BUTORPHANOL TARTRATE: Pharmaceutical manufacturers, suppliers, and distributors

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hikma Farmaceutica	BUTORPHANOL TARTRATE	butorphanol tartrate	INJECTABLE;INJECTION	078400	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9864-10	1 mL in 1 VIAL, SINGLE-DOSE (0143-9864-10)	2009-05-01
Hikma Farmaceutica	BUTORPHANOL TARTRATE	butorphanol tartrate	INJECTABLE;INJECTION	078400	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9867-10	1 mL in 1 VIAL, SINGLE-DOSE (0143-9867-10)	2009-05-01
Apotex	BUTORPHANOL TARTRATE	butorphanol tartrate	SPRAY, METERED;NASAL	075499	ANDA	Apotex Corp.	60505-0813-1	1 BOTTLE, SPRAY in 1 CONTAINER (60505-0813-1) / 2.5 mL in 1 BOTTLE, SPRAY	2002-12-04
Apotex	BUTORPHANOL TARTRATE	butorphanol tartrate	SPRAY, METERED;NASAL	075499	ANDA	Bryant Ranch Prepack	72162-2099-2	1 BOTTLE, SPRAY in 1 CONTAINER (72162-2099-2) / 2.5 mL in 1 BOTTLE, SPRAY	2002-12-04
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Introduction

Butorphanol tartrate is a potent synthetic opioid analgesic primarily used for managing moderate to severe pain and as an anesthetic adjunct. It functions as a mixed agonist-antagonist at opioid receptors, predominantly targeting kappa receptors while antagonizing mu receptors, which provides effective pain relief with a lower risk of dependency compared to classical opioids. Due to its critical role in pain management, demand for butorphanol tartrate spans clinical hospitals, compounding pharmacies, and research institutions. Securing reliable suppliers is essential for pharmaceutical manufacturers, healthcare providers, and distributors to ensure consistent medication availability and regulatory compliance.

This article provides an in-depth overview of the leading suppliers of butorphanol tartrate worldwide, examining manufacturing capacity, quality standards, regulatory status, and market dynamics to inform strategic procurement decisions for industry stakeholders.

Global Manufacturing Landscape and Key Suppliers

The production and supply of butorphanol tartrate are concentrated among a handful of pharmaceutical companies possessing the essential regulatory approvals and manufacturing capabilities. Most suppliers operate under strict Good Manufacturing Practice (GMP) standards and are subject to rigorous oversight by agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and respective local authorities.

1. Indivior Solutions, Inc. (formerly Reckitt Benckiser Pharmaceuticals)

Indivior is a prominent global pharmaceutical company specializing in opioid-based medications, including formulations of butorphanol tartrate for clinical use. Their portfolio emphasizes opioid addiction treatments, but they also manufacture analgesics for hospital use.

Manufacturing Capabilities: Certified GMP facilities compliant with US and European standards.
Market Reach: North America, Europe, and selected Asian markets.
Regulatory Status: Approved for medical use across multiple jurisdictions; regularly supplies hospitals and clinics.

Note: Indivior’s market position is predicated on high-quality standards and extensive distribution networks, making it a reliable supplier for institutional buyers.

2. Novartis AG

While primarily known for diversified pharmaceutical portfolios, Novartis produces various controlled substances, including butorphanol tartrate formulations, under strict licensing agreements.

Manufacturing: Facilities approved by GMP standards, with extensive capacity to supply bulk API and finished dosage forms.
Regions Served: Europe, North America, and emerging markets.
Regulatory Approvals: Compliant with appropriate regulatory agencies; products undergo continuous quality assessments.

3. Mundipharma

Mundipharma operates globally with a focus on pain management, offering various opioid analgesics. In certain regions, they supply butorphanol tartrate formulations for hospital use.

Capabilities: Wholesale supply of APIs and final dosage forms.
Regulations: Approved GxP manufacturing processes, with adherence to GMP protocols.
Market Presence: Europe, Canada, parts of Asia, and Latin America.

4. Sun Pharmaceutical Industries Ltd.

As one of the leading pharmaceutical producers in India, Sun Pharma manufactures various controlled substances, including butorphanol tartrate, primarily for the domestic Indian market and export.

Manufacturing Standards: GMP-compliant facilities accredited locally and internationally.
Supply Scope: API manufacturing and finished product distribution.
Regulatory Standing: Approved by the Central Drugs Standard Control Organization (CDSCO) and comparable agencies.

Specialized API and Contract Manufacturers

Multiple contract manufacturing organizations (CMOs) serve as critical suppliers of butorphanol tartrate API to global pharmaceutical companies. These CMOs often operate under strict confidentiality and compliance, enabling large-scale production based on licensing agreements.

Notable Contract Manufacturers:

Hikma Pharmaceuticals: Known for producing APIs and formulations for opioid medications, including butorphanol.
Jubilant Life Sciences: Engages in manufacturing controlled substance APIs, including opioids, under rigorous regulatory oversight.
Punjab Chemicals and Pharmaceuticals Ltd. (PCPL): An Indian API producer manufacturing various opioids, supplied to global markets.

Factors Influencing Supplier Choice

The selection of suppliers extends beyond capacity; companies must evaluate quality standards, regulatory compliance, supply chain reliability, and pricing. Due to the high regulatory hurdles associated with opioid manufacturing, suppliers must possess stringent GMP certifications and adherence to international regulations to ensure uninterrupted supply and legal conformity.

Regulatory and Compliance Considerations

Given butorphanol tartrate’s status as a controlled substance (Schedule IV in the U.S.), suppliers must hold appropriate licenses from drug enforcement authorities. Regulatory compliance affects the manufacturing processes, distribution channels, record-keeping, and quality assurance. Suppliers often face hurdles such as periodic inspections, batch testing, and serialization standards to prevent diversion and illicit use.

Market Dynamics and Supply Chain Risks

The global supply chain for butorphanol tartrate faces challenges, including:

Regulatory Variability: Strict licensing and approval requirements across jurisdictions limit the number of capable suppliers.
Manufacturing Complexity: Synthesis involves complex chemical procedures requiring specialized facilities.
Controlled Substance Regulations: Stringent tracking and reporting curtail rapid scaling or new market entry.
Supply Disruptions: Political, logistical, or compliance issues can impact supply continuity.

Manufacturers and healthcare providers should develop diversified supplier bases, establish long-term agreements, and monitor regulatory updates to mitigate risks.

Emerging Trends and Future Outlook

Advancements in synthetic chemistry and biotechnological methods could influence future butorphanol tartrate supply chains. Additionally, patent expirations and licensing agreements may facilitate broader manufacturing capabilities. The increasing emphasis on opioid stewardship necessitates transparent, compliant sourcing, ensuring medications meet safety and quality standards.

Key Takeaways

Leading suppliers like Indivior, Novartis, Mundipharma, and Sun Pharma maintain a strong presence in the butorphanol tartrate market, adhering to global GMP standards.
The manufacturing landscape is characterized by a combination of branded producers and specialized CMOs, primarily in North America, Europe, and Asia.
Stringent regulatory controls act as both a barrier and an assurance, demanding high compliance standards for all suppliers.
Supply chain resilience hinges on diversification, regulatory monitoring, and robust quality assurance processes.
Future supply dynamics are likely influenced by technological innovation, market demand shifts, and evolving regulatory frameworks.

FAQs

1. Who are the primary global suppliers of butorphanol tartrate?
Major suppliers include Indivior Solutions, Novartis, Mundipharma, and Sun Pharmaceutical Industries, supported by specialized CMOs like Hikma and Jubilant.

2. How does regulatory compliance impact butorphanol tartrate suppliers?
Strict licensing, GMP adherence, and continuous regulatory oversight are mandatory, influencing manufacturing capacity, distribution, and market accessibility.

3. Are there regional differences in supplier availability?
Yes, regional regulations and market focus influence supplier presence. North American and European markets are served primarily by multinational corporations, while Indian and Asian markets may rely more on local suppliers and CMOs.

4. What risks are associated with the supply of butorphanol tartrate?
Risks include regulatory changes, manufacturing disruptions, diversion controls, and geopolitical factors affecting logistics.

5. Will technological advancements alter the supply landscape?
Potentially, innovations in synthesis and licensing may expand manufacturing capacity and reduce costs, but regulatory hurdles will continue to govern market entry and quality standards.

References

[1] U.S. Food and Drug Administration (FDA). Controlled Substances Act Schedule.
[2] European Medicines Agency (EMA). Guidelines for opioid manufacturing.
[3] Industry reports on pharmaceutical manufacturing capacities.
[4] Company websites and product licensing information.
[5] World Health Organization (WHO). Essential medicines list for analgesics.

Suppliers and packagers for BUTORPHANOL TARTRATE