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Events
Webinars & Exhibitions
PEGS Boston SummitPEGS Boston Summit
Industry Trade Show
Not Confirmed
11 May-15 November, 2026
DIA Global Annual Meet...DIA Global Annual Meeting
Industry Trade Show
Not Confirmed
14-18 June, 2026
Discovery EuropeDiscovery Europe
Industry Trade Show
Not Confirmed
15-16 June, 2026
Digital content

27 Apr 2026
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/zentiva-appeals-eu-court-decision-on-urban-wastewater-directive-302754396.html

09 Apr 2026
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/gtcr-completes-acquisition-of-zentiva-a-leading-european-generics-pharmaceutical-company-302737491.html

16 Mar 2026
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/zentiva-publishes-2025-sustainability-report-reinforcing-commitment-to-people-partners-and-the-planet-302714495.html

23 Feb 2026
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/zentiva-demands-eulevel-stoptheclock-on-the-uwwtd-to-protect-medicine-availability-302694497.html

01 Dec 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/zentiva-expands-into-biologics-with-the-eu-wide-launch-of-its-first-biosimilar-302628251.html

28 Nov 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/demonstrating-accountability-zentiva-receives-prestigious-esg-transparency-award-2025-302628149.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

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

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2024-234 - Rev 01
Issue Date : 2025-12-18
Type : Chemical
Substance Number : 1556
Status : Valid

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

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2023-124 - Rev 01
Issue Date : 2026-01-19
Type : Chemical
Substance Number : 2020
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2023-469 - Rev 01
Issue Date : 2026-01-19
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]
Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Details:
Levamlodipine is a small molecule drug, which is currently being evaluated in Phase III clinical studies for the treatment of hypertension.
Lead Product(s): Levoamlodipine
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 01, 2026

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Lead Product(s) : Levoamlodipine
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Levamlodipine is a small molecule drug, which is currently being evaluated in Phase III clinical studies for the treatment of hypertension.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
June 01, 2026

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Details:
Under the acquisition, Methylphenidate HCl, a small molecule product targeting Dopamine transporter and Norepinephrine transporter, will advance treatment for Attention Deficit Disorder with Hyperactivity.
Lead Product(s): Methylphenidate Hydrochloride
Therapeutic Area: Psychiatry/Psychology Brand Name: Affenid XL
Study Phase: Approved FDFProduct Type: Controlled Substance
Sponsor: GTCR
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition April 09, 2026

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Lead Product(s) : Methylphenidate Hydrochloride
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : GTCR
Deal Size : Undisclosed
Deal Type : Acquisition
GTCR Acquires Zentiva, Top European Generics Pharma Company
Details : Under the acquisition, Methylphenidate HCl, a small molecule product targeting Dopamine transporter and Norepinephrine transporter, will advance treatment for Attention Deficit Disorder with Hyperactivity.
Product Name : Affenid XL
Product Type : Controlled Substance
Upfront Cash : Undisclosed
April 09, 2026

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Details:
Phytosterol is a plant extract/herbal drug, which is currently being evaluated in clinical studies for the treatment of hyperlipoproteinemias.
Lead Product(s): Phytosterols,Artichoke Extract,Vitamin B1
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Plant Extract/Herbal
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 12, 2026

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Lead Product(s) : Phytosterols,Artichoke Extract,Vitamin B1
Therapeutic Area : Endocrinology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Phytosterol is a plant extract/herbal drug, which is currently being evaluated in clinical studies for the treatment of hyperlipoproteinemias.
Product Name : Undisclosed
Product Type : Plant Extract/Herbal
Upfront Cash : Inapplicable
February 12, 2026

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Details:
An antibody, unconjugated, is showing promising results in treating bone conditions.
Lead Product(s): Undisclosed
Therapeutic Area: Musculoskeletal Brand Name: Undisclosed
Study Phase: Approved FDFProduct Type: Antibody, Unconjugated
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 01, 2025

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Lead Product(s) : Undisclosed
Therapeutic Area : Musculoskeletal
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Zentiva Launches First Biosimilar in EU
Details : An antibody, unconjugated, is showing promising results in treating bone conditions.
Product Name : Undisclosed
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
December 01, 2025

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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
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
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
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
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
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
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
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
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
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
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
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
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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Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Brand Name : Sertralin Zentiva
Dosage Strength : 25mg
Packaging :
Approval Date : 06-10-2021
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Brand Name : Sertralin Zentiva
Dosage Strength : 50mg
Packaging :
Approval Date : 15-05-2024
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Approved
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Brand Name : Sertralin Zentiva
Dosage Strength : 100mg
Packaging :
Approval Date : 15-05-2024
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden

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Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Film Coated Tablet
Brand Name : Abacavir Zentiva
Dosage Strength : 300MG
Packaging :
Approval Date : 30-07-2021
Application Number : 86115
Regulatory Info : Authorized
Registration Country : Spain

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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

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Regulatory Info : Deregistered
Registration Country : Sweden
Dosage Form : Film Coated Tablet
Brand Name : Abacavir/Lamivudine Zenti...
Dosage Strength : 600mg;300mg
Packaging :
Approval Date : 07-08-2020
Application Number : 2.02E+13
Regulatory Info : Deregistered
Registration Country : Sweden

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Regulatory Info : Prescription
Registration Country : Estonia
Dosage Form : Film-Coated Tablet
Brand Name : Abiraterone Zentiva
Dosage Strength : 500mg
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia

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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

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Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Tablet
Brand Name : Abiraterona Zentiva
Dosage Strength : 250MG
Packaging :
Approval Date : 16-03-2021
Application Number : 85849
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Authorized
Registration Country : Spain
Dosage Form : Film Coated Tablet
Brand Name : Abiraterona Zentiva
Dosage Strength : 500MG
Packaging :
Approval Date : 16-03-2021
Application Number : 85850
Regulatory Info : Authorized
Registration Country : Spain

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Country : Romania
City/Region : Bucarest
Audit Date : 2024-01-10
Audit Type : On-Site
Country : India
City/Region : Ankleshwar
Audit Date : Aug-25
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
Zentiva is a supplier offers 19 products (APIs, Excipients or Intermediates).
Find Articaine Hydrochloride bulk with DMF, CEP, WC offered by Zentiva
Find Glibenclamide bulk with DMF, CEP, WC offered by Zentiva
Find Pentoxifylline bulk with CEP, WC offered by Zentiva
Find Tamsulosin bulk with CEP, WC offered by Zentiva
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