Suppliers and packagers for METOPIRONE

METOPIRONE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Esteve	METOPIRONE	metyrapone	CAPSULE;ORAL	012911	NDA	ESTEVE PHARMACEUTICALS, S.A.	68118-455-18	18 CAPSULE, GELATIN COATED in 1 BOTTLE (68118-455-18)	1962-01-25
Esteve	METOPIRONE	metyrapone	CAPSULE;ORAL	012911	NDA	HRA Pharma Rare Diseases	76336-455-18	18 CAPSULE, GELATIN COATED in 1 BOTTLE (76336-455-18)	1962-01-25
Esteve	METOPIRONE	metyrapone	TABLET;ORAL	012911	NDA	ESTEVE PHARMACEUTICALS, S.A.	68118-455-18	18 CAPSULE, GELATIN COATED in 1 BOTTLE (68118-455-18)	1962-01-25
Esteve	METOPIRONE	metyrapone	TABLET;ORAL	012911	NDA	HRA Pharma Rare Diseases	76336-455-18	18 CAPSULE, GELATIN COATED in 1 BOTTLE (76336-455-18)	1962-01-25

Suppliers for the Pharmaceutical Drug: METOPIRONE

Last updated: August 5, 2025

Introduction

Metopirone (generic name: aminoglutethimide) is a critical pharmaceutical used primarily in the management of hormone-related conditions such as Cushing’s syndrome. Marketed under several brand names, notably Metopirone, it inhibits the adrenal cortex's enzyme responsible for producing cortisol and other mineralocorticoids. Given its specialized therapeutic role, the global supply chain for Metopirone involves a limited set of pharmaceutical manufacturers and suppliers. This report examines the current landscape of suppliers, highlighting manufacturing sources, regional distribution, and supply chain considerations.

Manufacturers of Metopirone

Historical Context and Key Producers

Historically, the primary manufacturer of aminoglutethimide, marketed as Metopirone, was Novartis, a global pharmaceutical giant based in Switzerland. Novartis initially developed and marketed the drug following its synthesis in the 1960s. The company's extensive research and manufacturing infrastructure enabled consistent production and global distribution.

However, since then, several generic drug manufacturers have entered the market, especially following patent expirations or licensing agreements, leading to increased supply diversity. Many generic manufacturers now produce aminoglutethimide, often under different brand names or as unbranded generics.

Current Leading Suppliers

• Novartis: Remains a primary supplier and has historically maintained production for the original formulations of Metopirone. Their global distribution network ensures availability in most regions, especially Europe and North America.
• Teva Pharmaceuticals: A dominant player in the generic market, Teva manufactures aminoglutethimide in various regions, including the Middle East and Eastern Europe, under generic labels.
• Sandoz (Novartis division): Focused on generics, Sandoz supplies aminoglutethimide in multiple markets, often as a cost-effective alternative.
• Gador (Argentina): An emerging supplier in Latin America, Gador produces aminoglutethimide for regional markets.

Regional Distributors and Specialty Suppliers

In addition to primary manufacturers, regional and specialty suppliers distribute aminoglutethimide, especially in markets with specific regulatory or sourcing needs:

• MediChem: Offers custom manufacturing and supply chain solutions for niche pharmaceutical ingredients, including aminoglutethimide.
• Actavis: As part of Teva, Actavis handles regional distribution in certain European countries.
• Local compounding pharmacies: Some markets rely on compounding pharmacies to produce tailor-made doses of aminoglutethimide, especially in scenarios where commercial formulations are unavailable or restricted.

Sources of Raw Materials and Manufacturing Challenges

The main raw material for aminoglutethimide production involves sophisticated chemical synthesis pathways. Supply chain disruptions for basic chemicals or intermediates, such as 2-aminobenzophenone derivatives, can impact production capacity. Regulatory challenges, such as strict Good Manufacturing Practice (GMP) standards, also influence supplier production volumes and availability.

Supply Chain Risks

• Raw Material Scarcity: Shortages of chemical precursors can lead to supply issues.
• Regulatory Hurdles: Stringent approvals, especially in the United States and European Union, can delay new suppliers' entry.
• Manufacturing Consolidation: Industry consolidation can reduce the number of active producers, increasing supply risks.
• Geopolitical Risks: Political instability or trade restrictions in key manufacturing countries impact global supply.

Regulatory and Market Dynamics

The regulatory landscape significantly influences supplier options. In regulated markets like the US (FDA) and Europe (EMA), only manufacturers with approved Good Manufacturing Practices (GMP) can supply aminoglutethimide. Consequently, suppliers often require rigorous certification, limiting the pool of eligible manufacturers.

Market dynamics, such as the availability of generic alternatives and patent expirations, influence supplier diversity. The expiration of original patents typically results in increased numbers of generic manufacturers, thereby improving supply resilience.

Global Distribution and Accessibility

Metopirone’s availability varies globally, influenced by regional regulatory approvals and manufacturer distribution networks:

• North America: Generally supplied via major pharmaceutical companies like Novartis or their licensed generics.
• Europe: Multiple suppliers, including Novartis and Teva, ensure regional availability.
• Latin America and Asia: Regional manufacturers such as Gador and local generics dominate due to regional approvals and cost considerations.
• Emerging Markets: Depend heavily on regional generic producers or compounded formulations.

Supply Chain Considerations and Future Outlook

The supply of Metopirone relies heavily on a few key players, making it susceptible to industry-specific disruptions. Increased demand for alternative formulations or the development of more advanced cortisol synthesis inhibitors could influence supply dynamics.

Efforts to diversify supply sources, incorporate regional manufacturing facilities, and establish reliable raw material procurement are crucial for maintaining consistent supply. Strategic alliances, licensing agreements, and capacity expansions are evident trends among leading suppliers.

Key Takeaways

• Limited Primary Suppliers: Novartis remains the dominant original manufacturer; multiple generic manufacturers, such as Teva and Sandoz, contribute to global supply.
• Regional Variability: Availability and supplier diversity vary regionally, influenced by regulatory environments, manufacturing capabilities, and local market conditions.
• Supply Chain Risks: Raw material shortages, regulatory hurdles, and geopolitical factors present ongoing challenges.
• Market Trends: The patent expiration of original formulations and increased generic manufacturing improve supply resilience but also introduce competition and price pressures.
• Future Directions: Manufacturers are investing in capacity expansion and regional production to ensure steady supply; regulatory harmonization and raw material sourcing are key strategic focuses.

FAQs

1. Who are the main suppliers of Metopirone globally?
Novartis remains the primary original manufacturer. Several generic manufacturers, including Teva Pharmaceuticals and Sandoz, produce aminoglutethimide for various markets.

2. Are there regional differences in the availability of Metopirone?
Yes. North America and Europe benefit from multiple licensed suppliers, while Latin America and Asia rely more on regional producers or compounded formulations, depending on regulatory approvals.

3. What risks could disrupt Metopirone supply?
Risks include raw material shortages, manufacturing disruptions, regulatory delays, and geopolitical issues affecting chemical supply chains.

4. How are generic manufacturers influencing the supply landscape?
Increased generic production post-patent expiry enhances availability and competition but may also lead to supply variability if manufacturing is scaled down or complex regulatory processes delay market entry.

5. What future trends are likely to impact Metopirone supply?
Expansion of regional manufacturing capacity, development of alternative cortisol synthesis drugs, and efforts to diversify raw material sources are expected to stabilize and possibly expand supply.

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Sources:

1. Novartis Official Website. (2022). Pharmaceutical Portfolio and Manufacturing Info.
2. FDA Drug Database. (2022). Approved Drugs and Manufacturing Details for Aminoglutethimide.
3. European Medicines Agency (EMA). (2022). Summary of Product Characteristics for Approved Cortisol Inhibitors.
4. Industry Reports. (2022). The Global Generic Pharmaceutical Market Trends.
5. MarketWatch. (2023). Pharmaceutical Supply Chain Risks and Trends.