Suppliers and packagers for SYMBICORT

SYMBICORT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929	NDA	AstraZeneca Pharmaceuticals LP	0186-0370-20	1 POUCH in 1 CARTON (0186-0370-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER	2007-05-29
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929	NDA	AstraZeneca Pharmaceuticals LP	0186-0370-28	1 POUCH in 1 CARTON (0186-0370-28) / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER	2007-05-29
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929	NDA	AstraZeneca Pharmaceuticals LP	0186-0372-20	1 POUCH in 1 CARTON (0186-0372-20) / 1 CANISTER in 1 POUCH / 120 AEROSOL in 1 CANISTER	2007-05-29
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929	NDA	AstraZeneca Pharmaceuticals LP	0186-0372-28	1 POUCH in 1 CARTON (0186-0372-28) / 1 CANISTER in 1 POUCH / 60 AEROSOL in 1 CANISTER	2007-05-29

Suppliers for the Pharmaceutical Drug: SYMBICORT

Last updated: August 2, 2025

Introduction

SYMBICORT, a combination inhaler used to manage asthma and chronic obstructive pulmonary disease (COPD), has become an essential medication in respiratory therapy. Developed by AstraZeneca, it combines budesonide (a corticosteroid) and formoterol fumarate dihydrate (a long-acting beta-agonist), offering anti-inflammatory and bronchodilator effects. Given its widespread adoption, understanding its supply chain, key suppliers, and manufacturing landscape is critical for stakeholders including healthcare providers, pharmaceutical companies, and policymakers seeking to ensure drug availability and supply chain resilience.

This analysis provides an in-depth exploration of the primary suppliers involved in the manufacturing and distribution of SYMBICORT, examining the manufacturing partners, raw material providers, contract manufacturer relations, and supply chain considerations pivotal to its availability globally.

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Manufacturing Partners and Production Facilities

AstraZeneca's In-House Manufacturing

AstraZeneca, the original developer of SYMBICORT, maintains robust manufacturing capabilities primarily through its facilities in the United States and Europe. These facilities are accredited by regulatory agencies such as the FDA and EMA, ensuring compliance with Good Manufacturing Practices (GMP). AstraZeneca oversees production quality, regulatory submissions, and distribution logistics, making the company the central orchestrator of the drug’s supply chain.

Contract Manufacturing Organizations (CMOs)

In recent years, AstraZeneca has engaged Contract Manufacturing Organizations (CMOs) to increase production capacity, mitigate risks, and diversify its supply sources. These partnerships are critical for scaling production to match rising demand across North America, Europe, and emerging markets.

Key CMOs involved in SYMBICORT production include:

• Recipharm: A leading contract manufacturer based in Sweden, specializing in inhalation products and sterile pharmaceuticals. Recipharm's facilities have the capability to produce inhalation drug products at scale, adhering to strict quality standards.

• Catalent: A global provider of drug development and manufacturing solutions, including inhalation drug products. Catalent’s facilities in the US and Europe support inhaler production, ensuring supply continuity.

• Hovione: A pharmaceutical development company with inhalation manufacturing capacity, primarily providing formulation and process development support, as well as manufacturing.

Global Manufacturing Footprint

These manufacturing partnerships enable AstraZeneca to optimize regional distribution and meet the regulatory requirements of different jurisdictions, such as the US, Europe, and Asia-Pacific. The collaboration with CMOs helps mitigate supply disruptions and adapt swiftly to market demands.

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Raw Material and Active Pharmaceutical Ingredient (API) Suppliers

Budesonide and Formoterol API Production

The core of SYMBICORT involves two APIs:

• Budesonide: A corticosteroid that reduces inflammation in the lungs.
• Formoterol fumarate dihydrate: A long-acting beta-agonist that relaxes airway muscles.

The suppliers of these APIs are crucial to the drug’s supply chain stability.

Leading API Suppliers

1. Dr. Reddy’s Laboratories: A major supplier of budesonide, particularly for markets in India, Russia, and other emerging economies. Dr. Reddy’s produces high-quality APIs compliant with international standards and supplies pharma companies worldwide.

2. Sun Pharma: A prominent Indian pharmaceutical manufacturer, Sun Pharma provides both budesonide and formoterol APIs, leveraging economies of scale to ensure volume availability for inhaled therapies.

3. Cipla: An Indian pharma giant, Cipla produces both APIs and finished dosage forms, especially for regional markets, and supplies APIs for inhaler products.

4. Boehringer Ingelheim: While primarily a manufacturer of inhalers and formulations, Boehringer Ingelheim also supplies certain APIs for respiratory medications, although AstraZeneca sources these APIs from multiple vendors based on market needs.

5. Other Asian API Producers: Several Chinese and South Korean API manufacturers also contribute, with GMP-certified facilities supplying APIs for both domestic and international markets.

Supply Chain Risks and Mitigation

Dependence on API suppliers from India and China poses risks such as geopolitical tensions, regulatory disruptions, and manufacturing shortages. AstraZeneca, along with major pharmaceutical companies, increasingly emphasizes supply diversification, strategic stockpiling, and regional API manufacturing to ensure continuity.

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Distribution and Logistics

Global Supply Chain Dynamics

The distribution of SYMBICORT involves multiple layers, from manufacturing facilities through distribution hubs to healthcare providers. AstraZeneca primarily controls this through its global logistics network, ensuring timely delivery across key markets.

Regulatory Compliance

Manufacturers and suppliers coordinate with regulatory agencies (FDA, EMA, PMDA) to maintain compliance. Supply chain security initiatives such as serialization, track-and-trace systems, and quality audits are integral to preventing counterfeit infiltration and ensuring drug integrity.

Impact of COVID-19

The pandemic exposed vulnerabilities in pharmaceutical supply chains, emphasizing the need for diversified sourcing, regional manufacturing, and digital inventory management. AstraZeneca’s collaborations with CMOs and API suppliers have aimed to build resilience against such disruptions.

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Key Players in the SYMBICORT Supply Chain

Stakeholder Type	Major Entities	Role in Supply Chain
Original Developer	AstraZeneca	Overall supply chain oversight, formulation, distribution
Contract Manufacturers (CMOs)	Recipharm, Catalent, Hovione	Scale-up production, capsule filling, inhaler assembly
API Suppliers	Dr. Reddy's, Sun Pharma, Cipla, Boehringer Ingelheim	Raw material supply, API production
Raw Material Providers	Specialized chemical suppliers, excipient manufacturers	Raw chemicals, propellants, inhalation device components
Logistics Providers	DHL, FedEx, UPS	Warehousing, transportation, customs clearance

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Regulatory and Market Considerations

Regulatory authorities scrutinize the manufacturing quality, supply chain integrity, and API sourcing of respiratory inhalers like SYMBICORT. Variations in regional regulations influence supplier choices and manufacturing strategies. The European Medicines Agency (EMA), US Food and Drug Administration (FDA), and local agencies enforce standards that shape sourcing and manufacturing decisions.

Expanding patent protections and generic manufacturing are also impacting suppliers, with some markets witnessing increased competition from biosimilar and generic inhalers, affecting supply dynamics for AstraZeneca.

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Future Supply Chain Trends

• Vertical Integration: AstraZeneca and other pharma firms are investing in API manufacturing facilities in key regions to reduce reliance on external suppliers.

• Regional Manufacturing Hubs: Increasing focus on Asia-Pacific and Eastern Europe to meet local demand and reduce logistics complexity.

• Supply Chain Digitization: Implementation of blockchain and IoT for improved traceability and inventory management.

• Sustainable Sourcing: Greater emphasis on environmentally friendly raw materials and manufacturing processes aligned with ESG (Environmental, Social, Governance) principles.

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Key Takeaways

• Diverse Manufacturing Network: SYMBICORT’s supply relies on AstraZeneca’s in-house facilities supplemented by partnerships with CMOs such as Recipharm, Catalent, and Hovione, ensuring scalable and resilient production capacities.

• API Sourcing: Critical APIs are supplied mainly by Indian manufacturers like Dr. Reddy’s and Sun Pharma, with efforts underway to diversify sources and increase regional API manufacturing to mitigate supply risks.

• Global Supply Chain Management: Ensuring regulatory compliance, quality assurance, and logistics efficiency is vital for maintaining steady availability across markets.

• Mitigation of Disruption Risks: Strategic diversification, regional manufacturing investments, and digital supply chain solutions are key to resilient SYMBICORT supply.

• Market Dynamics: Patent landscapes, regulatory requirements, and geopolitical factors influence supplier relationships and production strategies.

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FAQs

1. Who are the primary manufacturers of SYMBICORT?
AstraZeneca leads production through its proprietary facilities and partnerships with CMOs like Recipharm, Catalent, and Hovione, which supply components, formulations, and inhaler devices.

2. What are the main raw materials used in SYMBICORT?
The key raw materials are the APIs: budesonide and formoterol fumarate dihydrate, sourced from major API manufacturers such as Dr. Reddy’s Laboratories, Sun Pharma, and Cipla.

3. How does AstraZeneca ensure a stable supply of SYMBICORT?
By diversifying manufacturing through multiple CMOs, securing API supply from various vendors, and establishing regional manufacturing hubs, AstraZeneca mitigates supply risks and adapts to market demands.

4. Are there regional differences in SYMBICORT suppliers?
Yes. Development and manufacturing are region-specific, with regional API producers and CMOs catering to local regulations and market needs, particularly in Asia-Pacific, Europe, and North America.

5. What future trends could impact SYMBICORT’s supply chain?
Increased vertical integration, regional API production, digital supply chain innovations, and sustainability focus are key trends shaping the future of SYMBICORT’s supply landscape.

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References:

1. AstraZeneca. (2023). Corporate Website.
2. EMA. (2022). Regulatory filings and product approvals.
3. Industry reports on inhalation drug manufacturing.
4. Company disclosures and partner collaborations.