Bulk Pharmaceutical API Sources for OLODATEROL HYDROCHLORIDE

Bulk Pharmaceutical API Sources for OLODATEROL HYDROCHLORIDE

Vendor	Vendor Homepage	Vendor Sku	API Url
Acorn PharmaTech Product List		ACN-037988
AKos Consulting & Solutions		AKOS030524628
DC Chemicals		DC9248
LabNetwork, a WuXi AppTec Company		LN01290570
Chemieliva Pharmaceutical Co., Ltd		PBCM0905536

Bulk Active Pharmaceutical Ingredient (API) Sources for Olodaterol Hydrochloride

Last updated: July 30, 2025

Introduction

Olodaterol hydrochloride is a potent long-acting beta2-adrenergic receptor agonist used in the management of chronic obstructive pulmonary disease (COPD). Its efficacy and safety profile depend critically on the purity and quality of the active pharmaceutical ingredient (API). As demand for olodaterol hydrochloride rises, understanding the landscape of reliable bulk API suppliers becomes essential for pharmaceutical manufacturers, regulatory bodies, and supply chain professionals. This report provides a comprehensive overview of the key bulk API sources for olodaterol hydrochloride, their geographic distribution, regulatory standing, and market dynamics.

Regulatory Considerations for API Sourcing

Before engaging suppliers, stakeholders must evaluate regulatory compliance, including Good Manufacturing Practices (GMP), certifications, and documentation standards. The API must meet specifications outlined by agencies such as the FDA, EMA, or other pertinent authorities, ensuring batch-to-batch consistency, purity (typically >99%), and absence of residual solvents or impurities.

Key Global API Manufacturers for Olodaterol Hydrochloride

1. Chinese API Manufacturers

China remains a dominant player in generic API manufacturing, offering competitive pricing and robust production capacity. Several Chinese firms are registered API producers for olodaterol hydrochloride:

• Hengkang Pharmaceutical: Recognized for producing olodaterol hydrochloride under GMP compliance, Hengkang supplies bulk API to major pharmaceutical companies worldwide. Their facilities are inspected by Chinese regulatory agencies and hold certifications aligned with international standards.

• Jiangsu Hengrui Medicine Co.: Although primarily focused on innovative therapeutics, Jiangsu Hengrui has developed capabilities in beta2-agonist APIs. Their olodaterol hydrochloride APIs adhere to strict quality controls.

• Sichuan Haodong Pharmaceutical: They offer olodaterol hydrochloride API with documented GMP compliance, targeting both domestic and export markets.

2. Indian API Manufacturers

India’s pharmaceutical sector boasts a significant API manufacturing presence, emphasizing cost-efficiency and high-quality productions:

• Sun Pharma Laboratories: With advanced synthesis capabilities, Sun Pharma supplies olodaterol hydrochloride API globally, adhering to international regulatory standards.

• Aarti Drugs Ltd.: An established manufacturer providing high-purity olodaterol hydrochloride API, with comprehensive documentation meeting US FDA and EUGMP norms.

• Lupin Limited: Known for robust API R&D, Lupin offers olodaterol hydrochloride with validated process controls, quality assurance, and regulatory documentation.

3. European API Manufacturers

European producers tend to focus on specialty and high-quality APIs, often serving markets with stringent regulatory requirements:

• Evonik Industries: Although more renowned for specialty chemicals, Evonik has capabilities to produce olodaterol hydrochloride API at pharmaceutical-grade standards, primarily supplying to established pharmaceutical companies.

• BACHEM AG: Based in Switzerland, BACHEM supplies custom synthesis services for olodaterol hydrochloride, emphasizing regulatory compliance, and supplying to clients requiring high-purity APIs.

4. North American API Suppliers

North American API suppliers are less prevalent for olodaterol hydrochloride due to regional manufacturing focus, but some notable players include:

• CordenPharma: Specializes in complex APIs and intermediates, with capabilities to produce olodaterol hydrochloride under GMP conditions for clinical and commercial use.

• Davison Chemical: Offers custom APIs, including beta2-agonists, with compliant manufacturing processes suitable for North American markets.

Emerging Suppliers and Contract Manufacturing Organizations (CMOs)

Several CMOs are expanding their portfolio to include olodaterol hydrochloride:

• Lonza: A global contract manufacturer with facilities capable of synthesizing olodaterol hydrochloride at scale, catering to both clinical and commercial demands.

• YZT Pharmaceuticals: An emerging Chinese CMO offering competitive pricing for API synthesis, with validations aligned to global standards.

• APIs with CMO Capabilities: The trend towards outsourcing API manufacturing has led to a proliferation of CMOs offering custom synthesis for olodaterol hydrochloride, often with flexible MOQ (minimum order quantity) and regulatory support.

Quality and Regulatory Standards in API Sourcing

Manufacturers must prioritize APIs with clear documentation of compliance with GMP standards, batch records, analytical data, and stability profiles. Suppliers with approved inspections from FDA, EMA, and other agencies facilitate smoother registration and market approval processes. Audits and site visits remain critical before establishing long-term supply agreements.

Market Dynamics and Supply Chain Considerations

The sourcing landscape for olodaterol hydrochloride is influenced by factors such as:

• Pricing competitiveness: Chinese and Indian suppliers often offer lower-cost APIs, but regulatory differences may impact integration into certain markets.

• Supply stability: Long-term relationships with GMP-compliant suppliers ensure consistency amid geopolitical and logistical fluctuations.

• Regulatory approvals: Suppliers with established certifications streamline approval timelines and reduce compliance risks.

• Intellectual property (IP): While olodaterol hydrochloride is off-patent, contractual protections and confidentiality agreements remain vital.

Challenges and Risks in API Procurement

• Regulatory Barriers: Some API sources face scrutiny or delays due to non-compliance or inspection deficiencies.

• Quality Variability: Not all manufacturers maintain consistent quality standards; rigorous screening and audits are essential.

• Supply Chain Disruptions: Global disruptions, such as pandemics or geopolitical tensions, can affect supply availability and lead times.

• Intellectual Property and Patent Status: Sourcing from non-transparent suppliers may entail patent risks, although olodaterol hydrochloride is generally off-patent.

Conclusion

Sourcing high-quality bulk olodaterol hydrochloride API requires diligent supplier selection based on robust regulatory compliance, consistent quality, and reliable supply. Chinese and Indian manufacturers dominate the market, supplemented by European CMOs providing high-purity, high-standard APIs. Strategic partnerships with reputable suppliers, supported by thorough audits, regulatory evaluations, and quality assurance protocols, will ensure a resilient supply chain for pharmaceutical developers aiming to produce olodaterol-based therapies.

---

Key Takeaways

• The global API sourcing landscape for olodaterol hydrochloride is primarily led by Chinese and Indian manufacturers offering competitive pricing and extensive GMP-compliant production capacity.

• Quality assurance, regulatory compliance, and supplier transparency are critical factors in selecting an API supplier.

• European and North American suppliers tend to focus on high-purity APIs suitable for markets with stringent regulatory requirements.

• Contract manufacturing organizations expand the supply options, offering flexible and scalable synthesis services.

• Proactive supply chain management, including supplier audits and regulatory vetting, minimizes risks associated with quality variability and disruptions.

---

FAQs

1. Is olodaterol hydrochloride API available from multiple suppliers globally?
Yes. Multiple manufacturers across China, India, Europe, and North America produce olodaterol hydrochloride API, offering a range of options based on quality, cost, and regulatory compliance.

2. What certifications should I look for in an olodaterol hydrochloride API supplier?
Suppliers should hold GMP certification, with documentation compliant with FDA, EMA, or relevant regulatory bodies, including batch records, analytical data, and stability reports.

3. How does the price of olodaterol hydrochloride API vary across regions?
Chinese and Indian suppliers typically offer lower prices due to manufacturing cost advantages. European and North American suppliers may have higher costs but often provide APIs with higher regulatory acceptability for strict markets.

4. What are common quality concerns when sourcing olodaterol hydrochloride API?
Potential issues include impurity profiles, residual solvents, potency deviations, and batch-to-batch consistency. Thorough supplier audits and analytical testing mitigate these risks.

5. Are there risks associated with sourcing from emerging or less-established suppliers?
Yes. Risks include variable quality standards, regulatory non-compliance, and supply inconsistency. Due diligence, including site audits and regulatory verification, is essential before engagement.

---

References
[1] U.S. Food and Drug Administration (FDA). Guidance for Industry: API Drug Substance Master Files.
[2] European Medicines Agency (EMA). Guidelines on Good Manufacturing Practice.
[3] Pharmaceutical outsourcing reports and market analyses.
[4] Company websites and supplier registries.