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22 Jul 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216456

23 Apr 2024
// Blake Brittain REUTERS
https://www.reuters.com/legal/us-supreme-court-rejects-vanda-pharmaceuticals-case-over-sleep-drug-patents-2024-04-22/

30 Mar 2024
// Fraiser Kansteiner FIERCE PHARMA
https://www.fiercepharma.com/pharma/teva-follows-suit-after-hikmas-2023-complaint-arguing-amarin-locked-drug-ingredient-supply

01 Feb 2024
// Kevin Dunleavy FIERCE PHARMA
https://www.fiercepharma.com/pharma/continuing-its-transformation-teva-confirms-intent-sell-api-business

25 Dec 2021
// TIMESOFISRAEL
https://www.timesofisrael.com/accused-of-complicity-in-opioid-crisis-teva-launches-nasal-spray-to-treat-overdose/

09 Sep 2021
// N. H. Dunn FIERCEPHARMA
https://www.fiercepharma.com/pharma/teva-trailing-cgrp-rivals-migraine-can-t-find-a-win-ajovy-analysis-versus-biohaven-and
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 228MF10057
Registrant's Address : Neot-Hovav Eco-Industrial Park, Be\'er Sheva 8412316, Israel
Initial Date of Registration : 2016-02-18
Latest Date of Registration :
NDC Package Code : 63415-0085
Start Marketing Date : 2019-08-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2021-07-11
Registration Number : 20210711-209-J-1033
Manufacturer Name : Asia Chemical Industries Ltd.
Manufacturer Address : Neot-Hovav Eco-Industrial Park, Emek Sara, PO Box 2049, Be'er Sheva 8412316 Israel

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 224MF10142
Registrant's Address : Neot-Hovav Eco-Industrial Park, Emek Sara P. O. Box 2049 Be\'er Sheva 8412316, Israel
Initial Date of Registration : 2012-07-31
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 225MF10130
Registrant's Address : Neot-Hovav Eco-Industrial Park, Emek Sara P. O. Box 2049 Be\'er Sheva 8412316, Israel
Initial Date of Registration : 2013-07-09
Latest Date of Registration :
NDC Package Code : 63415-0034
Start Marketing Date : 2017-11-27
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2005-09-30
Registration Number : 20050930-28-C-18-10
Manufacturer Name : Asia Chemical Industries Ltd. Teva-Tech Site
Manufacturer Address : Neot-Hovav Eco-Industrial Park, Emek Sara, PO Box, 2049 Be'er Sheva 8412316, Israel

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 302MF10024
Registrant's Address : Neot-Hovav Eco-Industrial Park, Be\'er Sheva 8412316, Israel
Initial Date of Registration : 2020-02-06
Latest Date of Registration :
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2010-09-30
Registration Number : 711-6-ND
Manufacturer Name : Asia Chemical Industries Ltd.
Manufacturer Address : Neot-Hovav Eco-Industrial Park, Emek Sara, POB 2049, Be'er Sheva, 8412316, Israel

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 219MF10026
Registrant's Address : Neot-Hovav Eco-Industrial Park, Emek Sara P. O. Box 2049 Be\'er Sheva 8412316, Israel
Initial Date of Registration : 2007-02-05
Latest Date of Registration :
NDC Package Code : 63415-0060
Start Marketing Date : 2017-12-07
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2005-09-30
Registration Number : 20050930-3-B-200-07
Manufacturer Name : Asia Chemical Industries Ltd. (Teva-Tech site)
Manufacturer Address : Neot-Hovav Eco-Industrial Park, Emek Sara, POB 2049, Be'er Sheva, 8412316, Israel

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 218MF10535
Registrant's Address : Neot-Hovav Eco-Industrial Park, Be\'er Sheva 8412316, Israel
Initial Date of Registration : 2006-06-01
Latest Date of Registration :
NDC Package Code : 63415-0056
Start Marketing Date : 2020-04-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 226MF10176
Registrant's Address : Neot-Hovav Eco-Industrial Park, Be\'er Sheva 8412316, Israel
Initial Date of Registration : 2014-09-01
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 227MF10270
Registrant's Address : Neot-Hovav Eco-Industrial Park, Be\'er Sheva 8412316, Israel
Initial Date of Registration : 2015-11-19
Latest Date of Registration :
NDC Package Code : 63415-0036
Start Marketing Date : 2019-08-13
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
Registrant Name : JW Pharmaceutical Co., Ltd.
Registration Date : 2023-05-11
Registration Number : 20230511-209-J-1490
Manufacturer Name : Assia Chemical Industries Ltd. (Teva Tech site)
Manufacturer Address : Neot-Hovav Eco-Ind. Park, Emek Sara, P.OB. 2049, Be'er Sheva, 8412316, Israel

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 228MF10045
Registrant's Address : Neot-Hovav Eco-Industrial Park, Emek Sara P. O. Box 2049 Be\'er Sheva 8412316, Israel
Initial Date of Registration : 2016-02-08
Latest Date of Registration :
Registrant Name : Sam-O Pharmaceutical Co., Ltd.
Registration Date : 2018-03-12
Registration Number : 20180312-209-J-80
Manufacturer Name : Assia Chemical Industries Ltd.Teva-Tech site
Manufacturer Address : Neot-Hovav Eco-Industrial Park, Emek Sara, PO Box 2049, Be'er Sheva 8412316, Israel

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 225MF10045
Registrant's Address : Neot-Hovav Eco-Industrial Park, Be\'er Sheva 8412316, Israel
Initial Date of Registration : 2013-03-05
Latest Date of Registration :
NDC Package Code : 63415-0532
Start Marketing Date : 2023-07-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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:
AUSTEDO (deutetrabenazine) is the first and only vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of tardive dyskinesia (TD) in adults and for the treatment of chorea associated with Huntington’s disease.
Lead Product(s): Deutetrabenazine
Therapeutic Area: Musculoskeletal Brand Name: Austedo
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 18, 2022

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Lead Product(s) : Deutetrabenazine
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Teva Announces Results from 3-Year Study Assessing the Safety and Tolerability of AUSTEDO® (deute...
Details : AUSTEDO (deutetrabenazine) is the first and only vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of tardive dyskinesia (TD) in adults and for the treatment of chorea associated with ...
Product Name : Austedo
Product Type : Miscellaneous
Upfront Cash : Inapplicable
October 18, 2022

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Details:
Study evaluated the effect of ProAir Digihaler System on asthma control versus standard of care as measured by Asthma Control Test, and explored use of the ProAir Digihaler System to help support patient-physician interactions for asthma management versus standard of care.
Lead Product(s): Salbutamol Sulphate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: ProAir Digihaler
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 29, 2022

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Lead Product(s) : Salbutamol Sulphate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Teva to Present First Data Set from the CONNECT1 Clinical Trial on ProAir® Digihaler® (albuterol...
Details : Study evaluated the effect of ProAir Digihaler System on asthma control versus standard of care as measured by Asthma Control Test, and explored use of the ProAir Digihaler System to help support patient-physician interactions for asthma management versu...
Product Name : ProAir Digihaler
Product Type : Miscellaneous
Upfront Cash : Inapplicable
August 29, 2022

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mdc-IRM, (risperidone) extended-release injectable suspension for the treatment of patients with schizophrenia (Teva codename: TV-46000), is the most advanced investigational product based on MedinCell’s BEPO® technology.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Brand Name: mdc-IRM
Study Phase: Phase IIIProduct Type: Miscellaneous
Recipient: Teva Pharmaceutical Industries
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 03, 2022

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Lead Product(s) : Risperidone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Recipient : Teva Pharmaceutical Industries
Deal Size : Inapplicable
Deal Type : Inapplicable
MedinCell’s Partner Teva Provides Additional Information Regarding the New Drug Application for ...
Details : mdc-IRM, (risperidone) extended-release injectable suspension for the treatment of patients with schizophrenia (Teva codename: TV-46000), is the most advanced investigational product based on MedinCell’s BEPO® technology.
Product Name : mdc-IRM
Product Type : Miscellaneous
Upfront Cash : Inapplicable
May 03, 2022

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Details:
MedinCell and Teva announced yesterday the FDA acceptance of the New Drug Application for mdc-IRM for patients with schizophrenia.
Lead Product(s): Risperidone
Therapeutic Area: Psychiatry/Psychology Brand Name: mdc-IRM
Study Phase: Phase IIIProduct Type: Miscellaneous
Recipient: Teva Pharmaceutical Industries
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 01, 2021

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Lead Product(s) : Risperidone
Therapeutic Area : Psychiatry/Psychology
Highest Development Status : Phase III
Recipient : Teva Pharmaceutical Industries
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : MedinCell and Teva announced yesterday the FDA acceptance of the New Drug Application for mdc-IRM for patients with schizophrenia.
Product Name : mdc-IRM
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 01, 2021

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Details:
Ironwood and AbbVie have reached an agreement with Teva Pharmaceuticals providing a license to Teva's abbreviated new drug application seeking approval to market a generic version of 72 mcg LINZESS® (linaclotide) prior to the expiration of the companies' applicable patents.
Lead Product(s): Linaclotide
Therapeutic Area: Gastroenterology Brand Name: Linzess
Study Phase: Approved FDFProduct Type: Peptide, Unconjugated
Recipient: Ironwood Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement May 26, 2021

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Lead Product(s) : Linaclotide
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Recipient : Ironwood Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Agreement
Ironwood Pharmaceuticals Announces Agreement with Teva Involving LINZESS® (linaclotide) 72 mcg Do...
Details : Ironwood and AbbVie have reached an agreement with Teva Pharmaceuticals providing a license to Teva's abbreviated new drug application seeking approval to market a generic version of 72 mcg LINZESS® (linaclotide) prior to the expiration of the companies...
Product Name : Linzess
Product Type : Peptide, Unconjugated
Upfront Cash : Undisclosed
May 26, 2021

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AVT02 is a proposed biosimilar of HUMIRA® (adalimumab) with high concentration (100mg/mL) dosage forms that are expected to be beneficial to patients and to be differentiated from most biosimilar competitors, while matching the newest dosage forms of the reference product.
Lead Product(s): Adalimumab
Therapeutic Area: Dermatology Brand Name: Simlandi
Study Phase: Phase IIIProduct Type: Antibody, Unconjugated
Recipient: Alvotech
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 19, 2020

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Lead Product(s) : Adalimumab
Therapeutic Area : Dermatology
Highest Development Status : Phase III
Recipient : Alvotech
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : AVT02 is a proposed biosimilar of HUMIRA® (adalimumab) with high concentration (100mg/mL) dosage forms that are expected to be beneficial to patients and to be differentiated from most biosimilar competitors, while matching the newest dosage forms of th...
Product Name : Simlandi
Product Type : Antibody, Unconjugated
Upfront Cash : Inapplicable
November 19, 2020

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Details:
Under this partnership agreement, Alvotech will be responsible for the development, registration and supply of the biosimilars, while Teva will be exclusively commercializing the products in the U.S.
Lead Product(s): Undisclosed
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Undisclosed
Recipient: Alvotech
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership August 05, 2020

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Lead Product(s) : Undisclosed
Therapeutic Area : Oncology
Highest Development Status : Undisclosed
Recipient : Alvotech
Deal Size : Undisclosed
Deal Type : Partnership
Teva and Alvotech Announce Strategic Partnership to Collaborate in the U.S. Biosimilar Market
Details : Under this partnership agreement, Alvotech will be responsible for the development, registration and supply of the biosimilars, while Teva will be exclusively commercializing the products in the U.S.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Undisclosed
August 05, 2020

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : AMLODIPINE BESYLATE
Dosage Strength : EQ 2.5MG BASE
Approval Date : 2026-01-22
Application Number : 219686
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : AMLODIPINE BESYLATE
Dosage Strength : EQ 5MG BASE
Approval Date : 2026-01-22
Application Number : 219686
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : AMLODIPINE BESYLATE
Dosage Strength : EQ 10MG BASE
Approval Date : 2026-01-22
Application Number : 219686
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ATORVASTATIN CALCIUM
Dosage Strength : EQ 10MG BASE
Approval Date : 2025-11-13
Application Number : 220276
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ATORVASTATIN CALCIUM
Dosage Strength : EQ 20MG BASE
Approval Date : 2025-11-13
Application Number : 220276
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ATORVASTATIN CALCIUM
Dosage Strength : EQ 40MG BASE
Approval Date : 2025-11-13
Application Number : 220276
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD : No
TE Code : AB
Dosage Form : TABLET; ORAL
Proprietary Name : ATORVASTATIN CALCIUM
Dosage Strength : EQ 80MG BASE
Approval Date : 2025-11-13
Application Number : 220276
RX/OTC/DISCN : RX
RLD : No
TE Code : AB

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RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : CABOZANTINIB
Dosage Strength : 20MG
Approval Date :
Application Number : 215942
RX/OTC/DISCN :
RLD :
TE Code :

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RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : CABOZANTINIB
Dosage Strength : 40MG
Approval Date :
Application Number : 215942
RX/OTC/DISCN :
RLD :
TE Code :

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RLD :
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : CABOZANTINIB
Dosage Strength : 60MG
Approval Date :
Application Number : 215942
RX/OTC/DISCN :
RLD :
TE Code :

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Assia Chemical Industries Ltd is a supplier offers 72 products (APIs, Excipients or Intermediates).
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