NALBUPHINE HYDROCHLORIDE: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	070914	ANDA	Henry Schein, Inc.	0404-9918-01	1 AMPULE in 1 BAG (0404-9918-01) / 1 mL in 1 AMPULE	2022-01-13
Hospira	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	070914	ANDA	Hospira, Inc.	0409-1463-49	10 AMPULE in 1 TRAY (0409-1463-49) / 1 mL in 1 AMPULE (0409-1463-69)	2008-06-27
Hospira	NALBUPHINE HYDROCHLORIDE	nalbuphine hydrochloride	SOLUTION;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	070914	ANDA	Hospira, Inc.	0409-1463-01	10 AMPULE in 1 TRAY (0409-1463-01) / 1 mL in 1 AMPULE (0409-1463-71)	2008-06-27
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Nalbuphine hydrochloride is a potent synthetic opioid analgesic primarily used for pain management, especially during surgeries and labor. Its unique pharmacological profile, acting as a mixed kappa-opioid receptor agonist and mu-opioid receptor antagonist, makes it a valuable alternative to other opioids, particularly in patients where mu-opioid side effects are undesirable. Due to its clinical importance, the pharmaceutical supply chain for nalbuphine hydrochloride involves a range of suppliers globally, including active pharmaceutical ingredient (API) manufacturers, bulk drug producers, and finished dosage form (FDF) manufacturers.

This article provides a detailed overview of key suppliers involved in the production and distribution of nalbuphine hydrochloride, highlighting their geographic distribution, manufacturing capacities, and market positioning. Businesses seeking reliable sources for API procurement or partnerships will find this analysis crucial for strategic planning.

Manufacturers of Nalbuphine Hydrochloride API

The core of the supply chain for nalbuphine hydrochloride revolves around API manufacturers. These firms produce the raw pharmacological substance used by pharmaceutical companies worldwide.

1. Zhejiang Haibin Pharmaceutical Co., Ltd. (China)

Zhejiang Haibin Pharmaceutical is among leading Chinese API producers, with extensive experience in opioid synthesis. The company reports certified production facilities compliant with Good Manufacturing Practices (GMP), catering to both domestic and international markets. Their nalbuphine hydrochloride API capacity exceeds several hundred kilograms annually, with exports to North America, Europe, and Southeast Asia.

Strengths: Competitive pricing, high-quality standards, robust export network.

2. Jiangsu Nhwa Pharmaceutical Co., Ltd. (China)

Jiangsu Nhwa is a well-established pharmaceutical enterprise specializing in APIs, including opioid analgesics. Their manufacturing facilities are certified by global regulatory agencies such as the FDA (for US export) and EMA (for Europe). Their nalbuphine hydrochloride API production is scaled to serve both generics manufacturers and research institutions.

Strengths: Regulatory compliance, scalable manufacturing, global distribution channels.

3. Akorn Pharmaceuticals (India)

Akorn is an Indian pharmaceutical company with a growing portfolio of injectable and oral APIs. Their nalbuphine hydrochloride is primarily supplied for domestic markets, with some international distribution through strategic alliances. Akorn emphasizes adherence to GMP standards and quality assurance.

Strengths: Cost-efficient production, established distribution, regulatory approvals for key markets.

4. Synthesis Pharmaceutical Industries (India)

Sourced predominantly through local Indian manufacturers, Synthesis Pharmaceutical Industries produces nalbuphine hydrochloride API for both domestic and export markets. The firm holds certifications including ISO 9001 and cGMP, highlighting their commitment to quality.

Strengths: Price competitiveness, flexible supply chain, diverse opioid API portfolio.

Finished Dosage Form Manufacturers

While API suppliers are fundamental, final medication formulation is handled by established pharmaceutical companies that incorporate the API into injectable or other presentation formats.

5. Teva Pharmaceutical Industries (Israel)

Teva is a global leader in generic pharmaceuticals, including opioids like nalbuphine. The company produces various formulations, ensuring compliance with international standards. Their extensive distribution network makes Teva a reliable partner for procurement and supply chain stability.

Strengths: Global reach, consistent quality, large-scale manufacturing.

6. Mylan / Viatris (USA/Worldwide)

Viatris, formed from Mylan and Pfizer's merger, supplies nalbuphine hydrochloride formulations to hospitals worldwide. Their robust manufacturing infrastructure and quality assurance protocols ensure supply reliability.

Strengths: Wide product portfolio, global logistics, regulatory expertise.

7. Sun Pharmaceutical Industries (India)

Sun Pharma produces a range of injectable opioids, including nalbuphine hydrochloride based formulations. Their extensive manufacturing facilities in India support large-scale production for domestic and international markets.

Strengths: Cost competitiveness, deep market penetration in Asia, extensive manufacturing capacity.

Regulatory and Market Considerations

Nalbuphine hydrochloride's status as a controlled substance varies across jurisdictions, influencing supplier qualifications, licensing, and distribution protocols. Suppliers compliant with international standards, such as cGMP and ISO, are preferred for their reliability and legal compliance.

The geopolitical landscape impacts supply chain stability. Chinese API manufacturers dominate the market, but recent trade restrictions or quality concerns prompt buyers to diversify sourcing, including Indian and Israeli producers.

Emerging Trends and Future Market Dynamics

API Manufacturing Shift: Increasing regulatory oversight pushes companies toward GMP-certified Asian API suppliers, with some Western manufacturers exploring in-house production or partnerships to ensure supply security.
Supply Chain Diversification: Buyers seek multiple suppliers to mitigate geopolitical and regulatory risks due to opioid manufacturing's sensitive nature.
Technological Innovations: Advanced synthesis methods reduce costs and improve purity, benefiting high-quality suppliers willing to invest in process optimization.
Regulatory Environment: Growing regulations, such as the US Drug Enforcement Administration (DEA) controls on opioids, necessitate thorough compliance from suppliers.

Conclusion

The global supply landscape for nalbuphine hydrochloride encompasses a diverse array of API and finished dosage form manufacturers. Chinese companies like Zhejiang Haibin and Jiangsu Nhwa lead in API production, supported by Indian firms such as Akorn and Synthesis Pharmaceuticals. On the finished product side, companies like Teva, Viatris, and Sun Pharma dominate international markets, offering ready-to-use formulations.

For pharmaceutical companies and distributors, evaluating supplier credibility involves assessing regulatory compliance, manufacturing capacity, quality standards, and geopolitical stability. Establishing diversified supply chains with certified suppliers ensures consistent availability in a competitive and highly regulated environment.

Key Takeaways

Chinese API manufacturers dominate the nalbuphine hydrochloride market; quality compliance and export capacity are critical factors.
Indian firms present cost-effective API options, with a growing presence in global opioid supply chains.
Major international pharmaceutical companies provide finished formulations, leveraging extensive logistics networks.
Regulatory compliance (GMP, cGMP, ISO) remains a central criterion for supplier selection.
Diversification and robust quality assurance mitigate supply risks associated with geopolitical and regulatory changes.

FAQs

1. Who are the leading API suppliers for nalbuphine hydrochloride globally?
Chinese companies like Zhejiang Haibin Pharmaceutical and Jiangsu Nhwa are leading API suppliers, complemented by Indian firms such as Akorn and Synthesis Pharmaceuticals.

2. What regulatory standards must suppliers of nalbuphine hydrochloride adhere to?
Suppliers should comply with Good Manufacturing Practices (GMP), ISO standards, and possess relevant certifications for international markets, especially if exporting to the US and Europe.

3. How does geopolitical instability affect nalbuphine hydrochloride supply?
Trade restrictions, tariffs, and regulatory controls on opioids can disrupt supply chains. Diversification across multiple suppliers and regions mitigates these risks.

4. Are there alternatives to Chinese API manufacturers for nalbuphine hydrochloride?
Yes, Indian and Israeli manufacturers are increasingly providing alternatives, offering competitive quality and cost advantages, and helping diversify supply sources.

5. What should healthcare providers consider when sourcing nalbuphine hydrochloride formulations?
They should prioritize suppliers with verified regulatory compliance, consistent quality, reliable logistics, and adherence to legal controls surrounding opioid products.

Sources

[1] Pharmaceutical Market Analysis Reports, 2022.
[2] WHO Critical Medicines List, 2023.
[3] FDA and EMA regulatory guidelines, 2022.
[4] Company websites and manufacturing disclosures (Zhejiang Haibin, Jiangsu Nhwa, Akorn, Sun Pharma).

Suppliers and packagers for NALBUPHINE HYDROCHLORIDE