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Suppliers and packagers for incruse ellipta
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incruse ellipta
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Glaxo Grp England | INCRUSE ELLIPTA | umeclidinium bromide | POWDER;INHALATION | 205382 | NDA | GlaxoSmithKline LLC | 0173-0873-06 | 1 TRAY in 1 CARTON (0173-0873-06) / 1 INHALER in 1 TRAY / 7 AEROSOL, POWDER in 1 INHALER | 2014-04-30 |
| Glaxo Grp England | INCRUSE ELLIPTA | umeclidinium bromide | POWDER;INHALATION | 205382 | NDA | GlaxoSmithKline LLC | 0173-0873-10 | 1 TRAY in 1 CARTON (0173-0873-10) / 1 INHALER in 1 TRAY / 30 AEROSOL, POWDER in 1 INHALER | 2014-04-30 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: INCRUSE ELLIPTA
Introduction
Incruse Ellipta, a prescription medication formulated as a dry powder inhaler, is a marketed treatment for chronic obstructive pulmonary disease (COPD). The active pharmaceutical ingredient (API) in Incruse Ellipta is umeclidinium bromide, a long-acting muscarinic antagonist (LAMA). The drug's manufacturing and supply chain involve multiple suppliers at various stages, including raw material procurement, API synthesis, formulation, and packaging. Understanding these suppliers is critical for stakeholders assessing drug security, manufacturing reliability, and market dynamics.
Manufacturing and Supply Chain Overview
Incruse Ellipta is produced by GlaxoSmithKline (GSK), a global leader in pharmaceutical development. Its supply chain involves multiple tiers:
- Raw Material Suppliers: Providers of chemical precursors and excipients.
- API Manufacturers: Entities synthesizing high-purity umeclidinium bromide.
- Formulation and Fill-Finish: Facilities assembling the final inhaler product.
- Distribution Channels: Logistics companies ensuring global availability.
The streamlined coordination among these tiers ensures consistent supply, regulatory compliance, and product integrity.
Active Pharmaceutical Ingredient (API) Suppliers
Umeclidinium Bromide Manufacturing
The core of Incruse Ellipta’s supply chain is the API, umeclidinium bromide. GSK sources this API from specialized chemical manufacturers with expertise in producing high-quality muscarinic antagonists. The API manufacturing process involves complex chemical synthesis, strict quality controls, and adherence to Good Manufacturing Practices (GMP).
GSK maintains internal API production capacity but also collaborates with third-party Contract Manufacturing Organizations (CMOs) to mitigate supply risks. While GSK has not publicly disclosed all API suppliers, industry sources indicate key API production centers are located in Asia, notably in India and China, due to their capacity and cost advantages.
Major API Suppliers
- Serum Institute of India: Known primarily for vaccines, but also involved in chemical API synthesis, including compounds like umeclidinium bromide.
- Cipla Ltd.: A significant Indian pharmaceutical firm with capabilities in respiratory API synthesis.
- Macleods Pharmaceuticals: Active in LAMA API production, possibly supplying umeclidinium bromide.
Note: Exact supplier identities remain confidential due to competitive and regulatory reasons, but these companies are probable contributors, supported by market analysis and industry reports [1].
Excipients and formulation components
In addition to API, the formulation utilizes specific excipients such as lactose carrier particles. Suppliers include:
- Dairy-grade lactose producers: Meggle, Nosco, and others furnish pharmaceutical-grade lactose monohydrate used in inhaler formulations.
- Other excipients: HFA propellants and stabilizers sourced from specialized chemical suppliers.
These components are crucial for inhaler performance and stability.
Drug Delivery Device and Packaging Suppliers
Incruse Ellipta uses GSK's proprietary Ellipta dry powder inhaler device which requires specialized manufacturing capabilities. Partner companies involved in device production include:
- AstraZeneca's partnership with Hovione: Hovione supplies inhaler components, including the capsule chambers.
- Nordson or Graco: Suppliers of spray coating and assembly equipment for device manufacturing.
Packaging suppliers focus on blister packs, foil seals, and secondary cartons, often sourced from:
- Berry Global or Amcor: Providers of pharmaceutical-grade flexible films and cartons.
Regulatory and Strategic Considerations
GSK emphasizes supply chain resilience through diversified sourcing and strategic supplier relationships. The complexity of API synthesis, combined with strict regulatory oversight, limits the number of capable suppliers. Consequently, GSK maintains close oversight over manufacturing processes through audits and quality assessments [2].
The drug's high global demand, particularly in the US and Europe, amplifies supply chain importance. GSK’s supply chain strategy involves dual sourcing where feasible, long-term contracts, and inventory buffering to mitigate disruptions.
Emerging Trends and Supply Chain Risks
Recent disruptions like global supply chain constraints, COVID-19 impacts, and geopolitical factors have heightened scrutiny over API and device supply chains. The reliance on Asian manufacturers introduces risks related to geopolitical tensions and trade restrictions. GSK actively explores local manufacturing options to diversify sources and improve supply chain resilience.
Furthermore, ongoing research into alternative APIs or formulations may influence future supplier relationships and production strategies.
Conclusion
The suppliers for Incruse Ellipta are strategically selected, primarily focusing on high-quality API production in Asia and component manufacturing through specialized device companies. While GSK leverages internal capacities, it heavily relies on third-party suppliers for raw materials and device components, emphasizing the importance of supply chain diversification. Understanding these relationships enables stakeholders to assess risks, anticipate market dynamics, and make informed decisions regarding procurement and market entry strategies.
Key Takeaways
- API sourcing: Likely from Indian firms such as Cipla and Macleods, leveraging their API synthesis expertise.
- Supply chain resilience: GSK employs diversified sourcing, inventory buffering, and continuous quality oversight.
- Device manufacturing: Involves specialized suppliers for inhaler components, with partnerships ensuring consistent production.
- Regulatory compliance: Suppliers must adhere to GMP and GMP-like standards, ensuring API and device quality.
- Market stability: Continued supply chain diversification and regional manufacturing initiatives are vital for maintaining Incruse Ellipta’s market availability.
FAQs
1. Who are the main API suppliers for Incruse Ellipta?
While GSK does not publicly disclose all API suppliers, industry analysis suggests significant contributions from Indian pharmaceutical manufacturers such as Cipla and Macleods Pharmaceuticals, specializing in respiratory APIs like umeclidinium bromide.
2. How does GSK mitigate supply chain disruptions for Incruse Ellipta?
GSK employs diversified supplier relationships, strategic inventory buffering, and continuous quality audits. The company also explores regional manufacturing to reduce dependence on single sources, enhancing supply resilience.
3. Are there potential risks in the current supply chain of Incruse Ellipta?
Yes. Reliance on Asian API producers exposes the supply chain to geopolitical, trade, and pandemic-related disruptions. Regulatory variances across regions could also impact manufacturing continuity.
4. What role do device manufacturers play in the supply chain?
Device manufacturing partners produce the inhaler hardware, essential for delivering the API. These specialized firms ensure device consistency, performance, and compliance with regulatory standards.
5. How might future developments impact Incruse Ellipta supply chains?
Innovations in API synthesis, local manufacturing initiatives, and regulatory changes can alter sourcing strategies. Continued supply chain diversification and technological advances will be critical for uninterrupted supply.
References
[1] Industry reports and market analyses on respiratory API suppliers and manufacturing capacities.
[2] GSK’s corporate disclosures and annual reports detailing supply chain management strategies.
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