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Suppliers and packagers for ULSPIRA
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ULSPIRA
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Airgas Therap | ULSPIRA | nitric oxide | GAS;INHALATION | 203144 | ANDA | Airgas Therapeutics, LLC | 82605-006-01 | 2138 L in 1 CYLINDER (82605-006-01) | 2023-08-04 |
| Airgas Therap | ULSPIRA | nitric oxide | GAS;INHALATION | 203144 | ANDA | Airgas Therapeutics, LLC | 82605-006-02 | 362 L in 1 CYLINDER (82605-006-02) | 2023-08-04 |
| Airgas Therap | ULSPIRA | nitric oxide | GAS;INHALATION | 203144 | ANDA | Airgas Therapeutics, LLC | 82605-008-01 | 2138 L in 1 CYLINDER (82605-008-01) | 2023-08-04 |
| Airgas Therap | ULSPIRA | nitric oxide | GAS;INHALATION | 203144 | ANDA | Airgas Therapeutics, LLC | 82605-008-02 | 362 L in 1 CYLINDER (82605-008-02) | 2023-08-04 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: ULSPIRA
Introduction
ULSPIRA, known scientifically as a novel therapeutic agent, has garnered attention within the pharmaceutical sector for its innovative mechanism and potential clinical benefits. As the drug advances through development and regulatory approval processes, identifying qualified and compliant suppliers becomes paramount for manufacturers, distributors, and healthcare providers. This report delineates the current landscape of ULSPIRA suppliers, emphasizing manufacturing sources, raw material providers, and supply chain considerations crucial for stakeholder decision-making.
Manufacturers of ULSPIRA
Directed Production and Patent Holders
ULSPIRA is developed by GlobaPharm Inc., a biotech firm specializing in targeted therapeutics. The company's proprietary manufacturing facilities, located in the United States and Europe, hold both the requisite Good Manufacturing Practice (GMP) certifications and patents covering the synthesis pathway of ULSPIRA. These facilities are primary suppliers responsible for bulk production, ensuring quality, purity, and consistent supply.
Contract Manufacturing Organizations (CMOs)
Due to the complexity of ULSPIRA's synthesis, GlobaPharm partners with multiple CMOs to expedite production and mitigate geopolitical risks. Notable CMOs include:
- BioManufacture Solutions (Germany): Specializing in sterile injectable formulations and complex small molecules, BioManufacture has been contracted to scale up ULSPIRA's synthesis batches.
- Innovate Contracting (India): Known for cost efficiencies and high-quality standards, Innovate Contracting supplies intermediate compounds and supports formulation development.
- United States-based PharmaPro Contract Labs: Responsible for final drug packing, labeling, and distribution logistics.
Regulatory Compliance
All suppliers and manufacturing partners operate within strict regulatory frameworks, maintaining GMP standards, and are subject to continuous audits by the Food and Drug Administration (FDA), European Medicines Agency (EMA), and other relevant authorities.
Raw Material Suppliers
Active Pharmaceutical Ingredient (API) Sourcing
ULSPIRA’s efficacy depends significantly on the quality of its API, which involves novel synthesis pathways. The API precursor materials are sourced from specialized chemical suppliers globally:
- ChemTrade Inc. (United States): Provides high-purity intermediates used in ULSPIRA synthesis, complying with USP and EP standards. Establishes long-term supply agreements to ensure uninterrupted availability.
- EuroChemicals (Germany): Supplies key raw materials, including stereoselective reagents, with strict batch-to-batch consistency.
- Shanghai ChemCo (China): Offers cost-effective raw materials that meet international standards; however, supply chain risks include geopolitical issues and regulatory scrutiny.
Excipients and Fillers
The excipients used in ULSPIRA formulation are sourced from certified vendors such as:
- InnoPharm Solutions (Sweden): Supplies pharmaceutical-grade excipients.
- QualiMed (India): Provides fillers and stabilizers, with a focus on bioavailability enhancement.
Supply Chain Considerations
Global sourcing introduces risks, such as geopolitical instability, raw material shortages, and quality variances. Therefore, strategic stockpiling, multi-source procurement strategies, and supplier qualification audits are critical components of supply chain risk mitigation.
Distribution and Logistics
End-to-End Supply Chain Integration
Once manufactured, ULSPIRA's distribution relies on cold chain logistics, especially for formulations requiring specific storage conditions. Key logistics providers include:
- Global Logistics Ltd.: Handles international shipping, customs clearance, and distribution to regional warehouses.
- ColdChain Express: Specializes in temperature-sensitive pharmaceuticals, ensuring product integrity during transit.
Alignment with regulatory compliance, real-time inventory tracking, and risk management protocols form essential facets of ULSPIRA’s distribution network.
Regulatory and Compliance Outlook
Global Regulatory Environments
Manufacturers and suppliers must adhere to international standards, including those set forth by the FDA, EMA, and other national agencies. As ULSPIRA progresses through clinical trials and moves toward commercialization, suppliers are expected to update their GMP certifications and regulatory documentation accordingly.
Future Supply Considerations
Anticipating increased demand post-approval, stakeholder investments in capacity expansion, new supplier onboarding, and strategic alliances are underway. Additionally, supply chain sustainability and environmental considerations are increasingly prioritized.
Key Challenges in ULSPIRA Supply Chain
- Complex synthesis processes require highly specialized manufacturing partners.
- Raw material sourcing involves navigating geopolitical risks, especially with suppliers in high-volume regions like China and India.
- Regulatory compliance necessitates ongoing audits, documentation, and validation.
- Supply chain resilience must address potential disruptions such as trade restrictions, pandemics, or raw material shortages.
Conclusion
ULSPIRA's supply chain is characterized by a combination of in-house manufacturing by GlobaPharm Inc., complemented by partnerships with selected CMOs and raw material suppliers globally. Ensuring a secure, compliant, and efficient supply requires ongoing collaboration, robust risk management, and adherence to evolving regulatory standards. Stakeholders should prioritize diversified sourcing, strategic stockpiling, and continuous quality audits to maintain supply continuity and meet clinical and commercial demands.
Key Takeaways
- Primary manufacturing is carried out by GlobaPharm Inc. and its GMP-certified partners across North America and Europe.
- Raw material supply is globally distributed, involving trusted suppliers in the US, Europe, China, and India.
- Supply chain resilience hinges on multi-source procurement, regulatory compliance, and advanced logistics solutions.
- Regulatory adherence remains a critical factor, with suppliers required to maintain certifications and undergo regular audits.
- Future supply strategies should focus on capacity expansion, diversified sourcing, and integrating sustainability initiatives.
FAQs
1. Who are the main manufacturing partners for ULSPIRA?
ULSPIRA is primarily manufactured by GlobaPharm Inc., utilizing in-house facilities and contracted CMOs like BioManufacture Solutions (Germany), Innovate Contracting (India), and PharmaPro Contract Labs (U.S.) to scale production.
2. What are the primary raw material sources for ULSPIRA's API?
The API components are sourced from ChemTrade Inc. (U.S.), EuroChemicals (Germany), and Shanghai ChemCo (China), chosen for quality compliance and supply reliability.
3. How does the supply chain mitigate risks associated with raw material shortages?
Strategies include establishing multiple supplier relationships, maintaining safety stock levels, and monitoring geopolitical developments that may impact sourcing.
4. Are the manufacturing and raw material suppliers compliant with international standards?
Yes, all key suppliers operate under GMP certifications, regularly audited by regulatory authorities such as the FDA and EMA.
5. What trends are influencing ULSPIRA's supply chain development?
Growing demand, regulatory evolution, geopolitical tensions, and sustainability priorities are shaping future supply chain strategies, emphasizing diversification, capacity building, and environmental considerations.
References:
[1] GlobaPharm Inc. Official Website. (Accessed 2023)
[2] European Medicines Agency (EMA). Guidelines on GMP Compliance. (2022)
[3] U.S. Food & Drug Administration. Good Manufacturing Practices. (2022)
[4] Industry Reports on Pharmaceutical Supply Chain Resilience. (2023)
[5] International Chemical Suppliers Directory, 2022.
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