Company profile for H. Lundbeck AS

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About

Lundbeck is a global pharmaceutical company highly committed to improving the quality of life for people suffering from brain diseases. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company’s products are targeted at diseases such as depression and anxiety, psychotic disorders, epilepsy and Huntington’s, Alzheimer’s and Parkinso...
Lundbeck is a global pharmaceutical company highly committed to improving the quality of life for people suffering from brain diseases. For this purpose, Lundbeck is engaged in the research, development, production, marketing and sale of pharmaceuticals across the world. The company’s products are targeted at diseases such as depression and anxiety, psychotic disorders, epilepsy and Huntington’s, Alzheimer’s and Parkinson’s diseases. More information about Lundbeck

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CONTACT DETAILS

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Country
Country
Denmark
Address
Address
Ottiliavej 9 2500 Valby
Telephone
Telephone
+45 3630 1311
Linkedin
Linkedin
youtube
YouTube
Twitter
Twitter

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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.lundbeck.com/us/newsroom/2024/lundbeck-to-acquire-longboard-pharmaceuticals-in-a-strategic-deal

PRESS RELEASE
04 Dec 2024

https://www.pharmiweb.com/press-release/2024-11-27/lundbeck-initiates-a-phase-iii-trial-with-amlenetug-for-the-treatment-of-multiple-system-atrophy

PHARMAWEB
27 Nov 2024

https://www.fiercebiotech.com/biotech/lundbeck-slashes-value-250m-abide-buyout-after-pain-setback

FIERCE BIOTECH
24 Oct 2024

https://www.reuters.com/markets/deals/lundbeck-buy-longboard-pharma-26-billion-deal-2024-10-14/

REUTERS
15 Oct 2024

https://www.fiercebiotech.com/biotech/lundbeck-taps-charles-river-ai-enabled-neuro-drug-discovery

FIERCE BIOTECH
02 Oct 2024

https://www.businesswire.com/news/home/20240926223627/en

BUSINESSWIRE
26 Sep 2024

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Trimipramine

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Vortioxetine Hydrobromide

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Argatroban

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Argatroban

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Dapsone

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Desipramine Hydrochloride

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Imipramine

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Metoclopramide Hydrochloride

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Drugs in Development

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Details:

Lundbeck gains access to LP352 (bexicaserin), a novel 5-HT2C agonist in development for seizures associated with DEEs, including Dravet syndrome, Lennox-Gastaut syndrome, and other rare epilepsies.


Lead Product(s): Bexicaserin

Therapeutic Area: Neurology Brand Name: LP352

Study Phase: Phase IIIProduct Type: Small molecule

Recipient: Longboard Pharmaceuticals

Deal Size: $2,600.0 million Upfront Cash: $2,600.0 million

Deal Type: Acquisition October 14, 2024

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H. Lundbeck AS

Denmark
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Antibody Engineering
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H. Lundbeck AS

Denmark
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Antibody Engineering
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Details : Lundbeck gains access to LP352 (bexicaserin), a novel 5-HT2C agonist in development for seizures associated with DEEs, including Dravet syndrome, Lennox-Gastaut syndrome, and other rare epilepsies.

Brand Name : LP352

Molecule Type : Small molecule

Upfront Cash : $2,600.0 million

October 14, 2024

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The agreement aims to advance the discovery of novel drugs for neurological disease by utilizing Logica which translates biological insights into optimized preclinical candidates.


Lead Product(s): Undisclosed

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: Discovery PlatformProduct Type: Small molecule

Recipient: Charles River Laboratories, Inc

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement October 02, 2024

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H. Lundbeck AS

Denmark
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Antibody Engineering
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H. Lundbeck AS

Denmark
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Details : The agreement aims to advance the discovery of novel drugs for neurological disease by utilizing Logica which translates biological insights into optimized preclinical candidates.

Brand Name : Undisclosed

Molecule Type : Small molecule

Upfront Cash : Undisclosed

October 02, 2024

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Details:

Lundbeck will cease all promotional efforts for Trintellix (vortioxetine hbr) with Takeda in the U.S. fully reallocate resources to other growth opportunities and accelerate growth for these products.


Lead Product(s): Vortioxetine Hydrobromide

Therapeutic Area: Psychiatry/Psychology Brand Name: Trintellix

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Takeda Pharmaceutical

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration August 01, 2024

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H. Lundbeck AS

Denmark
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H. Lundbeck AS

Denmark
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Details : Lundbeck will cease all promotional efforts for Trintellix (vortioxetine hbr) with Takeda in the U.S. fully reallocate resources to other growth opportunities and accelerate growth for these products.

Brand Name : Trintellix

Molecule Type : Small molecule

Upfront Cash : Undisclosed

August 01, 2024

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Rexulti (brexpiprazole) is an partial agonist of serotonin 5-HT1A, which is being investigated in combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD).


Lead Product(s): Brexpiprazole,Sertraline Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Rexulti

Study Phase: Phase IIIProduct Type: Small molecule

Recipient: Otsuka Pharmaceutical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 25, 2024

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H. Lundbeck AS

Denmark
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H. Lundbeck AS

Denmark
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Details : Rexulti (brexpiprazole) is an partial agonist of serotonin 5-HT1A, which is being investigated in combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD).

Brand Name : Rexulti

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 25, 2024

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Details:

Rexulti (brexpiprazole) is an partial agonist activity at serotonin 5-HT1A, which is being investigated in combination therapy with sertraline for the treatment of post-traumatic stress disorder.


Lead Product(s): Brexpiprazole,Sertraline Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Rexulti

Study Phase: Phase IIIProduct Type: Small molecule

Recipient: Otsuka Pharmaceutical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 09, 2024

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H. Lundbeck AS

Denmark
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H. Lundbeck AS

Denmark
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Details : Rexulti (brexpiprazole) is an partial agonist activity at serotonin 5-HT1A, which is being investigated in combination therapy with sertraline for the treatment of post-traumatic stress disorder.

Brand Name : Rexulti

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 09, 2024

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Rexulti (brexpiprazole) 5-HT2A receptor, is being evaluated in combination with sertraline in late-stage clinical trials with adult patients for the treatment of post-traumatic stress disorder.


Lead Product(s): Brexpiprazole,Sertraline Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Rexulti

Study Phase: Phase IIIProduct Type: Small molecule

Recipient: Otsuka Pharmaceutical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 09, 2024

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H. Lundbeck AS

Denmark
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H. Lundbeck AS

Denmark
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Details : Rexulti (brexpiprazole) 5-HT2A receptor, is being evaluated in combination with sertraline in late-stage clinical trials with adult patients for the treatment of post-traumatic stress disorder.

Brand Name : Rexulti

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 09, 2024

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Details:

Rexulti (brexpiprazole) is an partial agonist activity at serotonin 5-HT1A, which is investigated in combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD).


Lead Product(s): Brexpiprazole,Sertraline Hydrochloride

Therapeutic Area: Psychiatry/Psychology Brand Name: Rexulti

Study Phase: Phase IIIProduct Type: Small molecule

Recipient: Otsuka Pharmaceutical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 07, 2023

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H. Lundbeck AS

Denmark
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Antibody Engineering
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H. Lundbeck AS

Denmark
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Details : Rexulti (brexpiprazole) is an partial agonist activity at serotonin 5-HT1A, which is investigated in combination therapy with sertraline for the treatment of post-traumatic stress disorder (PTSD).

Brand Name : Rexulti

Molecule Type : Small molecule

Upfront Cash : Not Applicable

September 07, 2023

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Details:

Rexulti (brexpiprazole) is an atypical antipsychotic, is the first and only pharmacological treatment approved in the U.S. for agitation associated with dementia due to Alzheimer’s disease.


Lead Product(s): Brexpiprazole

Therapeutic Area: Psychiatry/Psychology Brand Name: Rexulti

Study Phase: ApprovedProduct Type: Small molecule

Recipient: Otsuka Pharmaceutical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 11, 2023

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H. Lundbeck AS

Denmark
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H. Lundbeck AS

Denmark
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Details : Rexulti (brexpiprazole) is an atypical antipsychotic, is the first and only pharmacological treatment approved in the U.S. for agitation associated with dementia due to Alzheimer’s disease.

Brand Name : Rexulti

Molecule Type : Small molecule

Upfront Cash : Not Applicable

May 11, 2023

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Details:

Under the agreement, Neuro3 will receive a worldwide license for intellectual property covering two clinical stage and one pre-clinical stage KCNQ2 activator programs and will be responsible for their further development through clinical PoC for the treatment of epilepsy.


Lead Product(s): Undisclosed

Therapeutic Area: Neurology Brand Name: Undisclosed

Study Phase: UndisclosedProduct Type: Undisclosed

Sponsor: Neuro3 Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement May 08, 2023

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H. Lundbeck AS

Denmark
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H. Lundbeck AS

Denmark
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Lead Product(s) : Undisclosed

Therapeutic Area : Neurology

Highest Development Status : Undisclosed

Partner/Sponsor/Collaborator : Neuro3 Therapeutics

Deal Size : Undisclosed

Deal Type : Licensing Agreement

Details : Under the agreement, Neuro3 will receive a worldwide license for intellectual property covering two clinical stage and one pre-clinical stage KCNQ2 activator programs and will be responsible for their further development through clinical PoC for the trea...

Brand Name : Undisclosed

Molecule Type : Undisclosed

Upfront Cash : Undisclosed

May 08, 2023

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Details:

Abilify (aripiprazole) action includes a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors. It is approved by USFDA for the treatment of schizophrenia and for bipolar I disorder in adults.


Lead Product(s): Aripiprazole

Therapeutic Area: Psychiatry/Psychology Brand Name: Abilify Asimtufii

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Otsuka Holdings

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 28, 2023

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H. Lundbeck AS

Denmark
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Antibody Engineering
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H. Lundbeck AS

Denmark
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Details : Abilify (aripiprazole) action includes a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors. It is approved by USFDA for the treatment of schizophrenia and for bipolar I disorder in adults.

Brand Name : Abilify Asimtufii

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 28, 2023

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Inspections and registrations

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FDA

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FDA Audited

USA
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FDA Audited

USA
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H. Lundbeck AS

City : Deerfield

State : IL

Country/Area : US

Zip : 60015-2542

District : CHI

Center : CDER

Project Area : Postmarket Surv. and Epidemiolog...

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-08-01

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FDA Audited

USA
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FDA Audited

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H. Lundbeck AS

City : Valby

State :

Country/Area : DK

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2009-05-08

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03

FDA Audited

USA
Antibody Engineering
Not Confirmed
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FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

H. Lundbeck AS

City : Valby

State :

Country/Area : DK

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2013-06-10

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04

FDA Audited

USA
Antibody Engineering
Not Confirmed
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FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

H. Lundbeck AS

City : Nykobing Sj

State :

Country/Area : DK

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2013-06-17

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05

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

H. Lundbeck AS

City : Padova

State :

Country/Area : IT

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2012-09-28

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06

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

H. Lundbeck AS

City : Padova

State :

Country/Area : IT

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2009-03-13

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07

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

H. Lundbeck AS

City : Padova

State :

Country/Area : IT

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2015-04-17

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08

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

H. Lundbeck AS

City : Deerfield

State : IL

Country/Area : US

Zip : 60015

District : CHI

Center : CDER

Project Area : Postmarket Surv. and Epidemiolog...

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-06-02

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09

FDA Audited

USA
Antibody Engineering
Not Confirmed
arrow

FDA Audited

USA
arrow
Antibody Engineering
Not Confirmed

H. Lundbeck AS

City : Padova

State :

Country/Area : IT

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-05-12

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ABOUT THIS PAGE

Contact H. Lundbeck AS and get a quotation

H. Lundbeck AS is a supplier offers 33 products (APIs, Excipients or Intermediates).

Find a price of Citalopram Hydrobromide bulk with DMF, CEP offered by H. Lundbeck AS

Find a price of Diazoxide bulk with DMF, JDMF offered by H. Lundbeck AS

Find a price of Escitalopram Oxalate bulk with DMF, JDMF offered by H. Lundbeck AS

Find a price of Trimipramine bulk with DMF, CEP offered by H. Lundbeck AS

Find a price of Vortioxetine Hydrobromide bulk with DMF, JDMF offered by H. Lundbeck AS

Find a price of Argatroban bulk with DMF offered by H. Lundbeck AS

Find a price of Argatroban Monohydrate bulk with JDMF offered by H. Lundbeck AS

Find a price of Clomipramine Hydrochloride bulk with DMF offered by H. Lundbeck AS

Find a price of Dapsone bulk with DMF offered by H. Lundbeck AS

Find a price of Desipramine Hydrochloride bulk with DMF offered by H. Lundbeck AS

Find a price of Imipramine bulk with DMF offered by H. Lundbeck AS

Find a price of Indomethacin Sodium bulk with JDMF offered by H. Lundbeck AS

Find a price of Metoclopramide Hydrochloride bulk with DMF offered by H. Lundbeck AS

Find a price of Nalmefene Hydrochloride bulk with JDMF offered by H. Lundbeck AS

Find a price of Ritodrine Hydrochloride bulk with JDMF offered by H. Lundbeck AS

Find a price of Thip Hydrochloride bulk with DMF offered by H. Lundbeck AS

Find a price of Vortioxetine Hydrobromide bulk with JDMF offered by H. Lundbeck AS

Find a price of Alfuzosin HCl bulk offered by H. Lundbeck AS

Find a price of Calcium Amphomycin bulk offered by H. Lundbeck AS

Find a price of Ethotoin bulk offered by H. Lundbeck AS

Find a price of Imipramine Hydrochloride bulk offered by H. Lundbeck AS

Find a price of Melperone bulk offered by H. Lundbeck AS

Find a price of Sertindole bulk offered by H. Lundbeck AS

Find a price of Tedatioxetine Hydrobromide bulk offered by H. Lundbeck AS

Find a price of Tetrabenazine bulk offered by H. Lundbeck AS

Find a price of LU 3-010 bulk offered by H. Lundbeck AS

Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN LAMSAS, DENMARK bulk offered by H. Lundbeck AS

Find a price of LU-25-109-M DRUG SUBSTANCE bulk offered by H. Lundbeck AS

Find a price of LU 28-179-CAPSULES bulk offered by H. Lundbeck AS

Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN SEAL SANDS, UNITED KINGDOM bulk offered by H. Lundbeck AS

Find a price of FACILITY IN NYKOBING SJ., DENMARK bulk offered by H. Lundbeck AS

Find a price of LU 28-179-C, DRUG SUBSTANCE bulk offered by H. Lundbeck AS

Find a price of MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN VALBY, DENMARK bulk offered by H. Lundbeck AS

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