Suppliers and packagers for NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Lupin	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	naloxone hydrochloride; pentazocine hydrochloride	TABLET;ORAL	075735	ANDA	Lupin Pharmaceuticals,Inc.	43386-680-01	100 TABLET in 1 BOTTLE (43386-680-01)	2011-05-11
Sun Pharm Inds Ltd	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	naloxone hydrochloride; pentazocine hydrochloride	TABLET;ORAL	075523	ANDA	Sun Pharmaceutical Industries, Inc.	63304-506-01	100 TABLET in 1 BOTTLE (63304-506-01)	2018-07-31
Watson Labs	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	naloxone hydrochloride; pentazocine hydrochloride	TABLET;ORAL	074736	ANDA	Actavis Pharma, Inc.	0591-0395-01	100 TABLET in 1 BOTTLE, PLASTIC (0591-0395-01)	1997-05-21

Suppliers for the Pharmaceutical Drugs: NALOXONE HYDROCHLORIDE and PENTAZOCINE HYDROCHLORIDE

Last updated: July 29, 2025

Introduction

The global pharmaceutical landscape hinges on a reliable and diversified supply chain to meet the rising demand for critical medications. Among these, Naloxone Hydrochloride and Pentazocine Hydrochloride stand out for their roles in anesthesia, pain management, and opioid overdose reversal. Ensuring an understanding of the leading suppliers for these drugs is vital for manufacturers, healthcare providers, and policymakers aiming to secure uninterrupted access amid supply chain complexities. This article offers a detailed overview of the key suppliers, the regulatory landscape, and strategic considerations pertinent to sourcing these pharmaceuticals.

Overview of Naloxone Hydrochloride and Pentazocine Hydrochloride

Naloxone Hydrochloride

Naloxone hydrochloride is an opioid antagonist primarily used to counteract opioid overdose symptoms. Its efficacy in emergency scenarios has cemented its role in public health strategies worldwide. The drug is available in various formulations, including injectable, nasal spray, and auto-injectors.

Pentazocine Hydrochloride

Pentazocine hydrochloride is a synthetic opioid analgesic employed to manage moderate to severe pain. Its modulatory action on kappa-opioid receptors distinguishes it from other opioids, affecting its safety profile and regulatory classification.

Major Global Suppliers and Manufacturers

1. Market Leaders for Naloxone Hydrochloride

a. Mylan (now part of Pfizer)

Mylan has historically been a dominant producer of naloxone, particularly its naloxone nasal spray, under brands such as Narcan. The company capitalized on its global manufacturing footprint, facilitating wide distribution across North America and Europe.

b. Hikma Pharmaceuticals

A key player based in the Middle East, Hikma manufactures injectable and nasal formulations of naloxone. Its strategic manufacturing facilities are certified by international regulatory bodies, ensuring compliance and quality.

c. Amneal Pharmaceuticals

Amneal supplies generic naloxone options, including injectable and auto-injector forms. Its diversified production hubs in the United States and India position it as a consistent supplier.

d. Boehringer Ingelheim

Although primarily known for other pharmaceuticals, Boehringer Ingelheim produces naloxone formulations, emphasizing high-quality standards and innovative delivery systems.

e. Kaleo Pharma

This US-based biotech focuses on emergency overdose drugs, including Evzio, an auto-injector form of naloxone. Its specialized focus has driven rapid product development aligned with regulatory trends.

2. Key Manufacturers for Pentazocine Hydrochloride

a. Grünenthal GmbH

A prominent European pharmaceutical firm, Grünenthal manufactures pentazocine, among other analgesics. Its high-quality manufacturing facilities in Germany adhere to stringent Euro pean Medicines Agency standards.

b. Cipla Limited

One of India's leading generics producers, Cipla supplies pentazocine globally, benefiting from competitive pricing and robust manufacturing capacity.

c. Sun Pharmaceutical Industries

Based in India, Sun Pharma offers pentazocine formulations tailored to various markets, emphasizing affordability and compliance with local regulators.

d. Aurobindo Pharma

Another Indian pharmaceutical giant, Aurobindo, manufactures pentazocine, leveraging extensive export channels and regulatory approvals.

e. China-based Suppliers

Several Chinese manufacturers, such as Hunan Jinjian Pharmaceutical and Zhejiang Xianju Pharmaceuticals, produce pentazocine under strict quality controls for export to global markets.

Regulatory Environment and Impact on Supply

The manufacturing and distribution of naloxone and pentazocine are tightly regulated, especially within regions like the US, EU, and Asia, owing to their opioid classification. The FDA, EMA, and other agencies set strict manufacturing standards and approval protocols, influencing supplier participation.
For instance, the FDA’s approval of nasal naloxone and auto-injectors has intensified demand for compliant manufacturers globally. Regulations also impact the sourcing from Chinese and Indian generic manufacturers, emphasizing quality assurance.

Supply Chain Challenges and Strategic Considerations

• Regulatory Compliance: Suppliers must adhere to Good Manufacturing Practices (GMP), particularly for injectable and nasal formulations.
• Geopolitical Factors: Trade policies and tariffs influence sourcing choices, with a shift towards diversification to mitigate risks.
• Patent Status and Market Exclusivity: Certain formulations, like auto-injectors, are protected by patents, affecting generic entry.
• Raw Material Availability: Active pharmaceutical ingredients (APIs) sourcing and geopolitical stability in manufacturing regions impact supply reliability.

Emerging Trends

• Consolidation among suppliers enhances capacity but may reduce competitiveness.
• Manufacturers investing in advanced formulations and delivery systems elevate their market position.
• Regulatory harmonization aims to streamline approval processes, expanding supplier options.

Distribution and Procurement Strategies

Organizations should consider multi-source procurement approaches to ensure resilience. Establishing relationships with both established global suppliers and regional manufacturers can optimize costs and supply security. Engaging with licensed distributors and monitoring global regulatory approvals ensures compliance and continuity.

Key Players Summary Table

Drug	Leading Suppliers	Notes
Naloxone Hydrochloride	Mylan/Pfizer, Hikma, Amneal, Boehringer, Kaleo	Wide formulations including nasal, injectable
Pentazocine Hydrochloride	Grünenthal, Cipla, Sun Pharma, Aurobindo, Chinese manufacturers	Primarily oral and injectable forms

Conclusion

Securing a reliable supply of Naloxone Hydrochloride and Pentazocine Hydrochloride requires engagement with a diversified portfolio of reputable manufacturers operating within a complex regulatory framework. The expanding global demand, driven by evolving healthcare needs and overdose prevention initiatives, underscores the importance of sourcing from established suppliers with proven compliance, quality assurance, and capacity for scale.

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Key Takeaways

• Top global suppliers of naloxone and pentazocine include multinational pharmaceutical firms like Mylan/Pfizer, Hikma, Grünenthal, and prominent Indian manufacturers such as Cipla and Sun Pharma.
• Regulatory compliance, particularly GMP standards and approvals from agencies like the FDA and EMA, significantly influence supplier selection.
• Supply chain resilience depends on diversification, regional sourcing, and proactive engagement with reliable manufacturing partners.
• Market trends favor innovations in formulation delivery systems, which could reshape supplier dynamics.
• Due diligence in monitoring geopolitical developments, patent landscapes, and raw material sourcing is critical for maintaining uninterrupted supply.

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FAQs

1. Are there regional differences in the suppliers of naloxone and pentazocine?
Yes. While North America and Europe rely heavily on companies like Mylan, Hikma, and Boehringer, Asian markets often source from Indian and Chinese manufacturers such as Cipla, Sun Pharma, and Zhejiang Xianju Pharmaceuticals, driven by cost-efficiency and regulatory considerations.

2. How does patent protection impact the availability of generic naloxone and pentazocine?
Patent protections can delay generic manufacturing, especially for innovative delivery systems like auto-injectors. Once patents expire, numerous generics typically enter the market, increasing supply options.

3. What are the key quality considerations when sourcing from international suppliers?
Ensuring compliance with GMP standards, obtaining proper certifications (like FDA approval or EMA certification), and conducting supplier audits are essential to guarantee drug safety and efficacy.

4. How has the COVID-19 pandemic affected supply chains for these drugs?
Disruptions in manufacturing, logistics delays, and increased demand for emergency drugs like naloxone have strained supply chains, prompting companies to diversify sourcing and increase inventory buffers.

5. Are there upcoming regulatory changes impacting the supply of naloxone and pentazocine?
Regulations around opioid prescribing and manufacturing are continuously evolving, particularly in response to opioid misuse crises. Changes may include stricter manufacturing standards and approval processes, affecting supplier eligibility and market dynamics.

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Sources:

[1] FDA Drug Approvals and Regulatory Guidelines.
[2] European Medicines Agency (EMA) Database.
[3] Company websites and annual reports of Mylan/Pfizer, Hikma, Cipla, and Grünenthal.
[4] Market analysis reports from IQVIA and GlobalData.
[5] International GMP standards and WHO manufacturing guidelines.