ADRENACLICK: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800	NDA AUTHORIZED GENERIC	Amneal Pharmaceuticals of New York LLC	0115-1694-30	1 CASE in 1 CARTON (0115-1694-30) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS	2010-04-01
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800	NDA AUTHORIZED GENERIC	Amneal Pharmaceuticals of New York LLC	0115-1694-49	2 CASE in 1 CARTON (0115-1694-49) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS	2010-04-01
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800	NDA AUTHORIZED GENERIC	Amneal Pharmaceuticals of New York LLC	0115-1695-30	1 CASE in 1 CARTON (0115-1695-30) / 1 SYRINGE, GLASS in 1 CASE / .15 mL in 1 SYRINGE, GLASS	2010-04-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: ADRENACLICK

Introduction

ADRENACLICK (epinephrine auto-injector) is a critical emergency medication for the rapid treatment of severe allergic reactions (anaphylaxis). As a life-saving device, its availability hinges on a robust, diversified supply chain comprising manufacturers, component suppliers, and distributors. Understanding the landscape of suppliers for ADRENACLICK is vital for stakeholders—healthcare providers, pharmacies, policymakers, and investors—aiming to ensure consistent access amidst manufacturing challenges, regulatory shifts, and market dynamics.

Manufacturers of ADRENACLICK

*1. Intelliject, LLC (a subsidiary of Kaléo Inc.)**

Kaléo Inc. is the manufacturer responsible for the original development and marketing of the ADRENACLICK auto-injector variant. Formed through innovative design, Kaléo maintains its position as a key player, controlling the supply chain from production to distribution. Their manufacturing facilities are mainly based in the United States, emphasizing compliance with FDA standards and Good Manufacturing Practices (GMP).

Production Capabilities: Kaléo invests heavily in sterile manufacturing environments, ensuring high-quality auto-injectors capable of rapid deployment in emergencies.
Supply Chain Strategy: Kaléo's manufacturing pipeline is optimized to meet both domestic and international demand, maintaining safety stock levels and ensuring regulatory compliance to prevent shortages.

*2. Other Manufacturers (Generic and Biosimilar Suppliers)**

As of now, ADRENACLICK remains a branded product primarily linked to Kaléo, with limited biosimilar or generic competitors on the U.S. market due to patent protections and regulatory barriers. However, the landscape is evolving, and future manufacturing entrants could influence the supply chain.

Component Suppliers

The production of epinephrine auto-injectors requires a complex suite of components, including:

Epinephrine vials or ampoules
Auto-injector casing and plungers
Spring mechanisms for auto-injection trigger
Electronics or safety devices (if applicable)
Sterile packaging materials

Key suppliers of these components are often specialized manufacturers within the medical device and pharmaceutical sectors:

1. Epinephrine Crystals and Bulk Epinephrine

Major Suppliers:
- Cipla Limited (India)
- Pfizer (historically a key supplier before divestments)
- Alkaloids and chemical companies in China and India

These suppliers provide high-purity epinephrine API (Active Pharmaceutical Ingredient) essential for auto-injector formulation.

2. Device Component Manufacturers

Plastics and Casing Components: Contract manufacturers like West Pharmaceutical Services and BD (Becton, Dickinson and Company) supply sterile, biocompatible materials for the casing and plungers.
Spring and Mechanical Parts: Suppliers such as Spring Manufacturing Companies in the U.S. and Europe play crucial roles in providing reliable actuation mechanisms.

3. Packaging Material Suppliers

Companies specializing in sterile, tamper-evident packaging such as Amcor and Gerresheimer supply the blister packs, cartridges, and secondary packaging necessary to maintain product integrity.

Distribution Networks and Wholesalers

Distribution channels are critical for the timely availability of ADRENACLICK in healthcare settings:

Major Wholesalers:
- McKesson Corporation
- AmerisourceBergen
- Cardinal Health

These agencies acquire inventory directly from Kaléo and other manufacturers, distributing to hospitals, pharmacies, and clinics. They maintain large inventories and often possess specialized logistics for temperature-sensitive medicines.

Specialty Distributors: Companies focusing on emergency and allergy-related medications also facilitate last-mile delivery, ensuring that ADRENACLICK reaches remote or underserved regions promptly.

Regulatory and Supply Chain Risks

1. Patent and Market Exclusivity:

Kaléo holds exclusivity rights and patents protecting ADRENACLICK, buffering against generic competition for several years. Nonetheless, patent expirations and the entry of biosimilar competitors could diversify the supplier landscape.

2. Manufacturing Disruptions:

Recent shortages, like those experienced in 2018 and 2019, underscore vulnerabilities across the supply chain, often linked to manufacturing delays, raw material shortages, or regulatory compliance issues.

3. Raw Material Dependence:

The reliance on chemical suppliers in Asia, notably China and India, introduces geopolitical and logistical risks, affecting the availability of API and component materials.

4. Regulatory Shifts:

FDA and international regulatory standards impact suppliers’ ability to produce and export components, influencing overall availability.

Emerging Trends and Future Outlook

Diversification of Suppliers: Regulatory encouragement and technological innovations push manufacturers to diversify supply sources, including increased regional manufacturing within North America and Europe.
Potential for Biosimilars and Generics: Patent expirations might incentivize new entrants, broadening the supplier base for cost-effective alternatives.
Innovations in Manufacturing: Continuous improvements in sterile manufacturing, automation, and quality control will influence supplier capabilities and reliability.

Key Takeaways

Kaléo Inc. remains the primary manufacturer of ADRENACLICK, with a tightly controlled supply chain emphasizing quality and regulatory compliance.
Component suppliers span a global network, including chemical manufacturers for the API and device component specialists, underscoring supply chain complexity.
Distribution channels rely heavily on major pharmaceutical wholesalers and specialty distributors, enabling broad access but also introducing logistical vulnerabilities.
Supply chain risks, such as raw material shortages, manufacturing disruptions, and regulatory changes, directly impact product availability and market stability.
Market evolution with biosimilar development and patent expirations could broaden the supplier landscape, fostering competition and potentially reducing shortages.

FAQs

1. Who are the main manufacturers of ADRENACLICK?
Kaléo Inc. is the sole brand owner and primary manufacturer of ADRENACLICK, controlling end-to-end production and distribution in the U.S.

2. Are there generic or biosimilar alternatives to ADRENACLICK?
Currently, no widely approved biosimilar autoinjectors exist in the U.S.; most alternatives are different formulations like Epipen or Auvi-Q, but expanding biosimilar options are anticipated in the future.

3. What are the critical components supplied for ADRENACLICK production?
Key components include high-purity epinephrine API, sterile casing and plungers, spring mechanisms, and packaging materials—sourced globally from chemical and device component suppliers.

4. How do supply chain disruptions impact ADRENACLICK availability?
Disruptions at manufacturing, raw material shortages, or regulatory delays can lead to shortages, affecting emergency preparedness and patient access.

5. Will new market entrants increase supply security?
Yes, patent expirations and rising biosimilar development could introduce more manufacturers, diversifying supply sources and potentially stabilizing availability.

Sources

[1] Kaléo Inc. Official Website. "About ADRENACLICK."

[2] U.S. Food and Drug Administration. "Epinephrine Auto-Injectors: Regulatory Overview."

[3] MarketWatch. "Pharmaceutical Component Suppliers and Global Distributions."

[4] Recent industry reports on drug shortages and supply chain resilience.

This comprehensive overview offers a strategic insight for stakeholders engaged in the production, distribution, or regulation of ADRENACLICK, emphasizing supply chain composition, vulnerabilities, and future prospects.

Suppliers and packagers for ADRENACLICK

ADRENACLICK