Suppliers and packagers for METHIMAZOLE

METHIMAZOLE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aiping Pharm Inc	METHIMAZOLE	methimazole	TABLET;ORAL	040547	ANDA	Upsher-Smith Laboratories, LLC	0832-6072-11	100 TABLET in 1 BOTTLE (0832-6072-11)	2016-07-01
Aiping Pharm Inc	METHIMAZOLE	methimazole	TABLET;ORAL	040547	ANDA	Upsher-Smith Laboratories, LLC	0832-6073-11	100 TABLET in 1 BOTTLE (0832-6073-11)	2016-07-01
Bionpharma	METHIMAZOLE	methimazole	TABLET;ORAL	218149	ANDA	AvPAK	50268-495-15	50 BLISTER PACK in 1 BOX (50268-495-15) / 1 TABLET in 1 BLISTER PACK (50268-495-11)	2025-10-13
Bionpharma	METHIMAZOLE	methimazole	TABLET;ORAL	218149	ANDA	AvPAK	50268-496-15	50 BLISTER PACK in 1 BOX (50268-496-15) / 1 TABLET in 1 BLISTER PACK (50268-496-11)	2025-10-13
Bionpharma	METHIMAZOLE	methimazole	TABLET;ORAL	218149	ANDA	Bionpharma Inc.	69452-328-20	100 TABLET in 1 BOTTLE (69452-328-20)	2024-03-25

Methimazole API Suppliers: Global Landscape and Competitive Dynamics

Last updated: February 19, 2026

This report analyzes the global supply chain for methimazole Active Pharmaceutical Ingredient (API), identifying key manufacturers, their production capacities, and geographic distribution. The analysis focuses on market concentration, regulatory compliance, and potential supply chain risks relevant to pharmaceutical manufacturers and investors.

Who Are the Major Methimazole API Manufacturers?

The global methimazole API market is characterized by a limited number of established suppliers. Key players include:

• Evolva S.A.: A Swiss-based biotechnology company with a history in producing niche APIs.
• Bafna Pharmaceuticals Ltd.: An Indian pharmaceutical manufacturer with significant API production capabilities.
• Dipharma Francis S.r.l.: An Italian API manufacturer with a broad product portfolio.
• Loba Chemie Pvt. Ltd.: An Indian company specializing in laboratory chemicals and pharmaceutical intermediates.
• Merck KGaA: A multinational science and technology company that manufactures a range of pharmaceutical ingredients.
• Sanofi S.A.: A global pharmaceutical company with integrated API manufacturing operations.

These companies represent a significant portion of the global methimazole API supply. Production is concentrated in regions with established pharmaceutical manufacturing infrastructure, notably India and Europe.

What is the Production Capacity and Geographic Distribution of Methimazole API?

Accurate, publicly disclosed production capacities for specific APIs like methimazole are often proprietary. However, market intelligence indicates that production is primarily located in:

• India: This region hosts several manufacturers with substantial API production capacity, leveraging cost advantages and a strong chemical synthesis industry.
• Europe: European manufacturers, including those in Italy and Switzerland, contribute to the supply, often focusing on high-purity grades and compliance with stringent regulatory standards.
• China: While historically a major producer of many APIs, the specific contribution of Chinese manufacturers to the methimazole market is less publicly detailed but is a factor in the global supply.

The global demand for methimazole is relatively stable, driven by its use in treating hyperthyroidism. Supply chain disruptions, such as geopolitical instability or regulatory changes, can impact the availability and pricing from these concentrated production hubs.

What are the Key Regulatory Considerations for Methimazole API Suppliers?

Methimazole API suppliers must adhere to a complex web of international and national regulations to ensure product quality, safety, and efficacy. Key regulatory frameworks include:

• Good Manufacturing Practices (GMP): Manufacturers are required to comply with GMP standards set by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the World Health Organization (WHO). These standards cover all aspects of production, including quality control, facility maintenance, and personnel training.
• Drug Master Files (DMFs): API manufacturers typically file DMFs with regulatory agencies. A DMF is a submission to support a new drug application (NDA) or an abbreviated new drug application (ANDA). It contains confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. For methimazole, this includes detailed specifications for the API, impurity profiles, and stability data.
• ICH Guidelines: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines on quality, safety, efficacy, and multidisciplinary aspects. Compliance with ICH Q7 (Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients) is crucial.
• Pharmacopeial Standards: Methimazole API must meet the specifications outlined in major pharmacopeias, such as the United States Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.). These monographs define the identity, strength, quality, and purity of the API.
• REACH and CLP Regulations (Europe): Manufacturers exporting to the European Union must comply with the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation and the Classification, Labelling and Packaging (CLP) regulation, which address chemical safety and hazard communication.

Failure to meet these regulatory requirements can result in product recalls, import bans, and significant financial penalties, impacting supplier viability.

What is the Competitive Landscape and Pricing Dynamics?

The competitive landscape for methimazole API is moderately concentrated. The primary drivers of competition include:

• Price: Given the mature nature of the methimazole market, price is a significant competitive factor. Manufacturers in lower-cost regions, particularly India, often have a pricing advantage.
• Quality and Purity: Pharmaceutical formulators prioritize API quality, seeking suppliers with consistent batch-to-batch purity and robust impurity profiling. Suppliers with strong regulatory track records and adherence to pharmacopeial standards command a premium.
• Supply Chain Reliability: Consistent availability and timely delivery are critical. Companies that can demonstrate a secure and resilient supply chain are preferred.
• Regulatory Compliance: Suppliers with pre-approved DMFs and a history of successful regulatory inspections (e.g., FDA, EMA) reduce risk for formulators.

Pricing for methimazole API can fluctuate based on raw material costs, energy prices, currency exchange rates, and global demand. Typical price ranges, though subject to significant variation based on volume, quality, and supplier, can be observed from contract manufacturing organizations and API distributors. Bulk pricing for methimazole API is generally in the low to mid-single-digit USD per kilogram range, but can be higher for smaller quantities or highly purified grades.

What are the Potential Supply Chain Risks for Methimazole?

Several risks can impact the global supply of methimazole API:

• Geopolitical Instability: Concentration of manufacturing in specific geographic regions, such as India, makes the supply chain vulnerable to political unrest, trade disputes, or export restrictions in those countries.
• Raw Material Sourcing: Dependence on a limited number of suppliers for key starting materials or intermediates can create bottlenecks. Fluctuations in the availability or price of these upstream components directly affect methimazole production costs and lead times.
• Regulatory Changes: Evolving GMP requirements, new impurity limits, or stricter environmental regulations in manufacturing countries can necessitate costly process modifications or lead to temporary supply interruptions.
• Environmental Regulations: Increased scrutiny on chemical manufacturing processes due to environmental concerns can lead to production shutdowns or increased compliance costs for certain facilities.
• Quality Incidents and Recalls: A single quality failure by a major supplier can lead to product shortages for multiple pharmaceutical companies. Product recalls, even if localized, damage a supplier's reputation and can disrupt market access.
• Natural Disasters and Pandemics: Unforeseen events such as earthquakes, floods, or global health crises can disrupt manufacturing operations and logistics, impacting global supply.

Key Takeaways

The methimazole API market is supplied by a concentrated group of manufacturers, predominantly located in India and Europe. Regulatory compliance, particularly GMP, pharmacopeial standards, and DMF filings, is paramount for suppliers. Competition centers on price, quality, and supply chain reliability. Potential supply chain risks include geopolitical instability, raw material sourcing issues, and evolving regulatory landscapes.

Frequently Asked Questions

1. How does the regulatory status of a methimazole API supplier influence sourcing decisions? A supplier's regulatory status, including current GMP certifications from major agencies (FDA, EMA) and the acceptance and completeness of their Drug Master Files (DMFs), directly influences sourcing decisions by pharmaceutical companies. Strong regulatory compliance reduces the risk of audit failures, import alerts, and product recalls, ensuring a more stable and predictable supply chain.

2. What is the typical shelf life of methimazole API, and how is it determined? The typical shelf life of methimazole API is generally between 2 to 5 years. This is determined through rigorous stability testing conducted by the API manufacturer, following ICH Q1A(R2) guidelines. These studies involve storing the API under various controlled temperature and humidity conditions for extended periods and periodically testing it for degradation products, potency, and physical characteristics to establish its expiration date.

3. Are there any significant differences in the quality or impurity profiles between methimazole APIs sourced from different regions (e.g., India vs. Europe)? While all APIs must meet pharmacopeial standards, subtle differences in impurity profiles can exist between methimazole APIs from different regions due to variations in synthetic routes, raw materials, and manufacturing processes. European manufacturers, often subject to more stringent environmental controls and quality oversight, may consistently produce APIs with lower levels of certain process-related impurities. However, reputable Indian manufacturers also adhere to strict GMP and can produce high-quality methimazole API meeting all pharmacopeial requirements. Pharmaceutical companies often conduct thorough analytical testing and supplier audits to ensure the quality and suitability of API for their specific formulation.

4. What is the typical lead time for ordering methimazole API from a primary manufacturer? The typical lead time for ordering methimazole API from a primary manufacturer can range from 4 to 12 weeks. This lead time depends on the manufacturer's current production schedule, inventory levels, order volume, and the complexity of any required quality assurance documentation or release testing. For exceptionally large orders or for suppliers with high demand, lead times can be extended.

5. How do fluctuations in raw material costs impact the price of methimazole API? Fluctuations in raw material costs directly impact the price of methimazole API. Methimazole synthesis involves several chemical intermediates, and the availability and cost of these precursor chemicals, as well as other essential manufacturing inputs like solvents and catalysts, are subject to market dynamics. Increases in raw material prices typically lead to a proportional increase in the API's manufacturing cost, which is then passed on to formulators in the form of higher API prices. Conversely, a decrease in raw material costs may allow for price reductions.

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Citations

[1] European Medicines Agency. (n.d.). Good Manufacturing Practice (GMP). Retrieved from https://www.ema.europa.eu/en/human-regulatory/manufacturing-quality/good-manufacturing-practice

[2] U.S. Food and Drug Administration. (n.d.). Drug Master Files (DMFs). Retrieved from https://www.fda.gov/drugs/drug-master-file/drug-master-files

[3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (n.d.). ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. Retrieved from https://www.ich.org/products/guidelines/quality/article/quality-guidelines

[4] United States Pharmacopeia. (n.d.). United States Pharmacopeia (USP). Retrieved from https://www.usp.org/

[5] European Directorate for the Quality of Medicines & HealthCare. (n.d.). European Pharmacopoeia (Ph. Eur.). Retrieved from https://www.edqm.eu/en/european-pharmacopoeia-ph-eur

[6] European Chemicals Agency. (n.d.). REACH - Registration, Evaluation, Authorisation and Restriction of Chemicals. Retrieved from https://echa.europa.eu/regulations/reach

[7] European Chemicals Agency. (n.d.). CLP - Classification, Labelling and Packaging. Retrieved from https://echa.europa.eu/regulations/clp