Company profile for Teva Pharmaceutical Industries

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About

Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a year at 70 manufacturing facilities. We rank among the leading pharmaceutical companies in the world and are active in 60 countries. Approximately 43,000 employees around the world are dedicated to our mission. Building on our strong glob...
Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a year at 70 manufacturing facilities. We rank among the leading pharmaceutical companies in the world and are active in 60 countries. Approximately 43,000 employees around the world are dedicated to our mission. Building on our strong global footprint, size and scale, Teva is reaffirming its commitment to place people at the center of our strategy, and enable as many as possible to live better, healthier days.

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CONTACT DETAILS

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Country
Country
Israel
Address
Address
5 Basel St., Petach Tikva Israel, 49131
Telephone
Telephone
+972-3-9267267
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INTERVIEW #SpeakPharma

[Sponsored by another company]
“Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”
This week, SpeakPharma interviews Denise Sutton, Chief Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years. In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services. HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services How has the Nottingham site transformed from when it was founded, to what it is today? Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed. At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform. We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel. We explored the application of ICH Q8 Quality by Design (QbD) guidelines to introduce a compositional design space into the CMC section of our regulatory dossier. This officially created a methodology for applying the Translational Pharmaceutics platform, and we haven't looked back since. Today, we have expanded substantially. Our Nottingham site is a campus of five buildings. We have development and analytical labs, six GMP suites, six clinical wards with a total of 85 beds (where we conduct healthy volunteer phase 1 clinical studies), and many talented colleagues covering our spectrum of CRO and CDMO services. HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites   How is Translational Pharmaceutics applied to drug development programs? We apply Translational Pharmaceutics across three core applications: first-in-human clinical studies, drug product optimization programs through rapid formulation development and clinical testing, and as a part of human ADME (absorption, distribution, metabolism, and excretion) programs. No matter how a client chooses to work with us to apply Translational Pharmaceutics, the benefits of using a single organization and project management team to integrate services lets our clients remain in control and one step ahead of the emerging data that impacts the success of their molecule. Over all these years, our flagship Translational Pharmaceutics platform for drug development has remained unchanged in the way it empowers our customers and offers them unparalleled flexibility. HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control   What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs? Nowhere else would a single project manager oversee such a broad spectrum of activities, let alone be expected to ensure seamless, timely progression across functions that in any other company (i.e. at other CDMOs or CROs) would be delivered through multiple operating areas or through the use of a combination of third-party vendors. The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity. I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way. HIGHLIGHTS// project management team is truly world-leading/ high-performing, supportive, cross-functional teams/ 25 years at Quotient  

Impressions: 303

https://www.pharmacompass.com/speak-pharma/translational-pharmaceutics-our-flagship-platform-for-drug-development-empowers-our-clients-with-unparalleled-flexibility

Radio Compass
16 Dec 2024

VLOG #PharmaReel

[Sponsored by another company]

DATA COMPILATION #PharmaFlow

[Sponsored by another company]
Chinese FDA-registered generic facilities gain steam, India maintains lead with 396 facilities
Every year, the US Food and Drug Administration (FDA) publishes the user fee amounts it will collect from manufacturers of pharmaceuticals, generic drugs, biosimilars and medical devices in the coming financial year. The fee for fiscal year 2025 under the Generic Drug User Fee Act (GDUFA) was published on July 31, 2024.The GDUFA, established in 2012, authorizes FDA to assess and collect fees from drug manufacturers to expedite the delivery of safe, high-quality, and affordable generic drugs to the American public.The FDA’s facility payments list under GDUFA reveals that as of November 14, 2024, 1,397 facilities had paid their registration fees for financial year 2025. Of these facilities, 707 or 50.6 percent are active pharmaceutical ingredients (API) facilities, 405 or 29 percent are finished dosage forms (FDF) facilities, 69 (4.9 percent) are facilities that produce both APIs and FDFs, and 216 (15.5 percent) are contract manufacturing services (CMO) sites.Teva Pharmaceuticals, with 29 facility registrations, led the list of companies, followed by Aurobindo Pharma, Sun Pharma, and Dr. Reddy's Laboratories. Fiscal year Facility Registrations 2016 1,425 2017 1,442 2018 1,269 2019 1,286 2020 1,300 2021 1,340 2022 1,385 2023 1,394 2024 1,447 2025 1,397  Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available)India continues to lead with 396 facilities, US and China follow India maintains its dominance in total facility registrations with the FDA, registering 396 facilities for FY2025. This includes 214 API facilities, 135 FDF facilities, 21 facilities engaged in both API and FDF activities, and 26 CMO facilities.The United States holds the second position with 328 facilities, while China strengthened its third position with 197 facilities.With 214 API facilities, India continues to have the largest share of API manufacturing sites, outmatching the combined total of China (128) and the US (83), which together account for 211 facilities. Among European manufacturers, Italy leads with 59 API manufacturing sites, followed by Spain (30) and Germany (25).The US has maintained its lead in FDF facilities with 143 sites, followed closely by India with 135 sites and China with 45 sites. Country API FDF Both CMO Total India 214 135 21 26 396 US 83 143 13 89 328 China 128 45 12 12 197 Italy 59 3 2 19 83 Germany 25 4 1 15 45 Spain 30 9 1 4 44 Canada 7 17   13 37 Taiwan 9 6 5 4 24 Switzerland 15 4   4 23 France 16     6 22 Japan 18   1   19 United Kingdom 12 1   2 15 Mexico 9 1   1 11 Ireland 5 5   1 11   Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) GDUFA III user fee rates increase across categories for FY25The GDUFA, which was reauthorized on September 30, 2022 (as GDUFA III), continues with provisions that will last until September 30, 2027. In July 2024, the FDA published updated user fee rates for FY2025.The facility fees have seen increases across all categories. API facility fees increased by 3 percent for domestic sites (to US$ 41,580) and 2 percent for foreign sites (to US$ 56,580). FDF facility fees rose by 5 percent for both domestic (to US$ 231,952) and foreign sites (to US$ 246,952). CMO facility fees increased by 5 percent for domestic sites (to US$ 55,668) and 4 percent for foreign sites (to US$ 70,668).Additionally, the fee for large-, medium- and small-sized drug applicants has increased by over 9 percent, compared to the 7 percent increase seen in 2023. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) China leads new facility registrations as FDA records 41 new units in FY25Out of the total 1,397 facilities registered for FY2025, 41 were new registrations (going by Facility FDA Establishment Identifier numbers). China led the way with 13 new facilities, followed closely by India with 11 new facilities, while the US secured the third position with eight new facilities.The new registrations included 15 API facilities, 13 CMO facilities, 12 FDF facilities, and one facility engaged in both API and FDF activities. Chinese companies dominated the new FDF registrations with six facilities: Chengdu Shuode Pharma, Chengdu Suncadia Medicine, Cipla (Jiangsu), GE Healthcare (Shanghai), Luoxin Aurovitas Pharma (Chengdu), and Zhejiang Xianju Pharma.India added two new FDF facilities through Eugia Steriles and Zydus Pharma. Malaysia registered two FDF facilities through Novugen Pharma and Novugen Oncology, while Turkey’s Insud Pharma subsidiary Exeltis and US’ RK Pharma registered one FDF facility each.The 13 new CMO facilities included, Acme Generics, Emcure, Esjay Pharma, Fordoz Pharma, Fourrts Laboratories, Laboratoires KABS, PharmaMax, Quality Packaging Specialists International, Ritsa Pharma, Shanghai Aucyun Pharma, Sichuan Huiyu Pharma, Taejoon Pharm, and Tubilux Pharma.In the API category, the 15 new registrations included Acharya Chemicals, Hainan Poly Pharma, CBL Patras, EUROAPI, Hybio Pharma, Medilux Laboratories, Metrochem API, Purolite, Chengdu Easton Biopharma, Sionc Pharma, Smithfield Bioscience, Xttrium Laboratories, Zhejiang Hengkang Pharma, Moehs Iberica and Shilpa Pharma. Armstrong Pharmaceuticals registered the sole facility for both APIs and FDFs.So far, 92 facilities have not renewed their registration. Among these was a facility owned by Sandoz subsidiary Eon Labs in Wilson, North Carolina (US), which is permanently closed. In fact, the geographical distribution of non-renewals shows that 30 facilities were from the US, while India and China accounted for 14 and nine non-renewals respectively. Generic Drug Facilities Registered with the US FDA for FY2025 (Free Excel Available) Our viewThe FY 2025 GDUFA facility registration data indicates a continued strong presence of Indian manufacturers in the US generic drug market, particularly in API production. However, China's leadership in new facility registrations, especially in FDF manufacturing, suggests that the global generic drug supply chain landscape may evolve considerably in the coming years. 

Impressions: 11518

https://www.pharmacompass.com/radio-compass-blog/chinese-fda-registered-generic-facilities-gain-steam-india-maintains-lead-with-396-facilities

#PharmaFlow by PHARMACOMPASS
21 Nov 2024

NEWS #PharmaBuzz

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https://www.tevapharm.com/news-and-media/latest-news/teva-and-sanofi-announce-duvakitug-anti-tl1a-positive-phase-2b-results-demonstrating-best-in-class-pote/

PRESS RELEASE
18 Dec 2024

https://www.globenewswire.com/news-release/2024/12/11/2995354/0/en/Teva-Announces-New-Patient-Access-Program-with-Direct-Relief-to-Provide-Access-to-Inhalers-for-Uninsured-Patients.html

GLOBENEWSWIRE
11 Dec 2024

https://www.reuters.com/business/healthcare-pharmaceuticals/pharma-firm-teva-divest-its-business-venture-japan-2024-12-05/

REUTERS
07 Dec 2024

https://www.accesswire.com/947666/teva-launches-vital-medicines-program-in-el-salvador-for-underserved-communities

ACCESSWIRE
27 Nov 2024

https://www.globenewswire.com/news-release/2024/11/25/2987135/0/en/Teva-to-Present-at-the-7th-Annual-Evercore-ISI-HealthCONx-Conference.html

GLOBENEWSWIRE
25 Nov 2024

https://www.accesswire.com/945101/teva-takes-on-antimicrobial-resistance-amr-what-you-need-to-know

ACCESSWIRE
20 Nov 2024

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Drugs in Development

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TEV-'749 is an investigational once-monthly subcutaneous LAI of the 2nd generation antipsychotic olanzapine being developed in in adult patients diagnosed with schizophrenia.


Lead Product(s): Olanzapine

Therapeutic Area: Psychiatry/Psychology Brand Name: TV-44749

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 01, 2024

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Details : TEV-'749 is an investigational once-monthly subcutaneous LAI of the 2nd generation antipsychotic olanzapine being developed in in adult patients diagnosed with schizophrenia.

Brand Name : TV-44749

Molecule Type : Small molecule

Upfront Cash : Not Applicable

November 01, 2024

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Selarsdi (ustekinumab) is a monoclonal antibody, binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses. It is approved for treating ulcerative colitis.


Lead Product(s): Ustekinumab

Therapeutic Area: Gastroenterology Brand Name: Selarsdi

Study Phase: ApprovedProduct Type: Large molecule

Recipient: Alvotech

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 22, 2024

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Details : Selarsdi (ustekinumab) is a monoclonal antibody, binds to two cytokines, IL-12 and IL-23, that are involved in inflammatory and immune responses. It is approved for treating ulcerative colitis.

Brand Name : Selarsdi

Molecule Type : Large molecule

Upfront Cash : Not Applicable

October 22, 2024

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TVB-009P(denosumab) is a biosimilar candidate to Prolia, which is being developed for the high risk for fracture, such as osteoporosis in postmenopausal women.


Lead Product(s): Denosumab

Therapeutic Area: Musculoskeletal Brand Name: TVB-009P

Study Phase: Phase IIIProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 08, 2024

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Details : TVB-009P(denosumab) is a biosimilar candidate to Prolia, which is being developed for the high risk for fracture, such as osteoporosis in postmenopausal women.

Brand Name : TVB-009P

Molecule Type : Large molecule

Upfront Cash : Not Applicable

October 08, 2024

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mAbxience will lead the development and production of an anti PD-1 biosimilar and Teva will manage regulatory approvals and oversee commercialization of this oncology treatment.


Lead Product(s): Anti PD-1-based Therapy

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: UndisclosedProduct Type: Large molecule

Sponsor: Mabxience

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership October 03, 2024

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Details : mAbxience will lead the development and production of an anti PD-1 biosimilar and Teva will manage regulatory approvals and oversee commercialization of this oncology treatment.

Brand Name : Undisclosed

Molecule Type : Large molecule

Upfront Cash : Undisclosed

October 03, 2024

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Sandostatin-Generic (octreotide acetate) is a somatostatin analogue peptide, which is being evaluated for the treatment of acromegaly, carcinoid tumors & vasoactive intestinal peptide tumors.


Lead Product(s): Octreotide Acetate

Therapeutic Area: Endocrinology Brand Name: Sandostatin-Generic

Study Phase: ApprovedProduct Type: Peptide

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 01, 2024

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Details : Sandostatin-Generic (octreotide acetate) is a somatostatin analogue peptide, which is being evaluated for the treatment of acromegaly, carcinoid tumors & vasoactive intestinal peptide tumors.

Brand Name : Sandostatin-Generic

Molecule Type : Peptide

Upfront Cash : Not Applicable

October 01, 2024

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FDA has approved Teva's AUSTEDO XR (deutetrabenazine,vmat2 inhibitor) extended-release tablets as a once-daily treatment option for adults with tardive dyskinesia and Huntington’s disease chorea.


Lead Product(s): Deutetrabenazine

Therapeutic Area: Neurology Brand Name: Austedo

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 23, 2024

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Details : FDA has approved Teva's AUSTEDO XR (deutetrabenazine,vmat2 inhibitor) extended-release tablets as a once-daily treatment option for adults with tardive dyskinesia and Huntington’s disease chorea.

Brand Name : Austedo

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 23, 2024

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TEV-‘749 is being developed as a once-monthly subcutaneous LAI of olanzapine with the use of SteadyTeq™ technology, a copolymer technology for the treatment of adults with schizophrenia.


Lead Product(s): Olanzapine

Therapeutic Area: Psychiatry/Psychology Brand Name: TEV-‘749

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 21, 2024

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Details : TEV-‘749 is being developed as a once-monthly subcutaneous LAI of olanzapine with the use of SteadyTeq™ technology, a copolymer technology for the treatment of adults with schizophrenia.

Brand Name : TEV-‘749

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 21, 2024

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Details:

TEV-‘749 is being developed as a once-monthly subcutaneous LAI of olanzapine with the use of SteadyTeq™ technology, a copolymer technology for the treatment of adults with schizophrenia.


Lead Product(s): Olanzapine

Therapeutic Area: Psychiatry/Psychology Brand Name: TEV-‘749

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: MedinCell

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 05, 2024

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Antibody Engineering
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Details : TEV-‘749 is being developed as a once-monthly subcutaneous LAI of olanzapine with the use of SteadyTeq™ technology, a copolymer technology for the treatment of adults with schizophrenia.

Brand Name : TEV-‘749

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 05, 2024

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TEV-’574 (duvakitug) is a potential best-in-class human IgG1-lambda 2 mAb that targets tumor necrosis factor (TNF)-like ligand 1A, also known as TNF superfamily member 15 (TNFSF15).


Lead Product(s): Duvakitug

Therapeutic Area: Gastroenterology Brand Name: TEV-48574

Study Phase: Phase IIProduct Type: Large molecule

Sponsor: Sanofi

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 24, 2024

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Details : TEV-’574 (duvakitug) is a potential best-in-class human IgG1-lambda 2 mAb that targets tumor necrosis factor (TNF)-like ligand 1A, also known as TNF superfamily member 15 (TNFSF15).

Brand Name : TEV-48574

Molecule Type : Large molecule

Upfront Cash : Not Applicable

July 24, 2024

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Ajovy (fremanezumab) a FDA approved, humanized mAb which selectively binds the calcitonin gene-related peptide (CGRP). It is being investigated for the prevention of migraine in 6-17 years patients.


Lead Product(s): Fremanezumab

Therapeutic Area: Neurology Brand Name: Ajovy

Study Phase: Phase IIIProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 19, 2024

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Details : Ajovy (fremanezumab) a FDA approved, humanized mAb which selectively binds the calcitonin gene-related peptide (CGRP). It is being investigated for the prevention of migraine in 6-17 years patients.

Brand Name : Ajovy

Molecule Type : Large molecule

Upfront Cash : Not Applicable

July 19, 2024

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