Suppliers and packagers for korlym

korlym

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107	NDA	Corcept Therapeutics Incorporated	76346-073-01	28 TABLET in 1 BOTTLE (76346-073-01)	2012-02-17
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107	NDA	Corcept Therapeutics Incorporated	76346-073-02	280 TABLET in 1 BOTTLE (76346-073-02)	2012-02-17
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107	NDA	Corcept Therapeutics Incorporated	76346-654-03	280 TABLET in 1 BOTTLE (76346-654-03)	2024-05-28

Suppliers for the Pharmaceutical Drug: Korlym

Last updated: August 1, 2025

Introduction

Korlym (mifepristone) is a prescription medication primarily used for the treatment of endogenous hyperglycemia associated with Cushing's syndrome in adults who are not candidates for surgery. As a selective progesterone receptor modulator, Korlym has a specific molecular profile and regulatory status that influence its supply chain. Understanding its suppliers is crucial for stakeholders including healthcare providers, pharmaceutical companies, and regulatory agencies aiming to ensure drug availability, quality, and compliance.

Manufacturing and Regulatory Background

Mifepristone, marketed as Korlym, is produced by Corcept Therapeutics, a biopharmaceutical company based in the United States. Corcept holds exclusive rights to manufacture and distribute Korlym, alongside other related compounds. The drug’s manufacturing process must adhere to Good Manufacturing Practices (GMP), overseen by the U.S. Food and Drug Administration (FDA).

Corcept’s manufacturing process involves sourcing raw materials through specialized chemical suppliers capable of providing high-purity intermediates. The active pharmaceutical ingredient (API) used in Korlym is complex and requires precise synthesis.

Primary Suppliers for Korlym

1. Active Pharmaceutical Ingredient (API) Suppliers

• Corcept Therapeutics: As the sole producer of Korlym’s API, Corcept manages a tightly controlled supply chain for mifepristone. The company oversees the synthesis and quality assurance of the API, ensuring it meets stringent regulatory standards.

• Contract Manufacturing Organizations (CMOs): While Corcept itself produces the API, the company collaborates with specialized chemical manufacturers globally to source intermediates and raw materials. These contract manufacturers are located primarily in the United States and Europe, where high-quality chemical synthesis is feasible.

2. Excipients and Formulation Components Suppliers

Korlym’s formulation includes excipients necessary for tablet manufacturing. Suppliers include:

• Global excipients manufacturers such as Rhodia (an Ingredient supplier), BASF, and DuPont. These firms provide pharmaceutical-grade excipients that comply with USP or EP standards.

3. Packaging and Distribution Partners

Corcept also partners with packaging firms and distribution networks to supply Korlym to pharmacies and healthcare institutions. These include:

• Specialized pharmaceutical packaging companies with capabilities for blister packs, bottles, and labels compliant with regulatory standards.

• Distribution agreements primarily with large wholesale distributors such as McKesson, Cardinal Health, and AmerisourceBergen.

Supply Chain Challenges and Considerations

• Regulatory Compliance: Since Korlym contains a potent API, the supply chain must comply with strict regulatory landscapes in the U.S. and globally. Any disruption in API manufacturing or quality issues could impair availability.

• Complex Manufacturing Process: The synthesis of mifepristone involves multi-step chemical reactions requiring advanced expertise and controlled environments, limiting the pool of qualified suppliers.

• Global Sourcing: Suppliers located in different geographies introduce logistical challenges, especially amid geopolitical tensions, trade restrictions, or pandemics impacting raw material supply.

• Patent and Exclusivity: Corcept's patent protections and exclusive rights to Korlym limit competition, thereby constraining alternative suppliers and influencing pricing dynamics.

Emerging Trends in/Korlym Supply Dynamics

• Potential Generic Development: The expiration of patent exclusivity could open pathways for generic manufacturers to produce mifepristone, increasing supply diversity.

• Drug Repurposing and Expanded Indications: Research into other therapeutic applications may affect demand and influence the robustness of the supply chain.

• Supply Chain Resilience: COVID-19 underscored the need for resilient manufacturing and logistics strategies, prompting Corcept and associated suppliers to diversify and secure supply chains.

Conclusion

The supply of Korlym hinges heavily on Corcept Therapeutics’ control of the manufacturing process and its selected network of raw material suppliers and manufacturing partners. These elements ensure high-quality production aligned with regulatory standards. While presently dominated by Corcept’s in-house manufacturing, future shifts toward generics or new manufacturing partnerships could diversify supply sources. Stakeholders must monitor regulatory developments, patent landscapes, and global manufacturing trends to anticipate potential supply disruptions or expansions.

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Key Takeaways

• Corcept Therapeutics remains the exclusive producer of Korlym’s API, controlling supply and quality standards.
• The global chemical and excipient supplier networks are integral to manufacturing, with reliance on specialized, high-reg purity raw materials.
• Supply risks stem from regulatory compliance, complex chemical synthesis, and geopolitical issues affecting raw material sourcing.
• Potential market entry of generic alternatives post-patent expiry could diversify supply sources and impact pricing.
• Supply chain resilience is critical amid ongoing global disruptions; proactive strategies are necessary to ensure continuous availability.

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FAQs

1. Who are the primary producers of Korlym?
Corcept Therapeutics is the sole producer of Korlym’s active pharmaceutical ingredient (mifepristone) and manages its distribution through exclusive licensing and manufacturing agreements.

2. Can other companies manufacture generic mifepristone?
Yes, once patent protections expire or if authorized via regulatory pathways, other pharmaceutical companies can develop generic versions, expanding the supply base.

3. What are the main risks to Korlym’s supply chain?
Regulatory non-compliance, raw material shortages, complex chemical synthesis, geopolitical tensions, and disruptions from global crises like COVID-19 are key supply risks.

4. How does Corcept ensure the quality of Korlym’s supply?
Through adherence to GMP standards, rigorous quality control, and supplier qualification processes for raw materials and intermediates.

5. Are there alternative suppliers for Korlym’s excipients and packaging materials?
Yes, multiple global manufacturers supply pharmaceutical-grade excipients and packaging, providing options for contingency and redundancy.

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References

1. Corcept Therapeutics. (2022). Corporate Website. [Online] Available at: https://corcept.com
2. U.S. Food and Drug Administration. (2022). FDA Drug Approvals and Labeling.
3. European Pharmacopeia. (2021). Standards for pharmaceutical excipients.
4. Industry Reports on API Manufacturing. (2022). Chemical Supply Chain Analysis.