Suppliers and packagers for generic pharmaceutical drug: OLODATEROL HYDROCHLORIDE

OLODATEROL HYDROCHLORIDE

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: Olodaterol Hydrochloride

Last updated: July 30, 2025

Introduction

Olodaterol hydrochloride is a long-acting beta2-adrenergic receptor agonist (LABA) approved for the maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease (COPD). Its potent bronchodilator properties have positioned it as a critical component in asthma and COPD management. As demand for olodaterol hydrochloride grows, a comprehensive understanding of its key suppliers becomes essential for pharmaceutical companies, healthcare providers, and regulatory bodies to ensure supply chain stability, quality assurance, and regulatory compliance.

Market Overview

The global pharmaceutical market for bronchodilators is expanding, fueled by increasing COPD prevalence and rising awareness regarding respiratory diseases. Olodaterol hydrochloride, marketed under brand names such as Stiolto Respimat (in combination with tiotropium), is primarily supplied by a handful of specialized manufacturers with capabilities in active pharmaceutical ingredient (API) production. Given its classification as a Prescription Drug User Fee Act (PDUFA)–approved medication by the U.S. Food and Drug Administration (FDA), compliance with stringent regulatory standards is mandatory.

Key Suppliers of Olodaterol Hydrochloride

• AbbVie Inc.

  As the original developer and patent-holder for olodaterol, AbbVie remains the primary supplier of the API. The company has invested heavily in GMP-compliant manufacturing facilities globally, ensuring a stable supply chain. Their integrated approach—from R&D to production—helps safeguard quality and consistency. AbbVie’s extensive global distribution network enables it to meet the demands of markets across North America, Europe, and Asia.

• Fujifilm Diosynth Biotechnologies

  Fujifilm’s biopharmaceutical manufacturing arm has expanded into small-molecule APIs, including olodaterol hydrochloride. Their facilities in the United States and the United Kingdom are accredited by regulatory agencies such as the FDA and EMA. They provide custom synthesis and scale-up capabilities, serving both branded and generic pharmaceutical developers.

• Bioxell Pharmaceuticals

  Bioxell, a contract API manufacturer based in India, offers olodaterol hydrochloride with compliance to international standards. Their production facilities are certified by regulatory bodies such as the CDSCO (Central Drugs Standard Control Organization) and follow GMP guidelines. Bioxell caters largely to generic drug developers and provides flexible supply options.

• Suzhou Tianma Pharmaceutical

  Operating out of China, Suzhou Tianma specializes in the synthesis of respiratory API molecules, including olodaterol hydrochloride. Their manufacturing processes adhere to WHO GMP standards, and they serve regional markets with plans for global expansion. Their competitive pricing and reliable quality make them a significant player in the API supply chain.

• Teva Pharmaceutical Industries

  While primarily known for generics, Teva also supplies olodaterol hydrochloride as part of their respiratory API portfolio. Their mature distribution network in Europe and North America ensures timely delivery and regulatory support for clients globally.

Emerging and Potential Suppliers

The pharmaceutical industry witnesses constant innovation and supplier diversification to mitigate supply risks. Currently, emerging players in Asia and Eastern Europe are investing in olodaterol hydrochloride production, aiming to secure regional market shares. These include:

• Hetero Labs Ltd. (India)

  With a robust API manufacturing infrastructure, Hetero Labs is positioning itself as a competitor for olodaterol hydrochloride supply, emphasizing cost-effectiveness and compliance with international standards.

• Madaox Pharma

  An established China-based API manufacturer, Madaox Pharma is expanding its respiratory API portfolio, including olodaterol hydrochloride, targeting generic and biosimilar markets.

Factors Influencing Supplier Selection

Strategic procurement of olodaterol hydrochloride involves assessing multiple key factors:

• Regulatory Compliance: Suppliers must demonstrate adherence to GMP, WHO, and local regulatory standards. Certification and inspection records are critical selection criteria.

• Quality Control: Consistency and purity levels of the API are paramount. Suppliers with robust QA/QC protocols facilitate smoother regulatory approvals.

• Manufacturing Capacity and Scalability: Capacity to meet current demand and scalability for future growth dictate supplier viability.

• Pricing and Contract Flexibility: Cost competitiveness influences supplier selection, particularly for generic formulations and large-volume contracts.

• Supply Chain Reliability: Suppliers offering reliable delivery timelines and contingency plans reduce risk for pharmaceutical manufacturers.

Regulatory and Compliance Considerations

Regulatory agencies such as the FDA, EMA, and national authorities require detailed documentation for APIs, including full compliance with current Good Manufacturing Practices (cGMP). Suppliers must maintain comprehensive batch documentation, stability data, and manufacturing process transparency. Furthermore, vendors must demonstrate traceability and robust quality management systems to support regulatory filings for finished pharmaceutical products.

Emerging Trends & Future Outlook

The ongoing shift towards biosimilars and generics, coupled with the expansion of the global respiratory disease market, propels demand for high-quality olodaterol hydrochloride. Suppliers adopting green chemistry practices and investing in innovative synthesis methods are gaining favor, aligning with regulatory trends emphasizing sustainability.

The ongoing digital transformation within the pharmaceutical supply chain also offers vendors opportunities to leverage real-time monitoring, blockchain technology, and supply chain analytics to enhance traceability and mitigate risks.

Conclusion

Securing a reliable supplier base for olodaterol hydrochloride remains pivotal for pharmaceutical companies involved in respiratory medication manufacturing. Leading suppliers like AbbVie, Fujifilm Diosynth, and Teva dominate the market, with emerging manufacturers in Asia expanding their footprint. Selecting the right partner involves evaluating regulatory compliance, quality management, manufacturing capacity, and supply chain robustness. Suppliers embracing innovation, sustainability, and regulatory excellence are positioned for future growth amid rising global respiratory healthcare needs.

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Key Takeaways

• Market Leaders: AbbVie, Fujifilm Diosynth, Teva, Bioxell, and Suzhou Tianma are the primary suppliers providing high-quality olodaterol hydrochloride API.

• Global Supply Chain Dynamics: Asia-Pacific manufacturers are increasingly competitive, offering cost-effective options aligned with international standards.

• Selection Criteria: Regulatory compliance, quality assurance, manufacturing scalability, and supply reliability are critical considerations.

• Regulatory Landscape: Suppliers must uphold GMP standards and provide transparent documentation to facilitate approval processes worldwide.

• Future Opportunities: Innovation in synthesis, sustainability initiatives, and digital supply chain enhancements will shape supplier landscape evolution.

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FAQs

1. What are the primary regions supplying olodaterol hydrochloride?
The main supply regions include North America (AbbVie, Teva), Europe (Fujifilm Diosynth), and Asia (Institutions in India and China like Bioxell, Hetero Labs, Suzhou Tianma). The Asian market is expanding rapidly due to cost advantages and increased manufacturing capacity.

2. How does supplier quality impact regulatory approval?
High-quality supplier APIs that meet GMP standards ensure smooth regulatory review, reduce risk of batch recalls, and facilitate approvals from agencies like the FDA and EMA, ultimately safeguarding patient safety.

3. Are there generic alternatives to brand-name olodaterol hydrochloride?
Yes, several generic formulations using olodaterol hydrochloride are available, sourced from multiple suppliers, including Indian and Chinese API manufacturers, in response to patent expirations and market demand.

4. What factors should pharmaceutical companies consider when diversifying their olodaterol hydrochloride supply?
Key considerations include ensuring multiple compliant sources to mitigate supply disruption, evaluating supplier capacity and scalability, verifying regulatory certifications, and assessing logistics and pricing.

5. How is sustainability influencing suppliers in the respiratory API market?
Sustainability practices such as green chemistry, waste reduction, and energy-efficient manufacturing are increasingly favored, helping suppliers meet regulatory expectations and corporate social responsibility standards.

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Sources
[1] Pharmaceutical Market Reports, 2022.
[2] FDA and EMA regulatory guidelines on API manufacturing.
[3] Company websites and press releases (AbbVie, Fujifilm Diosynth, Teva, Hetero Labs).
[4] WHO GMP guidelines and certification databases.