Suppliers and packagers for generic pharmaceutical drug: albendazole

albendazole

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actavis Elizabeth	ALBENDAZOLE	albendazole	TABLET;ORAL	208094	ANDA	Actavis Pharma, Inc.	0591-2712-02	2 TABLET, FILM COATED in 1 BOTTLE (0591-2712-02)	2019-06-13
Alembic	ALBENDAZOLE	albendazole	TABLET;ORAL	215652	ANDA	Alembic Pharmaceuticals Limited	46708-681-02	2 TABLET, FILM COATED in 1 BOTTLE (46708-681-02)	2024-09-11
Alembic	ALBENDAZOLE	albendazole	TABLET;ORAL	215652	ANDA	Alembic Pharmaceuticals Limited	46708-681-28	28 TABLET, FILM COATED in 1 BOTTLE (46708-681-28)	2024-09-11
Alembic	ALBENDAZOLE	albendazole	TABLET;ORAL	215652	ANDA	Alembic Pharmaceuticals Inc.	62332-681-02	2 TABLET, FILM COATED in 1 BOTTLE (62332-681-02)	2024-09-11
Alembic	ALBENDAZOLE	albendazole	TABLET;ORAL	215652	ANDA	Alembic Pharmaceuticals Inc.	62332-681-28	28 TABLET, FILM COATED in 1 BOTTLE (62332-681-28)	2024-09-11

Albendazole Drug Supply Chain Analysis

Last updated: February 19, 2026

This report details key suppliers and manufacturing considerations for albendazole, a broad-spectrum benzimidazole anthelmintic. The analysis focuses on active pharmaceutical ingredient (API) production, regulatory compliance, and supply chain stability, providing data for R&D and investment decisions.

Who Are the Primary API Manufacturers for Albendazole?

The production of albendazole API is concentrated among a limited number of manufacturers, primarily located in India and China. These entities possess the chemical synthesis capabilities and adhere to the regulatory standards required for pharmaceutical ingredient production.

Key Albendazole API Manufacturers:

• Lupin Limited (India): A major global pharmaceutical company with significant API manufacturing capacity. Lupin is a well-established supplier of albendazole.
• Dr. Reddy's Laboratories (India): Another leading Indian pharmaceutical firm with a broad API portfolio, including anthelmintics.
• Sun Pharmaceutical Industries Ltd. (India): India's largest pharmaceutical company by market capitalization, it manufactures and supplies a range of APIs.
• Zhejiang NHU Co., Ltd. (China): A prominent Chinese chemical and pharmaceutical company with extensive API production facilities.
• Hubei Biocause Pharmaceutical Co., Ltd. (China): A Chinese manufacturer involved in the production of various pharmaceutical intermediates and APIs.

These manufacturers typically operate under Good Manufacturing Practice (GMP) guidelines and are subject to audits by regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Their production capacities and pricing structures are critical factors for downstream drug product manufacturers.

What Regulatory Approvals Do Albendazole API Manufacturers Hold?

Regulatory approvals are a crucial indicator of a supplier's quality and compliance. Manufacturers typically seek approvals from major global regulatory bodies to facilitate market access.

Common Regulatory Filings and Certifications:

• U.S. FDA Drug Master Files (DMFs): A DMF is submitted to the FDA to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs. Albendazole API manufacturers often maintain FDA DMFs.
• European Directorate for the Quality of Medicines & HealthCare (EDQM) Certificates of Suitability (CEP): A CEP demonstrates that the quality of a substance is suitably controlled by the relevant monograph(s) of the European Pharmacopoeia. This simplifies the regulatory process for marketing authorizations in European Union member states and other countries that recognize CEPs.
• World Health Organization (WHO) Prequalification: For suppliers involved in supplying to global health organizations or tenders, WHO Prequalification is often a key requirement. This program assesses quality, safety, and efficacy.
• National Regulatory Authority Approvals: Manufacturers also seek approvals from the regulatory bodies of individual countries where their API will be used.

The presence and status of these approvals directly impact a drug product manufacturer's ability to secure regulatory submission approvals and maintain a compliant supply chain. Specific DMF numbers and CEP status can be obtained through direct supplier engagement or regulatory databases.

What Are the Production Processes and Chemical Synthesis Routes for Albendazole?

Albendazole synthesis involves multi-step organic chemistry processes. Understanding these routes provides insight into potential impurities, raw material dependencies, and manufacturing scalability.

General Synthesis Pathway:

The synthesis of albendazole typically begins with 4-chloro-3-nitrobenzoic acid or a related precursor. Key reaction steps generally include:

1. Reduction of the nitro group: The nitro group is reduced to an amine.
2. Acylation: The amine is then acylated, often with a methyl carbamate derivative.
3. Reaction with thiourea: The intermediate is reacted with thiourea to form the benzimidazole ring system.
4. Alkylation: The final step involves the introduction of the propylthioether side chain.

Key Raw Materials and Intermediates:

• 4-chloro-3-nitrobenzoic acid
• Methyl chloroformate
• Sodium nitrite
• Thiocarbonyldiimidazole
• 1-bromopropane
• Various solvents and catalysts (e.g., methanol, ethanol, palladium catalysts, bases).

Variations in synthesis routes can lead to different impurity profiles. Manufacturers must control critical process parameters to ensure consistent API quality and minimize genotoxic impurities. The availability and cost of key raw materials can influence API pricing and supply stability.

What Are the Key Quality Control Parameters and Specifications for Albendazole API?

Adherence to pharmacopoeial standards is essential for albendazole API quality. These standards define the acceptable limits for purity, impurities, and physical characteristics.

Major Pharmacopoeial Standards:

• United States Pharmacopeia (USP): The USP monograph for albendazole specifies tests for identification, assay (typically by HPLC), related substances (impurities), residual solvents, heavy metals, and microbial limits.
• European Pharmacopoeia (Ph. Eur.): Similar to the USP, the Ph. Eur. monograph details stringent requirements for albendazole API quality.
• Indian Pharmacopoeia (IP): The IP also provides a monograph with specific quality standards.

Typical Quality Specifications:

• Assay: Not less than 98.0% and not more than 102.0% of albendazole (on the dried basis).
• Impurities: Limits are set for specific known impurities (e.g., albendazole sulfoxide, albendazole sulfone) and for unspecified impurities. The total impurities are typically limited to a maximum of 1.0%.
• Loss on Drying: Not more than 1.0%.
• Sulphated Ash: Not more than 0.1%.
• Heavy Metals: Limits are set according to pharmacopoeial requirements (e.g., not more than 10 ppm).
• Residual Solvents: Limits are defined according to ICH Q3C guidelines.

Manufacturers must implement robust quality management systems, including in-process controls and final product testing, to ensure compliance with these specifications.

What Are the Potential Supply Chain Risks for Albendazole?

The globalized nature of pharmaceutical manufacturing exposes the albendazole supply chain to various risks, impacting cost, availability, and quality.

Identified Supply Chain Risks:

• Geopolitical Instability: Concentration of manufacturing in specific regions (e.g., India, China) can lead to disruptions from trade disputes, political unrest, or export restrictions.
• Raw Material Shortages or Price Volatility: Dependence on specific chemical precursors or intermediates can lead to supply chain vulnerabilities if their production is disrupted or prices escalate.
• Regulatory Changes and Enforcement: Stricter environmental regulations in manufacturing regions or increased scrutiny from regulatory bodies can lead to temporary plant shutdowns or increased compliance costs.
• Quality Control Failures: Batch failures due to deviations in manufacturing processes or raw material quality can lead to recalls and significant supply disruptions.
• Logistical Challenges: Shipping delays, port congestion, and transportation cost increases can impact timely delivery of API to drug product manufacturers.
• Intellectual Property Landscape: While albendazole itself is off-patent, new formulations or manufacturing processes might be subject to patent protection, influencing market entry and supplier choice.
• Natural Disasters and Pandemics: Global events such as pandemics or natural disasters can disrupt manufacturing operations, labor availability, and transportation networks.

Mitigation strategies include dual sourcing, robust supplier qualification programs, maintaining safety stocks, and continuous monitoring of geopolitical and regulatory landscapes.

How Does the Patent Landscape Affect Albendazole Supply?

Albendazole is an established drug with a long history of use. The primary patents covering the compound itself have long since expired, making it a generic drug. However, the patent landscape can still influence the supply chain through other avenues.

Key Patent Considerations:

• Composition of Matter Patents: Expired. This allows for generic API and drug product manufacturing.
• Process Patents: While the original synthesis patents have expired, companies may develop and patent novel or improved manufacturing processes for albendazole API. These patents could offer a competitive advantage to the patent holder but typically do not prevent others from using established, non-infringing processes.
• Formulation Patents: New formulations of albendazole, such as sustained-release versions or combinations with other drugs, may be patented. These patents protect the final drug product rather than the API itself.
• Polymorph Patents: Patents can be granted for specific crystalline forms (polymorphs) of an API if they demonstrate advantageous properties (e.g., improved stability, bioavailability). The existence of such patents could restrict the use of specific polymorphs.

The absence of composition of matter patents allows for a competitive generic market for albendazole API, driven by cost-effectiveness and quality. However, potential process or polymorph patents necessitate due diligence for manufacturers developing new production methods or exploring specific crystalline forms.

What Are the Market Dynamics and Pricing Trends for Albendazole API?

The market for albendazole API is characterized by significant competition due to its generic status. Pricing is largely driven by production costs, supply-demand balance, and the competitive intensity among API manufacturers.

Market Dynamics:

• Dominance of Generic Manufacturers: The market is served by numerous generic API manufacturers, primarily in India and China, leading to competitive pricing.
• Volume-Based Pricing: Larger volume purchases generally command lower per-unit prices.
• Impact of Regulatory Compliance Costs: Manufacturers investing in and maintaining high regulatory standards (e.g., FDA-approved facilities, GMP compliance) may have slightly higher cost structures, but these are often offset by market access advantages.
• Global Health Initiatives: Demand is influenced by large-scale procurement by organizations like the WHO and national health programs targeting parasitic infections.

Pricing Trends:

• Historically Stable with Minor Fluctuations: Albendazole API prices have generally remained stable over time, with minor fluctuations driven by raw material costs, energy prices, and shifts in global supply.
• Competitive Pressure: Intense competition among suppliers tends to suppress significant price increases.
• Regional Variations: Prices can vary slightly by region due to logistical costs, import duties, and local market dynamics.

Manufacturers seeking to procure albendazole API should engage in thorough supplier qualification and negotiate contracts based on long-term supply agreements to ensure price stability and consistent quality.

Key Takeaways

• Albendazole API manufacturing is concentrated in India and China, with key players including Lupin, Dr. Reddy's Laboratories, Sun Pharma, Zhejiang NHU, and Hubei Biocause.
• Regulatory compliance, evidenced by FDA DMFs and EDQM CEPs, is critical for market access and supply chain reliability.
• The synthesis of albendazole involves multi-step organic chemistry, with control over raw materials and process parameters essential for API quality.
• Quality control adheres to stringent pharmacopoeial standards (USP, Ph. Eur., IP) with defined limits for assay, impurities, and residual solvents.
• Supply chain risks include geopolitical instability, raw material volatility, regulatory changes, and logistical challenges.
• The patent landscape for albendazole is primarily characterized by expired composition of matter patents, fostering a competitive generic market, though process and formulation patents may exist.
• Market dynamics are driven by generic competition, volume-based pricing, and global health initiatives.

Frequently Asked Questions

1. What is the typical lead time for an order of albendazole API from a major supplier? Lead times can vary from 4 to 12 weeks, depending on the supplier's current production schedule, order volume, and existing inventory. Expedited orders may be possible at a premium.

2. Are there alternative APIs with similar anthelmintic efficacy to albendazole? Yes, other benzimidazole anthelmintics like mebendazole and fenbendazole share similar mechanisms of action and broad-spectrum activity. Non-benzimidazole options also exist for specific parasitic infections.

3. How does the impurity profile of albendazole API differ between manufacturers? Differences in synthesis routes, raw material sourcing, and process controls can lead to variations in the types and levels of impurities. Key impurities to monitor include albendazole sulfoxide and albendazole sulfone.

4. What are the primary challenges in ensuring a continuous supply of albendazole API? Challenges include managing the geopolitical risks associated with manufacturing concentration, securing reliable sources of key raw materials, and navigating evolving regulatory requirements.

5. Can albendazole API be sourced from regions other than India and China? While India and China are the dominant manufacturing hubs, some smaller-scale production may exist in other regions. However, these are typically not significant contributors to the global supply chain due to scale and cost-competitiveness.

Citations

[1] United States Pharmacopeia. (n.d.). Albendazole. United States Pharmacopeia–National Formulary.

[2] European Directorate for the Quality of Medicines & HealthCare. (n.d.). Monographs. European Pharmacopoeia.

[3] Indian Pharmacopoeia Commission. (n.d.). Albendazole. Indian Pharmacopoeia.

[4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2015). ICH Harmonised Tripartite Guideline: Impurities: Guideline for Residual Solvents Q3C(R6).