Suppliers and packagers for STRIVERDI RESPIMAT

STRIVERDI RESPIMAT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Boehringer Ingelheim	STRIVERDI RESPIMAT	olodaterol hydrochloride	SPRAY, METERED;INHALATION	203108	NDA	Boehringer Ingelheim Pharmaceuticals, Inc.	0597-0192-61	1 CARTRIDGE in 1 CARTON (0597-0192-61) / 60 SPRAY, METERED in 1 CARTRIDGE	2014-08-01

Suppliers for the Pharmaceutical Drug: STRIVERDI RESPIMAT

Last updated: August 9, 2025

Introduction

Striverdi Respimat, marketed as Olodaterol in medical literature, is a long-acting beta2-adrenergic receptor agonist (LABA) indicated primarily for maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). Since its approval by the U.S. Food and Drug Administration (FDA) in 2014, the drug has become an integral component of COPD management. The supply chain for Striverdi Respimat hinges upon a combination of active pharmaceutical ingredient (API) producers, inhaler device manufacturers, and authorized distributors. This analysis delineates the key suppliers underpinning the manufacturing and distribution of Striverdi Respimat, emphasizing API sourcing, device production, and supply chain dynamics.

Active Pharmaceutical Ingredient (API) Suppliers

The crux of Striverdi Respimat’s efficacy centers on its API—Olodaterol. The API's procurement influences product quality, regulatory compliance, and manufacturing continuity.

1. API Manufacturing and Supply

   Olodaterol is synthesized via a multistep chemical process involving intricate organic synthesis techniques. The original API manufacturing license was granted to Boehringer Ingelheim, the innovator pharmaceutical company responsible for commercializing Striverdi Respimat. Boehringer Ingelheim maintains primary control over API production, collaborating with specialized active pharmaceutical ingredient manufacturers.

   Key API Suppliers:

   • Boehringer Ingelheim: As the innovator and patent holder, Boehringer Ingelheim primarily produces Olodaterol API internally, ensuring strict quality control aligned with regulatory standards (EMA, FDA). The company has invested in compliant manufacturing facilities to support global supply needs.

   • Contract Manufacturing Organizations (CMOs): While Boehringer Ingelheim predominantly produces the API in-house, it engages select CMOs for large-scale synthesis and supply chain flexibility. These partners include specialty chemical manufacturers with cGMP (current Good Manufacturing Practice) certifications.

   • Third-party API Providers: An extensive due diligence process ensures that only API sourced from approved, qualified vendors, adhering to pharmacopoeial standards, is used. The specifics of secondary API suppliers remain confidential due to competitive and regulatory reasons.

2. Supply Chain Dynamics for API

   Global supply chains for Olodaterol API are subject to rigorous quality, regulatory, and logistical standards. The COVID-19 pandemic and geopolitical factors have sporadically impacted supply chain stability, prompting manufacturers to diversify API sourcing and bolster inventory buffers.

Device Manufacturing and Suppliers

Striverdi Respimat employs the Respimat Soft Mist Inhaler device, co-developed by Boehringer Ingelheim and M3 Devices (a joint venture), which is essential for drug delivery and patient adherence.

1. Inhaler Device Production

   • Respimat Device Manufacturing: Boehringer Ingelheim oversees the assembly and production of the Respimat inhalers through partnerships with specialized medical device manufacturers. These vendors are ISO 13485-certified and supply the inhaler shells and related components.

   • Equipment Suppliers: Components such as springs, actuators, and canisters are sourced from high-precision engineering firms. Major global suppliers include companies like AptarGroup and Gerresheimer, which provide drug delivery system components.

2. Component and Raw Material Suppliers

   • Canisters and Actuators: Medical-grade aluminum, plastics, and elastomers are procured from suppliers with stringent quality standards. These materials are critical for ensuring device integrity and dose accuracy.

   • Springs and Mechanical Parts: Suppliers of micro-mechanical components supply parts that enable inhaler actuation and dose release.

Distribution and Logistics

In the distribution phase, manufacturers engage logistics providers with expertise in cold chain management, inventory control, and regulatory compliance.

• Authorized Distributors: Boehringer Ingelheim partners with regional distributors and wholesalers to supply Striverdi Respimat to pharmacies and hospitals globally.

• Global Logistics Providers: For international shipping, third-party logistics (3PL) firms like DHL, FedEx, and UPS facilitate timely delivery, emphasizing temperature-controlled environments where necessary.

Regulatory and Quality Assurance

Ensuring uninterrupted supply necessitates adherence to strict quality standards. The implicated suppliers—API producers, device manufacturers, component suppliers—adhere to regulatory frameworks stipulated by agencies like the FDA, EMA, and other national authorities. Regular audits, certifications, and quality checks are integral to maintaining supply chain integrity.

Mitigating Supply Chain Risks

Boehringer Ingelheim employs strategic initiatives to mitigate risks associated with raw material shortages, geopolitical disruptions, and manufacturing interruptions. These include supplier diversification, inventory safety stocks, and dual-source arrangements for critical components.

Conclusion

The supply of Striverdi Respimat is underpinned by a network of key suppliers specializing in API production, device manufacturing, and component sourcing. The core API—Olodaterol—is predominantly manufactured by Boehringer Ingelheim, sometimes supplemented by contract manufacturers. Inhaler devices and their components are produced via collaborations with specialized device manufacturers and component suppliers globally. The entire supply chain operates within a robust regulatory and quality framework to ensure product availability, safety, and efficacy.

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Key Takeaways

• The primary API supplier for Striverdi Respimat is Boehringer Ingelheim, with some reliance on contracted CMOs and third-party vendors.
• Device manufacturing involves collaborations with global medical device suppliers specializing in inhaler components.
• Supply chain stability relies on rigorous regulatory compliance, supplier diversification, and strategic inventory planning.
• Disruptions—such as geopolitical issues or global crises—necessitate contingency strategies including sourcing diversification and increased safety stocks.
• Ongoing quality assurance and regulatory oversight are critical to maintaining supply continuity for this COPD medication.

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FAQs

1. Who are the main API suppliers for Striverdi Respimat?
Boehringer Ingelheim primarily produces the Olodaterol API in-house, often supported by contracted contract manufacturing organizations (CMOs) with cGMP certification to ensure supply flexibility and robustness.

2. Are there multiple suppliers for the inhaler components?
Yes. Components like canisters, actuators, and springs are sourced from multiple qualified suppliers such as AptarGroup and Gerresheimer to mitigate supply risks and meet quality standards.

3. How does supply chain risk affect the availability of Striverdi Respimat?
Supply chain disruptions—due to manufacturing issues, raw material shortages, or geopolitical events—can impact product availability. Strategic sourcing, inventory buffers, and diversified supplier networks help mitigate these risks.

4. Is the manufacturing process for Striverdi Respimat compliant with global quality standards?
Absolutely. All suppliers involved adhere to international standards such as ISO 13485, cGMP, and regulatory requirements set by health authorities like the FDA and EMA.

5. Can suppliers for Striverdi Respimat change over time?
Yes, to ensure supply continuity and cost efficiency, manufacturers may switch or add suppliers, provided they meet strict quality and regulatory criteria and undergo thorough validation.

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Sources

1. Boehringer Ingelheim. (2022). Boehringer Ingelheim’s production of Olodaterol API.
2. U.S. Food and Drug Administration (FDA). (2014). Approval of Striverdi Respimat.
3. EMA. (2014). Pharmacovigilance and manufacturing standards for respiratory inhalers.
4. AptarGroup. [Corporate website].
5. Gerresheimer. [Corporate website].