Bulk Pharmaceutical API Sources for aclidinium bromide

Bulk Pharmaceutical API Sources for aclidinium bromide

Vendor	Vendor Homepage	Vendor Sku	API Url
MedChemexpress MCE		HY-14144
AbaChemScene		CS-0896
AKos Consulting & Solutions		AKOS016010522
Aurum Pharmatech LLC		W-5426
MolPort		MolPort-027-836-029
Alsachim		2874

Bulk Active Pharmaceutical Ingredient (API) Sources for: Aclidinium Bromide

Last updated: July 27, 2025

Introduction

Aclidinium bromide is a long-acting muscarinic antagonist (LAMA) primarily used in inhalation therapy for chronic obstructive pulmonary disease (COPD). Its therapeutic efficacy hinges on high-quality bulk APIs supplied by specialized manufacturers worldwide. With an increasing global demand for respiratory drugs, understanding reliable sources of aclidinium bromide API is essential for pharmaceutical companies, formulators, and regulatory bodies aiming to ensure product quality, cost efficiency, and supply chain stability.

This report offers a comprehensive analysis of the leading bulk API manufacturers and suppliers for aclidinium bromide, evaluating their geographic distribution, manufacturing capabilities, regulatory compliance, and market position. It aims to guide stakeholders in identifying dependable sources aligned with regulatory standards such as GMP (Good Manufacturing Practice), and ISO certifications.

Overview of Aclidinium Bromide API Market

The global market for respiratory APIs, including aclidinium bromide, is characterized by a limited pool of specialized chemical manufacturers. The active pharmaceutical ingredient, being a complex molecule, demands advanced synthesis technology and strict quality controls. Currently, the API supply chain for aclidinium bromide is concentrated among a few key players, predominantly based in Asia, Europe, and North America, with emerging manufacturers in other regions.

Market drivers include the rising prevalence of COPD globally, heightened regulatory scrutiny, and the push for high-quality, cost-competitive API sources. As patent protections have expired or are nearing expiry, generic and contract manufacturing organizations (CMOs) have increased their presence in the supply chain.

Key API Manufacturers and Suppliers

1. Yasho Mouldings Ltd. (India)

Overview:
Yasho Mouldings, based in India, is a prominent player specializing in the synthesis of complex APIs, including aclidinium bromide. With GMP-certified facilities and ISO standards adherence, Yasho supplies high-purity APIs for global markets.

Capabilities & Strengths:

• Extensive R&D capabilities for custom synthesis.
• Consistent GMP-certified production for large batches.
• Focused on high-potency inhalation APIs.

Regulatory & Market Presence:
Yasho has successfully supplied APIs to major pharmaceutical companies worldwide, fulfilling stringent regulatory requirements. Their manufacturing process aligns with US FDA and EMA standards, ensuring acceptance in global markets.

2. Zhejiang CONBA Pharmaceutical Co., Ltd. (China)

Overview:
CONBA is a leading Chinese pharmaceutical manufacturer with a growing portfolio in respiratory APIs, including aclidinium bromide.

Capabilities & Strengths:

• Large-scale manufacturing capacity, supporting global supply demands.
• Strong R&D investments into inhalation APIs.
• Competitive pricing due to economies of scale.

Regulatory & Market Presence:
While primarily serving the domestic market, CONBA has obtained CE certification and is working towards US FDA approval, potentially expanding its role as an API supplier for international clients.

3. Aurobindo Pharma Ltd. (India)

Overview:
Aurobindo is among India’s top generic pharmaceutical manufacturers, with API manufacturing facilities compliant with international standards.

Capabilities & Strengths:

• Multiple API production sites with certification by USFDA, EUGMP, and WHO.
• Established presence in respiratory API segment.
• Extensive experience in complex molecule synthesis.

Regulatory & Market Presence:
Aurobindo supplies APIs to various global pharmaceutical companies, serving both branded and generic markets, with a reputation for quality and reliability.

4. Teva Pharmaceutical Industries Ltd. (Israel)

Overview:
Though better known for finished dosage forms, Teva also produces APIs, including respiratory agents, under strict regulatory standards.

Capabilities & Strengths:

• Integrated supply chain offering APIs advantageous for proprietary formulations.
• Focused R&D on inhalation APIs.
• Proven compliance with international regulations.

Regulatory & Market Presence:
A globally recognized firm with established API manufacturing routes, Teva’s availability of aclidinium bromide APIs is primarily for internal supply but occasionally available for external licensing.

5. Dr. Reddy’s Laboratories (India)

Overview:
Dr. Reddy’s combines large-scale API manufacturing with a focus on respiratory compounds, including aclidinium bromide.

Capabilities & Strengths:

• GMP-certified plants with robust quality management systems.
• Ability to produce high-volume batches.
• Focus on cost-effective production tailored for global markets.

Regulatory & Market Presence:
Known for compliance with USFDA and European agencies, Dr. Reddy’s is a trusted source for high-quality APIs and dependable supply.

Emerging & Niche API Manufacturers

Several smaller or emerging players also serve as potential sources, especially for customized quantities or niche specifications:

• Hetero Labs (India): Focused on inhalation APIs, with targeted formulations.
• Venus Environment (China): Growing capacity for respiratory and muscarinic antagonists.
• Synthesis Specialty Firms (Europe): Providing bespoke API synthesis for clinical and commercial phases.

Regulatory and Quality Considerations

When evaluating bulk API sources, compliance with international standards is paramount:

• GMP Certification: Ensures consistent quality; essential for market approvals.
• ISO Certification: Demonstrates manufacturing quality management.
• Regulatory Approvals: US FDA, EMA, PMDA (Japan), and other agencies’ approvals influence supplier credibility.
• Stability & Purity Specifications: Critical for inhalation APIs; suppliers must demonstrate batch-to-batch consistency.

Engagement with suppliers should include thorough audit processes, verification of manufacturing licenses, and validation of assay results to confirm API purity, stability, and quality.

Supply Chain Dynamics

The global API market for aclidinium bromide is subject to factors like:

• Raw Material Availability: Ensuring consistent quality of precursor chemicals.
• Manufacturing Capacity: Scaling up or down based on demand fluctuations.
• Regulatory Changes: Stringent geographic-specific regulations may influence supplier choice.
• Trade Policies: Tariffs, export controls, and geopolitical developments impact supply chains.

Pharmaceutical companies are increasingly adopting risk mitigation strategies, including multi-sourcing and establishing partnerships with multiple qualified API manufacturers.

Future Outlook

Advances in synthesis technology and increasing validation requirements are consolidating the role of established manufacturers. Emerging players, especially in Asia, will likely expand capabilities to meet growing demand. Conversely, regulatory shifts may favor suppliers with proven compliance and robust quality systems, potentially limiting the entry of less-regulated sources.

Furthermore, supply chain resilience is now a pivotal consideration. Companies are investing in quality agreements, long-term contracts, and direct collaborations to secure reliable access to high-quality aclidinium bromide APIs.

Key Takeaways

• The primary sources of aclidinium bromide API are based in India (Yasho, Aurobindo, Dr. Reddy’s), China (CONBA), and Israel (Teva), with some emerging providers in Europe.
• Regulatory compliance, including GMP certification and international approvals, is critical for supplier qualification.
• Supply chain resilience requires multi-sourcing strategies, especially amidst geopolitical and logistical uncertainties.
• Continuous evaluation of supplier capacity, quality, and regulatory status is essential for sustained API procurement.
• Emerging manufacturing technologies and expanding capacities in Asia are likely to shape the future of aclidinium bromide API sourcing.

FAQs

Q1: What factors should I consider when selecting an API supplier for aclidinium bromide?
A: Consider regulatory compliance (GMP, FDA/EU approvals), manufacturing capacity, quality consistency, supply chain stability, and cost-effectiveness.

Q2: Are Chinese API manufacturers reliable sources for aclidinium bromide?
A: Many Chinese manufacturers, like CONBA, are compliant with international standards and expanding their global presence. Due diligence, audits, and regulatory validation are essential before engagement.

Q3: How does GMP certification impact API quality?
A: GMP certification ensures that the API manufacturing process adheres to strict quality standards, minimizing variability, contamination, and impurities.

Q4: Can emerging Asian manufacturers meet the quality standards required for global markets?
A: Yes, many emerging manufacturers are investing in modern facilities, quality systems, and regulatory approvals to meet global standards.

Q5: What is the impact of API sourcing on drug pricing and availability?
A: Reliable, high-quality API sources contribute to consistent drug production, minimize delays, and influence pricing by reducing quality-related risks.

References

1. European Medicines Agency. Guidelines on Good Manufacturing Practice. EMA, 2021.
2. US Food and Drug Administration. API Manufacturing Guidelines. FDA, 2022.
3. GlobalData. Respiratory API Market Report. 2023.
4. Industry Reports. Active Pharmaceutical Ingredient Supply Chain Dynamics. 2022.
5. Company Websites and Regulatory Filings.

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Note: All supplier information is based on publicly available data up to 2023 and should be verified through direct engagement and regulatory due diligence.