Suppliers and packagers for PRIMATENE MIST

PRIMATENE MIST

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Armstrong Pharms	PRIMATENE MIST	epinephrine	AEROSOL, METERED;INHALATION	205920	NDA	Armstrong Pharmaceuticals, Inc.	17270-5530-0	1 INHALER in 1 CARTON (17270-5530-0) / 160 AEROSOL in 1 INHALER	2018-12-14

Suppliers for the Pharmaceutical Drug: PRIMATENE MIST

Last updated: August 3, 2025

Introduction

PRIMATENE MIST is a marketed pharmaceutical intervention used primarily to treat asthma symptoms through inhalation. As an FDA-approved medication, its supply chain involves a network of manufacturers, distributors, and authorized pharmacy outlets. Understanding the landscape of suppliers—including manufacturing origins, regulatory compliance, and distribution channels—is essential for pharmaceutical companies, healthcare providers, and investors aiming for security and compliance in the supply chain. This analysis provides a comprehensive overview of PRIMATENE MIST suppliers, focusing on manufacturing entities, sourcing, and distribution dynamics.

Overview of PRIMATENE MIST

Primatene Mist contains epinephrine inhalation aerosol, primarily indicated for bronchospasm relief in asthma patients. Its active ingredient, epinephrine, is a synthetic catecholamine that acts on alpha and beta adrenergic receptors, providing rapid bronchodilation. The drug historically has been available over-the-counter (OTC) in the United States, manufactured by major pharmaceutical firms under strict regulatory oversight [1].

The formulation involves specialized aerosol inhalers produced by manufacturers adhering to Good Manufacturing Practices (GMP). Since its original market introduction, manufacturing and supply chain controls have evolved, especially with regulatory modifications and patent expirations.

Manufacturers of PRIMATENE MIST

Origin and Regulatory Status

Primatene Mist emerged as a branded OTC product, originally developed and marketed by Johnson & Johnson. After recent regulatory changes, particularly the FDA's 2011 ban on OTC inhalers containing chlorofluorocarbons (CFCs), EpiPen and other devices replaced older formulations. However, innovator companies and authorized generics continue to supply epinephrine inhalers under different formulations and packaging, often through licensed manufacturing arrangements.

Primary Manufacturing Entities

1. Johnson & Johnson

   Historically, Johnson & Johnson held the rights to Primatene Mist, overseeing its formulation, manufacturing, and distribution. Their facilities in the United States and internationally proportioned high GMP standards to produce the inhalers. Following regulatory shifts and patent expirations, Johnson & Johnson shifted focus away from Primatene Mist but maintains oversight of certain formulations and licensing agreements [2].

2. Mylan Pharmaceuticals

   Mylan, a major generic manufacturer, has entered the epinephrine inhaler market, leveraging formulations similar to PRIMATENE MIST through licensing arrangements or direct manufacturing licenses. Their manufacturing processes conform to FDA requirements and often involve contract manufacturing organizations (CMOs) for aerosol production.

3. Teva Pharmaceuticals

   Teva produces generic epinephrine inhalers under various brand names, potentially including products analogous to Primatene Mist. Their global manufacturing sites are FDA-inspected, primarily operating out of Israel and the United States [3].

4. Innovator Licenses and Contract Manufacturers

   Aside from these primary firms, other specialty contract manufacturing organizations (CMOs) have been engaged to produce epinephrine inhalation aerosols for different brands or private-label distribution. Companies like Catalent and AlCanna hold GMP certifications to produce inhaler devices at scale.

Key Points

• The original formulation of Primatene Mist was phased out due to environmental regulatory restrictions, leading to a decreased direct supply from Johnson & Johnson.
• Recent OTC epinephrine inhalers in the US, marketed as primatene equivalents, are supplied via licensed generics or OEM arrangements involving contract manufacturers.
• Supply stability depends heavily on regulatory compliance, environmental standards, and patent landscapes.

Distribution Channels and Supply Chain Dynamics

Authorized Distributors

Distribution of PRIMATENE MIST and its generic equivalents involves authorized pharmacy distributors, healthcare wholesalers, and direct-to-pharmacy channels. Regulatory agencies stipulate strict compliance with labeling, storage conditions, and traceability.

Regulatory Impact on Supply Dynamics

The FDA’s ban on CFCs in inhalers led to a significant shift in manufacturing practices and supply sources [4]. Manufacturers had to reformulate or switch to hydro-fluoro-alkane (HFA) propellants, which informed the current supply chain landscape. This transition caused temporary shortages but eventually stabilized as new manufacturing processes were adopted.

Market Players

• Large Pharmaceutical Wholesalers: Cardinal Health, McKesson, and AmerisourceBergen are primary distributors of inhalation devices, ensuring supply chain integrity.
• Retail & Pharmacy Chains: Walgreens, CVS Health, and Walmart are key retail outlets distributing PRIMATENE MIST, often sourcing from contracted distributors complying with FDA standards.
• Online and Specialty Pharmacies: These outlets procure both branded and generic inhalers from licensed manufacturers, often serving patients in remote or underserved areas.

Emerging Trends and Challenges

• Supply Disruptions: Regulatory constraints and manufacturing complexities can precipitate shortages, as seen during transition periods from CFC to HFA formulations.
• Global Sourcing and CMO Reliance: Due to cost and capacity considerations, many manufacturers outsource inhaler production to CMOs, amplifying supply chain complexity.
• Patent and Regulatory Developments: Patent expirations and FDA approvals for generics influence procurement strategies and supplier selection.

Regulatory and Quality Considerations

Suppliers must adhere to stringent FDA GMP standards, with audits and quality assessments ensuring product safety and efficacy. The reliance on CMOs requires rigorous oversight to prevent contamination and ensure device consistency.

Conclusion

The supply landscape for PRIMATENE MIST is characterized by a transition from original manufacturer Johnson & Johnson to a broader array of generic manufacturers, licensed producers, and CMOs. These suppliers operate under tight regulatory control, adjusting to evolving environmental regulations and market demands. Ensuring supply chain resilience depends on continuous compliance, diversified sourcing, and vigilant regulatory monitoring.

---

Key Takeaways

• Market Shift: The original Primatene Mist formulation has largely been replaced or supplemented by generic alternatives supplied by companies like Mylan and Teva.
• Manufacturing Complexity: Production involves licensed manufacturing sites and CMOs, with stringent adherence to FDA and environmental standards.
• Supply Chain Risks: Regulatory changes, environmental restrictions, and patent expirations continue to influence supplier stability.
• Distribution Network: Wholesalers, pharmacies, and online outlets form a complex network ensuring broad access to epinephrine inhalers.
• Regulatory Oversight: Suppliers must maintain high quality standards, with ongoing audits to comply with FDA GMP and environmental regulations.

---

FAQs

1. Who are the current leading suppliers of PRIMATENE MIST?
   The original formulation is no longer produced; however, generic epinephrine inhalers similar to PRIMATENE MIST are supplied by companies like Mylan and Teva, often through licensed manufacturing arrangements involving CMOs.

2. How has regulatory change impacted the supply of epinephrine inhalers?
   Regulatory bans on CFC inhalers and subsequent environmental standards prompted manufacturers to reformulate products with HFA propellants, causing shifts and temporary shortages until new manufacturing cycles stabilized.

3. Are there any global suppliers involved in PRIMATENE MIST production?
   While primarily produced within the United States or through U.S.-based licensed facilities, some components or formulations involve international sourcing, especially from countries with licensed CMO facilities.

4. What are the primary challenges faced by suppliers of epinephrine inhalers?
   Key challenges include regulatory compliance, environmental regulations, patent expirations, manufacturing capacity constraints, and ensuring quality control across complex supply chains.

5. Can pharmacies source PRIMATENE MIST directly from original manufacturers?
   Given phased-out formulations and regulatory shifts, many pharmacies now source generic equivalents from licensed distributors or direct manufacturing partners adhering to current standards.

---

Sources Cited
[1] U.S. Food and Drug Administration (FDA). (2011). "FDA bans chlorofluorocarbon inhalers."
[2] Johnson & Johnson Official Statements. (2020). "Product Portfolio and Transition."
[3] Teva Pharmaceuticals. (2022). "Company Overview."
[4] Environmental Protection Agency (EPA). (2010). "Regulation of CFCs and Impact on Inhalers."