Company profile for Hyloris Pharmaceuticals

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About

Hyloris is an innovative specialty pharmaceutical company focused on adding value to the healthcare system by reformulating well-known pharmaceuticals. We unlock the untapped potentials of existing medications to create new and improved treatment options. We develop innovative proprietary products that offer significant advantages compared to currently available alternatives. Our aim is to address the unmet medical needs of pa...
Hyloris is an innovative specialty pharmaceutical company focused on adding value to the healthcare system by reformulating well-known pharmaceuticals. We unlock the untapped potentials of existing medications to create new and improved treatment options. We develop innovative proprietary products that offer significant advantages compared to currently available alternatives. Our aim is to address the unmet medical needs of patients, hospitals, physicians, payors and other stakeholders in the healthcare system.

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CONTACT DETAILS

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Country
Country
Belgium
Address
Address
Boulevard Gustave Kleyer 17, 4000 Liège,
Telephone
Telephone
+32 (0)4 346 02 07
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: 4587

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]
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. 

Impressions: 400

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

NEWS #PharmaBuzz

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read-more

https://www.globenewswire.com//news-release/2024/03/14/2845976/0/en/Hyloris-Reports-Full-Year-Results-for-2023-Provides-Business-Outlook.html

GLOBENEWSWIRE
14 Mar 2024

https://www.globenewswire.com//news-release/2024/03/14/2845961/0/en/Communication-at-the-request-of-the-FSMA-on-the-transactions-with-Qliniq.html

GLOBENEWSWIRE
14 Mar 2024

https://www.globenewswire.com/news-release/2024/03/08/2842882/0/en/Hyloris-to-Report-2023-Full-Year-Results-on-14-March-2024.html

GLOBENEWSWIRE
08 Mar 2024

https://www.globenewswire.com//news-release/2024/02/14/2829330/0/en/Hyloris-Enrolls-First-Patient-in-Phase-3-Clinical-Trial-for-its-Proprietary-Mouth-Rinse-to-Control-Incidences-of-Bleeding-Related-to-Dental-Procedures.html

GLOBENEWSWIRE
14 Feb 2024

https://www.globenewswire.com/news-release/2024/01/30/2819574/0/en/Hyloris-and-Purna-Female-Healthcare-Announce-Positive-Results-from-Phase-2-Trial-in-Patients-with-Acute-Vulvovaginal-Candidiasis-VVC.html

GLOBENEWSWIRE
30 Jan 2024

https://www.globenewswire.com//news-release/2024/01/18/2811837/0/en/Hyloris-Broadens-Pipeline-with-new-Product-Candidate-for-Vulvar-Lichen-Sclerosus-VLS.html

GLOBENEWSWIRE
18 Jan 2024

Drugs in Development

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Details:

Combogesic IV (acetaminophen & ibuprofen) is an opioid-free pain relief medicine approved for adults to relieve mild to moderate pain and manage moderate to severe pain as an adjunct to opioids.


Lead Product(s): Paracetamol,Ibuprofen

Therapeutic Area: Neurology Brand Name: Combogesic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Hikma Pharmaceuticals

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 27, 2024

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Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : Combogesic IV (acetaminophen & ibuprofen) is an opioid-free pain relief medicine approved for adults to relieve mild to moderate pain and manage moderate to severe pain as an adjunct to opioids.

Brand Name : Combogesic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 27, 2024

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Details:

Tranexamic acid oral rinse is a USFDA approved antifibrinolytic agent, plasminogen inhibitor, which is being evaluatd in phase 3 clinical trials for the treatment of dental bleeding.


Lead Product(s): Tranexamic Acid

Therapeutic Area: Dental and Oral Health Brand Name: Tranexamic Acid Oral Rinse

Study Phase: Phase IIIProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable February 14, 2024

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Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : Tranexamic acid oral rinse is a USFDA approved antifibrinolytic agent, plasminogen inhibitor, which is being evaluatd in phase 3 clinical trials for the treatment of dental bleeding.

Brand Name : Tranexamic Acid Oral Rinse

Molecule Type : Small molecule

Upfront Cash : Not Applicable

February 14, 2024

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Details:

MCZ-DB (miconazole nitrate + domiphen bromide) vaginal cream is being evaluated in phase 2 clinical trials for the treatment of acute vulvovaginal candidiasis.


Lead Product(s): Miconazole Nitrate,Domiphen Bromide

Therapeutic Area: Infections and Infectious Diseases Brand Name: MCZ-DB

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Purna Female Healthcare

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 30, 2024

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Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : MCZ-DB (miconazole nitrate + domiphen bromide) vaginal cream is being evaluated in phase 2 clinical trials for the treatment of acute vulvovaginal candidiasis.

Brand Name : MCZ-DB

Molecule Type : Small molecule

Upfront Cash : Not Applicable

January 30, 2024

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Details:

PTX-252 (previously referenced as a Plecoid™Agent) is a novel molecular entity. It is under clinical development for the treatment of cute Myeloid Leukaemia (AML).


Lead Product(s): PTX-252

Therapeutic Area: Oncology Brand Name: PTX-252

Study Phase: UndisclosedProduct Type: Undisclosed

Sponsor: Pleco Therapeutics

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 16, 2024

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Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : PTX-252 (previously referenced as a Plecoid™Agent) is a novel molecular entity. It is under clinical development for the treatment of cute Myeloid Leukaemia (AML).

Brand Name : PTX-252

Molecule Type : Undisclosed

Upfront Cash : Not Applicable

January 16, 2024

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Details:

HY-029 (valaciclovir) is a viral dna polymerase inhibitor small molecule drug candidate, which is currently being evaluated for the treatment of Herpes Simplex Infections.


Lead Product(s): Valacyclovir

Therapeutic Area: Infections and Infectious Diseases Brand Name: HY-029

Study Phase: Phase IProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 26, 2023

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Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : HY-029 (valaciclovir) is a viral dna polymerase inhibitor small molecule drug candidate, which is currently being evaluated for the treatment of Herpes Simplex Infections.

Brand Name : HY-029

Molecule Type : Small molecule

Upfront Cash : Not Applicable

December 26, 2023

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Details:

FDA approved ANDA for Podofilox Gel, a tubulin binder causing cell mitotic arrest, making it ththe first generic topical drug product for the treatment of external genital and perianal warts.


Lead Product(s): Podophyllotoxin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Condylox-Generic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 04, 2023

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06

Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : FDA approved ANDA for Podofilox Gel, a tubulin binder causing cell mitotic arrest, making it ththe first generic topical drug product for the treatment of external genital and perianal warts.

Brand Name : Condylox-Generic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

December 04, 2023

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Details:

Maxigesic via intravenous infusion, combines the power of paracetamol and ibuprofen in a unique double-action formulation for fast effective, non-opioid pain relief.


Lead Product(s): Paracetamol,Ibuprofen

Therapeutic Area: Neurology Brand Name: Maxigesic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 18, 2023

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07

Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : Maxigesic via intravenous infusion, combines the power of paracetamol and ibuprofen in a unique double-action formulation for fast effective, non-opioid pain relief.

Brand Name : Maxigesic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

October 18, 2023

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Details:

Alenura is a unique, combination product of alkalinised lidocaine and the glycosaminoglycan heparin. Alkalinised lidocaine penetrates the transitional epithelial cell layer and provides immediate pain relief.


Lead Product(s): Lidocaine,Heparin Sodium

Therapeutic Area: Urology Brand Name: Alenura

Study Phase: Phase IIProduct Type: Small molecule

Sponsor: Vaneltix Pharma

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 22, 2023

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08

Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : Alenura is a unique, combination product of alkalinised lidocaine and the glycosaminoglycan heparin. Alkalinised lidocaine penetrates the transitional epithelial cell layer and provides immediate pain relief.

Brand Name : Alenura

Molecule Type : Small molecule

Upfront Cash : Not Applicable

June 22, 2023

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Details:

The funding will be used for the first part of the development of HY-083, a TRPV1 agonist, administered intranasally as a spray, for the treatment of idiopathic rhinitis.


Lead Product(s): HY-083

Therapeutic Area: Immunology Brand Name: HY-083

Study Phase: PreclinicalProduct Type: Small molecule

Sponsor: Walloon Region

Deal Size: $1.0 million Upfront Cash: Undisclosed

Deal Type: Funding June 08, 2023

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09

Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : The funding will be used for the first part of the development of HY-083, a TRPV1 agonist, administered intranasally as a spray, for the treatment of idiopathic rhinitis.

Brand Name : HY-083

Molecule Type : Small molecule

Upfront Cash : Undisclosed

June 08, 2023

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Details:

Maxigesic® via intravenous infusion, combines the power of paracetamol and ibuprofen in a unique double-action formulation for fast effective, non-opioid pain relief.


Lead Product(s): Paracetamol,Ibuprofen

Therapeutic Area: Neurology Brand Name: Maxigesic

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 18, 2023

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10

Pharma, Lab & Chemical Expo
Not Confirmed
Pharma, Lab & Chemical Expo
Not Confirmed

Details : Maxigesic® via intravenous infusion, combines the power of paracetamol and ibuprofen in a unique double-action formulation for fast effective, non-opioid pain relief.

Brand Name : Maxigesic

Molecule Type : Small molecule

Upfront Cash : Not Applicable

April 18, 2023

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