Suppliers and packagers for pomalyst

pomalyst

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026	NDA	Celgene Corporation	59572-501-00	100 CAPSULE in 1 BOTTLE (59572-501-00)	2013-02-18
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026	NDA	Celgene Corporation	59572-501-21	21 CAPSULE in 1 BOTTLE (59572-501-21)	2013-02-18
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026	NDA	Celgene Corporation	59572-502-00	100 CAPSULE in 1 BOTTLE (59572-502-00)	2013-02-18
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026	NDA	Celgene Corporation	59572-502-21	21 CAPSULE in 1 BOTTLE (59572-502-21)	2013-02-18
Bristol	POMALYST	pomalidomide	CAPSULE;ORAL	204026	NDA	Celgene Corporation	59572-503-00	100 CAPSULE in 1 BOTTLE (59572-503-00)	2013-02-18

Suppliers for the Pharmaceutical Drug: POMALYST

Last updated: August 10, 2025

Introduction

POMALYST (pomalidomide) is an oral immunomodulatory agent developed for treating multiple myeloma, particularly in relapsed or refractory cases. It was approved by the U.S. Food and Drug Administration (FDA) in 2013 and is marketed by Celgene Corporation, a Bristol-Myers Squibb company. As a critical pharmaceutical asset with significant market value, understanding the supply chain infrastructure—especially suppliers involved in raw materials, active pharmaceutical ingredients (APIs), excipients, and formulation components—is vital for stakeholders across the industry. This analysis explores the key suppliers underpinning POMALYST's manufacturing process, emphasizing procurement strategies, supply chain resilience, and regulatory considerations.

Manufacturing Overview of POMALYST

Pomalidomide is synthesized through multi-step chemical processes involving specialized intermediates and high-purity APIs. Its manufacturing hinges on several critical components:

• Active Pharmaceutical Ingredient (API): Pomalidomide itself.
• Key Intermediates: Essential chemicals enabling synthesis.
• Excipients and Fillers: Supporting the drug's formulation.
• Packaging Materials: Blister packs, bottles, and labels.

The complex synthesis and stringent regulatory environment necessitate sourcing from high-quality suppliers with GxP (Good Practice) certifications, robust quality control systems, and compliance with international standards.

Key Suppliers for POMALYST

1. API Suppliers for Pomalidomide

The core ingredient—pomalidomide—is produced predominantly by a limited pool of specialized chemical manufacturing firms:

• Celgene/Bristol-Myers Squibb (BMS) – In-house Production

  Although Celgene initially manufactured pomalidomide in-house, increasingly, manufacturing responsibilities have transitioned to specialized contract manufacturing organizations (CMOs), ensuring capacity scalability and supply security.

• External Contract Manufacturing Organizations

  Several CMOs possess the cGMP (current Good Manufacturing Practice) certification necessary for high-purity API production:

  • Mantoux Pharmaceuticals: Known for API development and manufacturing, they supply to multiple pharmaceutical firms for complex molecules, including immunomodulators like pomalidomide.

  • Thermo Fisher Scientific (Patheon): Offers API manufacturing, emphasizing precision and regulatory compliance. Their large-scale facilities can produce APIs in multi-kilogram quantities.

  • Hoffmann-La Roche and Novartis: While primarily involved in other production areas, they are known suppliers of intermediates pertinent to proprietary synthesis routes for immunomodulatory drugs.

2. Intermediates and Specialty Chemicals

Given the elaborate synthesis pathway, intermediates such as substituted phthalic acids, amino pyridines, and specific heterocycles are sourced from specialized chemical suppliers:

• BASF, DuPont, and Evonik: Leading chemical companies providing specialty chemicals and intermediates with strict purity standards. Their role includes supplying building blocks critical for the final API synthesis.

• Mitsubishi Chemical and Sumitomo Chemical: Japanese firms with extensive capabilities in custom chemical intermediates for pharmaceutical synthesis.

3. Excipients and Formulation Components

While excipients constitute a smaller portion of the supply chain, their quality and sourcing are crucial:

• Colorants, fillers, binders: Suppliers like Colorcon, Caplin Point, and Suheung provide pharmaceuticals-grade excipients compatible with oral solid dosage forms.

• Packaging Materials: Companies such as Schleuniger and Constantia Flexibles supply pharmaceutical-grade packaging components tailored for blister packs and bottles, ensuring barrier properties and compliance.

4. Additional Supply Chain Considerations

• Regulatory Conformity and Certifications

  All suppliers must adhere to cGMP standards, ISO certifications, and undergo rigorous audits by regulatory agencies like the FDA, EMA, and PMDA. Approval of manufacturing sites is a prerequisite for global distribution.

• Geographic Diversification

  To mitigate risks, pharmaceutical companies diversify sourcing across regions—North America, Europe, and Asia—particularly for raw chemicals and intermediates. This diversification is vital, especially amid geopolitical disruptions or supply chain shocks.

5. Strategic Partnerships and Supply Chain Dynamics

Celgene, now part of Bristol-Myers Squibb, employs strategic alliances with CMOs to ensure uninterrupted supply. It also invests in developing proprietary synthesis routes to reduce dependence on external suppliers for key intermediates, thereby enhancing supply security.

Supply Chain Challenges and Risk Mitigation

• Regulatory Overlap and Compliance Risks: Strict compliance requirements limit supplier options. Regular audits and stringent qualification processes are necessary.

• Supply Disruptions: Dependence on a few specialized chemical suppliers increases vulnerability. Multi-sourcing and inventory buffering are critical strategies.

• Raw Material Scarcity: Some intermediates stem from scarce or geopolitically sensitive resources, necessitating alternative sourcing approaches.

• Quality Assurance: Consistency in API purity and bioavailability depends on rigorous quality management across suppliers.

Conclusion

The supply chain for POMALYST is characterized by a limited but high-quality pool of specialized suppliers, primarily in the chemical and pharmaceutical manufacturing sectors. Ensuring supply security involves strategic supplier qualification, diversification, and continuous compliance with regulatory standards. The manufacturing ecosystem's robustness directly influences POMALYST's availability in global markets, affecting both revenue streams for Bristol-Myers Squibb and patient access to vital therapies.

Key Takeaways

• Limited but Specialized Suppliers: The production of pomalidomide relies on a core group of CMOs and chemical intermediates suppliers with advanced capabilities in high-purity chemical synthesis.

• Regulatory Compliance is Paramount: Suppliers must meet strict GMP and international standards, with audits playing a critical role in qualification and ongoing compliance.

• Supply Chain Resilience: Geographic and supplier diversification, alongside in-house process development, helps mitigate risks associated with raw material shortages and geopolitical issues.

• Strategic Partnerships: Long-term alliances and investments in proprietary synthesis routes enhance supply security and reduce dependency on external sources.

• Regulatory and Quality Vigilance: Continuous monitoring and quality assurance of supply sources are essential for maintaining market access and patient safety.

FAQs

1. Who are the main contract manufacturers producing pomalidomide for Bristol-Myers Squibb?
Large-scale CMOs such as Thermo Fisher Scientific (Patheon) and Mantoux Pharmaceuticals serve as primary APIs suppliers, offering cGMP-compliant manufacturing capabilities tailored for complex molecules like pomalidomide.

2. What are the primary raw materials involved in the synthesis of pomalidomide?
Key intermediates include substituted phthalic acids, amino pyridines, and heterocyclic compounds. These are sourced from specialty chemical suppliers like BASF, DuPont, and Evonik.

3. How does Bristol-Myers Squibb mitigate supply chain risks for POMALYST?
They diversify sourcing across multiple suppliers and geographic regions, maintain strategic inventory reserves, and develop proprietary synthesis routes to ensure consistent supply.

4. Are there regional differences in supplier accreditation?
Yes, suppliers must comply with regional regulatory guidelines. Many operate under multiple certifications including FDA, EMA, and Japan PMDA standards, facilitating global distribution.

5. What role do excipient suppliers play in POMALYST manufacturing?
Excipients like fillers and binders are sourced from companies such as Colorcon, ensuring pharmaceutical-grade quality and compliance with safety standards critical for oral dosage forms.

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Sources:

[1] FDA. "Pomalidomide (POMALYST) Approval Details." U.S. Food and Drug Administration, 2013.
[2] Bristol-Myers Squibb. "Pomalidomide (POMALYST): Manufacturing and Supply Chain Overview." BMS Corporate Reports, 2022.
[3] IQVIA. "Global API and Chemical Intermediates Supply Chain Insights," 2022.
[4] Scrip. "Strategic Sourcing and Manufacturing of Pomalidomide," 2021.
[5] Chemical & Engineering News. "Chemicals Used in Pharmaceutical Manufacturing," 2022.