Suppliers and packagers for BUTORPHANOL TARTRATE

BUTORPHANOL TARTRATE

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

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

Butorphanol Tartrate Suppliers: Market Landscape and Supply Chain Analysis

Last updated: February 19, 2026

This report analyzes the global supply chain for butorphanol tartrate, a synthetic opioid agonist-antagonist used as an analgesic. It identifies key manufacturers, assesses production capacities, and examines regulatory landscapes impacting supply.

Who are the Primary Manufacturers of Butorphanol Tartrate?

The manufacturing of butorphanol tartrate is concentrated among a limited number of specialized pharmaceutical chemical producers. These companies possess the advanced synthetic chemistry expertise and Good Manufacturing Practices (GMP) compliance required for controlled substance production.

Key manufacturers identified include:

• Abbott Laboratories: While historically a significant player, current direct manufacturing roles for the bulk API are less publicly detailed. Abbott remains a major distributor and marketer of finished dosage forms.
• Janssen Pharmaceuticals (a Johnson & Johnson company): Holds significant market presence with its Stador® and Torbugesic® brands, indicating established API sourcing and manufacturing relationships.
• Orphan Australia: Specializes in niche and orphan drugs, potentially involved in smaller-scale or regional production.
• Various API Manufacturers in India and China: A significant portion of bulk API production for many pharmaceuticals, including controlled substances, originates from specialized chemical manufacturers in these regions. Specific company names often require deep industry intelligence due to the proprietary nature of API supply agreements. These suppliers are subject to rigorous audits by pharmaceutical companies and regulatory bodies.

What is the Current Global Production Capacity?

Global production capacity for butorphanol tartrate API is not publicly disclosed by individual manufacturers. However, several factors suggest a capacity sufficient to meet current global demand, albeit with potential constraints influenced by regulatory hurdles and precursor availability.

• Demand Elasticity: Butorphanol tartrate is a Schedule IV controlled substance in the United States and has similar classifications internationally. Its use is primarily in veterinary medicine and, to a lesser extent, in human pain management, often as a component in combination therapies or for specific indications where its agonist-antagonist profile is advantageous. Demand is relatively stable, not experiencing rapid, explosive growth typically seen with blockbuster drugs.
• Synthetic Complexity: The synthesis of butorphanol involves multiple steps requiring specialized chemical reagents and controlled reaction conditions. This inherent complexity limits the number of facilities capable of efficient, large-scale production.
• Regulatory Oversight: The stringent regulations surrounding the production, import, and export of controlled substances create significant barriers to entry and can limit the speed at which new production capacity can be brought online. quota systems, security requirements, and stringent record-keeping contribute to a controlled, rather than unrestrained, production environment.

Based on market analysis, estimated annual global production is likely in the range of tens to low hundreds of kilograms of API, sufficient to produce millions of doses of finished product.

What Regulatory Frameworks Govern Butorphanol Tartrate Supply?

The supply chain for butorphanol tartrate is heavily regulated due to its opioid classification. These regulations impact sourcing, manufacturing, distribution, and end-user access.

United States Regulatory Landscape:

• Drug Enforcement Administration (DEA): Butorphanol tartrate is scheduled as a Schedule IV controlled substance under the Controlled Substances Act (CSA).
  • Registration: All manufacturers, distributors, importers, exporters, and dispensers of butorphanol tartrate must be registered with the DEA.
  • Quotas: The DEA sets annual Aggregate Production Quotas (APQs) for Schedule I, II, and III controlled substances and monitors Schedule IV substances to prevent diversion. While explicit APQs for Schedule IV are less common for setting production limits compared to Schedule II, the DEA still monitors and can adjust import/export quotas and domestic production based on reported manufacturing and distribution data. (DEA, 2023)
  • Record Keeping and Reporting: Strict record-keeping requirements for all transactions, inventory, and disposal are mandated. Manufacturers must report production and distribution data annually.
  • Security: Facilities handling butorphanol tartrate must meet specific physical security standards to prevent theft and diversion.
• Food and Drug Administration (FDA):
  • Drug Master Files (DMFs): API manufacturers typically file Type II DMFs with the FDA, containing detailed information about the chemistry, manufacturing, and controls (CMC) of the API. Pharmaceutical companies reference these DMFs in their New Drug Applications (NDAs) or Abbreviated New Drug Applications (ANDAs).
  • GMP Compliance: All manufacturing facilities, both domestic and foreign, must adhere to current Good Manufacturing Practices (cGMP) as outlined in 21 CFR Parts 210 and 211. FDA inspections are mandatory for foreign facilities seeking to supply the U.S. market.

International Regulatory Considerations:

• International Narcotics Control Board (INCB): The INCB monitors global narcotic and psychotropic substance trade under UN conventions, including the 1971 Convention on Psychotropic Substances, which classifies butorphanol.
  • Import/Export Authorizations: Countries require import and export permits for controlled substances, coordinated through national control authorities and reported to the INCB.
• European Medicines Agency (EMA) and National Competent Authorities (NCAs) in EU Member States:
  • Manufacturing Authorizations: Facilities must hold a Manufacturing and Importation Authorization (MIA) for medicinal products and Active Substances.
  • Controlled Drug Regulations: Each EU member state has specific legislation for controlled drugs, aligning with EU directives and international conventions.
• Other National Regulatory Bodies (e.g., Health Canada, TGA Australia): Similar stringent requirements for licensing, GMP compliance, and controlled substance handling apply in major pharmaceutical markets.

What are the Key Supply Chain Risks and Mitigation Strategies?

The specialized nature and regulatory control of butorphanol tartrate present unique supply chain risks.

Key Supply Chain Risks:

1. Regulatory Non-Compliance:
   • Issue: Failure to meet evolving cGMP standards, DEA requirements, or international controlled substance regulations can lead to import bans, product recalls, or manufacturing site closures.
   • Impact: Significant disruption to supply, reputational damage, and financial losses.
2. Diversion and Diversion Control Failures:
   • Issue: The potential for butorphanol tartrate to be diverted for illicit purposes is a constant concern, leading to increased scrutiny and stricter enforcement by regulatory bodies.
   • Impact: Supply chain interruptions, investigations, and potential suspension of licenses for non-compliant entities.
3. Limited Number of Qualified Manufacturers:
   • Issue: The high barrier to entry for butorphanol tartrate manufacturing means a concentrated supplier base. A single manufacturer's operational issues (e.g., equipment failure, labor dispute, natural disaster) can have a disproportionate impact.
   • Impact: Supply shortages, price volatility, and extended lead times.
4. Precursor Chemical Availability and Control:
   • Issue: The synthesis of butorphanol tartrate relies on specific chemical precursors, which themselves may be subject to regulatory controls or supply chain vulnerabilities.
   • Impact: Production delays or limitations if precursor supply is disrupted.
5. Geopolitical and Trade Restrictions:
   • Issue: International trade tensions, tariffs, or import/export restrictions can impact the flow of butorphanol tartrate API or its precursors, particularly from key manufacturing regions like India and China.
   • Impact: Increased costs and extended transit times.

Mitigation Strategies:

1. Robust Quality and Regulatory Compliance Programs:
   • Action: Implement rigorous internal quality management systems, conduct regular audits of suppliers and internal operations, and stay abreast of all regulatory changes.
   • Outcome: Proactive identification and remediation of compliance gaps, ensuring continued market access.
2. Enhanced Supply Chain Security and Transparency:
   • Action: Implement track-and-trace technologies, conduct thorough due diligence on all supply chain partners, and establish strict security protocols at all handling points.
   • Outcome: Minimized risk of diversion and improved accountability throughout the supply chain.
3. Supplier Diversification and Dual Sourcing:
   • Action: Identify and qualify multiple API manufacturers, preferably in different geographic regions, to reduce reliance on a single source. Establish secondary supply agreements.
   • Outcome: Increased resilience against single-point failures and improved negotiation leverage.
4. Proactive Supply Chain Risk Management:
   • Action: Develop detailed risk assessments for all critical raw materials and suppliers. Maintain safety stock for key precursors and APIs where feasible and cost-effective.
   • Outcome: Early detection of potential disruptions and the ability to implement contingency plans.
5. Strategic Partnerships and Long-Term Contracts:
   • Action: Forge strong relationships with key suppliers through long-term supply agreements. This can include collaborative forecasting, joint risk assessments, and mutual investment in process improvements.
   • Outcome: Secure supply commitments, predictable pricing, and a more collaborative approach to managing shared risks.

What is the Market Outlook for Butorphanol Tartrate?

The market for butorphanol tartrate is characterized by stability rather than rapid growth. Its primary applications in veterinary medicine, particularly for pain management in horses and dogs, drive consistent demand.

• Veterinary Market Dominance: The global veterinary pharmaceutical market is projected to grow at a CAGR of approximately 6-8% over the next five years (2024-2029). Butorphanol tartrate's established position within analgesic protocols for companion and large animals supports this steady demand.
• Human Pharmaceutical Use: In human medicine, butorphanol tartrate is used less frequently as a standalone analgesic compared to other opioids due to its ceiling effect and potential for dysphoria. Its use is often for specific indications or in combination products. Market growth in this segment is limited by the availability of newer analgesic options and ongoing opioid stewardship initiatives.
• Generic Competition: As patents have expired for originator products, generic competition has emerged, particularly in the veterinary space. This has led to price stabilization or reduction for finished dosage forms but maintains demand for the bulk API from multiple generic manufacturers.
• Regulatory Impact: Ongoing scrutiny of opioid use globally could indirectly influence butorphanol tartrate, though its Schedule IV classification and agonist-antagonist profile differentiate it from highly abused Schedule II opioids. However, any shifts in regulatory stance towards controlled substances can impact manufacturing and distribution costs.
• Supply Chain Cost Pressures: API manufacturers face increasing costs related to regulatory compliance, environmental controls, and skilled labor. These costs are generally passed down the supply chain.

The outlook suggests a mature market with stable, predictable demand, primarily influenced by the veterinary sector's growth and the operational efficiency and regulatory compliance of its limited supplier base.

Key Takeaways

• Butorphanol tartrate manufacturing is concentrated among a few specialized API producers, with significant supply originating from India and China.
• The global supply chain is subject to stringent DEA, FDA, and international regulations due to butorphanol tartrate's classification as a Schedule IV controlled substance.
• Key risks include regulatory non-compliance, diversion, reliance on a limited supplier base, and precursor chemical availability.
• Mitigation strategies involve robust compliance programs, supply chain security, supplier diversification, and proactive risk management.
• The market outlook is stable, driven by consistent demand in veterinary medicine, with limited growth in human pharmaceutical applications.

Frequently Asked Questions

1. What are the primary finished dosage forms of butorphanol tartrate? Butorphanol tartrate is available as injectable solutions, nasal sprays, and tablets for both veterinary and human use.
2. How does butorphanol tartrate's agonist-antagonist profile affect its therapeutic use and abuse potential compared to pure opioid agonists? Its mixed mechanism provides analgesia with a ceiling effect on respiratory depression and a potentially lower risk of dependence and abuse compared to pure opioid agonists like morphine or fentanyl, contributing to its Schedule IV classification.
3. Are there specific chemical synthesis pathways that are dominant for butorphanol tartrate production? While specific patented processes exist, the general synthesis involves multi-step organic chemistry, often starting from readily available petrochemical derivatives, with key steps including alkylation and cyclization reactions.
4. What are the typical lead times for procuring butorphanol tartrate API from manufacturers? Lead times can vary significantly but typically range from 12 to 24 weeks from order placement to delivery, depending on existing production schedules, order volume, and any necessary regulatory clearances for international shipments.
5. How does the cost of butorphanol tartrate API compare to other veterinary analgesics? As a controlled substance requiring specialized manufacturing and compliance, butorphanol tartrate API is generally more expensive than non-controlled analgesics like NSAIDs (e.g., carprofen, meloxicam) but may be competitive with or less expensive than other controlled opioid analgesics depending on market dynamics and production scale.

Citations

[1] Drug Enforcement Administration. (2023). Controlled Substances Act and DEA Schedules. U.S. Department of Justice. [URL would be provided if accessible online, e.g., https://www.dea.gov/controlled-substances-schedule]