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

Korlym Drug Supply Chain Analysis

Last updated: February 19, 2026

Korlym (mifepristone) is a medication used for medical termination of pregnancy and for the treatment of Cushing's syndrome. Its supply chain is concentrated, with limited manufacturers and distributors. The primary active pharmaceutical ingredient (API) for mifepristone is manufactured by a small number of entities. Distribution in the United States is largely controlled by Danco Laboratories, the sole FDA-approved distributor of Korlym.

Who Manufactures the Active Pharmaceutical Ingredient (API) for Korlym?

The active pharmaceutical ingredient (API) for mifepristone, the core component of Korlym, is manufactured by a limited number of global chemical synthesis companies. Specific manufacturing sites are often proprietary, but the landscape is characterized by specialized chemical producers.

• Key API Producers: While precise details on all API manufacturers are not publicly disclosed due to commercial confidentiality, the production is understood to be concentrated among a few entities with expertise in complex organic synthesis. These are not typically large, multinational pharmaceutical companies but rather specialized API suppliers.
• Geographic Concentration: API production for many pharmaceuticals, including complex molecules like mifepristone, is often geographically concentrated in regions with established chemical manufacturing infrastructure and competitive pricing. This can include countries in Asia and Europe.
• Regulatory Oversight: API manufacturers must adhere to stringent Good Manufacturing Practices (GMP) regulations set by health authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to ensure product quality, safety, and efficacy.

Who Formulates and Distributes Korlym in the United States?

In the United States, the formulation of mifepristone into the finished drug product Korlym and its subsequent distribution is primarily managed by Danco Laboratories.

• Danco Laboratories: Danco Laboratories is the sole U.S. entity licensed by the FDA to distribute mifepristone under the brand name Korlym. This exclusivity significantly concentrates the distribution channels within the U.S.
• Manufacturing of Finished Product: While Danco Laboratories holds the marketing and distribution rights, the actual formulation and packaging of Korlym may be contracted to a third-party contract manufacturing organization (CMO) with FDA-approved facilities. The specific CMOs are typically not disclosed by Danco Laboratories for competitive reasons.
• Supply Chain Control: Danco Laboratories exercises significant control over the U.S. supply chain for Korlym, managing importation (if API is sourced internationally), formulation, packaging, and wholesale distribution.

What are the Regulatory Hurdles for Mifepristone Supply?

The supply chain for mifepristone is subject to significant regulatory oversight in the United States, impacting its availability and the entities involved.

• FDA Approval and REMS Program: Korlym is approved by the FDA. Its distribution and dispensing are governed by a Risk Evaluation and Mitigation Strategy (REMS) program. This program imposes specific requirements on healthcare providers, pharmacies, and patients, which can influence the logistical pathways and the number of dispensing sites.
• State-Level Regulations: Beyond federal regulations, individual U.S. states have enacted their own laws and regulations concerning the prescribing, dispensing, and accessibility of mifepristone. These can vary significantly and create a complex patchwork of compliance requirements for distributors and healthcare providers.
• Importation Restrictions: The U.S. has specific regulations regarding the importation of pharmaceutical products. For mifepristone, Danco Laboratories operates within these frameworks, and any diversion or unauthorized importation can lead to regulatory action.

What are the Key Global Players in Mifepristone Production?

The global production of mifepristone, both as an API and in finished dosage forms, involves a limited number of international manufacturers and distributors, beyond Danco Laboratories in the U.S.

• European Manufacturers: Historically, some of the initial development and manufacturing of mifepristone originated in Europe. Companies in countries like France have played a role in its API and finished product manufacturing for markets outside the U.S.
• Asian API Suppliers: As is common for many APIs, specialized chemical manufacturers in countries such as China and India may produce mifepristone API for global pharmaceutical companies. These suppliers must meet international GMP standards.
• International Distributors: Outside the U.S., other pharmaceutical companies or distributors may hold rights to market and distribute mifepristone in different countries, often under different brand names and regulatory pathways.

What is the Competitive Landscape for Mifepristone Supply?

The competitive landscape for mifepristone supply is characterized by a high degree of concentration rather than a broad market.

• Limited API Sources: The proprietary nature of API production and the specialized chemical processes required mean that the number of companies capable of producing mifepristone API at scale is small.
• Exclusive U.S. Distributor: Danco Laboratories' role as the sole U.S. distributor creates a monopolistic situation for Korlym within the United States market.
• Generic Competition (Limited): While generic versions of mifepristone exist in some international markets, the pathway to market for generics in the U.S. has been subject to legal and regulatory challenges, limiting direct generic competition to Korlym as currently distributed by Danco.

What are the Potential Supply Chain Vulnerabilities?

The concentrated nature of the mifepristone supply chain presents specific vulnerabilities.

• API Production Disruptions: Reliance on a small number of API manufacturers means that any disruption at these facilities, whether due to regulatory issues, geopolitical events, natural disasters, or quality control failures, can significantly impact global supply.
• Distribution Bottlenecks: The single-distributor model in the U.S. (Danco Laboratories) can create bottlenecks. Issues within Danco's operations or its contractual CMOs could halt supply.
• Regulatory Changes: Shifts in regulatory policies, both in the U.S. and in countries where API or finished product is manufactured, can rapidly alter supply chain dynamics and market access.
• Geopolitical Risks: For API sourced from specific regions, geopolitical tensions or trade disputes can impact import/export flows and increase lead times or costs.

Key Takeaways

• The U.S. supply chain for Korlym (mifepristone) is highly concentrated, with Danco Laboratories as the sole FDA-approved distributor.
• Active Pharmaceutical Ingredient (API) production for mifepristone is handled by a limited number of specialized chemical synthesis companies globally.
• Regulatory frameworks, including FDA REMS and state-specific laws, significantly shape the distribution and accessibility of Korlym in the U.S.
• The supply chain faces vulnerabilities due to its limited number of API producers and the exclusive U.S. distribution model.

FAQs

1. Are there any other companies in the U.S. that legally manufacture or distribute mifepristone besides Danco Laboratories? No, Danco Laboratories is the sole FDA-approved distributor of mifepristone under the brand name Korlym in the United States.

2. Where is the API for Korlym primarily manufactured? The API is manufactured by specialized chemical synthesis companies globally, with production often concentrated in regions like Asia and Europe, though specific sites are proprietary.

3. What is the impact of the REMS program on the Korlym supply chain? The Risk Evaluation and Mitigation Strategy (REMS) program imposes specific requirements for dispensing and distribution, influencing the logistical pathways and the number of authorized dispensing sites for Korlym.

4. Could a disruption in API manufacturing in one country affect Korlym availability in the U.S.? Yes, due to the limited number of API manufacturers, a disruption in production at a key facility, regardless of its location, can significantly impact the global supply of mifepristone and, consequently, Korlym's availability in the U.S.

5. Does Danco Laboratories manufacture the finished Korlym product itself, or does it use contract manufacturers? Danco Laboratories holds the distribution rights. The actual formulation and packaging of Korlym may be performed by a third-party contract manufacturing organization (CMO) with FDA-approved facilities.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Mifepristone. Retrieved from [Provide URL if available, or specific FDA document title/identifier] [2] Danco Laboratories. (n.d.). About Us. Retrieved from [Provide URL if available, or specific Danco Laboratories document title/identifier] [3] European Medicines Agency. (n.d.). Good Manufacturing Practice (GMP). Retrieved from [Provide URL if available, or specific EMA document title/identifier] [4] U.S. Food and Drug Administration. (n.d.). Risk Evaluation and Mitigation Strategies (REMS). Retrieved from [Provide URL if available, or specific FDA document title/identifier]