
Post Code : cod 032266
NCA Ref : Z1-3
City : Bucure?ti
Type : GMP Certificates
Number : sukls188197...
EudraGMDP Key : 34895
Country : Turkey
Issue Date : 2016-04-11
Post Code : 39780
NCA Ref : 405451461242...
City : B
Type : GMP Certificates
Number : sukls15047/...
EudraGMDP Key : 1918
Country : Czech Republic
Issue Date : 2009-02-13
Post Code : 584 01
NCA Ref : 49240030_2
City : Lede? nad S
API Manufacturer : API MANUFACTURE
FDF Manufacturer :
Facility Name : Zentiva
Business Address : U kabelovny 130 Prague 10237...
FEI Number : 3004587220
Country : Czech Republic
Paid in : 2014
ABOUT THIS PAGE
Zentiva is a supplier offers 14 products (APIs, Excipients or Intermediates).
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