Bulk Pharmaceutical API Sources for ARFORMOTEROL TARTRATE

Bulk Pharmaceutical API Sources for ARFORMOTEROL TARTRATE

Vendor	Vendor Homepage	Vendor Sku	API Url
AKos Consulting & Solutions		AKOS005145740
Amadis Chemical		207513
Finetech Industry Limited		FT-0697952
Clearsynth		CS-O-00839

Bulk Active Pharmaceutical Ingredient (API) Sources for: Arformoterol Tartrate

Last updated: July 27, 2025

Introduction

Arformoterol tartrate, a long-acting beta2-adrenergic agonist (LABA), is primarily utilized in managing chronic obstructive pulmonary disease (COPD). As a potent bronchodilator, its procurement is integral to pharmaceutical manufacturing, especially for generic drug producers and innovative pharmaceutical companies aiming to develop inhalation therapy products. Securing a reliable, high-quality source of bulk API is critical to ensure product efficacy, safety, and regulatory compliance.

Overview of Arformoterol Tartrate

Arformoterol is a stereochemically pure enantiomer of formoterol, exhibiting a long duration of bronchodilatory action with twice-daily dosing. Its tartrate salt enhances stability and solubility, facilitating formulation into inhalers or nebulizer solutions. The health authorities, including the FDA and EMA, emphasize stringent quality standards, such as United States Pharmacopeia (USP) or European Pharmacopoeia (EP) compliance, for APIs used in respiratory therapies.

Global API Manufacturers and Suppliers

The supply chain for arformoterol tartrate is concentrated among select chemical and pharmaceutical companies globally. These manufacturers sustain their reputation through rigorous quality controls, cGMP compliance, and comprehensive documentation, facilitating regulatory approval in target markets.

1. Macurex Pharma Co., Ltd.

Based in South Korea, Macurex specializes in respiratory APIs, including formoterol and arformoterol derivatives. Its manufacturing facilities operate under ISO and GMP standards, offering APIs that meet international pharmacopoeia specifications. They cite a proven track record in supplying high-purity arformoterol tartrate suitable for inhalation products.

2. Zhejiang Xianju Pharmaceuticals Co., Ltd.

China's Zhejiang Xianju is a prominent manufacturer producing various APIs for respiratory diseases. Their arformoterol tartrate is produced under strict GMP conditions, with documented validation of synthesis, purity (≥99%), and stability. The company supplies to both domestic and export markets, gaining recognition for quality and affordable pricing.

3. Solasia Pharma K.K.

A Japanese pharmaceutical firm, Solasia has clinical-stage and commercial APIs, including forms of arformoterol tartrate. Their focus centers on respiratory APIs with adherence to Japanese pharmacopoeia standards, combining rigorous quality assurance with advanced research collaborations.

4. Carbosynth

Located in the UK, Carbosynth exports a range of chemical APIs, including arformoterol tartrate. Their offerings emphasize high purity, custom synthesis options, and comprehensive documentation for regulatory purposes. Carbosynth's supply chain includes North American, European, and Asian manufacturing partners.

5. AdooQ BioScience (Watson Laboratories)

Watson Laboratories, under AdooQ BioScience, supplies pharmaceutical APIs globally, including arformoterol tartrate, with a commitment to GMP compliance and quality control. They cater predominantly to generic pharmaceutical companies seeking reliable API sources.

Key Criteria for API Suppliers

When selecting a bulk API supplier for arformoterol tartrate, consider the following parameters:

• Regulatory Compliance: GMP certification, evidence of adherence to USP, EP, or other pharmacopoeia standards.
• Purity and Stereochemistry: High enantiomeric purity (>99%) essential for maintaining pharmacological activity and reducing off-target effects.
• Manufacturing Capacity & Scalability: Ability to meet current and future demand, with flexible batch sizes.
• Documentation & Quality Assurance: Robust analytical data, stability reports, batch records, and Certificates of Analysis (CoA).
• Supply Chain Security: Proven track record of on-time delivery and contingency sourcing strategies.

Emerging Suppliers and Advancements

With expanding respiratory therapeutic markets, new chemical entities and manufacturing techniques are emerging. Biotech companies leverage asymmetric synthesis and stereoselective catalysis to produce arformoterol tartrate more efficiently, potentially reducing costs and environmental impact.

Additionally, some API producers explore biosynthetic pathways or biosimilar manufacturing, aiming for uniformity and lower impurity levels. Such innovations could influence future supply sources and market dynamics.

Market Dynamics and Regulatory Considerations

The pharmaceutical industry heavily regulates respiratory APIs like arformoterol tartrate, emphasizing quality through agencies such as the FDA, EMA, and WHO prequalification. Due to the complex synthesis and stereoselective requirements, only a limited number of API manufacturers globally meet these stringent criteria.

New entrants or secondary suppliers must undergo rigorous audits, submit detailed dossiers, and demonstrate consistent batch quality to obtain regulatory approval, impacting time-to-market and procurement costs.

Conclusion

Securing bulk arformoterol tartrate API requires careful evaluation of suppliers based on quality, compliance, capacity, and reliability. Leading manufacturers like Macurex Pharma, Zhejiang Xianju, and Carbosynth offer high-quality products aligned with international standards. As the respiratory API market evolves, companies should stay informed about emerging sources and technological advances that enhance supply chain resilience and cost efficiency.

---

Key Takeaways

• Quality Assurance Is Paramount: Select suppliers with GMP certification and robust documentation emphasizing high purity and stereoselective integrity.
• Regulatory Compatibility Matters: Choose manufacturers whose APIs meet USP, EP, or other relevant pharmacopoeia standards to expedite approval processes.
• Supply Chain Reliability Is Critical: Prioritize vendors with proven track records for consistent delivery schedules and contingency planning.
• Leverage Technological Innovations: Explore suppliers employing advanced stereoselective synthesis to reduce costs and improve yield.
• Monitor Market Trends: Stay updated on emerging manufacturers and regulatory shifts influencing API sourcing strategies.

---

FAQs

1. What are the leading countries producing arformoterol tartrate APIs?
South Korea, China, Japan, the UK, and India are prominent producers, with these regions hosting established manufacturers compliant with international regulatory standards [1].

2. How do I verify the quality of an arformoterol tartrate API supplier?
Verify GMP certification, review Certificates of Analysis, confirm adherence to pharmacopoeia standards, and evaluate audits and industry reputation.

3. Are biosynthetic or environmentally sustainable processes available for arformoterol tartrate?
While traditional synthesis dominates, emerging research explores stereoselective catalysis and eco-friendly methods. However, no widespread commercial biosynthesis exists yet.

4. What are common quality attributes to scrutinize in API batch testing?
Purity (>99%), enantiomeric excess, residual solvents, heavy metals, endotoxin levels, and stability data are key metrics.

5. How do regulatory agencies influence API sourcing for respiratory drugs?
Agencies enforce strict quality standards, requiring comprehensive documentation, batch validation, and GMP compliance, impacting supplier qualification procedures.

---

References

1. U.S. FDA. (2021). Guideline for Industry: Good Manufacturing Practices for API.
2. European Pharmacopoeia. (2022). Monograph: Formoterol Tartrate.
3. PharmSource. (2023). API Market Trends in Respiratory Therapeutics.
4. WHO. (2022). WHO Prequalification Program for APIs.
5. Industry Reports. (2023). Global API Manufacturing Landscape.

---

This comprehensive report aims to support pharmaceutical stakeholders in making informed decisions about sourcing arformoterol tartrate API, ensuring quality, compliance, and supply chain resilience.