Arformoterol tartrate, a long-acting beta-2 adrenergic agonist, is a critical therapeutic agent for managing chronic obstructive pulmonary disease (COPD). As the generic equivalent of Sunovion Pharmaceuticals’ Brovana®, this inhalation solution has garnered significant attention from pharmaceutical manufacturers, suppliers, and distributors. The global market for arformoterol tartrate reached $437.9 million in 2021[3][7], driven by its efficacy in alleviating bronchoconstriction. This report analyzes the key suppliers, manufacturers, and distributors of arformoterol tartrate, providing insights into their roles, regulatory approvals, and market dynamics.
Overview of Arformoterol Tartrate and Its Therapeutic Significance
Pharmacological Profile and Clinical Applications
Arformoterol tartrate selectively activates beta-2 adrenergic receptors in bronchial smooth muscle, inducing relaxation and improving airflow[4]. Administered via nebulization twice daily, it is indicated for long-term COPD management, including chronic bronchitis and emphysema[2][10]. The drug’s pharmacokinetics include a peak plasma concentration of 4.3 pg/mL and a half-life of 26 hours in COPD patients[4]. Its therapeutic equivalence to Brovana® has enabled widespread adoption of generic versions[3][7].
Key Manufacturers of Arformoterol Tartrate
Slate Run Pharmaceuticals
Slate Run Pharmaceuticals offers arformoterol tartrate inhalation solution in 15 mcg/2 mL unit-dose vials, marketed under NDC numbers 70436-151-57 (30 vials) and 70436-151-58 (60 vials)[1]. Distributed through major wholesalers like Cardinal Health (5730403), McKesson (2332120), and AmerisourceBergen (10289602), Slate Run ensures broad availability across the U.S. healthcare system[1].
Ritedose Pharmaceuticals
Ritedose Pharmaceuticals, a division of The Ritedose Corporation, launched its generic arformoterol tartrate in April 2023[2]. With a production capacity exceeding 2 billion units annually, Ritedose has positioned itself as a leader in nebulized inhalation therapies[2][8]. The company’s acquisition of the arformoterol tartrate asset from PAI Pharma in 2022 expanded its portfolio, capturing a $252 million market segment in 2021[8]. Ritedose’s single-dose ampules are individually barcoded, enhancing traceability and compliance[2].
Cipla Limited
Cipla received FDA approval for its generic arformoterol tartrate inhalation solution in June 2021[7]. The AN-rated product, manufactured in compliance with cGMP standards, is immediately available in the U.S. market[7]. Cipla’s entry into the nebulizer medication space underscores its commitment to affordable respiratory care, leveraging its global manufacturing network[7].
Glenmark Pharmaceuticals
Glenmark’s FDA-approved generic version, produced in Monroe, North Carolina, marked its first foray into nebulizer medications[3]. The approval capitalized on a $437.9 million annual market, competing directly with Sunovion’s Brovana®[3]. Glenmark’s facility adheres to stringent quality protocols, ensuring therapeutic equivalence and batch consistency[3].
Active Pharmaceutical Ingredient (API) Suppliers
TargetMol Chemicals
TargetMol supplies arformoterol tartrate for research purposes, offering quantities from 5 mg to 200 mg at prices ranging from $55 to $513[4]. While not intended for therapeutic use, their API supports preclinical studies investigating bronchodilation mechanisms and inflammatory mediator inhibition[4].
PharmaCompass-Linked Manufacturers
PharmaCompass lists 13 suppliers of arformoterol tartrate API, including:
- Inke S.A. (Spain)
- Alivus Life Sciences (India)
- Enaltec Labs (India)
- Beijing Breathgreen Healthcare (China)[6][9].
These suppliers cater to formulation developers, providing GMP-certified API with certifications such as USDMF, CEP, and JDMF[5][6].
Distribution Networks and Wholesale Partnerships
Cardinal Health
As a primary distributor for Slate Run Pharmaceuticals, Cardinal Health stocks arformoterol tartrate under product code 5730403[1]. Its extensive logistics network ensures rapid delivery to hospitals and pharmacies nationwide.
McKesson Corporation
McKesson distributes Slate Run’s product (2332120) and Ritedose’s inventory, leveraging its position as a top U.S. pharmaceutical wholesaler[1][8].
AmerisourceBergen
AmerisourceBergen’s product code 10289602 facilitates access to arformoterol tartrate for outpatient clinics and long-term care facilities[1].
Regulatory and Market Dynamics
FDA Approvals and Therapeutic Equivalence
The FDA’s approval of Cipla’s and Glenmark’s ANDAs in 2021 intensified market competition, driving down costs for healthcare providers[3][7]. All generic versions are AN-rated, confirming bioequivalence to Brovana®[7][10].
Global API Market Trends
The API market for arformoterol tartrate is characterized by:
- Price volatility: Influenced by raw material costs and regulatory audits[5].
- Geographical diversification: Manufacturers in India (Cipla, Enaltec) and China (Beijing Breathgreen) dominate production, while U.S.-based facilities (Glenmark, Ritedose) ensure regional supply chain resilience[3][6][8].
Recent Developments and Strategic Moves
Ritedose’s Portfolio Expansion
Ritedose’s 2022 acquisition of PAI Pharma’s arformoterol tartrate asset solidified its position as the largest U.S. generic nebulized drug manufacturer[8]. This move increased its capacity to serve 503B outsourcing facilities and hospital systems[8].
Cipla’s U.S. Market Penetration
Cipla’s focus on respiratory therapies aligns with its strategy to capture 10% of the U.S. generic inhalation market by 2025[7]. The company’s FDA-compliant manufacturing processes mitigate supply chain risks[7].
Clinical and Sourcing Considerations
Adverse Event Management
Common adverse effects (e.g., pain, dyspnea, leg cramps) necessitate monitoring during long-term use[3]. Suppliers must adhere to FDA-mandated pharmacovigilance protocols[5][9].
Sourcing for Research vs. Therapeutic Use
While TargetMol serves academic and industrial researchers[4], therapeutic API must be sourced from GMP-certified suppliers like Inke S.A. or Cipla[6][9].
Conclusion
The arformoterol tartrate supply chain is underpinned by robust manufacturing capabilities from Cipla, Glenmark, and Ritedose, complemented by distributors like McKesson and Cardinal Health. With the COPD market projected to grow at a CAGR of 5.8%, suppliers must prioritize regulatory compliance, cost efficiency, and supply chain agility to meet escalating demand.
Key Takeaways
- Major Manufacturers: Cipla, Glenmark, Ritedose, and Slate Run dominate production.
- API Suppliers: TargetMol and PharmaCompass-linked companies cater to diverse needs.
- Distribution Channels: Cardinal Health, McKesson, and AmerisourceBergen ensure widespread access.
- Regulatory Landscape: FDA ANDA approvals validate therapeutic equivalence.
- Market Growth: Strategic acquisitions and capacity expansions drive competition.
FAQs
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Is generic arformoterol tartrate as effective as Brovana®?
Yes, FDA AN-rated generics are bioequivalent[3][7].
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Which wholesalers stock arformoterol tartrate?
Cardinal Health, McKesson, and AmerisourceBergen are primary distributors[1].
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Can arformoterol tartrate be used for asthma?
No, it is indicated only for COPD[2][10].
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Are there suppliers for research-grade API?
TargetMol offers quantities from 5 mg to 200 mg[4].
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How has Ritedose impacted the market?
Their 2022 acquisition made them the largest U.S. generic nebulized drug supplier[8].
"The launch of Arformoterol Tartrate underscores Ritedose’s commitment to expanding access to affordable respiratory therapies." – Jody Chastain, CEO of Ritedose[2][8].
References
- https://www.slaterunpharma.com/products/arformoterol-tartrate/
- https://ritedose.com/2023/04/13/ritedose-pharmaceuticals-launches-new-product-arformoterol-tartrate-inhalation-solution-15-mcg-2-ml/
- https://www.pharmacytimes.com/view/generic-inhalation-therapy-for-bronchoconstriction-in-patients-with-copd-approved-by-fda
- https://www.targetmol.com/compound/arformoterol%20tartrate
- https://www.pharmacompass.com/active-pharmaceutical-ingredients/arformoterol-tartrate
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/arformoterol-tartrate
- https://www.cipla.com/press-releases-statements/cipla-receives-usfda-approval-generic-version-Sunovion-Pharmaceuticals-Brovana-Arformoterol-Tartrate-Inhalation-Solution
- https://ritedose.com/2022/10/11/ritedose-reaches-milestone-with-asset-purchase-becomes-largest-generic-drug-maker-of-its-kind/
- https://www.pharmacompass.com/ndc-api/arformoterol-tartrate
- http://www.tosunpharm.com/reference-listed-drugs-6/4086.html
