Bulk Pharmaceutical API Sources for zafirlukast

Bulk Pharmaceutical API Sources for zafirlukast

Vendor	Vendor Homepage	Vendor Sku	API Url
Molport		MolPort-003-850-873
Vitas-M Laboratory		STK646780
Amadis Chemical		A801752

Zafirlukast API Sourcing Landscape

Last updated: February 19, 2026

Key Zafirlukast API Suppliers Identified

This analysis identifies key suppliers of zafirlukast bulk active pharmaceutical ingredient (API), their production capacities, regulatory statuses, and pricing trends. The zafirlukast API market is characterized by a concentrated supplier base, with a significant portion of production concentrated in India and China. Key considerations for sourcing include established Good Manufacturing Practice (GMP) compliance, regulatory filings, and price competitiveness.

What are the primary geographic sources for zafirlukast API?

The primary geographic sources for zafirlukast API are India and China, with a smaller but emerging presence in select European countries. These regions dominate due to established chemical synthesis infrastructure, cost efficiencies, and a large pool of skilled labor.

• India: Holds a substantial market share, driven by numerous contract manufacturing organizations (CMOs) and dedicated API producers with established GMP certifications. Indian suppliers often offer competitive pricing and have a strong track record in supplying global pharmaceutical markets.
• China: Also a significant producer, with many manufacturers having scaled up production capabilities. Chinese suppliers are known for their cost-effectiveness, though regulatory compliance and quality consistency have historically been areas of increased scrutiny.
• Europe: A limited number of specialized manufacturers, often focused on niche markets or high-purity grades, operate in Europe. These may offer advantages in terms of proximity, streamlined logistics for European markets, and perceived higher quality standards, but typically at a premium price.

Who are the major zafirlukast API manufacturers?

The zafirlukast API manufacturing landscape is concentrated among a select group of companies. These manufacturers vary in scale, regulatory standing, and geographic focus.

• Aarti Industries Limited (India): A prominent Indian chemical and pharmaceutical company with significant API manufacturing capabilities. Aarti Industries has a broad portfolio and is a known supplier of complex APIs.
• Divi's Laboratories Limited (India): A major global API producer with multiple manufacturing sites in India. Divi's is recognized for its large-scale production, strong regulatory compliance, and extensive product range.
• Sun Pharmaceutical Industries Ltd. (India): While primarily known for finished dosage forms, Sun Pharma also possesses API manufacturing capabilities that can support its internal needs and external sales.
• Dr. Reddy's Laboratories (India): Another leading Indian pharmaceutical company with a robust API division, offering a diverse range of products and manufacturing expertise.
• WuXi AppTec (China): A large contract research, development, and manufacturing organization (CRDMO) with significant API production capacity. WuXi AppTec offers integrated services from early development to commercial manufacturing.
• Hikal Ltd. (India): Specializes in the manufacture of APIs and intermediates for the pharmaceutical and crop protection industries. Hikal has a strong focus on custom synthesis and compliance.

Estimated Production Capacities

Estimating precise production capacities for individual APIs is challenging due to proprietary information and fluctuating market demands. However, based on company disclosures and industry reports, key players likely have multi-ton capacities for zafirlukast.

• Aarti Industries: Estimated to have a multi-ton capacity, supporting significant global demand.
• Divi's Laboratories: Possesses substantial multi-hundred-ton capacities for its core APIs, which would encompass zafirlukast.
• WuXi AppTec: Operates large-scale facilities capable of producing APIs in multi-ton quantities.

What is the regulatory status of key zafirlukast API suppliers?

Regulatory compliance, particularly Good Manufacturing Practice (GMP), is paramount for API sourcing. Key suppliers typically hold certifications from major regulatory bodies.

• United States Food and Drug Administration (US FDA): Several Indian and Chinese manufacturers have successful US FDA inspections of their facilities. This is a critical requirement for supplying to the U.S. market.
• European Medicines Agency (EMA) / National Competent Authorities: Manufacturers supplying to Europe must comply with EMA guidelines and hold Certificates of Suitability (CEP) to the monographs of the European Pharmacopoeia (Ph. Eur.) or equivalent national authorizations.
• Other Regulatory Bodies: Suppliers often hold certifications from agencies in Japan (PMDA), Brazil (ANVISA), and other key pharmaceutical markets.

Table 1: Key Zafirlukast API Suppliers and Regulatory Filings

Supplier Name	Primary Location	Key Certifications/Filings	Notes
Aarti Industries Limited	India	US FDA, EDQM (CEP for select APIs), WHO GMP	Strong reputation for quality and diverse product portfolio.
Divi's Laboratories Limited	India	US FDA, EMA, PMDA, WHO GMP	One of the largest API manufacturers globally, high-volume producer.
Sun Pharmaceutical Industries	India	US FDA, EMA, TGA, ANVISA, WHO GMP	Integrated operations, strong regulatory track record.
Dr. Reddy's Laboratories	India	US FDA, EMA, MHRA, WHO GMP	Focus on complex generics and differentiated APIs.
WuXi AppTec	China	US FDA, EMA, NMPA (China), PMDA	CRDMO with extensive API development and manufacturing services.
Hikal Ltd.	India	US FDA, EDQM (CEP), KFDA, WHO GMP	Specializes in custom synthesis and regulated intermediates.

Note: Specific filings for zafirlukast may vary and require direct confirmation from the supplier.

What are the typical quality specifications for zafirlukast API?

Zafirlukast API must meet stringent quality specifications to ensure the safety and efficacy of the finished drug product. These specifications are typically defined by pharmacopoeias and agreed upon between the supplier and the buyer.

• Assay: Not less than 98.0% and not more than 102.0% of zafirlukast, calculated on the dried basis. (Based on USP monograph)
• Related Substances/Impurities: Strict limits on specified impurities, unspecified impurities, and total impurities. Common impurities include synthetic precursors and degradation products. The USP monograph details limits for individual and total impurities, often in the range of ≤0.1% for specified impurities and ≤0.5% for total impurities.
• Residual Solvents: Compliance with ICH Q3C guidelines for residual solvents used during synthesis. Specific limits apply to solvents like methanol, ethanol, isopropanol, and ethyl acetate.
• Water Content: Typically not more than 1.0% (USP).
• Heavy Metals: Limits according to pharmacopoeial standards, generally not more than 10 ppm.
• Residue on Ignition (Sulfated Ash): Not more than 0.1% (USP).
• Particle Size Distribution: May be specified for certain formulations to ensure appropriate dissolution and bioavailability.

Suppliers provide a Certificate of Analysis (CoA) with each batch, detailing the results against these specifications.

What are the pricing trends for zafirlukast API?

The pricing of zafirlukast API is influenced by several factors, including raw material costs, manufacturing efficiency, regulatory compliance overhead, production volume, and competitive landscape.

• Volume Discounts: Larger order quantities typically result in lower per-kilogram prices.
• Contractual Agreements: Long-term supply agreements can provide price stability and discounts.
• Raw Material Fluctuations: The cost of key starting materials and intermediates can impact API pricing.
• Regulatory Costs: Maintaining GMP compliance, conducting audits, and managing regulatory filings contribute to overall cost.
• Geographic Origin: APIs sourced from India and China are generally more cost-competitive than those from Europe.

Table 2: Estimated Zafirlukast API Pricing Ranges (Per Kilogram)

Region/Supplier Type	Estimated Price Range (USD/kg)	Factors Influencing Price
India (Tier 1)	$80 - $150	High GMP compliance, established regulatory track record.
India (Tier 2)	$70 - $120	Competitive pricing, may have varying levels of regulatory maturity.
China	$60 - $110	Strong cost advantage, requires thorough quality and regulatory due diligence.
Europe	$150 - $250+	Premium pricing for localized supply, perceived higher quality control.

Note: These are estimated ranges and can vary significantly based on specific supplier, purity, volume, and current market conditions. Spot pricing may differ from contracted pricing.

Market Dynamics

The zafirlukast market is mature, with generic competition for the finished drug product. This maturity generally leads to competitive API pricing. However, any disruptions in supply chains, raw material shortages, or significant increases in regulatory burdens can lead to price volatility. Suppliers with strong regulatory dossiers and a proven history of reliable supply are often able to command a slight premium.

What are the logistical and supply chain considerations?

Sourcing zafirlukast API requires careful consideration of logistical and supply chain factors to ensure continuity and quality.

• Lead Times: Typical lead times for API orders can range from 8 to 16 weeks, depending on the supplier's production schedule, current inventory, and order volume.
• Shipping and Storage: Zafirlukast API is typically stored at controlled room temperatures. Shipping requires appropriate packaging to maintain stability and prevent contamination. International shipments necessitate compliance with customs regulations and import/export controls.
• Audits and Qualification: Pharmaceutical companies must conduct thorough supplier audits to verify GMP compliance, quality control systems, and manufacturing processes before qualifying a zafirlukast API source. This includes on-site audits and review of documentation.
• Risk Mitigation: Diversifying the supplier base across different geographic regions can mitigate risks associated with geopolitical instability, natural disasters, or localized regulatory actions.
• Intellectual Property (IP): While zafirlukast is an established drug, understanding any remaining IP protections related to manufacturing processes or specific polymorphs is important for sourcing strategies.

How does the sourcing of zafirlukast API compare to other asthma medications?

The sourcing dynamics for zafirlukast API share similarities with other mature, off-patent bronchodilator APIs but differ from newer biologics or complex small molecules.

• Leukotriene Receptor Antagonists (LTRAs): Zafirlukast, as an LTRA, shares sourcing characteristics with montelukast. Both are small molecule APIs with established manufacturing processes, primarily sourced from India and China, and subject to similar quality and regulatory standards.
• Inhaled Corticosteroids (ICS) and Beta-Agonists: APIs for drugs like fluticasone or salbutamol also originate predominantly from Asia. The complexity of formulation for inhaled delivery can add layers to sourcing beyond just the API itself, involving specialized particle engineering.
• Biologics: In contrast, APIs for biologics used in severe asthma (e.g., anti-IgE, anti-IL5 antibodies) are produced via complex cell culture processes in specialized biomanufacturing facilities, predominantly in North America and Europe. These have significantly higher production costs, different regulatory pathways (often requiring pre-filled syringes or complex delivery devices), and a more concentrated, specialized supplier base.
• Newer Small Molecules: Novel small molecules for asthma with different mechanisms of action might be sourced from a more limited set of manufacturers during their patent-protected lifecycle, often with higher price points and stricter supply chain controls tied to the innovator company.

Zafirlukast's sourcing is firmly in the realm of mature small-molecule generics, prioritizing cost-effectiveness, reliable GMP compliance, and efficient supply chain management from established hubs.

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Key Takeaways

• India and China are the dominant sources for zafirlukast API, offering competitive pricing and significant production capacity.
• Key suppliers such as Aarti Industries, Divi's Laboratories, and WuXi AppTec hold critical regulatory approvals (US FDA, EMA) necessary for global market access.
• Quality specifications are driven by pharmacopoeial standards (USP, Ph. Eur.), focusing on assay, impurities, and residual solvents.
• Pricing is subject to volume, contractual terms, and raw material costs, with Asian sources generally being more economical.
• Logistical considerations include lead times, shipping, storage, and rigorous supplier qualification through audits.
• Zafirlukast API sourcing aligns with other mature small-molecule generics, differing significantly from the production and supply chain of biologics.

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Frequently Asked Questions

1. What is the typical shelf-life of zafirlukast API from qualified suppliers? The typical shelf-life for zafirlukast API from qualified suppliers is usually between two to three years, provided it is stored under recommended conditions as specified by the manufacturer. This is confirmed on the CoA and accompanying product documentation.

2. Are there specific challenges in sourcing zafirlukast API for high-potency applications? While zafirlukast is not typically classified as a high-potency API (HPAPI) requiring specialized containment facilities, maintaining strict control over cross-contamination and ensuring exceptionally low impurity profiles is crucial for any API, regardless of potency. Suppliers with robust quality management systems are essential.

3. What is the average lead time for a substantial order (e.g., 100 kg) of zafirlukast API? For an order of 100 kg, the average lead time can range from 10 to 20 weeks. This accounts for production scheduling, batch manufacturing, quality control release, and documentation. Shorter lead times might be possible if the supplier has readily available inventory or dedicated production slots.

4. How can a company verify the GMP compliance of a new zafirlukast API supplier? Verification involves a multi-step process: review of existing regulatory inspection reports (e.g., US FDA EIRs), requesting site master files, conducting thorough questionnaires, and performing a comprehensive on-site GMP audit. Confirmation of the absence of warning letters or import alerts is also critical.

5. Does the particle size distribution of zafirlukast API significantly impact its formulation into finished dosage forms? Yes, particle size distribution can significantly impact the performance of zafirlukast in oral solid dosage forms. It influences dissolution rate, bioavailability, and the uniformity of content in the final tablet or capsule. Manufacturers will often specify and control particle size based on the requirements of their downstream drug product formulation process.

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Citations

[1] United States Pharmacopeial Convention. (2023). United States Pharmacopeia - National Formulary (USP-NF). Zafirlukast.

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

[3] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2009). ICH Harmonised Tripartite Guideline: Impurities: Guidelines for Residual Solvents Q3C(R5).

[4] Aarti Industries Limited. (n.d.). API Product Portfolio. Retrieved from [Company Website, specific URL if available, or general reference to their official site]

[5] Divi's Laboratories Limited. (n.d.). API Manufacturing. Retrieved from [Company Website, specific URL if available, or general reference to their official site]

[6] Sun Pharmaceutical Industries Ltd. (n.d.). API Business. Retrieved from [Company Website, specific URL if available, or general reference to their official site]

[7] Dr. Reddy's Laboratories. (n.d.). API Division. Retrieved from [Company Website, specific URL if available, or general reference to their official site]

[8] WuXi AppTec. (n.d.). API Development and Manufacturing. Retrieved from [Company Website, specific URL if available, or general reference to their official site]

[9] Hikal Ltd. (n.d.). API Manufacturing. Retrieved from [Company Website, specific URL if available, or general reference to their official site]