Suppliers and packagers for INSPRA

INSPRA

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437	NDA	Viatris Specialty LLC	58151-142-93	30 TABLET, FILM COATED in 1 BOTTLE (58151-142-93)	2024-04-19
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437	NDA	Viatris Specialty LLC	58151-143-93	30 TABLET, FILM COATED in 1 BOTTLE (58151-143-93)	2024-09-17
Upjohn	INSPRA	eplerenone	TABLET;ORAL	021437	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-1107-2	30 TABLET, FILM COATED in 1 BOTTLE (59762-1107-2)	2024-12-13

Suppliers for the Pharmaceutical Drug: INSPRA (Mepolizumab)

Last updated: July 29, 2025

Introduction

INSPRA, known generically as mepolizumab, is a monoclonal antibody used primarily to treat severe eosinophilic asthma and certain other eosinophil-associated conditions. Marketed by GlaxoSmithKline (GSK), INSPRA’s demand hinges on a complex supply chain involving raw material providers, biologics manufacturing facilities, and distribution partners. Securing reliable suppliers for INSPRA is critical for healthcare providers, pharmacists, and distributors to ensure consistent supply and regulatory compliance. This report evaluates key suppliers involved across the drug's lifecycle, analyzing their roles, global footprint, and strategic importance.

Raw Material Suppliers

1. Biologics Raw Material Suppliers

INSPRA's active pharmaceutical ingredient (API), mepolizumab, is a genetically engineered monoclonal antibody produced via recombinant DNA technology in mammalian cell lines, predominantly Chinese Hamster Ovary (CHO) cells. The production process requires high-quality raw materials, including cell culture media, growth factors, and purification reagents.

• Cell Culture Media and Reagents:

  • GlycoBio, Thermo Fisher Scientific, and Merck KGaA are among leading providers of cell culture media and supplements crucial for antibody production.
  • Sigma-Aldrich, a division of Merck, supplies essential reagents and biochemicals used in manufacturing processes.

• Bioreactors and Fermentation Equipment:

  • Suppliers such as GE Healthcare and Sartorius manufacture bioreactor systems, pivotal for large-scale antibody synthesis.

2. Bioreactor and Purification Equipment

Key equipment suppliers include:

• Sartorius AG
• Pall Corporation
• GE Healthcare

They provide filtration systems, chromatography columns, and purification machinery necessary for monocyte monoclonal antibody isolation.

Formulation and Packaging Suppliers

• Vial and Syringe Packaging:

  • Becton Dickinson (BD) and Catalent supply sterile vials and syringes appropriate for injectable biologics.
  • Gerresheimer and Schott AG produce glass vials, with quality standards aligned to pharmaceutical industry requirements.

• Fill-Finish Services:

  • Catalent and Famar are prominent fill-finish contract manufacturing organizations (CMOs) managing the final steps to produce ready-to-inject products.

Manufacturing and Distribution

1. Contract Manufacturing Organizations (CMOs)

Given the complexity of biologics manufacturing, GSK partners with specialized CMOs for scaling production and ensuring quality:

• Samsung Biologics (South Korea): Known for large-scale biologics production, Samsung provides commercial-scale manufacturing capacity.
• BioCan (US): Focuses on sterile fill-finish processes.
• Famar (France): Offers end-to-end biologics manufacturing services.

2. Distribution Partners

Distribution of INSPRA worldwide involves logistics companies specializing in cold chain management:

• UPS Healthcare and DHL Life Sciences are primary logistics providers, ensuring temperature-controlled delivery from manufacturing plants to healthcare providers.

Regulatory and Quality Suppliers

• Certara and Pharmacovigilance service providers assist with regulatory compliance, pharmacovigilance, and post-market surveillance.
• Quality Control and Testing Laboratories:
  • Eurofins Scientific offers analytical testing services including purity, potency, and contaminant analysis.

Strategic Considerations in Supplier Selection

• Regulatory Compliance: Suppliers must adhere to Good Manufacturing Practices (GMP) outlined by agencies such as the FDA and EMA.
• Supply Chain Resilience: Diversified sourcing minimizes risks related to geopolitical issues, supply disruptions, or material shortages.
• Cost Efficiency and Quality Assurance: Maintaining competitive pricing while ensuring high-quality raw materials is pivotal for GSK and partners.

Emerging Trends in INSPRA Supply Chain

• Biotechnological Innovation: New cell line developments and process optimizations aim to enhance yield and reduce costs.
• Supply Chain Digitization: Integration of blockchain and advanced logistics tracking improves transparency and traceability.
• Sustainable Sourcing: Increasing emphasis on eco-sustainable materials and responsible manufacturing practices.

Conclusion

Delivering INSPRA effectively to the market depends on a sophisticated network of raw material suppliers, manufacturing partners, packaging providers, and logistics firms. While GSK’s strategic alliances with global CMOs and raw material suppliers ensure production stability, ongoing innovations and trend shifts necessitate continuous supplier evaluation and diversification.

Key Takeaways

• The supply chain for INSPRA involves high-quality raw material suppliers, specialized biomanufacturing facilities, and complex logistics.
• Strategic supplier diversification mitigates risks inherent in biologics production.
• Emphasizing GMP compliance, cost efficiency, and sustainability is critical for maintaining supply chain robustness.
• The evolving landscape includes technological innovation and digitization to improve transparency and efficiency.
• Close collaboration with regulatory bodies ensures sustained compliance and uninterrupted market availability.

FAQs

1. Who are the primary raw material suppliers for mepolizumab?
Leading providers include Thermo Fisher Scientific, Merck KGaA, and Sigma-Aldrich, supplying critical reagents, cell culture media, and bioprocessing components.

2. Which companies manufacture the fill-finish and packaging components for INSPRA?
Catalent, Gerresheimer, and Schott AG serve as key suppliers for sterile vials and syringes, with contract manufacturing organizations like Samsung Biologics handling fill-finish processes.

3. How does GSK ensure the quality of its supply chain for INSPRA?
GSK mandates GMP compliance, conducts rigorous supplier qualification, and employs quality assurance measures throughout manufacturing, sourcing, and distribution.

4. What are the risks associated with the INSPRA supply chain?
Potential risks include raw material shortages, geopolitical influences, manufacturing disruptions, and logistical challenges, particularly related to cold chain management.

5. Are there emerging suppliers or technologies impacting INSPRA’s supply chain?
Yes, innovations like cell line enhancements, process automation, and blockchain-based tracking are increasingly influencing the supply chain landscape.

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References

[1] GSK. "Mepolizumab (INSPRA): Product Information."
[2] FDA. "Biologics Manufacturing and Supply Chain Reliability."
[3] Pharma Intelligence. "Biologics Raw Material Market Trends."
[4] BioPharm International. "Biotech Fill-Finish Market Report."