DULERA: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518	NDA	Organon LLC	78206-125-01	1 CANISTER in 1 CARTON (78206-125-01) / 120 AEROSOL in 1 CANISTER	2021-06-01
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518	NDA	Organon LLC	78206-125-59	1 CANISTER in 1 CARTON (78206-125-59) / 120 AEROSOL in 1 CANISTER	2021-06-01
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518	NDA	Organon LLC	78206-126-01	1 CANISTER in 1 CARTON (78206-126-01) / 120 AEROSOL in 1 CANISTER	2021-06-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Dulera, marketed under the brand name Dulera (mometasone furoate and formoterol fumarate dihydrate), is a prescription inhaler used for managing asthma and chronic obstructive pulmonary disease (COPD). Approved by the U.S. Food and Drug Administration (FDA) in 2010, Dulera combines a corticosteroid (mometasone furoate) and a long-acting beta-agonist (formoterol fumarate) to provide anti-inflammatory effects and bronchodilation, respectively. As with most pharmaceutical products, Dulera's manufacturing and distribution hinge on a network of qualified suppliers responsible for sourcing the active ingredients, excipients, and packaging components.

This article explores the key suppliers underpinning Dulera's production, highlighting their roles, geographic distribution, certifications, and the strategic importance of supply chain integrity for maintaining drug availability and regulatory compliance.

Active Pharmaceutical Ingredient (API) Suppliers

1. Mometasone Furoate Suppliers

Mometasone furoate, a potent corticosteroid, is essential for Dulera's anti-inflammatory activity. Several global suppliers manufacture and supply this API, distinguished by their capacity to comply with Good Manufacturing Practices (GMP) and international quality standards.

Recipharm AB (Sweden): Among the leading API manufacturers for mometasone furoate, Recipharm has a significant production site in Sweden. Recipharm emphasizes strict quality management, with GMP certifications from regulatory agencies such as the FDA and EMA.
Pharmaceutica Chemicals Limited (India): A prominent supplier in Asia, this company produces mometasone furoate, catering to global markets. Their manufacturing facilities are GMP-compliant, and they follow rigorous quality control protocols.
Lupin Limited (India): One of India’s major pharmaceutical manufacturers, Lupin supplies mometasone furoate API and has received multiple certifications including WHO-GMP, ensuring quality for global export.

2. Formoterol Fumarate Dihydrate Suppliers

As a long-acting beta-agonist, formoterol fumarate dihydrate is critical for Dulera’s bronchodilator effect.

Novartis AG (Switzerland): Novartis produces formoterol fumarate under strict regulatory standards, with multiple manufacturing sites worldwide aligned with GMP guidelines.
Meryx Pharmaceuticals (India): An established API supplier, Meryx offers formoterol fumarate dihydrate, certified GMP, and WHO-GMP licenses, facilitating global distribution to inhaler manufacturers.
Aarti Drugs Limited (India): Another key manufacturer providing the API for inhaler applications, with compliance certifications backing their production.

Excipients and Inhaler Components Suppliers

Dulera's functionality depends not only on active ingredients but also on excipients and device components, which are sourced from specialized suppliers.

1. Excipients:

BASF SE (Germany): Supplies pharmaceutical-grade excipients such as lactose monohydrate, which are used as carriers in dry powder inhalers like Dulera.
FMC Corporation (USA): Provides pharmaceutical polymers and stabilizers, ensuring product integrity during storage and inhalation.

2. Device Components:

Gerresheimer AG (Germany): Manufactures custom inhaler containers and molded components, adhering to pharmaceutical standards and ensuring device durability.
Optimer Pharmaceuticals (Ireland): Supplies precision-engineered actuator assemblies used in inhalers.

Packaging and Labeling Suppliers

Reliable packaging ensures product stability and tamper-evidence during distribution. Key suppliers include:

Mondi Group (UK): Provides blister packs and foil laminates designed for respiratory inhalers.
Berry Global Inc. (USA): Supplies plastic casing and secondary packaging solutions optimized for inhaler devices.

Supply Chain Considerations and Regulatory Compliance

Ensuring consistent supply of Dulera mandates partnerships with suppliers holding valid GMP, ISO certifications, and compliance with regulatory standards such as FDA, EMA, and WHO-GMP. The global API supply chain’s complexity necessitates meticulous supplier qualification processes, ongoing audits, and contingency planning to mitigate risks related to geopolitical events, raw material shortages, and quality lapses.

Recent supply chain disruptions—exacerbated by the COVID-19 pandemic—highlight the importance of diversified sourcing strategies. Manufacturers often rely on multiple API suppliers across different geographies to maintain uninterrupted drug availability, especially for critical medications like Dulera.

Market Dynamics and Supplier Strategic Importance

The concentration of API manufacturing in India and China evokes concerns regarding supply security; however, regulators and manufacturers actively pursue supplier diversification and vertical integration. Large pharmaceutical companies tend to establish strategic partnerships with multiple API suppliers to ensure consistent quality and supply, reducing dependency on single-source vendors.

Emerging trends indicate an increased focus on quality audits, supply chain transparency, and the adoption of advanced tracking systems such as serialization to combat counterfeit drugs and ensure traceability.

Key Takeaways

Dulera's production relies on high-quality APIs supplied by established manufacturers primarily based in Europe and India, such as Recipharm, Lupin, Novartis, and Meryx Pharmaceuticals.
Ensuring regulatory compliance across the supply chain is critical, with suppliers required to hold GMP and other international certifications.
The global API market's concentration in India and China underscores the importance of supply chain diversification to prevent disruptions.
Manufacturers also depend on specialized excipients, device components, and packaging suppliers, emphasizing the integrated nature of pharmaceutical supply chains.
Strengthening supplier relationships and implementing rigorous quality controls are strategic priorities to ensure reliable Dulera production amid geopolitical and logistical challenges.

FAQs

1. Who are the primary API suppliers for Dulera?
Major API suppliers include Recipharm (Sweden) and Pharmaceutica Chemicals Limited (India) for mometasone furoate, and Novartis (Switzerland) and Meryx Pharmaceuticals (India) for formoterol fumarate dihydrate.

2. What certifications do Dulera's suppliers need to ensure quality?
Suppliers must demonstrate compliance with GMP, ISO, and, in some cases, WHO-GMP standards. Regulatory approvals confirm adherence to quality, safety, and efficacy benchmarks.

3. How does supply chain diversification impact Dulera production?
Diversification reduces dependency on single-source suppliers, mitigating risks from geopolitical issues, raw material shortages, or quality lapses. It enhances supply resilience.

4. Are there regional differences in Dulera's supply chain?
Yes, API sourcing predominantly occurs in India and Europe, with some components sourced from North America and Asia, reflecting global manufacturing practices and strategic partnerships.

5. How might future regulatory trends influence suppliers for Dulera?
Enhanced regulatory scrutiny and demands for supply chain transparency are likely to incentivize suppliers to adopt advanced quality systems and expand sourcing options to meet global standards.

References

FDA approved drug labeling for Dulera [1].
Recipharm corporate overview [2].
WHO guidelines on pharmaceutical quality standards [3].
IMS Health reports on global API manufacturing trends [4].
Pharmaceutical supply chain analysis reports [5].

[1] U.S. Food & Drug Administration (FDA). Dulera (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol.
[2] Recipharm. API Manufacturing Capabilities.
[3] WHO. Guidelines on Good Manufacturing Practices (GMP).
[4] IMS Health. Global API Market Insights.
[5] Pharma Journal. Current Trends in Pharmaceutical Supply Chains.

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