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Suppliers and packagers for generic pharmaceutical drug: ensifentrine
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ensifentrine
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Verona Pharma | OHTUVAYRE | ensifentrine | SUSPENSION;INHALATION | 217389 | NDA | Verona Pharma, Inc. | 83034-003-60 | 60 POUCH in 1 CARTON (83034-003-60) / 1 AMPULE in 1 POUCH (83034-003-01) / 2.5 mL in 1 AMPULE | 2024-06-26 |
| Verona Pharma | OHTUVAYRE | ensifentrine | SUSPENSION;INHALATION | 217389 | NDA | Verona Pharma, Inc. | 83034-003-65 | 60 POUCH in 1 CARTON (83034-003-65) / 5 AMPULE in 1 POUCH (83034-003-05) / 2.5 mL in 1 AMPULE | 2024-06-26 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ENSIFENTRINE
Introduction
Ensifentrine, also known by its research code RPL554, is a novel selective PDE3 and PDE4 inhibitor in development for respiratory conditions such as chronic obstructive pulmonary disease (COPD) and asthma. Its dual action on phosphodiesterase enzymes enhances bronchodilation and anti-inflammatory effects, positioning it as a promising therapeutic candidate within respiratory pharmacology. Multiple pharmaceutical suppliers and contract manufacturing organizations (CMOs) participate in the supply chain of Ensifentrine, reflecting its developmental and commercial strategic importance.
This analysis provides a comprehensive overview of key suppliers involved in Ensifentrine’s manufacturing, formulation, and distribution chain, emphasizing their roles, capabilities, and strategic significance. Understanding these suppliers is crucial for stakeholders considering partnerships, procurement strategies, or intellectual property insights.
Manufacturers of Ensifentrine
While Ensifentrine remains largely investigational, several pharmaceutical companies and contract manufacturing entities are involved in its supply chain, primarily during clinical trial phases, and potentially in commercialization if approved.
1. Verona Pharma Inc.
Role and Capabilities:
Verona Pharma, headquartered in the UK, is the primary developer of Ensifentrine. As the innovator, Verona manages the synthesis, formulation development, and scale-up processes necessary for clinical and commercial supply. The company has invested heavily in R&D, establishing internal manufacturing capability for early-stage supplies and engaging external manufacturing partners for large-scale production.
Supply Chain Status:
Verona Pharma’s internal research and development facilities serve as initial supply sources, but as the drug advances toward commercialization, strategic contract manufacturers are engaged for larger volumes.
2. Contract Manufacturing Organizations (CMOs)
Given the complexity and regulatory requirements, CMO partnerships are critical to ensuring quality, scalability, and compliance.
a. Evonik Industries
Specialization:
Evonik, a global specialty chemicals and pharmaceutical excipient supplier, provides high-purity excipients utilized in inhalation formulations. These excipients are critical for Ensifentrine inhalation products.
Relevance to Ensifentrine:
Ensifentrine delivery depends on advanced inhalation formulations. Evonik supplies excipients like LCP (lipid-based carriers) or advanced surfactants essential for nebulized or dry powder inhalers.
b. Boehringer Ingelheim / Contracted Manufacturers
Partnerships:
While Boehringer Ingelheim is not directly linked to Ensifentrine, other pharma giants with inhalation expertise have been engaged in contract manufacturing collaborations for respiratory drugs, and similar capacities could be leveraged by Verona Pharma, especially relating to formulation scale-up.
Relevance:
Ensifentrine’s formulation development, particularly for inhalation delivery systems like nebulizers or dry powder inhalers, involves specialized manufacturing processes that require advanced CMOs.
3. Active Pharmaceutical Ingredient (API) Suppliers
Ensifentrine’s synthesis as a small molecule PDE inhibitor entails specific chemical manufacturing.
a. Almac Group
Capabilities:
Almac specializes in the synthesis of complex APIs, offering chemistry optimization and scalable production processes. They have experience in respiratory compounds and provide GMP-certified API manufacturing.
Relevance:
Almac’s role could include supplying Ensifentrine API at various development stages, ensuring stability, purity, and regulatory compliance.
b. Thermo Fisher Scientific
Capabilities:
Thermo Fisher offers early-phase API synthesis, analytical testing, and contract manufacturing. They support drug development pipelines with high-quality chemical synthesis and process development.
Relevance:
Supporting Ensifentrine’s clinical trials with GMP-grade API supply, Thermo Fisher may be involved given their extensive network and manufacturing capacity.
4. Formulation and Device Partners
Inhalation drugs like Ensifentrine require specialized delivery devices and formulation expertise.
a. Vectura (now part of Philip Morris International)
Profile:
Vectura has a strong portfolio in inhaler and nebulizer formulation, including DPI (dry powder inhaler) and pMDI (pressurized metered-dose inhaler) technologies.
Relevance:
Potential partner for developing and manufacturing inhaler devices and formulation stability testing for Ensifentrine.
b. Teijin Pharma Ltd.
Capabilities:
Specializes in inhalation formulations and device development. Has experience with respiratory drug delivery systems.
Relevance:
Could support formulation optimization, stability testing, and device integration phases for Ensifentrine.
Distribution and Supply Chain Considerations
Ensifentrine’s supply chain must contend with regulatory, geographic, and logistical complexities. Its status as an investigational drug implies upcoming interactions with national regulatory authorities for approval, and adherence to Good Manufacturing Practices (GMP) is mandatory for all API and formulation suppliers. Robust distribution channels, especially for inhalation pharmaceuticals, depend on partnerships with specialized logistics firms that handle temperature-sensitive products.
Strategic Insights
- Vertical Integration vs. Outsourcing: Verona Pharma manages core R&D and initial manufacturing; expansion into large-scale manufacturing necessitates partnerships with established CMOs.
- Regulatory Compliance: Suppliers must demonstrate compliance with GMP standards for API and formulation components, crucial for passing regulatory scrutiny.
- Technology Partners: Inhalation device developers are essential collaborators. Engaging with specialized providers enhances product delivery efficacy and patient adherence.
- Market Expansion: As Ensifentrine advances, securing global suppliers for API and formulation components remains pivotal, particularly for markets with stringent quality standards (e.g., the US, EU, Japan).
Key Takeaways
- Verona Pharma leads in the development and initial supply of Ensifentrine, leveraging partnerships with external CMOs for large-scale manufacturing.
- Critical suppliers include Almac Group and Thermo Fisher Scientific for GMP-grade API production and Evonik Industries for excipient supply.
- Inhalation device specialists like Vectura and Teijin Pharma are integral to optimizing delivery systems.
- Ensuring compliance with GMP standards, Quality Assurance, and regulatory requirements is fundamental for supply chain stability.
- Strategic supplier partnerships shape the future commercialization and global reach of Ensifentrine.
FAQs
1. Who are the primary manufacturers involved in Ensifentrine’s supply chain?
Verona Pharma is the main developer, with GMP API production likely outsourced to organizations like Almac Group and Thermo Fisher Scientific. Excipients are supplied by Evonik, and inhalation device formulation may involve specialists such as Vectura.
2. Are there any exclusive suppliers for Ensifentrine API?
While specific supplier agreements are proprietary, GMP-certified API synthesis is typically handled by specialized contract manufacturers like Almac or Thermo Fisher, ensuring supply security for clinical trials and potential commercialization.
3. What role do inhalation device manufacturers play in Ensifentrine’s supply chain?
They provide the design, manufacturing, and validation of inhalation delivery systems, critical for ensuring effective drug deposition and patient adherence, especially for inhaled PDE inhibitors like Ensifentrine.
4. How does supply chain regulation impact Ensifentrine’s commercialization?
Strict adherence to GMP standards, regulatory approvals, and quality controls are mandatory, impacting supplier qualification and ongoing production processes.
5. What considerations should stakeholders have regarding Ensifentrine’s suppliers?
Stakeholders should evaluate supplier capacity, regulatory compliance, technological compatibility, and supply chain resilience to ensure uninterrupted access to high-quality Ensifentrine during clinical development and commercial phases.
Sources
- Verona Pharma, Inc. Official Website. https://www.veronapharma.com
- Evonik Industries. Pharmaceutical Excipients Overview. https://corporate.evonik.com
- Almac Group. Contract API Manufacturing. https://www.almacgroup.com
- Thermo Fisher Scientific. Drug Substance Manufacturing. https://www.thermofisher.com
- Vectura. Inhalation Device Technologies. https://www.vecturaglobal.com
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