Suppliers and packagers for generic pharmaceutical drug: formoterol fumarate

formoterol fumarate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	FORMOTEROL FUMARATE	formoterol fumarate	SOLUTION;INHALATION	215078	ANDA	Alembic Pharmaceuticals Inc.	62332-655-30	30 POUCH in 1 CARTON (62332-655-30) / 1 VIAL in 1 POUCH (62332-655-01) / 2 mL in 1 VIAL	2021-11-22
Alembic	FORMOTEROL FUMARATE	formoterol fumarate	SOLUTION;INHALATION	215078	ANDA	Alembic Pharmaceuticals Inc.	62332-655-60	60 POUCH in 1 CARTON (62332-655-60) / 1 VIAL in 1 POUCH / 2 mL in 1 VIAL	2021-11-22
Dr Reddys	FORMOTEROL FUMARATE	formoterol fumarate	SOLUTION;INHALATION	215907	ANDA	Dr. Reddy's Laboratories Inc.	43598-778-30	30 POUCH in 1 CARTON (43598-778-30) / 1 VIAL in 1 POUCH (43598-778-11) / 2 mL in 1 VIAL	2025-01-30
Dr Reddys	FORMOTEROL FUMARATE	formoterol fumarate	SOLUTION;INHALATION	215907	ANDA	Dr. Reddy's Laboratories Inc.	43598-778-60	60 POUCH in 1 CARTON (43598-778-60) / 1 VIAL in 1 POUCH (43598-778-11) / 2 mL in 1 VIAL	2025-01-30

Suppliers for the Pharmaceutical Drug: Formoterol Fumarate

Formoterol fumarate, a long-acting beta2-adrenergic agonist, is a critical active pharmaceutical ingredient (API) used in managing chronic obstructive pulmonary disease (COPD) and asthma. This report provides a comprehensive analysis of the global supplier landscape for formoterol fumarate, examining key manufacturers, regulatory frameworks, market dynamics, and recent developments. With the API market projected to grow at a compound annual growth rate (CAGR) of 9.5% from 2026 to 2033, reaching $2.5 billion by 2033[8], understanding the supply chain complexities and regional distribution of manufacturers is essential for stakeholders.

Global Supplier Landscape of Formoterol Fumarate

Regional Distribution of Manufacturers

The production of formoterol fumarate is concentrated in regions with robust pharmaceutical manufacturing infrastructures, including India, Italy, Germany, and China. India dominates the market, with companies such as Coral Drugs Private Limited, Vamsi Labs, and Cipla operating large-scale facilities compliant with international regulatory standards[1][4]. European manufacturers like Axplora (Italy) and Fermion Oy (Finland) leverage advanced chemical synthesis technologies to produce high-purity APIs, often catering to regulated markets such as the U.S. and EU[11][4]. In China, suppliers such as Hangzhou Pharm & Chem and Fuan Pharmaceutical have expanded their capabilities, though their focus remains primarily on domestic and emerging markets[8].

Key Manufacturers and Their Certifications

Leading suppliers prioritize adherence to Good Manufacturing Practices (GMP) and hold certifications such as U.S. Drug Master Files (USDMF), Certificates of Suitability (CEP), and Japan Drug Master Files (JDMF). Axplora, for instance, operates an EUGMP, USFDA, and PMDA-approved facility in Italy, specializing in niche APIs like formoterol fumarate dihydrate[11]. Similarly, Teva API (Israel) and Mylan (India) maintain USDMF submissions, ensuring compliance with FDA requirements for U.S. market access[4][6]. These certifications not only validate quality but also enable suppliers to participate in high-value contracts with generic and branded pharmaceutical companies.

Pricing Dynamics and Supply Chain Considerations

The price of formoterol fumarate API fluctuates based on raw material costs, regulatory changes, and negotiated agreements. For example, TCI America prices the compound at $129.00 for a 10mg unit, with bulk pricing subject to quotation[5]. Suppliers like PharmaCompass facilitate direct connections between buyers and manufacturers, offering transparency in pricing trends and logistical support[1]. However, geopolitical factors, such as trade restrictions and supply chain disruptions, pose risks to consistent API availability, necessitating diversified supplier networks[8].

Regulatory and Compliance Framework

Good Manufacturing Practices (GMP)

Regulatory bodies mandate GMP compliance to ensure API safety, efficacy, and consistency. Formoterol fumarate manufacturers must implement stringent quality control measures, including impurity profiling and stability testing[2][11]. Axplora’s Farmabios facility, for instance, employs state-of-the-art micronization techniques to achieve uniform particle size distribution, critical for inhalation formulations[11]. Non-compliance can result in regulatory actions, as seen in 2016 when Novartis discontinued Foradil Aerolizer due to business decisions linked to regulatory overheads[13].

Patent Expirations and Generic Entry

The expiration of patents for branded formulations like Perforomist® has accelerated generic competition. Teva Pharmaceuticals launched the first generic formoterol fumarate inhalation solution in 2021, capturing a share of the $299 million annual U.S. market[6]. Aucta Pharmaceuticals followed in 2022 with FDA approval for its generic version, further intensifying price competition[10]. These entries underscore the importance of robust supplier partnerships to mitigate risks associated with patent litigation and market exclusivity losses[14].

Market Dynamics and Growth Drivers

Therapeutic Applications and Combination Therapies

Formoterol fumarate is predominantly used in inhalation solutions and dry powder inhalers for COPD and asthma management. Its rapid onset and prolonged bronchodilatory effects make it ideal for combination therapies, such as Symbicort® (budesonide/formoterol), which generated $3.5 billion in U.S. sales before generic entry[14]. The API’s compatibility with corticosteroids and anticholinergics has expanded its therapeutic applications, driving demand across both branded and generic sectors[11].

Regional Market Trends

North America accounts for the largest market share, fueled by high COPD prevalence and early generic approvals. Europe follows, with stringent regulatory standards favoring established players like Axplora and Fermion[8]. The Asia-Pacific region, led by India and China, is poised for rapid growth due to cost-efficient manufacturing and increasing API exports. However, quality concerns in some Asian markets necessitate rigorous supplier vetting to avoid non-compliant products[4][7].

Challenges and Risk Mitigation Strategies

Supply Chain Vulnerabilities

API production disruptions, such as those experienced during the COVID-19 pandemic, highlight vulnerabilities in single-source supplier models. Companies are increasingly adopting dual-sourcing strategies and investing in regional manufacturing hubs to enhance resilience[8]. For example, Viatris and Kindeva Drug Delivery collaborated to develop a generic Symbicort®, leveraging Kindeva’s California-based filling facilities to ensure U.S. supply continuity[14].

Regulatory Harmonization

Disparities in regulatory requirements across regions complicate global distribution. Manufacturers must navigate varying monograph specifications (e.g., USP, Ph. Eur.) and storage conditions, which impact formulation compatibility[5][11]. Harmonization initiatives, such as the International Council for Harmonisation (ICH) guidelines, aim to streamline standards, but regional nuances persist, requiring tailored compliance strategies[2].

Recent Developments and Future Outlook

First-Generic Launches and Market Impact

Teva’s 2021 launch of generic Perforomist® marked a pivotal shift, reducing treatment costs and expanding patient access[6]. Subsequent approvals, including Aucta’s 2022 entry, have eroded brand-name market share, with generics now constituting over 30% of U.S. sales[10]. Future launches, such as Viatris’ tentative approval for generic Symbicort®, are expected to further reshape competitive dynamics[14].

Innovations in API Manufacturing

Advances in continuous manufacturing and green chemistry are enhancing production efficiency and sustainability. Axplora’s micronized API grades, customized for specific inhalation devices, exemplify innovation aimed at improving drug delivery and patient outcomes[11]. Similarly, Fermion Oy’s investments in solvent recovery systems align with environmental regulations, reducing waste and operational costs[4].

Strategic Collaborations and Partnerships

Collaborations between API manufacturers and drug delivery specialists are critical for complex product development. Kindeva’s expertise in pressurized metered-dose inhalers (pMDIs) complemented Viatris’ regulatory capabilities, enabling efficient generic Symbicort® development[14]. Such partnerships are likely to increase as the industry shifts toward specialized, high-value formulations.

Conclusion

The global formoterol fumarate supply chain is characterized by a diverse manufacturer base, rigorous regulatory requirements, and evolving market dynamics. Key suppliers like Axplora, Teva, and Cipla leverage advanced manufacturing technologies and regulatory expertise to maintain competitive advantages. As patent expirations and generic entries reshape the landscape, stakeholders must prioritize supply chain resilience, regulatory compliance, and strategic collaborations to capitalize on growth opportunities. With the API market poised for significant expansion, suppliers that innovate and adapt to emerging trends will dominate this critical pharmaceutical sector.

Key Takeaways

• India and Europe are pivotal hubs for formoterol fumarate production, with stringent regulatory adherence.
• Generic entries post-2021 have disrupted market dynamics, emphasizing cost competitiveness.
• Regulatory compliance and supply chain diversification are critical for mitigating risks.
• Innovations in manufacturing and drug delivery systems are driving future growth.

FAQs

1. What certifications are essential for formoterol fumarate suppliers?
   Suppliers should hold USDMF, CEP, or GMP certifications to ensure compliance with U.S. and EU standards[1][11].

2. How do patent expirations affect the API market?
   Patent cliffs enable generic competition, reducing prices and expanding market access[6][10].

3. Which regions lead in formoterol fumarate manufacturing?
   India, Italy, and China are key producers, with India dominating due to cost-efficient operations[4][7].

4. What are the risks in the formoterol fumarate supply chain?
   Geopolitical disruptions, regulatory changes, and quality inconsistencies pose significant risks[8].

5. How are innovations shaping API production?
   Continuous manufacturing and green chemistry enhance efficiency and sustainability[11][14].

References

1. https://www.pharmacompass.com/manufacturers-suppliers-exporters/formoterol-fumarate
2. https://www.pharmacompass.com/manufacturers-suppliers-exporters/formoterol-fumarate-dihydrate
3. https://www.manusaktteva.com/api/Formoterol+fumarate
4. https://pharmaoffer.com/api-excipient-supplier/adrenergic-agents/formoterol/china
5. https://www.tcichemicals.com/US/en/p/F0881
6. https://www.tevapharm.com/news-and-media/latest-news/teva-announces-its-launch-of-the-first-generic-perforomist-formoterol-fumarate-inhalation-solution-20-/
7. https://www.chemicalbook.com/Manufacturers/Formoterol-fumarate.htm
8. https://www.verifiedmarketreports.com/product/formoterol-fumarate-api-market/
9. https://www.drugs.com/history/perforomist.html
10. https://www.biospace.com/aucta-announces-fda-approval-of-a-generic-version-of-perforomist-formoterol-fumarate-inhalation-solution
11. https://www.axplora.com/api-product/183814-30-4-hps/
12. https://respiratory-therapy.com/miscellaneous/fda-approves-dey-lps-perforomist-formoterol-fumarate-inhalation-solution-for-maintenance-treatment-of-copd/
13. https://respiratory-therapy.com/disorders-diseases/chronic-pulmonary-disorders/asthma/asthma-copd-foradil-aerolizer-to-be-discontinued/
14. https://www.biospace.com/viatris-inc-and-kindeva-drug-delivery-announce-fda-tentative-approval-of-the-first-abbreviated-new-drug-application-generic-version-of-symbicort-budesonide-formoterol-fumarate-dihydrate-inhalation-aerosol