H. Lundbeck AS DMF, CEP, Written Confirmations, FDF, Prices, Patents, Patents & Exclusivities, Dossier, Manufacturer, Licensing, Distributer, Suppliers, News, GMP

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

Virtual Booth

Contact Supplier

Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
Google Map, LinkedIn, Emails...

DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 211 NEWS #PharmaBuzz

media
INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
211 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

35 All APIs, 28 USDMF, 2 CEP/COS, 10 JDMF, 6 KDMF, 13 NDC API

35 All APIs
28 USDMF
2 CEP/COS
10 JDMF
6 KDMF
13 NDC API

DEVELOPMENTS

38 Drugs in Development

38 Drugs in Development

FINISHED DOSAGE FORMULATIONS

312 FDF Dossiers, 12 FDA Orange Book, 220 Europe, 20 Canada, 27 Australia, 30 South Africa, 3 Listed Dossiers

312 FDF Dossiers
12 FDA Orange Book
220 Europe
20 Canada
27 Australia
30 South Africa
3 Listed Dossiers

INSPECTIONS & REGISTRATIONS

9 FDA, 13 EDQM, 1 GDUFA

inspections
9 FDA
13 EDQM
1 GDUFA

Only Regulatory Products (API/FDF), Drugs in Developments and News are Updated on this Virtual Booth

Update your Virtual Booth on PharmaCompass, ask us

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...

DCAT WeekDCAT Week

Not Confirmed

Not Confirmed

17-20 March, 2025

New York, USA
DuphatDuphat

Not Confirmed

Not Confirmed

07-09 January, 2025

Dubai World Trade Center
Pharmatech Expo 2025Pharmatech Expo 2025

Not Confirmed

Not Confirmed

08-10 January, 2025

Gujarat, India

List your booth number for exhibitions, ask us

CONTACT DETAILS

Click the arrow to open the dropdown

Country

Denmark

Address

Ottiliavej 9 2500 Valby

Telephone

+45 3630 1311

enquiries@pharmacompass.com

Website

https://www.lundbeck.com/global

YouTube

Digital content

Create Content with PharmaCompass, ask us

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: 4916

VLOG #PharmaReel

[Sponsored by another company]

High-Quality Specialty Formulations

DATA COMPILATION #PharmaFlow

[Sponsored by another company]

BMS, J&J, Bayer lead 25,000+ pharma layoffs in 2024; Amylyx, FibroGen, Kronos Bio hit by trial failures, cash crunch

Since 2022, there has been a significant surge in layoffs by pharmaceutical and biotech companies. While this trend continued into 2024, the industry showed signs of stabilization in the last four months of the year with the pace of layoffs slowing down. Nonetheless, 2024 was a challenging year. Data compiled by PharmaCompass indicates that over 25,000 layoffs were announced in 2024, driven by economic pressures, failed clinical trials, and strategic pivots. Bristol Myers Squibb and Johnson & Johnson led the layoffs with about 2,300 job cuts each. Bayer announced elimination of 1,800 positions. View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) US, Europe, China bear brunt of job cuts; Big Pharma hands pink slips to 10,000 Over 190 biopharma companies announced layoffs in 2024. The year began on a grim note — 27 firms announced significant job cuts in January 2024. By the yearend, Big Pharma alone had contributed more than 10,000 layoffs to the year’s total of over 25,000. Novartis announced over 1,200 job cuts in 2024. It eliminated 330 jobs after it acquired German biotech MorphoSys through the closure of sites in Munich and Boston. Similarly, Bayer announced significant reductions at its US and Swiss facilities. North America saw increased retrenchments, especially at biotech hubs such as Boston, San Diego, and New Jersey. Massachusetts, with Boston and Cambridge as the epicenter of US biotechnology, saw around 4,000 layoffs, with companies like Relay Therapeutics, Editas Medicine, and Takeda driving the numbers. In San Diego, workforce reductions by Takeda, and Bavarian Nordic collectively resulted in over 900 job losses, significantly impacting the local biotech ecosystem. New Jersey was subject to broader restructuring efforts with BMS and Bayer contributing nearly 1,500 layoffs. The impact in Europe was equally severe. Germany, home to some of the world’s largest pharmaceutical companies, saw over 2,500 layoffs as Bayer and Boehringer Ingelheim scaled back operations. Novartis’ decision to shut down its Munich site added hundreds more to the tally. In Switzerland, Idorsia eliminated 270 positions. Dutch biotech UniQure reduced its workforce by 65 percent (around 300 jobs). That included the sale of a Massachusetts manufacturing facility to Genezen. Denmark also felt the strain, with Leo Pharma cutting 250 roles as part of a strategic revamp. China emerged as another focal point of workforce reductions in 2024. Global pharmaceutical giants, such as Merck and Johnson & Johnson, restructured their operations in response to market complexities in the region. Local companies such as Connect Biopharma, which is transitioning to a US-focused company, also scaled back their presence in the country. View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) Amylyx, FibroGen, Lyra, Athira drastically reduce staff over setbacks in clinical trials Clinical trial failures were one of the most significant drivers of layoffs in 2024. For instance, Amylyx Pharmaceuticals faced a devastating blow when its amyotrophic lateral sclerosis (ALS) therapy, Relyvrio, failed a confirmatory trial. This led to a 70 percent reduction in its workforce, leaving only 100 employees from the 384 full-time staff reported at the end of 2023. The company’s decision to pull the therapy from the market compounded the layoffs. BioMarin Pharmaceutical had to reduce its workforce, as it streamlined its pipeline in response to trial challenges. In August, the company announced a reduction of 225 employees, citing “organizational redesign efforts”. These layoffs followed 170 redundancies announced earlier in May. FibroGen, once considered a leader in oncology drug development, was among the most heavily impacted. The high-profile failure of its anti-CTGF antibody in two late-stage cancer trials led to the discontinuation of its lead candidate, resulting in a 75 percent reduction in its US workforce. Lyra Therapeutics also implemented a 75 percent workforce reduction, affecting 87 employees, after its chronic rhinosinusitis program struggled. Similarly, Athira Pharma cut 70 percent of its team after its Alzheimer’s candidate failed a phase 2/3 trial. View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) Cash crunch, mergers compel Kronos Bio, Editas, Vincerx, Gilead to downsize In addition to clinical failures, funding constraints played a pivotal role in reshaping the biotech landscape. Kronos Bio stood out as one of the hardest-hit firms, cutting 21 percent and 83 percent of its existing workforce in March and November, respectively, as it sought to divest assets and conserve cash. Editas Medicine’s inability to secure partnerships for its sickle cell program forced the company to revert to preclinical research, resulting in a 65 percent workforce reduction. The trend of scaling back R&D pipelines was particularly evident among biotechs struggling to advance preclinical programs to clinical trials. Boundless Bio and Senti Bio exemplified this, choosing to focus on a handful of promising candidates, while reducing discovery efforts. Consolidation often results in overlapping roles, leading to inevitable workforce reductions. Apart from the MorphoSys layoffs by Novartis, Vincerx Pharma faced job losses after it got acquired by Oqory (a clinical-stage ADC company). Vincerx had to cut its workforce by 55 percent. Amid ongoing reorganization efforts, Gilead closed its Seattle, Washington (US), office and laid off 72 employees of its subsidiary Kite Pharma. Gilead also announced that its Kite facility in Philadelphia, Pennsylvania (US), would close by mid-2025. That was followed by 104 additional layoffs at its California headquarters. In April, it had cut 58 jobs in California. Gilead also announced that its Kite facility in Philadelphia would close by mid-2025. Vir Biotechnology reduced its workforce by 25 percent (i.e. 140 layoffs) to focus on its hepatitis program, and GlycoMimetics let go of 80 percent of its workforce after the FDA demanded an additional clinical trial for its leukemia treatment. Meanwhile, Lexicon Pharmaceuticals reduced its workforce by 60 percent after it stopped commercial operations and transitioned back to being a clinical stage company. View Our Interactive Dashboard on Biopharma Layoffs in 2024 (Free Excel Available) Our view It takes decades to build innovation ecosystems. The concentration of layoffs in major biotech hubs has raised concerns about the potential long-term impact on these ecosystems. In 2025, the key challenge will be to maintain the momentum of innovation, as organizations operate with a leaner workforce and a more focused pipeline.

Impressions: 4560

NEWS #PharmaBuzz

JAMA Psychiatry Publishes Otsuka, Lundbeck PTSD Trial Results

18 Dec 2024

// BUSINESSWIRE

Lundbeck Showcases Commitment to Rare Epilepsy at AES Meeting

05 Dec 2024

// PR NEWSWIRE

Lundbeck acquires all outstanding shares of Longboard Pharma

04 Dec 2024

// PRESS RELEASE

Lundbeck Initiates Phase III Trial with Amlenetug for MSA

27 Nov 2024

// PHARMAWEB

Lundbeck slashes value of $250M Abide buyout after pain setback

24 Oct 2024

// FIERCE BIOTECH

Denmark's Lundbeck bets on epilepsy drug with $2.6 bln Longboard deal

15 Oct 2024

// REUTERS

ALL APIs

Click the button for full data set

01

Citalopram Hydrobromide

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

Pharmatech Expo 2025

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

USDMF

CEP/COS JDMF

EU-WC NDC

KDMF

VMF Others AUDIT

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

Pharmatech Expo 2025

Not Confirmed

Only 10 entries up to this point, click to access all

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

USDMF

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

CEP/COS

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

JDMF

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

KDMF

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

NDC API

Denmark

Pharmatech Expo 2025

Not Confirmed

Only 10 entries up to this point, click to access all

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

FDA Orange Book

Europe

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

Canada

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

Australia

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

Denmark

BIO Partnering at JPM

Not Confirmed

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

Inspections and registrations

Upload your audits for free, ask us

FDA

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

EDQM

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

GDUFA

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

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 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

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

Company profile for H. Lundbeck AS

VISIT THE VIRTUAL BOOTH

Review portfolio & marketing content

CONTACT DETAILS

Google Map, LinkedIn, Emails...

EVENTS

Webinars & Exhibitions

DIGITAL CONTENT

INTERVIEW #SpeakPharma

VLOG #PharmaReel

DATA COMPILATION #PharmaFlow

211 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

35 All APIs

28 USDMF

2 CEP/COS

10 JDMF

6 KDMF

13 NDC API

DEVELOPMENTS

38 Drugs in Development

FINISHED DOSAGE FORMULATIONS

312 FDF Dossiers

12 FDA Orange Book

220 Europe

20 Canada

27 Australia

30 South Africa

3 Listed Dossiers

INSPECTIONS & REGISTRATIONS

9 FDA

13 EDQM

1 GDUFA

01

02

03

04

05

06

07

08

09

10

01

Brand Name : Saroten

Brand Name : Saroten

02

Brand Name : Sarotex

Brand Name : Sarotex

03

Brand Name : Sarotex Retard

Brand Name : Sarotex Retard

04

Brand Name : Saroten

Brand Name : Saroten

05

Brand Name : Sarotex

Brand Name : Sarotex

06

Brand Name : Sarotex Retard

Brand Name : Sarotex Retard

07

Brand Name : Saroten

Brand Name : Saroten

08

Brand Name : Saroten

Brand Name : Saroten

09

Brand Name : Sarotex

Brand Name : Sarotex

10

Brand Name : Sarotex

Brand Name : Sarotex

01

Brand Name : Seropram

Brand Name : Seropram

02

Brand Name : Seropram

Brand Name : Seropram

03