Suppliers and packagers for generic pharmaceutical drug: aclidinium bromide

aclidinium bromide

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450	NDA	Covis Pharma US, Inc	70515-002-01	1 POUCH in 1 CARTON (70515-002-01) / 1 INHALER in 1 POUCH / 60 POWDER, METERED in 1 INHALER	2015-07-01
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450	NDA	Covis Pharma US, Inc	70515-002-02	1 POUCH in 1 CARTON (70515-002-02) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER	2015-07-01
Covis	TUDORZA PRESSAIR	aclidinium bromide	POWDER, METERED;INHALATION	202450	NDA	Covis Pharma US, Inc	70515-002-03	1 POUCH in 1 CARTON (70515-002-03) / 1 INHALER in 1 POUCH / 30 POWDER, METERED in 1 INHALER	2015-07-01

Suppliers for the Pharmaceutical Drug: Aclidinium Bromide

Last updated: August 1, 2025

Introduction

Aclidinium bromide, a long-acting muscarinic antagonist (LAMA), is primarily used in the management of chronic obstructive pulmonary disease (COPD). Its efficacy in bronchodilation, combined with a favorable safety profile, has established it as a key therapeutic agent. As demand for COPD treatments grows, identifying reliable suppliers for aclidinium bromide becomes critical for pharmaceutical companies, healthcare providers, and generic manufacturers. This article provides a comprehensive overview of current suppliers, manufacturing landscapes, and procurement considerations for aclidinium bromide.

Overview of Aclidinium Bromide

Aclidinium bromide presents as a quaternary ammonium compound with inhalation delivery. Its mechanism involves competitive inhibition of muscarinic receptors in the airway smooth muscle, resulting in bronchodilation. Approved by regulatory agencies such as the FDA and EMA, aclidinium bromide is marketed under brand names like Tudorza Pressair (FDA) and Bretaris Genuair (EMA). The active pharmaceutical ingredient (API) is synthesized through complex processes involving specialized chemical manufacturing.

Major Suppliers of Aclidinium Bromide API

The supply chain for aclidinium bromide is concentrated among a few key pharmaceutical manufacturers, primarily within China, India, and Europe. These regions host facilities with the capacity for producing bulk API at commercial scales, complying with Good Manufacturing Practices (GMP):

1. Suzhou Zhejiang Aleidian Pharmaceutical Co., Ltd. (China)

   • Overview: This Chinese manufacturer is recognized for producing high-quality aclidinium bromide API, serving both domestic and international markets.
   • Capabilities: GMP-compliant facilities with scalable manufacturing processes.
   • Certifications: EU-GMP, WHO-GMP, and ISO certifications.

2. Hetero Labs Limited (India)

   • Overview: Hetero is a prominent global contract manufacturer specializing in respiratory APIs and formulations.
   • Capabilities: Extensive API manufacturing capacity for bronchodilators, including aclidinium bromide.
   • Portfolio: Supplies to multiple multinational pharmaceutical companies and private labels.

3. Siegfried AG (Switzerland)

   • Overview: Siegfried's integrated manufacturing infrastructure includes API synthesis and formulation development.
   • Capabilities: Production of complex inhalation APIs, including aclidinium bromide, with a focus on quality and regulatory compliance.

4. Merck KGaA (Germany)

   • Overview: As a leading innovator in respiratory drugs, Merck’s manufacturing units produce and supply APIs linked to respiratory therapies, potentially including aclidinium bromide through licensing or partnerships.

5. Other Emerging Suppliers
   Several smaller or regional players in India, China, and Southeast Asia are gradually entering the market, offering competitive pricing for API procurement. Their authenticity and quality should be validated through audits and documentation checks.

Contract Manufacturing and OEM Partners

In addition to in-house production, many pharmaceutical entities outsource aclidinium bromide synthesis to Contract Manufacturing Organizations (CMOs). CMOs with GMP accreditation provide scalable production, quality assurance, and regulatory compliance, enabling rapid market entry and supply chain flexibility:

• Lonza Group
• BASF
• Recipharm

While not all these CMOs produce aclidinium bromide explicitly, their capabilities in inhalation API manufacturing make them potential partners.

Distribution Channels and Wholesalers

Once API is produced, it moves through distributors and wholesalers to pharmaceutical formulators and generic manufacturers. Major chemical intermediaries and API distributors globally include:

• Thermo Fisher Scientific
• AB Specialty Ingredients
• Fresenius Kabi

These players facilitate bulk API distribution, often holding stock to meet fluctuating demand.

Regulatory and Quality Considerations

API suppliers must meet stringent regulatory standards, including GMP compliance, stability, and purity specifications. Suppliers with multiple certifications (e.g., EU-GMP, USFDA) typically offer higher confidence levels for supply continuity and regulatory approvals in different jurisdictions.

Market Trends and Procurement Strategies

The globalization of supply chains fosters competitive pricing and diversification, mitigating risks related to geopolitical or manufacturing disruptions. Procurement agencies increasingly favor suppliers with proven regulatory dossiers, validated manufacturing practices, and robust quality management systems. Strategic alliances with established suppliers reduce time-to-market and ensure stability of supply.

Future Outlook

The demand for aclidinium bromide is poised to grow alongside COPD prevalence worldwide. This growth will incentivize new entrants and capacity expansions among existing suppliers. Innovations in synthesis processes—including greener chemistry approaches—may also reshape supply dynamics by enhancing quality and yield efficiencies.

Conclusion

Securing reliable suppliers for aclidinium bromide requires rigorous evaluation of manufacturing certifications, supply stability, and product quality. Leading manufacturers such as Suzhou Zhejiang Aleidian Pharmaceutical, Hetero Labs, and Siegfried AG dominate the API landscape. Engaging with these suppliers through verified channels and ensuring adherence to regulatory standards will optimize procurement strategies for pharmaceutical companies and formulators.

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Key Takeaways

• Major Suppliers: Top API producers include Chinese (Suzhou Zhejiang Aleidian), Indian (Hetero Labs), and European (Siegfried, Merck) manufacturers with GMP certification.
• Supply Chain Dynamics: Globalization and contract manufacturing expand options but require due diligence for quality and compliance.
• Regulatory Compliance: Suppliers with multiple certifications are preferred for regulatory acceptance and supply security.
• Market Growth: Increasing COPD prevalence will elevate demand, prompting capacity expansion and new supplier entry.
• Procurement Strategy: Diversify sourcing, verify supplier credentials, and prioritize quality certifications to ensure consistent supply.

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FAQs

1. Who are the leading global suppliers of aclidinium bromide API?
Leading suppliers include Suzhou Zhejiang Aleidian Pharmaceutical (China), Hetero Labs (India), and Siegfried AG (Switzerland), all of which hold GMP certifications and supply to international markets.

2. What criteria should be considered when selecting an aclidinium bromide supplier?
Key criteria include GMP certification, regulatory compliance, product purity and stability data, production capacity, supply reliability, and adherence to global quality standards.

3. Are there regional differences in aclidinium bromide suppliers?
Yes, Asian manufacturers (China and India) dominate global production due to cost advantages and extensive capacity, while European suppliers emphasize high regulatory compliance and quality assurance.

4. Can I source aclidinium bromide from contract manufacturing organizations?
Yes, CMOs with proven inhalation API manufacturing capabilities and GMP accreditation are potential partners for sourcing aclidinium bromide at scale.

5. What is the future outlook for the supply chain of aclidinium bromide?
The growing COPD market will lead to increased capacity expansion, new entrants, and technological innovations in API synthesis, enhancing global supply resilience and reducing costs.

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References

[1] U.S. Food and Drug Administration (FDA). "Aclidinium Bromide." Drugs@FDA.
[2] European Medicines Agency (EMA). "Aclidinium Bromide Summary."
[3] Chinese pharmaceutical manufacturer database. "Suzhou Zhejiang Aleidian Pharmaceutical."
[4] Hetero Labs Ltd. Corporate website and API manufacturing capabilities.
[5] Siegfried AG. “API Manufacturing for Respiratory Drugs.”