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    Company profile for Bayer AG

    DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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    Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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    xyz-pharma-m-2024-10-07

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    With Fermion, start the journey of your innovative API.

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    Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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    About

    For over a century, Bayer has stood for improving everyday health and wellness for millions of consumers worldwide. People everywhere make Bayer a trusted part of their daily lives. This deep connection with consumers has fueled the growth and innovation of our product portfolio and we believe that our brands will continue to play a critical role in the health and welfare of people worldwide. Our rich history began in 1897 wit...
    For over a century, Bayer has stood for improving everyday health and wellness for millions of consumers worldwide. People everywhere make Bayer a trusted part of their daily lives. This deep connection with consumers has fueled the growth and innovation of our product portfolio and we believe that our brands will continue to play a critical role in the health and welfare of people worldwide. Our rich history began in 1897 with the synthesis of a stable form of acetylsalicylic acid (ASA), which was introduced to the market as Aspirin™ in 1899. In 1969, Aspirin made it to the moon aboard the Apollo 11 and by the mid-1980’s.

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    Bayer AGGermany Flag
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    Mullerstr. 178, 13353 Berlin
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    +49 30 468 1111
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    INTERVIEW #SpeakPharma

    [Sponsored by another company]
    “Translational Pharmaceutics, our flagship platform for drug development, empowers our clients with unparalleled flexibility”

    “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  

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    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
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    VLOG #PharmaReel

    [Sponsored by another company]

    DATA COMPILATION #PharmaFlow

    [Sponsored by another company]
    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    CDMO Activity Tracker: Bora, PolPharma make acquisitions; Evonik, EUROAPI, Porton announce technological expansions

    The contract development and manufacturing organization (CDMO) space continued to grow at an impressive pace in the second half (H2) of 2024, with significant progress being made across cell and gene therapies (CGTs), antibody-drug conjugates (ADCs), novel drug modalities, and digital solutions.Some of the key players in the CDMO space include Lonza, EUROAPI, Evonik, SEQENS, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Axplora, PolPharma, and Famar from Europe; Mission CDMO, LGM Pharma, Veranova, and Thermo Fisher from the US; and Samsung Biologics, Bora Pharmaceuticals, and Porton Pharma Solutions from Asia. Texas-based Mission CDMO has been in the pharma industry for over 75 years. Today, it is known for its comprehensive contract services and high-quality manufacturing capabilities that have reinforced its position as a trusted partner. View CDMO Activity Tracker for H2 2024 (Free Excel Available)Bora, PolPharma drive CDMO acquisitions; Samsung Biologics clocks over US$ 4 bn in contract valueThe second half of 2024 saw several high-value acquisitions and expansions that reshaped the CDMO landscape. South Korea-based Samsung Biologics clocked a cumulative contract value of over US$ 4 billion. It signed its largest manufacturing deal with an Asia-based pharmaceutical company, valued at US$ 1.24 billion. It also announced a series of manufacturing deals with a European drugmaker worth over US$ 668 million. Samsung Biologics is also building a dedicated ADC facility that is likely to be complete soon. Taiwan’s largest CDMO, Bora Pharmaceuticals, announced its second acquisition of the year. It bought New Jersey-based Pyros Pharmaceuticals, a developer of rare disease treatments. Pyros recently launched Vigafyde, the only ready-to-use vigabatrin oral solution and the first new product approved to treat infantile spasms in 15 years. Bora also announced a strategic investment in Tanvex Biopharma, thereby creating a global platform for biologics development and supply.PolPharma acquired Ziołolek, a renowned manufacturer of dermatological products, medical devices, and OTC medicines, thereby expanding its product portfolio. It also launched a state-of-the-art HPAPI (highly potent active pharmaceutical ingredients) facility in Poland, which is being seen as another step towards securing Europe’s drug supply chain.In other developments, Avid Bioservices got acquired by funds managed by Ampersand and British healthcare investment firm GHO Capital Partners in an all-cash deal worth US$ 1.1 billion. And Agilent Technologies agreed to acquire Canadian specialty CDMO Biovectra for US$ 925 million, thereby enhancing its capabilities in gene-editing technologies and sterile fill-finish services. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Evonik, EUROAPI, Porton Pharma, GSK announce tieups, technological expansionsSeveral CDMOs announced new collaborations and acquired new capabilities to enhance their service offerings. Evonik expanded its formulation capabilities for lipid nanoparticles used for mRNA and gene therapies through a collaboration with KNAUER Wissenschaftliche Geräte. This partnership aims to expand Evonik’s portfolio of biosolutions.Evonik is also restructuring its keto and pharma amino acid business to focus on strategic core growth areas. Evonik launched Eudracap colon functional capsules for targeted delivery of oral drugs. These ready-to-fill capsules are designed to release their contents specifically in the colon, improving the efficacy of treatments for various gastrointestinal conditions. Evonik also opened a new facility for drying aqueous dispersions of Eudragit polymers in Darmstadt, Germany. This facility will enhance Evonik’s capabilities in producing high-quality polymers for pharmaceutical applications.EUROAPI launched a new AI-powered Electronic Batch Record solution in collaboration with Aizon to enhance manufacturing productivity. This collaboration aims to digitize operations towards more data-driven manufacturing, focusing on small-scale productions and highly flexible plants.Porton Pharma Solutions has expanded its reach through several strategic initiatives. In October, Porton entered into a partnership with Shanghai InnoStar to enhance its service offerings beyond small molecules, targeting peptides, oligonucleotide drugs, conjugated drugs, and advanced therapies. It continued to grow its capabilities by enhancing its GMP manufacturing capacity in Fengxian, Shanghai (China). The facility’s expansion is aimed at increasing the production of novel therapies, including peptides and oligonucleotide drugs. These moves are part of Porton’s broader strategy to position itself at the forefront of advanced pharmaceutical manufacturing.Corden Pharma is investing € 900 million (US$ 985 million) over the next three years to expand its peptide platform facilities in Colorado (US) and Europe. While the US site will help meet the rising demand for GLP-1 peptides, in Europe, CordenPharma will construct a greenfield facility for small to large-scale peptide development and manufacturing.CDMO Touchlight signed a licensing agreement with GSK that grants the drug behemoth non-exclusive rights to use Touchlight’s proprietary enzymatic doggybone DNA (dbDNA) technology for the development and production of mRNA-based products, particularly vaccines. Curia also integrated enzymatic dbDNA solutions through a collaboration with Touchlight, enhancing mRNA production for vaccine and cancer therapies. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Lonza, Merck, Dr. Reddy’s owned Aurigene invest in cell and gene therapiesThe CGT space continued to draw both deals and investments. Lonza and Vertex signed a long-term commercial supply agreement for Casgevy, the world’s first CRISPR/Cas9 gene-edited cell therapy, to treat sickle cell disease and beta thalassemia. This agreement includes manufacturing at Lonza’s Geleen (the Netherlands) cell therapy manufacturing facility, with plans to expand to Portsmouth, New Hampshire (US).Miltenyi Biotec began manufacturing lentiviral vectors for Adaptimmune’s Tecelra, the first engineered TCR T-cell therapy for the rare soft tissue cancer synovial sarcoma approved by the US Food and Drug Administration.Merck KGaA commenced commercial production at its first GMP-compliant manufacturing line for cell culture media (CCM) in China. This facility addresses the growing local demand for quality custom CCM used in biopharmaceuticals, vaccines, and novel therapeutics.Aurigene and Edity Therapeutics announced a strategic collaboration in cell therapy, with Aurigene providing cell therapy discovery services to support Edity’s clinical development. Additionally, Aurigene and its parent, Dr. Reddy’s Laboratories, signed a memorandum of understanding (MoU) with Kainomyx for the development and commercialization of an affordable anti-malarial drug. ProBio and UCI Therapeutics signed an MoU for a comprehensive collaboration in gene delivery technologies, including viral and non-viral approaches. Additionally, Korea’s VaxCell-Bio partnered with ProBio to accelerate the development of its chimeric antigen receptor (CAR)-related therapies.The ADC market continued to be a hotbed of innovation and strategic expansion. Merck KGaA invested € 70 million (US$ 75 million) to triple its ADC manufacturing capacity at its Missouri (US) facility, aiming to support the rising demand for oncology therapies.Sterling Pharma entered into a partnership with GlycoNex to support the clinical trials of their ADCs that target solid tumors. And, NJ Bio and Charles River Laboratories also announced a collaboration to optimize ADC manufacturing.The adeno-associated viral (AAV) vector field also saw activity with Rentschler Biopharma and Forge Biologics announcing the launch of a new service offering and a manufacturing platform, respectively. Similarly, Andelyn Biosciences was selected by Hubble Therapeutics to manufacture clinical grade AAV.Meanwhile, Lonza has gone in for a restructuring exercise in order to become a “pure-play CDMO”. It has exited its capsules and health ingredients business, and adopted a new organizational structure. The Swiss CDMO has also extended a collaboration with a major global biopharmaceutical partner for commercial-scale manufacture of ADCs. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Our viewAs pharmaceutical development becomes increasingly complex, CDMOs are no longer just manufacturing partners, but critical innovation hubs. Little wonder then that 2024’s biggest pharma deal was in the CDMO space – Novo Holdings’ US$ 16.5 billion buyout of Catalent. This trend should gather momentum. We expect more M&A activity in this space in 2025. 
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    Impressions: 365

    https://www.pharmacompass.com/radio-compass-blog/cdmo-activity-tracker-bora-polpharma-make-acquisitions-evonik-euroapi-porton-announce-technological-expansions

    #PharmaFlow by PHARMACOMPASS
    19 Dec 2024
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    NEWS #PharmaBuzz

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    Regeneron to expand high-dose Eylea's label after Ph 3 win
    Regeneron to expand high-dose Eylea's label after Ph 3 win

    18 Dec 2024

    // BIOSPACE

    https://www.biospace.com/drug-development/regeneron-bayer-build-retinal-vein-occlusion-case-for-eylea-as-biosimilar-pressure-mounts

    BIOSPACE
    18 Dec 2024
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    Bayer opens Berlin incubator and welcomes first resident
    Bayer opens Berlin incubator and welcomes first resident

    29 Nov 2024

    // PHARMAPHORUM

    https://pharmaphorum.com/news/bayer-opens-berlin-incubator-and-welcomes-first-resident

    PHARMAPHORUM
    29 Nov 2024
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    FDA Accepts NDA in Metastatic Hormone-Sensitive Prostate Cancer
    FDA Accepts NDA in Metastatic Hormone-Sensitive Prostate Cancer

    21 Nov 2024

    // BUSINESSWIRE

    https://www.businesswire.com/news/home/20241120748644/en

    BUSINESSWIRE
    21 Nov 2024
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    Bayer acquires rights to Cytokinetics' heart drug in Japan
    Bayer acquires rights to Cytokinetics' heart drug in Japan

    20 Nov 2024

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/bayer-acquires-rights-cytokinetics-heart-drug-japan-2024-11-19/

    REUTERS
    20 Nov 2024
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    Bayer shareholders call on CEO to stem the tide of bad news
    Bayer shareholders call on CEO to stem the tide of bad news

    15 Nov 2024

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/bayer-shareholders-call-ceo-stem-tide-bad-news-2024-11-15/

    REUTERS
    15 Nov 2024
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    D.E. Shaw Takes $108M Short Bet on Bayer, Filing Shows
    D.E. Shaw Takes $108M Short Bet on Bayer, Filing Shows

    13 Nov 2024

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/de-shaw-takes-1-bln-short-bayer-regulatory-filing-shows-2024-11-13/

    REUTERS
    13 Nov 2024
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    Excipients

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    District Decision : No Action Indicated

    Inspection End Date : 2010-03-12

    Bayer AG

    City : Mishawaka

    State : IN

    Country/Area : US

    Zip : 46544-3207

    District : DET

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : No Action Indicated

    Inspection End Date : 2010-03-12

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-03-12

    Bayer AG

    City : Mishawaka

    State : IN

    Country/Area : US

    Zip : 46544-3207

    District : DET

    Center : CDRH

    Project Area : Postmarket Assurance: Devices

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-03-12

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    District Decision : No Action Indicated

    Inspection End Date : 2012-07-20

    Bayer AG

    City : Mishawaka

    State : IN

    Country/Area : US

    Zip : 46544-3207

    District : DET

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : No Action Indicated

    Inspection End Date : 2012-07-20

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    District Decision : No Action Indicated

    Inspection End Date : 2012-07-20

    Bayer AG

    City : Mishawaka

    State : IN

    Country/Area : US

    Zip : 46544-3207

    District : DET

    Center : CDRH

    Project Area : Postmarket Assurance: Devices

    District Decision : No Action Indicated

    Inspection End Date : 2012-07-20

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    District Decision : No Action Indicated

    Inspection End Date : 2014-09-23

    Bayer AG

    City : Mishawaka

    State : IN

    Country/Area : US

    Zip : 46544-3207

    District : DET

    Center : CDRH

    Project Area : Compliance: Devices

    District Decision : No Action Indicated

    Inspection End Date : 2014-09-23

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-03-31

    Bayer AG

    City : Pine Brook

    State : NJ

    Country/Area : US

    Zip : 07058-9714

    District : NWJ

    Center : CDER

    Project Area : Bioresearch Monitoring

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-03-31

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-12-09

    Bayer AG

    City : Pine Brook

    State : NJ

    Country/Area : US

    Zip : 07058-9714

    District : NWJ

    Center : CDER

    Project Area : Bioresearch Monitoring

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2009-12-09

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    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-06-24

    Bayer AG

    City : Pine Brook

    State : NJ

    Country/Area : US

    Zip : 07058-9714

    District : NWJ

    Center : CDER

    Project Area : Postmarket Surv. and Epidemiolog...

    District Decision : Voluntary Action Indicated

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    District Decision : Voluntary Action Indicated

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    Bayer AG

    City : Morristown

    State : NJ

    Country/Area : US

    Zip : 07960-4526

    District : NWJ

    Center : CDER

    Project Area : Postmarket Surv. and Epidemiolog...

    District Decision : Voluntary Action Indicated

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    District Decision : Voluntary Action Indicated

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    Bayer AG

    City : Pine Brook

    State : NJ

    Country/Area : US

    Zip : 07058-9714

    District : NWJ

    Center : CDER

    Project Area : Bioresearch Monitoring

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-11-08

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    Bayer AG

    Type : GMP Certificates

    Number : 2006/UMC/PT...

    EudraGMDP Key : 6271

    Country : Germany

    Issue Date :

    Post Code : B1629MXA

    NCA Ref : 6.2711230643...

    City : Pilar

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    Bayer AG

    Type : GMP Certificates

    Number : UK GMP 3238...

    EudraGMDP Key : 9319

    Country : Germany

    Issue Date :

    Post Code : 94608

    NCA Ref : 411191-BAYER...

    City : EMERYVILLE

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    Bayer AG

    Type : GMP Certificates

    Number : DE_NW_04_GM...

    EudraGMDP Key : 16355

    Country : Germany

    Issue Date :

    Post Code : CA 94701-1986

    NCA Ref : 18166

    City : Berkeley

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    Bayer AG

    Type : GMP Certificates

    Number : DE_BE_01_GM...

    EudraGMDP Key : 16342

    Country : U.S.A

    Issue Date :

    Post Code : Codigo Postal 94450

    NCA Ref : 15658

    City : Veracruz

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    Bayer AG

    Type : GMP Certificates

    Number : DE_SH_01_GM...

    EudraGMDP Key : 22381

    Country : Germany

    Issue Date :

    Post Code : 66216

    NCA Ref : 19371

    City : SHAWNEE, Kansas

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    Bayer AG

    Type : GMP Certificates

    Number : DE_BE_01_GM...

    EudraGMDP Key : 16342

    Country : U.S.A

    Issue Date :

    Post Code : Codigo Postal 94450

    NCA Ref : 15658

    City : Veracruz

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    Bayer AG

    Type : GMP Certificates

    Number : DE_SH_01_GM...

    EudraGMDP Key : 22381

    Country : Germany

    Issue Date :

    Post Code : 66216

    NCA Ref : 19371

    City : SHAWNEE, Kansas

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    Bayer AG

    Type : GMP Certificates

    Number : IT/GMP/E/19...

    EudraGMDP Key : 28698

    Country : Germany

    Issue Date :

    Post Code : 94710

    NCA Ref : 2.8698141236...

    City : Berkeley

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    GDUFA

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    Paid in : 2019

    Bayer AG

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Bayer Pharma AG

    Business Address : Ernst-Schering Strasse 14 Be...

    FEI Number : 3002808084

    Country : Germany

    Paid in : 2019

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    Bayer AG

    API Manufacturer : API MANUFACTURE

    FDF Manufacturer :

    Facility Name : Bayer Pharma AG

    Business Address : Max-Dohrn-Strasse 8-10 Berli...

    FEI Number : 3002808063

    Country : Germany

    Paid in : 2019

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    ABOUT THIS PAGE

    Contact Bayer AG and get a quotation

    Bayer AG is a supplier offers 150 products (APIs, Excipients or Intermediates).

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