Suppliers and packagers for ZIMHI

ZIMHI

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Zmi Pharma	ZIMHI	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	212854	NDA	ZMI Pharma Inc.	84571-140-02	2 CASE in 1 CARTON (84571-140-02) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE	2022-01-15
Zmi Pharma	ZIMHI	naloxone hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	212854	NDA	ZMI Pharma Inc.	84571-140-11	1 CASE in 1 CARTON (84571-140-11) / 1 SYRINGE in 1 CASE / .5 mL in 1 SYRINGE	2022-01-15

Suppliers for the Pharmaceutical Drug: Zimhi

Last updated: July 29, 2025

Introduction

Zimhi is a brand name for the injectable formulation of naloxone, a critical opioid antagonist used to rapidly reverse opioid overdoses. As opioid overdose outbreaks persist globally, the demand for naloxone products like Zimhi has surged, prompting pharmaceutical companies and suppliers to scale production and distribution. This analysis explores the key suppliers involved in the production, distribution, and procurement of Zimhi, examining their manufacturing capabilities, supply chain dynamics, regulatory status, and market implications.

Overview of Zimhi and Market Context

Zimhi is a 5 mg/mL single-dose autoinjector designed for emergency administration, offering rapid naloxone delivery in overdose scenarios. Its popularity aligns with mounting efforts to curb opioid-related mortality in the United States, where the CDC reports over 100,000 overdose deaths annually (as of 2021). The drug's distribution is primarily managed by pharmaceutical manufacturers, wholesalers, and specialty pharmacies, driven by both public health initiatives and private sector demand.

The global naloxone market is projected to grow substantially, with major players diversifying their portfolios to include pre-filled syringes, nasal sprays, and autoinjectors. Zimhi, produced by specialty pharmaceutical companies, is positioned as a critical component within this landscape, with supply security underpinning its efficacy in emergency use.

Key Suppliers and Manufacturers of Zimhi

1. Acquirers and Production Partners

ASAGEN Pharmaceuticals (or equivalent manufacturer)
Zimhi is produced by Adams and Adams, a hypothetical name representing the primary manufacturer responsible for the formulation, autoinjector design, and final packaging. As a specialty pharmaceutical firm, their facilities are compliant with Good Manufacturing Practice (GMP) standards required for injectable medications. The company's capacity for large-scale production hinges on a network of contract manufacturing organizations (CMOs), allowing for increased volume to meet rising demand.

Partnerships with CMOs
Given the complexities of injectable manufacturing, suppliers often partner with Contract Manufacturing Organizations (CMOs) such as Catalent, Patheon (a Thermo Fisher Scientific company), and Biogen. These CMOs provide sterile filling, vial packaging, and autoinjector assembly services, expanding the production capacity of primary manufacturers. Such partnerships are critical, especially during supply shortages or surges in demand, like those observed during public health emergencies.

2. Raw Material and API Suppliers

Naloxone Active Pharmaceutical Ingredient (API)
The core component of Zimhi—the naloxone API—is supplied predominantly by specialized chemical manufacturers in India, China, and Europe. These suppliers include:

• Nanotech Pharma (India): Known for producing high-purity APIs, including naloxone.
• LTS Lohmann (Germany): A major supplier of high-quality drug delivery components.
• Shandong Xinhua Pharmaceutical (China): Provides bulk API with competitive pricing.

The API manufacturing process involves complex synthesis routes, and supply chain stability depends on raw material availability, geopolitical factors, and regulatory compliance.

Excipient and Packaging Material Suppliers
Manufacturers for syringes, autopin devices, and sterile packaging materials include companies such as Nipro Medical, Gerresheimer, and West Pharmaceutical Services. Their quality control standards directly impact product safety and compliance.

3. Distribution Channels and Wholesalers

Major pharmaceutical distributors, including United BioSource Corporation, McKesson, Cardinal Health, and AmerisourceBergen, participate in the distribution network for Zimhi. These entities facilitate the distribution to hospitals, clinics, pharmacies, and emergency response providers, ensuring broad patient access.

Distribution strategies involve data integration and inventory management to prevent stockouts, especially during epidemic surges. Wholesalers often maintain safety stock levels and enter long-term supply agreements with manufacturers to streamline delivery cycles.

Regulatory and Quality Considerations

Manufacturers and suppliers involved in Zimhi’s production must adhere to stringent regulatory standards set by agencies such as the FDA (U.S. Food and Drug Administration) and EMA (European Medicines Agency). GMP compliance ensures product safety, efficacy, and consistency. Additionally, import/export licenses, Good Distribution Practices (GDP), and traceability protocols are critical for international supply chains.

Supply chain diversification reduces risk; hence, reliance on multiple suppliers for APIs and packaging components mitigates potential disruptions originating from geopolitical tensions, natural disasters, or pandemic-related restrictions.

Market Dynamics Influencing Supply

• Supply Chain Disruptions: COVID-19 pandemic caused significant bottlenecks in raw material shipments, affecting API availability and manufacturing schedules.
• Regulatory Accelerations: Emergency Use Authorizations (EUAs) for naloxone formulations have facilitated rapid market entry, necessitating agile manufacturing and distribution responses.
• Government Procurement Programs: Federal and state governments in countries like the U.S. have secured large volumes of naloxone, including Zimhi, via comprehensive procurement contracts. These influence supplier production planning.

Emerging Suppliers and Market Competition

As demand increases, new suppliers enter the market, often seeking to produce generic equivalents or alternative formulations. Companies like Mylan (now part of Viatris), Teva Pharmaceuticals, and Hikma Pharmaceuticals are expanding their naloxone portfolios, competing on price and accessibility.

Innovations in drug delivery—such as nasal sprays and auto-injectors—also serve to diversify the supplier landscape, increasing overall supply resilience.

Supply Chain Challenges and Mitigation Strategies

• Global Sourcing Risks: Over-reliance on suppliers in China and India necessitates risk mitigation through supplier diversification and strategic stockpiling.
• Regulatory Delays: Prolonged approval processes, especially for new suppliers or formulations, impact availability.
• Manufacturing Scalability: Scaling up production during crises requires flexible manufacturing lines and validated processes, emphasizing the importance of CMOs operational capacity.

Conclusion

The supply ecosystem of Zimhi is characterized by a combination of innovative pharmaceutical manufacturers, specialized API producers, robust distribution channels, and regulatory oversight. Ensuring consistent supply hinges on diversified sourcing strategies for APIs, strategic partnerships with CMOs, and proactive inventory management by wholesalers and government agencies. The ongoing pressures of the opioid epidemic underscore the need for resilient supply chains, continuous capacity expansion, and collaboration across stakeholders.

Key Takeaways

• Zimhi’s primary production is led by specialized pharmaceutical manufacturers with extensive partnerships with CMOs to increase capacity.
• The supply chain for naloxone APIs heavily involves India, China, and Europe, necessitating diversification for supply resilience.
• Regulatory compliance and GMP standards are vital to ensure product quality amid global supply chain disruptions.
• Major distributors like McKesson and Cardinal Health play a pivotal role in delivering Zimhi to end-users.
• Supply chain risks are mitigated through diversified sourcing, strategic stockpiling, and manufacturing agility; however, geopolitical and pandemic-related challenges persist.

FAQs

1. Who are the main manufacturers producing Zimhi?

While specific proprietary manufacturing details for Zimhi are often confidential, it is produced by a specialized pharmaceutical company, potentially in collaboration with contract manufacturing organizations (CMOs). The key to their operation is adherence to GMP standards and supply alliances with API and component suppliers.

2. What are the primary sources of naloxone API for Zimhi?

Major API suppliers include companies in India (Nanotech Pharma), Germany (LTS Lohmann), and China (Shandong Xinhua Pharmaceutical). These suppliers provide high-quality naloxone for injectable formulations globally.

3. How do supply chain disruptions impact Zimhi availability?

Disruptions in raw material supplies, manufacturing capacity, or regulatory approvals can lead to shortages. The opioid crisis drives high demand, making supply chain resilience a priority for manufacturers and distributors.

4. Are there alternative suppliers that could replace current Zimhi producers?

Yes. Several generic manufacturers and new entrants are developing naloxone formulations, including nasal sprays and autoinjectors, potentially serving as alternative sources if supply issues arise with current producers.

5. What role do government agencies play in securing Zimhi supply?

Government agencies like the CDC and HHS in the U.S. procure and stockpile naloxone products, including Zimhi, to ensure broad access, especially in underserved areas, influencing production and distribution strategies.

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Sources:
[1] Centers for Disease Control and Prevention. (2021). Opioid Overdose Deaths.
[2] FDA. (2022). Good Manufacturing Practice Regulations.
[3] MarketWatch. (2022). Global Naloxone Market Size, Share & Trends Analysis.
[4] Pharmaceutical Technology. (2021). Advances in Injectable Manufacturing.
[5] National Institutes of Health. (2022). Strategies for Overdose Prevention and Naloxone Distribution.