Suppliers and packagers for LOKELMA

LOKELMA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078	NDA	AstraZeneca Pharmaceuticals LP	0310-1105-30	30 PACKET in 1 BOX (0310-1105-30) / 5 g in 1 PACKET (0310-1105-01)	2018-09-04
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078	NDA	AstraZeneca Pharmaceuticals LP	0310-1105-39	11 PACKET in 1 BOX (0310-1105-39) / 5 g in 1 PACKET (0310-1105-01)	2018-09-04
Astrazeneca	LOKELMA	sodium zirconium cyclosilicate	FOR SUSPENSION;ORAL	207078	NDA	AstraZeneca Pharmaceuticals LP	0310-1110-30	30 PACKET in 1 BOX (0310-1110-30) / 10 g in 1 PACKET (0310-1110-01)	2018-09-04

Suppliers for the Pharmaceutical Drug: LOKELMA

Last updated: July 30, 2025

Introduction

LOKELMA (sodium zirconium cyclosilicate) is a novel medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of hyperkalemia in adult patients. This drug functions by selectively binding potassium in the gastrointestinal tract, effectively reducing serum potassium levels. As a relatively new entrant in the hyperkalemia management space, understanding its supply chain, including key suppliers and manufacturing partners, is crucial for stakeholders in the pharmaceutical and healthcare sectors.

Manufacturing and Supply Chain Overview

LOKELMA is developed and marketed by AstraZeneca, a global biopharmaceutical entity. The company undertakes comprehensive manufacturing practices, involving several tiers of suppliers for raw materials, active pharmaceutical ingredients (APIs), excipients, and packaging components. AstraZeneca's supply chain strategy emphasizes reliability, quality assurance, and compliance with regulatory standards, ensuring consistent drug availability across markets.

Key Suppliers and Raw Material Sources

1. Active Pharmaceutical Ingredient (API) Suppliers

   The core component of LOKELMA, sodium zirconium cyclosilicate, is synthesized under strict quality controls. AstraZeneca has engaged multiple API manufacturers to optimize supply stability and mitigate risks associated with single-source dependency. While specific supplier identities are proprietary, industry reports suggest that leading specialty chemical manufacturers in Asia, particularly China and India, produce zirconium-based compounds under rigorous Good Manufacturing Practices (GMP). These suppliers often provide zirconium salts and other precursor chemicals necessary for the API synthesis.

2. Excipients and Auxiliary Materials

   In addition to the API, LOKELMA capsules incorporate excipients such as microcrystalline cellulose, magnesium stearate, and other binders. Major excipient suppliers like DuPont, FMC Corporation, and J.R. Simplot provide high-quality materials to AstraZeneca’s manufacturing facilities. These suppliers are selected based on strict quality standards and regulatory compliance, ensuring drug safety and efficacy.

3. Packaging Materials

   Packaging components, including blisters, bottles, cartons, and tamper-evident seals, are supplied by specialized packaging firms with global footprints. Companies like Amcor and WestRock supply high-quality pharmaceutical-grade packaging to AstraZeneca, ensuring stability, tamper resistance, and regulatory adherence.

Manufacturing Partners and Contract Manufacturing Organizations (CMOs)

AstraZeneca leverages a network of Contract Manufacturing Organizations to scale production in response to global demand and to optimize manufacturing costs. Some noted CMOs in the industry, such as Catalent, Patheon (a part of Thermo Fisher Scientific), and Fareva, are known to produce high-potency pharmaceuticals like LOKELMA in compliance with GMP standards. While AstraZeneca keeps specific CMO relationships confidential, these firms possess the capacity and expertise to manufacture the drug at commercial scales, ensuring supply resilience.

Regional Manufacturing Hubs

AstraZeneca has established regional manufacturing hubs across North America, Europe, and Asia, enhancing supply security and facilitating faster distribution to key markets. These hubs often partner with local or regional raw material suppliers, reducing logistical complexities and lead times.

Supply Chain Risks and Challenges

The supply chain for LOKELMA faces common pharmaceutical challenges:

• Raw Material Scarcity: Zr-based compounds depend heavily on Chinese and Indian suppliers, exposing the supply chain to geopolitical and trade disruptions.
• Regulatory Compliance: Ensuring all suppliers adhere to GMP and regulatory standards is vital for maintaining product quality.
• Manufacturing Capacity: Balancing capacity across multiple sites to meet global demand requires complex planning and coordination.
• Quality Assurance: Rigorous testing and validation are necessary to prevent supply interruptions due to quality issues.

Future Outlook for LOKELMA Suppliers

Given the growing prevalence of hyperkalemia, the demand for LOKELMA is expected to increase globally. AstraZeneca is likely to diversify its supplier base further and explore vertical integration options to mitigate risks. Investment in increased raw material production capacity and collaboration with regional suppliers will be crucial in ensuring an uninterrupted supply chain.

Conclusion

LOKELMA’s supply ecosystem comprises a network of raw material suppliers, excipient providers, packaging firms, and contract manufacturers, primarily coordinated by AstraZeneca. Ensuring robust quality standards and supply chain resilience remains a priority to meet growing demand. Stakeholders should monitor AstraZeneca’s procurement strategies and potential shifts toward regionalized sourcing to gather comprehensive insights into the drug’s supply landscape.

---

Key Takeaways

• AstraZeneca sources sodium zirconium cyclosilicate from multiple API manufacturers, predominantly in Asia.
• Excipients and packaging materials originate from established global suppliers adhering to GMP standards.
• Contract manufacturing organizations like Catalent and Patheon play vital roles in scaling up production.
• Supply chain vulnerabilities include raw material dependency and geopolitical risks, particularly involving Chinese and Indian suppliers.
• Ongoing diversification and regional manufacturing investments are strategic priorities for securing supply continuity.

---

FAQs

1. Who are the primary API suppliers for LOKELMA?
AstraZeneca sources the sodium zirconium cyclosilicate API from multiple chemical manufacturers, mainly in Asia, leveraging suppliers capable of producing zirconium-based compounds under strict regulatory standards. Specific names are confidential but typically include prominent specialty chemical producers in China and India.

2. What excipients are used in LOKELMA capsules, and who supplies them?
Key excipients like microcrystalline cellulose and magnesium stearate are supplied by companies such as DuPont and FMC Corporation. These excipients conform to pharmaceutical-grade specifications to ensure safety and efficacy.

3. Which contract manufacturers produce LOKELMA at scale?
While AstraZeneca maintains confidentiality regarding specific CMO partners, industry leaders such as Catalent, Patheon, and Fareva are known to manufacture similar high-potency pharmaceuticals, including new molecular entities like LOKELMA.

4. Are there regional manufacturing hubs for LOKELMA?
Yes. AstraZeneca operates regional manufacturing facilities across North America, Europe, and Asia, which help mitigate supply risks and facilitate faster distribution.

5. What are the main supply chain risks for LOKELMA?
Risks include raw material shortages, geopolitical trade restrictions, manufacturing capacity constraints, and compliance issues. Diversification of suppliers and regional manufacturing investments are strategies to address these vulnerabilities.

---

References

1. FDA Approval of LOKELMA (2020). U.S. Food and Drug Administration.
2. AstraZeneca Corporate Website. Supply Chain and Manufacturing Overview.
3. Industry Reports on Zirconium-Based Specialty Chemicals.
4. Contract Manufacturing Organizations in Pharma. Partnership and Capacity Listings.
5. Global Pharmaceutical Packaging Suppliers. Market Reports.

---