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10 Sep 2025
// REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/private-equity-gtcr-strikes-48-billion-deal-buy-zentiva-ft-reports-2025-09-11/

20 Aug 2025
// ECONOMICTIMES
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/aurobindo-leads-race-for-5-5-bn-zentiva-deal-set-to-be-indias-biggest-pharma-buyout/articleshow/123394210.cms

09 Jul 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/zentiva-and-lupin-sign-license-and-supply-agreement-for-tnf-alpha-inhibitor-biosimilar-medicine-302501088.html

27 Jun 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/zentiva-calls-for-pause--repair--relaunch-of-the-urban-wastewater-treatment-directive-uwwtd-302493177.html

22 May 2025
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/zentiva-inks-deal-worth-eu220m-commercialize-former-astrazeneca-gi-asset-europe

22 May 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/zentiva-and-euractiv-bring-policymakers-together-for-health-policy-conference-302463025.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 : 2023-03-11
Valid Till : 2026-10-14
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 : 2023-03-11
Valid Till : 2026-10-14
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 : 2023-03-11
Valid Till : 2026-10-14
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
Date of Issue : 2023-03-11
Valid Till : 2026-10-14
Written Confirmation Number : WC-0133
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Date of Issue : 2023-03-11
Valid Till : 2026-10-14
Written Confirmation Number : WC-0133
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Date of Issue : 2023-03-11
Valid Till : 2026-10-14
Written Confirmation Number : WC-0133
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Date of Issue : 2023-03-11
Valid Till : 2026-10-14
Written Confirmation Number : WC-0133
Address of the Firm :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Date of Issue : 2023-03-11
Valid Till : 2026-10-14
Written Confirmation Number : WC-0133
Address of the Firm :

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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Details:
GTCR’s acquisition of Zentiva includes its portfolio, ongoing R&D, and pipeline, continuing the company’s expansion of generics and development projects in Europe.
Lead Product(s): Methylphenidate Hydrochloride,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Affenid XL
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: GTCR
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition September 11, 2025

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Lead Product(s) : Methylphenidate Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : GTCR
Deal Size : Undisclosed
Deal Type : Acquisition
Zentiva Announces Sale from Advent to GTCR
Details : GTCR’s acquisition of Zentiva includes its portfolio, ongoing R&D, and pipeline, continuing the company’s expansion of generics and development projects in Europe.
Product Name : Affenid XL
Product Type : Miscellaneous
Upfront Cash : Undisclosed
September 11, 2025

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Details:
Zentiva holds a broad portfolio of generic and biosimilar products, including Affenid XL (methylphenidate hydrochloride) for the treatment of Attention-Deficit/Hyperactivity Disorder.
Lead Product(s): Methylphenidate Hydrochloride,Inapplicable
Therapeutic Area: Psychiatry/Psychology Brand Name: Affenid XL
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Aurobindo Pharma Limited
Deal Size: $5,500.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition August 20, 2025

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Lead Product(s) : Methylphenidate Hydrochloride,Inapplicable
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Aurobindo Pharma Limited
Deal Size : $5,500.0 million
Deal Type : Acquisition
Aurobindo Pharma closing in on $5.5b Zentiva buyout
Details : Zentiva holds a broad portfolio of generic and biosimilar products, including Affenid XL (methylphenidate hydrochloride) for the treatment of Attention-Deficit/Hyperactivity Disorder.
Product Name : Affenid XL
Product Type : Miscellaneous
Upfront Cash : Undisclosed
August 20, 2025

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Details:
Under the licensing agreement, Zentiva will hold the rights for the commercialization and manufacturing of linaprazan glurate, in Europe.
Lead Product(s): Linaprazan Glurate,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Recipient: Cinclus Pharma
Deal Size: $249.2 million Upfront Cash: $14.7 million
Deal Type: Licensing Agreement May 22, 2025

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Lead Product(s) : Linaprazan Glurate,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase II
Recipient : Cinclus Pharma
Deal Size : $249.2 million
Deal Type : Licensing Agreement
Zentiva Inks €220M Deal for Former AstraZeneca GI Drug in Europe
Details : Under the licensing agreement, Zentiva will hold the rights for the commercialization and manufacturing of linaprazan glurate, in Europe.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : $14.7 million
May 22, 2025

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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,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Raltegravir-Generic
Study Phase: Approved FDFProduct Type: Miscellaneous
Recipient: Lupin Ltd
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 22, 2024

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Lead Product(s) : Raltegravir Potassium,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Recipient : Lupin Ltd
Deal Size : Inapplicable
Deal Type : Inapplicable
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 : Miscellaneous
Upfront Cash : Inapplicable
July 22, 2024

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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,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Liraglutide-Generic
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Recipient: Biocon
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 28, 2024

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Lead Product(s) : Liraglutide,Inapplicable
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Recipient : Biocon
Deal Size : Inapplicable
Deal Type : Inapplicable
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, Unconjugated
Upfront Cash : Inapplicable
March 28, 2024

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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,Inapplicable
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

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Lead Product(s) : Undisclosed,Inapplicable
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

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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,Inapplicable
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

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Lead Product(s) : Undisclosed,Inapplicable
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

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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,Inapplicable
Therapeutic Area: Endocrinology Brand Name: Liraglutide-Generic
Study Phase: UndisclosedProduct Type: Peptide, Unconjugated
Recipient: Biocon
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement November 23, 2022

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Lead Product(s) : Liraglutide,Inapplicable
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, Unconjugated
Upfront Cash : Undisclosed
November 23, 2022

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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,Fluorouracil,Calcium Folinate
Therapeutic Area: Oncology Brand Name: Alymsys
Study Phase: Approved FDFProduct Type: Antibody, Unconjugated
Recipient: Mabxience
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration April 09, 2021

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Lead Product(s) : Bevacizumab,Fluorouracil,Calcium Folinate
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
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 : Antibody, Unconjugated
Upfront Cash : Undisclosed
April 09, 2021

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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: Approved FDFProduct Type: Hormone
Recipient: Mithra Pharmaceuticals
Deal Size: $2.2 million Upfront Cash: Undisclosed
Deal Type: Agreement July 06, 2020

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Lead Product(s) : Etonogestrel,Ethinyl Estradiol
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Approved FDF
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 : Hormone
Upfront Cash : Undisclosed
July 06, 2020

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Zentiva is a supplier offers 18 products (APIs, Excipients or Intermediates).
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