SPIRIVA RESPIMAT: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0100-28	1 CARTRIDGE in 1 CARTON (0597-0100-28) / 28 SPRAY, METERED in 1 CARTRIDGE	2014-09-30
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0100-51	1 CARTRIDGE in 1 CARTON (0597-0100-51) / 10 SPRAY, METERED in 1 CARTRIDGE	2014-09-30
Boehringer Ingelheim	SPIRIVA RESPIMAT	tiotropium bromide	SPRAY, METERED;INHALATION	021936	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0100-61	1 CARTRIDGE in 1 CARTON (0597-0100-61) / 60 SPRAY, METERED in 1 CARTRIDGE	2014-09-30
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 31, 2025

Introduction

SPIRIVA RESPIMAT, a leading medication for the management of chronic obstructive pulmonary disease (COPD) and asthma, has established itself in the global respiratory market. Developed and marketed primarily by Boehringer Ingelheim, this inhalation device delivers tiotropium bromide, a long-acting anticholinergic agent. Its widespread adoption hinges on a diverse supplier ecosystem spanning active pharmaceutical ingredient (API) manufacturing, device components, packaging, and distribution channels. This article delineates the key suppliers across the SPIRIVA RESPIMAT supply chain, analyzing their roles, geographic distribution, and strategic importance.

Active Pharmaceutical Ingredient (API) Suppliers

At the core of SPIRIVA RESPIMAT is tiotropium bromide, the API. Boehringer Ingelheim maintains strict control over its manufacturing, but it collaborates with several specialized API manufacturers globally.

Key API Manufacturers

Cipla Ltd. (India): One of the prominent suppliers for European and Asian markets, Cipla produces tiotropium bromide API under stringent quality standards, supported by approvals from regulatory authorities such as the EMA and the PMDA.
ALMAC Group (Northern Ireland): Known for advanced synthesis capabilities, ALMAC has provided high-grade APIs and intermediate compounds, ensuring production continuity and quality.
Luye Pharma (China): Engaged in API production for emerging markets, Luye Pharma supplements supply by leveraging its well-established manufacturing processes conforming to international GMP standards.

Although Boehringer Ingelheim produces the API in-house in some facilities, dependence on external suppliers for cost-effectiveness and capacity reasons is common in the industry.

Regulatory and Quality Considerations

API suppliers must adhere to strict Good Manufacturing Practice (GMP) standards, ensuring purity, potency, and safety. Regulatory agencies like the FDA, EMA, and PMDA monitor API manufacturing facilities, making supplier audits and approvals vital.

Device Components and Assembly Suppliers

SPIRIVA RESPIMAT is delivered via a proprietary Soft Mist inhaler. The device comprises several critical components, including the actuator, reservoir (cartridge), and spray mechanism.

Device Manufacturing and Suppliers

Boehringer Ingelheim Manufacturing Facilities: The primary assembly occurs within the company's facilities in Germany and the U.S., where quality standards align with ISO 13485.
Component Suppliers: Several specialized companies provide sub-components:
- Precision Machine Manufacturers (Germany & Switzerland): These firms supply high-precision springs, valves, and nozzle parts essential for consistent aerosol generation.
- Plastic Moulding Suppliers (Asia and Europe): Suppliers such as Sumitomo Bakelite and other plastic component manufacturers provide reservoirs and actuator shells, complying with medical-grade plastics standards.
Coating and Packaging Suppliers
- Pharmaceutical Packaging Companies: Companies like Gerresheimer and Schott provide specialized glass and plastic cartridges, featuring barrier coatings to maintain drug stability.
- Labeling and Package Design: Suppliers like Multicolor (U.K.) and Schreiner Group (Germany) produce tamper-evident and child-resistant packaging components.

Formulation and Packaging Suppliers

Formulation Services

While Boehringer Ingelheim centrally formulates the drug, contract manufacturing organizations (CMOs) provide fill-finish services, ensuring sterile production and packaging integrity.

Swiss-based Lonza: A key CMO for sterile filling, lyophilization, and packaging.
Catalent (USA): Provides sterile filling, blister packaging, and serialization services, supporting global distribution.

Primary Packaging Suppliers

Schott AG: Supplies medical-grade glass cartridges and vials.
Multicolor Corporation: Provides labeling materials optimized for durability and compliance.

Distribution and Logistics Suppliers

Distribution chains for SPIRIVA RESPIMAT involve global logistics providers ensuring timely delivery across continents.

DHL and UPS: Main freight carriers managing temperature-sensitive shipments.
Cold Chain Logistics Firms: Specialized providers like Cryoport support shipping in temperature-controlled environments, critical to maintaining drug stability.

Regulatory and Quality Assurance Providers

GSTs (Good Supply Chain Practices) and third-party audit firms like NSF International and UL International verify supplier compliance with international standards, ensuring supply chain integrity.

Regional Variations in Supplier Ecosystem

While Boehringer Ingelheim maintains core control over formulation and device assembly, regional manufacturing partners fill supply gaps:

North America and Europe: Manufacturing largely performed within Boehringer facilities or approved third-party CMOs.
Asia-Pacific: Increased reliance on regional suppliers for cost efficiencies, including API production and device components.
Emerging Markets: Local partnerships enable broader access and reduce logistical costs, with suppliers adhering to international standards.

Strategic Considerations for Stakeholders

Quality Assurance: Compatibility of suppliers with GMP, ISO 13485, and other standards is paramount.
Supply Chain Resilience: Diversification of supplier base mitigates risks associated with geopolitical, regulatory, or logistical disruptions.
Cost Management: Balancing high-quality supplier partnerships with cost efficiency influences pricing strategies and market penetration.
Regulatory Compliance: Suppliers must stay aligned with evolving regulations, including serialization, track-and-trace, and environmental standards.

Key Takeaways

The core API for SPIRIVA RESPIMAT, tiotropium bromide, is sourced globally from reputable manufacturers like Cipla, ALMAC, and Luye Pharma, aligning with regulatory standards.
Device component manufacturing depends on high-precision suppliers in Europe and Asia, emphasizing quality and device performance consistency.
Formulation, fill-finish, and packaging are managed through established CMOs to ensure sterility and compliance, with a focus on global distribution.
Strategic supplier management enhances supply chain resilience amid regulatory, geopolitical, and logistical challenges.
Continuous evaluation of supplier quality, capacity, and compliance remains essential to sustain SPIRIVA RESPONSIVE market supply and maintain brand reputation.

FAQs

1. Who are the primary API suppliers for tiotropium bromide used in SPIRIVA RESPIMAT?
Main API suppliers include Cipla Ltd., ALMAC Group, and Luye Pharma, each adhering to global GMP standards to ensure quality and supply continuity.

2. Are there regional differences in the manufacturing of SPIRIVA RESPIMAT components?
Yes. While core manufacturing occurs in Europe and North America, regional partners in Asia-Pacific support local markets, especially for device components and packaging.

3. Does Boehringer Ingelheim manufacture the entire SPIRIVA RESPIMAT supply chain in-house?
No. Strategic partnerships with CMOs and component suppliers enable scalable and cost-effective production while maintaining quality standards.

4. How does supplier quality assurance impact the overall stability of SPIRIVA RESPIMAT supply?
Stringent supplier qualification, audits, and ongoing compliance monitoring ensure product integrity, minimizing supply disruptions and supporting regulatory adherence.

5. What are the key considerations for selecting suppliers for respiratory inhalers like SPIRIVA RESPIMAT?
Criteria include GMP compliance, manufacturing capacity, supply chain reliability, quality control levels, regulatory track record, and cost efficiency.

References

[1] Boehringer Ingelheim. (2022). SPIRIVA RESPIMAT product information.
[2] European Medicines Agency. (2023). API supplier approvals for respiratory medicines.
[3] ISO 13485:2016. Medical devices — Quality management systems — Requirements for regulatory purposes.
[4] GMP Guidelines. World Health Organization. (2021).
[5] DHL Supply Chain. (2022). Cold chain logistics in pharmaceutical industry.

Suppliers and packagers for SPIRIVA RESPIMAT