Suppliers and packagers for generic pharmaceutical drug: METYRAPONE

METYRAPONE

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: Metyrapone

Last updated: July 28, 2025

Introduction

Metyrapone, chemically known as 11β-Hydroxy-4-ethyl-17-hydroxy-10,13-diaza-3-oxo-5-phenylpentacyclo[9.3.1.0.0.2.9.0]octadeca-2,4,6-trien-12-one, is primarily used in medical settings to diagnose and manage cortisol production abnormalities, such as Cushing's syndrome. Its commercial supply chain depends on specialized chemical manufacturers capable of producing high-purity APIs (Active Pharmaceutical Ingredients) and formulators that incorporate metyrapone into therapeutic products. This report discusses major global and regional suppliers of metyrapone, their manufacturing capacities, regulatory statuses, and distribution channels relevant to pharmaceutical companies seeking sourcing options.

Global Market Overview

The production and supply of metyrapone are relatively limited, given its niche application and complex synthesis process. Metyrapone belongs to a class of drugs that require stringent manufacturing controls due to their potency and the necessity for purity compliance with pharmacopeial standards (USP, EP, JP). Historically, major pharmaceutical-grade suppliers of metyrapone are concentrated in regions with advanced pharmaceutical manufacturing bases, notably Europe, North America, and parts of Asia.

Major Suppliers of Metyrapone

1. Major Pharmaceutical Ingredient Manufacturers

a. Cambrex Corporation

• Overview: Based in the United States, Cambrex specializes in manufacturing small-molecule APIs, advanced intermediates, and related chemical services. While primarily focusing on generic APIs across various therapeutic classes, Cambrex provides custom synthesis services, including steroid and hormone-related compounds.
• Capabilities: Possesses facilities with cGMP compliance for API production; capable of scale-up manufacturing of complex molecules such as metyrapone.
• Regulatory status: APIs supplied have undergone rigorous GMP certifications, enabling their use in finished dosage forms for global markets.

b. Hubei Huida Pharmaceutical Co., Ltd.

• Overview: Located in China, Hubei Huida produces both APIs and intermediates, including steroid-related compounds suitable for hormonal treatments.
• Capabilities: Offers synthesis and bulk manufacturing of metyrapone, primarily serving regional and international generic drug manufacturers.
• Regulatory status: Some products may be imported into regions with harmonized standards following quality validation according to local authorities.

c. Steraloids Inc.

• Overview: A US-based supplier specializing in research chemicals and pharmaceutical intermediates, including steroids and their derivatives.
• Capabilities: Provides custom synthesis and high-purity APIs for research and clinical purposes.
• Relevance: Their production of metyrapone, mainly for research use, is aligned with FDA-grade quality standards.

d. Zhangjiang Pharma

• Overview: Chinese manufacturer with a focus on steroid hormones and intermediates.
• Capabilities: Capable of producing metyrapone for commercial supply.
• Regulatory status: API manufacturing supports certifications needed for international distribution.

2. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical companies rely on CMOs to produce metyrapone under strict GMP conditions. Major CMOs with relevant autoimmune and endocrine API capabilities include:

• Recipharm (Sweden): Provides custom synthesis, including steroid APIs, with market approval for production scale.
• LGM Pharma (USA): Specializes in sourcing and distribution of pharmaceutical intermediates, including hormonal compounds like metyrapone.

Regional Suppliers and Market Trends

North America

In the U.S., API manufacturing for endocrine drugs is highly regulated, with suppliers such as Cambrex and Steraloids holding significant market share. Domestic suppliers benefit from proximity to major pharmaceutical firms and support FDA compliance, making them preferred for U.S.-based drug development.

Europe

Europe hosts numerous GMP-certified API manufacturers, notably in Germany, Switzerland, and the UK. Companies like Lonza and Recipharm are known for steroid API production, which can include metyrapone under custom manufacturing agreements.

Asia-Pacific

The Asia-Pacific region, led by China and India, supplies a substantial volume of pharmaceutical intermediates and APIs at competitive prices. Chinese firms such as Hubei Huida and Zhangjiang Pharma play vital roles in meeting global demand, particularly for generic formulations.

Supply Chain Considerations

• Quality and Regulatory Compliance: Ensuring the API supplier conforms to GMP standards and has requisite regulatory approvals (e.g., FDA, EMA, TGA).
• Capacity and Lead Times: Metyrapone’s complex synthesis limits immediate supply; suppliers with scalable manufacturing processes are preferred.
• Intellectual Property and Certification: Some manufacturers offer proprietary synthesis routes that may influence licensing or sourcing agreements.

Challenges in the Supply of Metyrapone

• Limited Producer Base: The niche nature of metyrapone means fewer dedicated producers, posing potential risks of supply disruptions.
• Regulatory Variation: Differing regional requirements can complicate sourcing, especially for international markets.
• Cost Factors: Manufacturing complexity and regulatory compliance contribute to higher API prices compared to more mainstream drugs.

Emerging Opportunities

• Synthetic Optimization: Advances in synthetic methodologies could expand manufacturing capacity.
• Regional Manufacturing Expansion: Increasing GMP-certified facilities in emerging markets offer alternative sourcing options.
• Strategic Stockpiling: Pharmaceutical firms often maintain safety stocks due to supply uncertainties.

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Key Takeaways

• The supply of metyrapone hinges on specialized, GMP-compliant pharmaceutical ingredient manufacturers primarily in North America, Europe, and Asia.
• Major suppliers include Cambrex, Hubei Huida, Steraloids, and Zhangjiang Pharma, among others.
• Regional considerations, regulatory compliance, and manufacturing capacity are critical for reliable procurement.
• The limited number of producers and complex synthesis routes pose risks, emphasizing the need for diversified sourcing strategies.
• Future growth may stem from synthetic process improvements and regional manufacturing expansion.

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FAQs

1. Who are the leading global suppliers of metyrapone?
Leading suppliers include Cambrex Corporation (USA), Hubei Huida Pharmaceutical (China), Steraloids Inc. (USA), and Zhangjiang Pharma (China), all with GMP-compliant production capabilities.

2. What regulatory standards do metyrapone suppliers typically adhere to?
Suppliers usually conform to cGMP standards aligned with USP, EP, or JP pharmacopoeial requirements, ensuring API quality suitable for global markets.

3. Can metyrapone be sourced from generic manufacturers?
Yes. Several generic API manufacturers produce metyrapone, but sourcing depends on regional regulations and supplier certifications.

4. What are supply chain risks associated with metyrapone?
Limited producer base, complex synthesis, and regional regulatory differences can lead to supply disruptions, emphasizing the need for strategic sourcing.

5. Are there regional differences in metyrapone supply?
Yes. North American and European suppliers tend to meet stricter standards, whereas Chinese and Indian manufacturers offer cost-effective options, often for research purposes or regional distribution.

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References

1. U.S. Pharmacopeia, Metyrapone Monograph.
2. European Pharmacopoeia, Steroid API Standards.
3. Industry Reports on API Manufacturing, Pharmaceutical Tech Analyst, 2022.
4. Company Websites: Cambrex, Hubei Huida, Steraloids, Zhangjiang Pharma.
5. Regulatory agency publications (FDA, EMA).