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    Company profile for Grifols International

    Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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    Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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    About

    We are a global healthcare company founded in Barcelona, Spain. Since 1940, we have been committed to improving the health and well-being of people around the world. We are an industry leader in producing plasma-derived medicines for patients around the world. Our business is organized into four divisions: Bioscience, Diagnostic, Hospital and Bio Supplies. We sell our products and services in more than 100 countries or reg...
    We are a global healthcare company founded in Barcelona, Spain. Since 1940, we have been committed to improving the health and well-being of people around the world. We are an industry leader in producing plasma-derived medicines for patients around the world. Our business is organized into four divisions: Bioscience, Diagnostic, Hospital and Bio Supplies. We sell our products and services in more than 100 countries or regions and have subsidiaries in 30 of them. We aim to be a global leader in our markets and an industry reference for quality, safety and innovation.

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    Avinguda de la Generalitat, 152 Parc empresarial Can Sant Joan 08174 Sant Cuga...
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    INTERVIEW #SpeakPharma

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    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    This week, SpeakPharma interviews four senior executives of LGM Pharma — Shailesh Vengurlekar (Senior VP, Quality and Regulatory Affairs), Deepak Thassu (Senior VP, R&D and Regulatory Submission), Selwyn Lustman (Senior VP, Global Sourcing and Procurement), and Mike Stenberg (VP, Business Development). The four VPs talk about expansion in manufacturing capabilities of the Florida-based contract development and manufacturing organization (CDMO), expertise that makes LGM a strong partner and the criteria it adopts while selecting its suppliers.  HIGHLIGHTS// expansion in manufacturing capabilities/ expertise that makes LGM a strong partner/ criteria for selecting its suppliers LGM Pharma recently invested heavily in expanding its CDMO capabilities by 50 percent. Can you share why offering standalone analytical testing services is important to LGM Pharma’s growth strategy? How does it benefit your clients? Vengurlekar: This recent expansion in CDMO capabilities is part of LGM Pharma’s growth strategy that lays importance on diversification. One key area of this diversification is the offering of standalone Analytical Testing Services (ATS). This service plays a crucial role in supporting our clients by providing them with greater flexibility and reliability. LGM Pharma is already a well-established leader in the API supply chain. We have now identified a significant need in the market and are now serving compounding pharmacies, including 503A and 503B facilities. These pharmacies not only require high-quality, GMP-compliant APIs, but also need a trusted, compliant, and capable laboratory to analyze both their APIs and compounded products. Recognizing this opportunity to further support our clients, LGM Pharma has expanded into ATS. We have witnessed tremendous growth since we’ve launched these services. By offering ATS under a separate legal entity — LGM Pharma Solutions — we are able to provide an additional layer of flexibility to our clients. This structure eliminates any conflict of interest. While LGM Pharma LLC handles API supply, LGM Pharma Solutions focuses on delivering top-tier ATS, all under the same LGM Pharma umbrella. This setup enhances trust and allows our clients to work with us more seamlessly. HIGHLIGHTS// diversified into standalone ATS/ well-established leader in API supply chain/ serving compounding pharmacies/ offering APIs and ATS under different legal entities. While suppositories offer clear advantages for certain medications, can you describe how LGM Pharma plans to leverage its expertise in this area to address specific unmet needs in the growing women’s health market? Thassu: We’re taking a dual approach to enhance both our R&D and manufacturing capabilities. First, we’ve introduced a new semi-automatic machine that allows us to produce smaller batches more efficiently. This is particularly important for the suppository segment, where demand doesn’t require large-scale production. The new system enables quicker adjustments to the manufacturing process, providing us with greater flexibility of producing small batches. Second, many of the materials we handle in the women’s health sector are sensitive to heat, light, and oxygen. To address this, we’re upgrading our facility to accommodate these specialized requirements. This ensures we can develop and manufacture products while maintaining the integrity of heat-, light-, and oxygen-sensitive ingredients. Additionally, we’re working closely with clients to prepare for various technical challenges. Whether it’s processing homeopathic ingredients or handling delicate fermentation-based materials, which are highly sensitive to both light and heat, our team has upgraded its skills and equipment to manage these complexities. From technology advancements in manufacturing to specialized handling conditions and improved technical expertise, we’ve made significant strides to ensure we can meet the evolving needs of our clients and their products. HIGHLIGHTS// dual approach to enhance R&D and manufacturing capabilities/ upgrading facilities to accommodate specialized requirements/ working with clients to address challenges. The pandemic underscored supply chain problems. Can you detail the specific criteria LGM Pharma uses while selecting suppliers for its manufacturing processes? Lustman: LGM looks at many facets of a manufacturer before proceeding to approve them for a specific project. We start by checking their regulatory history with the US Food and Drug Administration (FDA) and other authorities. We try to find out if they have received any warning letters. What is their inspection history? Have they received NAIs (no action indicated) and VAIs (voluntary action indicated)? We further investigate the company’s overall business status — we need to know that they are a stable partner to work with in the long term. Manufacturers are then assessed for their overall technology and the number of employees working in various fields, such as R&D, quality control, quality assurance, regulatory affairs, manufacturing, and the educational levels of these employees. Once we have established that the manufacturer is a potential partner, we check their status for a particular project. We look at their advantages, and whether they have a non-infringing route of synthesis (ROS) that will allow early launch. Are they developing a second process that will be more competitive in pricing? And, does the manufacturer have the necessary capacity and/or spare capacity for the project that we are assessing? We need to know whether the drug master file (DMF) has been registered, the current batch size, and the potential for increase in batch size. Pricing is a key indicator — we need to know whether the pricing of the manufacturer is competitive or not, and if the manufacturer will be able to compete in the future as the project matures. LGM always assesses for quality, price, and delivery. Goods must be of the correct quality, at the right price, with delivery time as desired, in order to meet commercial needs. HIGHLIGHTS// investigate various facets of manufacturer before approving them for a project/ look at advantages, non-infringing ROS/ assess for quality, price, delivery Can you highlight specific capabilities and experiences LGM Pharma possesses that make it a strong partner for companies developing antibody-drug-conjugates (ADCs)? Stenberg: ADCs are often peptides linked with small molecules. However, they may also be peptides linked with oligonucleotides. Regardless, LGM can help manage the supply chain associated with the components that are used in the conjugation of the ADC. LGM has extensive experience, and an extensive network around sourcing and managing the supply chain associated with ADC components. LGM’s experience and capabilities extend to sourcing peptides, small molecules or oligonucleotides used in the conjugation process. Additionally, given our deep relationships in the supply chain aspect of this process, LGM may also be able to identify partners who can help with the conjugation process itself. HIGHLIGHTS// extensive experience, network around sourcing, managing supply chain associated with ADC components / identify partners that can help with conjugation process

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    09 Nov 2024
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    Medical Breakthroughs in 2024: Alzheimer’s, schizophrenia, COPD, MASH see pathbreaking treatments

    Medical Breakthroughs in 2024: Alzheimer’s, schizophrenia, COPD, MASH see pathbreaking treatments

    This year has seen pivotal advancements in medical innovation. The US Food and Drug Administration (FDA) has approved several groundbreaking therapies that promise to transform patient care across multiple therapeutic areas.Some of the therapies approved have revolutionary delivery mechanisms, while others are first-in-class treatments for previously unaddressed conditions. This week, PharmaCompass brings you a compilation of new pathbreaking approvals of 2024, including advancements in neurology, chronic conditions, mental health conditions, and innovative solutions for various other ailments.Lilly, Alpha Cognition, BMS transform neurological care with new Alzheimer’s, schizophrenia drugsThe neurological treatment landscape saw several major breakthroughs in 2024, particularly in the treatment of Alzheimer’s disease (AD). Eli Lilly’s Kisunla represents a significant advancement in treating early, symptomatic AD. Following decades of failed efforts, Kisunla’s approval, along with that of Eisai-Biogen’s Leqembi last year, marks a turning point in addressing AD.The drug works by targeting and clearing beta amyloid plaque from the brain, thereby attacking the disease’s underlying pathology, rather than just managing symptoms. Administered as an infusion every four weeks, Kisunla’s Medicare coverage makes it accessible to patients in the US who desperately need new treatment options. Alpha Cognition’s Zunveyl emerged as a promising new oral treatment for mild-to-moderate Alzheimer’s-related dementia. Only the second oral AD treatment approved by the FDA in over a decade, Zunveyl is a prodrug, or a biologically inactive compound that can be metabolized by the body to produce a drug. It remains inactive as it passes through the stomach and enhances cholinergic function in the brain.Perhaps one of the most exciting breakthroughs of 2024 was Bristol-Myers Squibb’s Cobenfy. This revolutionary antipsychotic medication for schizophrenia represents the first novel approach to treatment since the 1950s. Unlike traditional antipsychotics that target dopamine receptors, Cobenfy works through cholinergic receptors, offering new hope to patients who struggle with the side effects of conventional treatments.Traditional antipsychotics have been associated with several mild and serious side effects such as weight gain, feeling unmotivated and sluggish, high rates of cardiac disease, and even early death. Cobenfy’s innovative mechanism of action has generated excitement in the medical community. Experts project Cobenfy to bring in US$ 7.5 billion in peak annual sales, thereby validating BMS’ recent, US$ 14-billion acquisition of Karuna Therapeutics.Verona, Sanofi’s drugs revolutionize COPD care; Madrigal’s Rezdiffra offers hope to MASH patients The landscape of chronic obstructive pulmonary disease (COPD) treatment saw remarkable advances in 2024. Verona Pharma’s Ohtuvayre brings the first new mechanism of action in over two decades for COPD treatment. This dual-action, inhaled medication serves as both a bronchodilator and an anti-inflammatory agent, offering a comprehensive approach to symptom management.Adding to this progress, Sanofi and Regeneron’s Dupixent achieved a historic milestone by becoming the first biologic approved for treating COPD. Dupixent is Sanofi’s best-selling drug. It is poised to cross over € 21 billion (US$ 23.5 billion) in sales by 2030, with COPD likely to contribute US$ 2.9 billion, predict analysts. Over 390 million people are living with COPD worldwide.In the field of liver disease, Madrigal Pharmaceuticals’ Rezdiffra became the first FDA-approved treatment for metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring. This approval represents a breakthrough in a field that has been notorious for being a graveyard for failed programs. Rezdiffra offers hope to patients with this common liver condition, which primarily affects those with obesity or type 2 diabetes. The American Liver Foundation has termed this approval a “game-changing” moment in hepatology.For the rare disease community, Ipsen’s Iqirvo emerged as the first new medicine approved in nearly a decade for primary biliary cholangitis (PBC). This first-in-class peroxisome proliferator-activated receptor (PPAR) agonist offers new hope for the approximately 100,000 Americans affected by this condition, particularly women aged 30 to 60 years.A significant breakthrough for patients with hypoparathyroidism came with the approval of Ascendis’ Yorvipath, making it the only treatment for hypoparathyroidism in adults. By directly addressing the underlying hormone deficiency, Yorvipath helps stabilize calcium levels in the blood, reducing the treatment burden associated with managing symptoms through calcium and vitamin D supplements alone.In the realm of pulmonary medicine, Merck’s Winrevair emerged as the first new therapy for pulmonary arterial hypertension (PAH) in over a decade. As the first approved activin-signaling inhibitor therapy, Winrevair represents a novel approach to treating this rare but severe condition that doctors call a “ticking time bomb”. The drug is the first treatment that targets the underlying cause of the lung condition, which typically leads to death within a decade of diagnosis.ARS Pharma launches nasal spray alternative to EpiPen, Eicos introduces med for severe frostbiteLeading the charge in innovative drug delivery is ARS Pharma’s Neffy, the first-ever nasal spray alternative to the EpiPen for treating severe allergic reactions. This groundbreaking advancement represents the first major innovation in anaphylaxis treatment in over a decade. For children and individuals with needle phobia, this nasal spray format addresses one of the most significant barriers to timely treatment of allergic emergencies. Speaking of emergency medicine, Eicos Sciences’ Aurlumyn made history as the first FDA-approved treatment for severe frostbite. This approval fills a critical gap in emergency care, offering a medical intervention that could prevent the need for amputation in severe cases.The cardiovascular space saw its first oral anti-hypertensive therapy that works through a new therapeutic pathway in almost 40 years. Idorsia’s Tryvio is a treatment for hypertension that offers new hope to patients whose blood pressure remains inadequately controlled on existing medications. Idorsia expects millions of patients to benefit from it.Our view This year, the pharmaceutical industry has taken a remarkable leap forward by addressing some of healthcare’s most challenging conditions. Treatments like BMS’ Cobenfy for schizophrenia and Madrigal’s Rezdiffra for MASH demonstrate the industry’s growing ability to translate science into practical therapies. With the growing use of artificial intelligence in the drug industry, we hope that these approvals are just a precursor to a bevy of pathbreaking therapies in the years to come. 
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    NEWS #PharmaBuzz

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    Grifols Receives FDA Approval for Pediatric Bleeding Treatment
    Grifols Receives FDA Approval for Pediatric Bleeding Treatment

    29 Oct 2024

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2024/10/29/2970751/0/en/Grifols-Receives-FDA-Approval-to-Treat-Surgical-Bleeding-in-Pediatric-Patients-With-its-Fibrin-Sealant-Solution.html

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    29 Oct 2024
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    Grifols Partners With BARDA For Ocular Immunoglobulin Testing
    Grifols Partners With BARDA For Ocular Immunoglobulin Testing

    22 Oct 2024

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    https://www.globenewswire.com/news-release/2024/10/22/2966887/0/en/Grifols-Partners-with-BARDA-for-Proof-of-Concept-Testing-of-Ocular-Immunoglobulin-as-Treatment-for-Sulfur-Mustard-Induced-Eye-Injury.html

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    22 Oct 2024
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    GigaGen garners up to $135M BARDA bucks to beat botulism
    GigaGen garners up to $135M BARDA bucks to beat botulism

    03 Oct 2024

    // FIERCE BIOTECH

    https://www.fiercebiotech.com/biotech/grifols-gigagen-garners-135m-barda-tackle-botulinum-biothreat

    FIERCE BIOTECH
    03 Oct 2024
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    Grifols Plans $402M Investment In New Industrial Centre
    Grifols Plans $402M Investment In New Industrial Centre

    30 Sep 2024

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/grifols-plans-invest-402-million-new-industrial-centre-el-economista-says-2024-09-30/

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    30 Sep 2024
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    Grifols minority shareholders team up to ask for a board seat
    Grifols minority shareholders team up to ask for a board seat

    20 Sep 2024

    // REUTERS

    https://www.reuters.com/business/healthcare-pharmaceuticals/grifols-minority-shareholders-team-up-ask-board-seat-2024-09-20/

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    20 Sep 2024
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    Grifols Receives Expanded XEMBIFY® Label In U.S. For IG Portfolio
    Grifols Receives Expanded XEMBIFY® Label In U.S. For IG Portfolio

    29 Jul 2024

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2024/07/29/2920220/0/en/Grifols-receives-expanded-XEMBIFY-immune-globulin-subcutaneous-human-klhw-label-in-U-S-strengthening-its-Ig-portfolio-for-patients.html

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    29 Jul 2024
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    Drugs in Development

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    Grifols and BARDA Partner on Ocular Immunoglobulin for Eye Injury Treatment

    Details:

    The partnership aims to test investigational ocular surface immunoglobulin (OSIG) eye drops for their ability to treat ocular damage from sulfur mustard exposure.


    Lead Product(s): OSIG-based Therapy

    Therapeutic Area: Ophthalmology Brand Name: Undisclosed

    Study Phase: PreclinicalProduct Type: Large molecule

    Sponsor: BARDA

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership October 22, 2024

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    Lead Product(s) : OSIG-based Therapy

    Therapeutic Area : Ophthalmology

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : BARDA

    Deal Size : Undisclosed

    Deal Type : Partnership

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    Grifols and BARDA Partner on Ocular Immunoglobulin for Eye Injury Treatment

    Details : The partnership aims to test investigational ocular surface immunoglobulin (OSIG) eye drops for their ability to treat ocular damage from sulfur mustard exposure.

    Brand Name : Undisclosed

    Molecule Type : Large molecule

    Upfront Cash : Undisclosed

    October 22, 2024

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    FDA approves expanded dosing for Grifols' XEMBIFY

    Details:

    Xembify is the first and only 20% subcutaneous immunoglobulin (SCIg) with FDA-approved dosing for treatment of primary humoral immunodeficiency in patients 2 years of age and older.


    Lead Product(s): Immune Globulin, Human

    Therapeutic Area: Immunology Brand Name: Xembify

    Study Phase: ApprovedProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 30, 2024

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    Lead Product(s) : Immune Globulin, Human

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    FDA approves expanded dosing for Grifols' XEMBIFY

    Details : Xembify is the first and only 20% subcutaneous immunoglobulin (SCIg) with FDA-approved dosing for treatment of primary humoral immunodeficiency in patients 2 years of age and older.

    Brand Name : Xembify

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    July 30, 2024

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    Grifols Announces Positive Topline Phase 3 Fibrinogen Clinical Trial Results

    Details:

    BT524 is a fibrinogen concentrate which acts as as fibrinogen stimulant. It is being developed for the treatment of acquired fibrinogen deficiency (AFD).


    Lead Product(s): BT524

    Therapeutic Area: Hematology Brand Name: BT524

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 14, 2024

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    Lead Product(s) : BT524

    Therapeutic Area : Hematology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Grifols Announces Positive Topline Phase 3 Fibrinogen Clinical Trial Results

    Details : BT524 is a fibrinogen concentrate which acts as as fibrinogen stimulant. It is being developed for the treatment of acquired fibrinogen deficiency (AFD).

    Brand Name : BT524

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    February 14, 2024

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    Grifols Completes Cohort 1 in Clinical Study of Alpha-1 15%, Evaluating First-in-Human Subcutaneous Dosing Option for Patients with Alpha1-Antitrypsin D...

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    PROLASTIN®-C is an alpha1-proteinase inhibitor (human) (alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1-PI.


    Lead Product(s): Human Alpha1-Proteinase Inhibitor

    Therapeutic Area: Genetic Disease Brand Name: Prolastin-C

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 15, 2023

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    Lead Product(s) : Human Alpha1-Proteinase Inhibitor

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    Grifols Completes Cohort 1 in Clinical Study of Alpha-1 15%, Evaluating First-in-Human Subcutaneou...

    Details : PROLASTIN®-C is an alpha1-proteinase inhibitor (human) (alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1-PI.

    Brand Name : Prolastin-C

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    November 15, 2023

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    Grifols Completes Enrollment in Phase 3 Study of Long-term Albutein® (albumin-human injection) Therapy for Patients with Decompensated Cirrhosis

    Details:

    Albutein® (albumin-human injection) is an abundant protein in plasma which has antioxidant and anti-inflammatory properties, and is being investigated for the treatment of decompensated Cirrhosis.


    Lead Product(s): Human Albumin

    Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Albutein

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 18, 2023

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    Lead Product(s) : Human Albumin

    Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

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    Grifols Completes Enrollment in Phase 3 Study of Long-term Albutein® (albumin-human injection) Th...

    Details : Albutein® (albumin-human injection) is an abundant protein in plasma which has antioxidant and anti-inflammatory properties, and is being investigated for the treatment of decompensated Cirrhosis.

    Brand Name : Albutein

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    July 18, 2023

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    Grifols Meets Enrollment Target in Phase 3 Study of Two Dose Regimens of Prolastin®-C in Patients with Emphysema Due to Alpha-1-Antitrypsin Deficiency

    Details:

    PROLASTIN®-C is an alpha1-proteinase inhibitor (human) (alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1-PI.


    Lead Product(s): Human Alpha1-Proteinase Inhibitor

    Therapeutic Area: Genetic Disease Brand Name: Prolastin-C

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 13, 2023

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    06

    Grifols International

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    Lead Product(s) : Human Alpha1-Proteinase Inhibitor

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Grifols Meets Enrollment Target in Phase 3 Study of Two Dose Regimens of Prolastin®-C in Patients...

    Details : PROLASTIN®-C is an alpha1-proteinase inhibitor (human) (alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1-PI.

    Brand Name : Prolastin-C

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    July 13, 2023

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    Grifols Meets Enrollment Target in Phase 3 Study of Two Dose Regimens of Prolastin®-C in Patients with Emphysema Due to Alpha-1-Antitrypsin Deficiency

    Details:

    PROLASTIN®-C is an alpha1-proteinase inhibitor (human) (alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1-PI.


    Lead Product(s): Human Alpha1-Proteinase Inhibitor

    Therapeutic Area: Genetic Disease Brand Name: Prolastin-C

    Study Phase: Phase IIIProduct Type: Large molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 13, 2023

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    07

    Grifols International

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    Lead Product(s) : Human Alpha1-Proteinase Inhibitor

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Grifols Meets Enrollment Target in Phase 3 Study of Two Dose Regimens of Prolastin®-C in Patients...

    Details : PROLASTIN®-C is an alpha1-proteinase inhibitor (human) (alpha1-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1-PI.

    Brand Name : Prolastin-C

    Molecule Type : Large molecule

    Upfront Cash : Not Applicable

    July 13, 2023

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    Selagine Enters into a Collaborative Agreement with Grifols for Development and Commercialization of Immunoglobulin Eye Drops for Treating Dry Eye Disea...

    Details:

    Grifols will develop and commercialise immunoglobulin eye drops, SLG-100, for dry eye disease. An immunoglobulin eye drop is a biologic drug that contains naturally occurring functional antibodies generated from human plasma collected from thousands of healthy donors.


    Lead Product(s): SLG-100

    Therapeutic Area: Ophthalmology Brand Name: SLG-100

    Study Phase: UndisclosedProduct Type: Large molecule

    Recipient: Selagine

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Collaboration March 06, 2023

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    Lead Product(s) : SLG-100

    Therapeutic Area : Ophthalmology

    Highest Development Status : Undisclosed

    Recipient : Selagine

    Deal Size : Undisclosed

    Deal Type : Collaboration

    DEALS_DEV arrow-down

    Selagine Enters into a Collaborative Agreement with Grifols for Development and Commercialization ...

    Details : Grifols will develop and commercialise immunoglobulin eye drops, SLG-100, for dry eye disease. An immunoglobulin eye drop is a biologic drug that contains naturally occurring functional antibodies generated from human plasma collected from thousands of h...

    Brand Name : SLG-100

    Molecule Type : Large molecule

    Upfront Cash : Undisclosed

    March 06, 2023

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    Grifols Signs Global Collaboration Agreement with Endpoint Health to Develop and Commercialize Antithrombin III for Sepsis

    Details:

    As part of the agreement, Grifols will contribute its industry-leading expertise in plasma-protein therapies and be the exclusive supplier of Antithrombin III (AT-III), a plasma protein that treats patients with blood clotting issues.


    Lead Product(s): Antithrombin III

    Therapeutic Area: Infections and Infectious Diseases Brand Name: AT-III

    Study Phase: PreclinicalProduct Type: Large molecule

    Sponsor: Endpoint Health

    Deal Size: $25.0 million Upfront Cash: Undisclosed

    Deal Type: Collaboration February 24, 2022

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    09

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    Lead Product(s) : Antithrombin III

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Preclinical

    Partner/Sponsor/Collaborator : Endpoint Health

    Deal Size : $25.0 million

    Deal Type : Collaboration

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    Grifols Signs Global Collaboration Agreement with Endpoint Health to Develop and Commercialize Ant...

    Details : As part of the agreement, Grifols will contribute its industry-leading expertise in plasma-protein therapies and be the exclusive supplier of Antithrombin III (AT-III), a plasma protein that treats patients with blood clotting issues.

    Brand Name : AT-III

    Molecule Type : Large molecule

    Upfront Cash : Undisclosed

    February 24, 2022

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    Synthetic Biologics Announces Planned Transformative Acquisition of VCN Biosciences; Developer of a Novel Oncolytic Virus Platform Targeting Pancreatic ...

    Details:

    VCN has the rights to four exclusive patents for proprietary technologies, including VCN-01, as well as technologies developed in collaboration with the Virotherapy Group of the Catalan Institute of Oncology (ICO-IDIBELL), with a number of additional patents pending.


    Lead Product(s): VCN-01,Gemcitabine,Paclitaxel

    Therapeutic Area: Oncology Brand Name: VCN-01

    Study Phase: Phase IProduct Type: Large molecule

    Recipient: VCN Biosciences

    Deal Size: $77.4 million Upfront Cash: $4.7 million

    Deal Type: Acquisition December 14, 2021

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    Grifols International

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    Lead Product(s) : VCN-01,Gemcitabine,Paclitaxel

    Therapeutic Area : Oncology

    Highest Development Status : Phase I

    Recipient : VCN Biosciences

    Deal Size : $77.4 million

    Deal Type : Acquisition

    DEALS_DEV arrow-down

    Synthetic Biologics Announces Planned Transformative Acquisition of VCN Biosciences; Developer of ...

    Details : VCN has the rights to four exclusive patents for proprietary technologies, including VCN-01, as well as technologies developed in collaboration with the Virotherapy Group of the Catalan Institute of Oncology (ICO-IDIBELL), with a number of additional pat...

    Brand Name : VCN-01

    Molecule Type : Large molecule

    Upfront Cash : $4.7 million

    December 14, 2021

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    01

    Brand Name : SODIUM CHLORIDE 0.9%...

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    Brand Name : SODIUM CHLORIDE 0.9%...

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    RLD : No

    TE Code : AP

    SODIUM CHLORIDE

    Grifols International

    Dosage Form : INJECTABLE; INJECTION

    Proprietary Name : SODIUM CHLORIDE 0.9% IN ...

    Dosage Strength : 900MG/100ML

    Approval Date : 2017-05-25

    Application Number : 207956

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AP

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    Find a price of THE PRODUCTION OF STERILE WATER FOR INJECTION PACKAGED IN SINGLE DOSE TYPE I GLASS VIALS (SOLVENT FOR PARENTERAL USE) bulk with DMF offered by Grifols International

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