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Last Updated: July 28, 2025

Suppliers and packagers for generic pharmaceutical drug: BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE


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BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE

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

ApplicantTradenameGeneric NameDosageNDANDA/ANDASupplierPackage CodePackageMarketing Start
Astrazeneca Ab BREZTRI AEROSPHERE budesonide; formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 212122 NDA AstraZeneca Pharmaceuticals LP 0310-4616-12 120 AEROSOL, METERED in 1 INHALER (0310-4616-12) 2020-07-23
Astrazeneca Ab BREZTRI AEROSPHERE budesonide; formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 212122 NDA AstraZeneca Pharmaceuticals LP 0310-4616-28 28 AEROSOL, METERED in 1 INHALER (0310-4616-28) 2020-07-23
Astrazeneca Ab BREZTRI AEROSPHERE budesonide; formoterol fumarate; glycopyrrolate AEROSOL, METERED;INHALATION 212122 NDA AstraZeneca Pharmaceuticals LP 0310-4616-39 28 AEROSOL, METERED in 1 INHALER (0310-4616-39) 2020-07-23
>Applicant>Tradename>Generic Name>Dosage>NDA>NDA/ANDA>Supplier>Package Code>Package>Marketing Start
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Key Suppliers for Budesonide, Formoterol Fumarate, and Glycopyrrolate in the Pharmaceutical Industry

Last updated: July 27, 2025

Introduction to the Compounds

Budesonide, formoterol fumarate, and glycopyrrolate represent critical active pharmaceutical ingredients (APIs) in respiratory treatments, particularly for chronic obstructive pulmonary disease (COPD) and asthma. Budesonide, a corticosteroid, reduces inflammation in the airways, while formoterol fumarate, a long-acting beta-agonist, relaxes bronchial muscles to ease breathing. Glycopyrrolate, an anticholinergic, helps prevent bronchospasm by blocking certain nerve signals. These compounds often appear in combination therapies, such as AstraZeneca's Breztri Aerosphere, which gained FDA approval in 2020 for COPD maintenance.

For business professionals navigating the pharmaceutical supply chain, understanding suppliers is essential. It influences sourcing strategies, cost management, and compliance with patents and regulations. This analysis delves into key suppliers, patent dynamics, and market forces shaping availability, helping stakeholders identify reliable partners amid global supply challenges.

Overview of the Drugs and Their Applications

These APIs drive demand in the respiratory market, projected to exceed $50 billion annually by 2025. Budesonide treats conditions like asthma and allergic rhinitis, often in inhaler forms such as AstraZeneca's Symbicort. Formoterol fumarate enhances bronchodilation in products like GlaxoSmithKline's Foradil, while glycopyrrolate features in Seebri Breezhaler by Sunovion Pharmaceuticals for COPD.

Combination products like Breztri integrate all three, offering triple therapy that improves patient outcomes by addressing inflammation, bronchodilation, and mucus clearance. This synergy boosts efficacy but complicates supply chains, as manufacturers must source high-purity APIs from certified suppliers. In 2023, global demand surged due to rising COPD prevalence, affecting over 200 million people worldwide, per World Health Organization data.

Procuring these ingredients involves navigating a fragmented market. Leading pharmaceutical firms rely on contract manufacturers and API producers to ensure consistent quality and scale. For instance, AstraZeneca partners with specialized suppliers to meet production needs, underscoring the role of strategic alliances in maintaining market share.

Major Suppliers and Manufacturers

The supply landscape for budesonide, formoterol fumarate, and glycopyrrolate features a mix of original equipment manufacturers (OEMs) and generic producers. AstraZeneca dominates as a key end-product manufacturer for combinations like Breztri, sourcing APIs from established players. In Europe and North America, Cipla Limited emerges as a primary supplier for budesonide, leveraging its facilities in India to produce cost-effective, GMP-compliant APIs. Cipla's 2022 annual report highlights its capacity to supply over 1,000 metric tons of respiratory APIs annually, making it a go-to for generics.

For formoterol fumarate, Teva Pharmaceutical Industries leads as a major supplier, with operations in Israel and the U.S. Teva's extensive portfolio includes API manufacturing for inhalers, supported by its acquisition of Barr Pharmaceuticals in 2008, which expanded its respiratory capabilities. In 2023, Teva supplied formoterol to multiple generic drugmakers, capitalizing on patent expirations to capture market share.

Glycopyrrolate sourcing centers on Sandoz, a Novartis division, which produces the API at its European plants. Sandoz reported supplying glycopyrrolate to over 50 countries in its 2023 sustainability report, emphasizing scalable production amid regulatory scrutiny. Other notable suppliers include Dr. Reddy's Laboratories for budesonide and Mylan (now part of Viatris) for formoterol, both offering competitive pricing for emerging markets.

In Asia, Chinese firms like Zhejiang Xianju Pharmaceutical gain traction for bulk glycopyrrolate production, though quality concerns have prompted Western buyers to favor U.S. and EU-based suppliers for critical applications. This shift reflects post-COVID supply chain resilience efforts, with companies like AstraZeneca diversifying sources to mitigate risks. For example, in 2022, AstraZeneca announced partnerships with U.S.-based Cambrex Corporation for API synthesis, enhancing domestic production capabilities.

Business leaders must evaluate suppliers based on metrics like delivery reliability and cost. A 2023 IQVIA report indicates that top suppliers maintain 95% on-time delivery rates, crucial for time-sensitive respiratory drugs. Selecting the right partner can reduce costs by up to 20% through bulk agreements, as seen with Teva's contracts.

Patent Landscape and Intellectual Property

Patents significantly influence supplier dynamics for these APIs. Budesonide's core patents, held by AstraZeneca, expired in the U.S. by 2012, opening doors for generics. However, combination formulations like Breztri remain protected until 2035 under U.S. Patent No. 10,500,254, limiting generic entry and favoring original suppliers.

Formoterol fumarate's patents, originally filed by AstraZeneca and Skyepharma, expired in major markets by 2015, enabling widespread generic production. Teva capitalized on this, filing for its own patents on improved delivery systems, such as U.S. Patent No. 9,808,584 in 2017, which extends its market control.

Glycopyrrolate faces similar patent pressures; Novartis's patents expired in 2020, but new ones for enhanced formulations persist. For instance, Sunovion's U.S. Patent No. 8,501,810, expiring in 2028, protects specific inhaler technologies, restricting supplier options.

Analysts tracking these patents, via databases like the USPTO, note that expirations drive supplier competition. In 2023, over 15 generic applications for budesonide-formoterol combinations entered the FDA pipeline, pressuring incumbents to innovate. This environment rewards suppliers with robust R&D, like Cipla, which invests 10% of revenue in patent navigation.

For procurement teams, monitoring patent databases ensures compliance and identifies opportunities. A recent analysis from the European Patent Office reveals that 40% of supplier disputes in pharmaceuticals stem from IP infringements, highlighting the need for due diligence.

Market Analysis and Supply Chain Dynamics

The global market for these APIs reached $2.5 billion in 2023, with North America accounting for 45% of demand, driven by high COPD rates and robust healthcare infrastructure. Suppliers face challenges like raw material shortages and geopolitical tensions, exemplified by the 2022 Ukraine conflict disrupting European supply lines.

Key players adapt through vertical integration; for example, AstraZeneca sources intermediates internally, reducing dependency. Teva's supply chain report from 2023 shows a 15% improvement in resilience via diversified sourcing from India, China, and the U.S.

Emerging trends, such as sustainable manufacturing, influence supplier selection. Cipla's eco-friendly processes for budesonide production align with ESG goals, appealing to corporate buyers. Meanwhile, digital tools like blockchain enhance traceability, with Sandoz implementing it in 2022 to verify glycopyrrolate origins.

Business professionals should assess supplier performance using metrics from reports like those from Gartner, which ranks Teva highly for innovation. Strategic sourcing can yield 10-15% savings, as demonstrated by Viatris's 2023 deals for formoterol.

Regulatory Considerations for Suppliers

Regulatory compliance is non-negotiable in this sector. Suppliers must adhere to FDA's Current Good Manufacturing Practice (cGMP) standards, with budesonide and formoterol requiring rigorous testing for purity and stability. The FDA's 2023 drug shortage list included glycopyrrolate due to quality issues at some Asian facilities, underscoring the importance of certified partners.

In Europe, the European Medicines Agency (EMA) mandates similar oversight, with suppliers like Sandoz achieving full compliance through regular audits. Recent EMA guidelines emphasize risk-based assessments, helping buyers prioritize suppliers with strong track records.

Firms like Dr. Reddy's navigate these regulations by maintaining multiple FDA-inspected sites, ensuring uninterrupted supply. For executives, partnering with EMA- and FDA-approved suppliers mitigates risks, as evidenced by a 2023 study from the Pharmaceutical Supply Chain Initiative, which linked compliance to a 20% reduction in operational disruptions.

Conclusion

In summary, the suppliers for budesonide, formoterol fumarate, and glycopyrrolate play a pivotal role in sustaining the respiratory drug market. From AstraZeneca's integrated approach to Teva's generic prowess, these entities drive innovation, efficiency, and accessibility. By understanding supplier capabilities, patent timelines, and regulatory demands, business professionals can optimize strategies for long-term success.

Key Takeaways

  • Strategic Supplier Selection: Prioritize partners like Cipla and Teva for reliable, cost-effective APIs to enhance supply chain resilience.
  • Patent Awareness: Monitor expirations, such as Breztri's 2035 deadline, to anticipate market shifts and generic opportunities.
  • Market Growth Potential: Leverage the expanding respiratory market, valued at $50 billion by 2025, for sourcing advantages.
  • Regulatory Compliance: Ensure suppliers meet FDA and EMA standards to avoid shortages and maintain product quality.
  • Cost and Efficiency Gains: Achieve up to 20% savings through bulk deals and diversified sourcing, as demonstrated by industry leaders.

FAQs

1. What factors should businesses consider when choosing a supplier for these APIs?
Businesses should evaluate factors like GMP compliance, delivery reliability, patent status, and cost competitiveness to ensure seamless integration into their supply chains.

2. How do patent expirations affect supplier availability for budesonide?
Patent expirations, such as those for budesonide in 2012, increase generic supplier options, potentially lowering costs but requiring verification of quality from new entrants.

3. Are there risks in sourcing from international suppliers like those in India?
Yes, risks include regulatory inconsistencies and geopolitical disruptions, but partnering with established firms like Cipla minimizes these through proven track records.

4. How has the COVID-19 pandemic impacted the supply of formoterol fumarate?
The pandemic exposed vulnerabilities in global chains, leading suppliers like Teva to bolster domestic production and improve resilience against future disruptions.

5. What role do combination therapies play in supplier demand for these compounds?
Combination therapies, such as Breztri, heighten demand by requiring coordinated sourcing of multiple APIs, pushing suppliers to offer integrated solutions for efficiency.

Sources

  1. FDA. "Drug Approvals and Databases." Accessed via FDA.gov, 2023.
  2. IQVIA Institute. "Global Use of Medicines Report." 2023 Edition.
  3. United States Patent and Trademark Office (USPTO). Patent Database Search for relevant patents, 2023.
  4. World Health Organization. "Chronic Obstructive Pulmonary Disease Fact Sheet." 2023.
  5. Teva Pharmaceutical Industries. "Annual Report and Sustainability Report." 2023.

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