Suppliers and packagers for METHADONE HYDROCHLORIDE INTENSOL

METHADONE HYDROCHLORIDE INTENSOL

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	METHADONE HYDROCHLORIDE INTENSOL	methadone hydrochloride	CONCENTRATE;ORAL	089897	ANDA	Hikma Pharmaceuticals USA	0054-0391-68	1000 mL in 1 BOTTLE (0054-0391-68)	2010-06-23
Hikma	METHADONE HYDROCHLORIDE INTENSOL	methadone hydrochloride	CONCENTRATE;ORAL	089897	ANDA	Hikma Pharmaceuticals USA Inc.	0054-3553-44	1 BOTTLE in 1 CARTON (0054-3553-44) / 30 mL in 1 BOTTLE	1988-09-06

Suppliers for the Pharmaceutical Drug: Methadone Hydrochloride Intensol

Last updated: August 6, 2025

Introduction

Methadone Hydrochloride Intensol is a liquid formulation of methadone, a synthetic opioid primarily used for pain management and opioid dependence treatment. Its importance in clinical settings underscores the need for reliable supply chains managed by reputable manufacturers. This article provides a comprehensive overview of key suppliers for Methadone Hydrochloride Intensol, analyzing their manufacturing capabilities, regulatory status, and market presence.

Regulatory Landscape and Market Overview

Methadone (CAS Number: 76-49-3) is listed under strict regulatory controls due to its potential for misuse and dependence. Agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and national regulatory bodies enforce stringent standards for manufacturing and distribution. Consequently, suppliers must demonstrate compliance with Good Manufacturing Practices (GMP) and obtain necessary licensing before market entry.

The market for Methadone Hydrochloride Intensol is concentrated among a few global and regional pharmaceutical manufacturers, with a focus on complying with strict international regulations to ensure product safety and efficacy.

Major Suppliers of Methadone Hydrochloride Intensol

1. Eczacıbaşı Pharma

Overview: Eczacıbaşı Pharma is a prominent Turkish pharmaceutical company known for manufacturing opioid analgesics, including methadone formulations. They have established a robust GMP-compliant manufacturing facility capable of producing liquid formulations such as Intensol.

Capabilities: The company produces Methadone Hydrochloride Intensol for local and export markets. Their manufacturing processes adhere to EU and WHO standards, facilitating access to regulatory approval in multiple jurisdictions.

Market Position: Eczacıbaşı Pharma serves regional markets primarily across Eastern Europe, the Middle East, and Africa. Their products are distinguished by competitive pricing and reliable quality assurance.

Regulatory Status: The company holds relevant licenses from Turkish Medicines and Medical Devices Agency (TİTCK) and has registered their formulations with key authorities, enabling international distribution.

2. Hikma Pharmaceuticals

Overview: Hikma Pharmaceuticals, headquartered in Jordan, is a global generic and injectable drug manufacturer with extensive experience in producing controlled substances, including methadone formulations.

Capabilities: Hikma's production facilities are certified GMP compliant (FDA, EMA, and TGA), capable of manufacturing both solid and liquid methadone products, including Intensol. They utilize advanced synthetic and formulation techniques to ensure drug stability and consistency.

Market Position: Hikma supplies Methadone Hydrochloride Intensol to North America, Europe, and emerging markets, leveraging its global distribution network and reputation for quality.

Regulatory Status: Their products are registered and approved by major regulatory agencies, with extensive documentation supporting compliance with controlled substance regulations.

3. Lannett Company

Overview: Lannett is a U.S.-based manufacturer specializing in generic pharmaceuticals, including controlled substances like methadone. The company operates FDA-registered facilities with a focus on high-quality injectable and oral formulations.

Capabilities: Lannett’s manufacturing processes are GMP-compliant, with capability to produce methadone hydrochloride solutions such as Intensol in accordance with U.S. pharmacopoeia standards.

Market Position: Lannett supplies Methadone Hydrochloride Intensol primarily within the United States and has a reputation for reliable, cost-effective manufacturing for institutional buyers.

Regulatory Status: The company maintains DEA registration for Schedule II controlled substances, ensuring legal compliance for both manufacturing and distribution.

4. Dr. Reddy’s Laboratories

Overview: Operating globally from India, Dr. Reddy’s Labs produces a wide range of generic pharmaceuticals, including opioids like methadone. They have an extensive R&D and manufacturing infrastructure.

Capabilities: Their GMP-certified manufacturing facilities support production of liquid methadone formulations, adhering to WHO and USFDA standards, with capabilities for large-scale supply.

Market Position: Dr. Reddy’s exports to several continents, including North America, Latin America, and Africa, especially focusing on supplying quality-controlled controlled substances.

Regulatory Status: Their products hold approvals from multiple regulators, including USFDA and EMA, with licenses to manufacture Schedule II narcotics.

5. Spectrum Pharmaceuticals

Overview: Spectrum Pharmaceuticals is an international biotech company involved in producing specialty drugs, including opioid analgesics. They focus on controlled substances strictly regulated by health authorities.

Capabilities: They possess GMP-compliant manufacturing units capable of producing liquid methadone formulations like Intensol, with high purity and stability standards.

Market Position: Spectrum supplies mainly to research institutions, hospitals, and government agencies, emphasizing compliance with stringent control measures.

Regulatory Status: The company maintains licenses for controlled substance manufacturing, adhering to DEA and EMA regulations.

Emerging and Niche Suppliers

While the above-listed are primary suppliers with extensive market presence, several smaller and regional manufacturers operate under licensing agreements with major firms or produce under contract manufacturing arrangements. Variability in regulatory compliance and product consistency remains a challenge within this segment.

Key Factors in Supplier Selection

• Regulatory Compliance: Suppliers must possess valid licenses from relevant authorities such as the DEA, TGA, or EMA to produce Schedule II controlled drugs.
• Manufacturing Quality: GMP-certification and process validation are non-negotiable for ensuring consistent, safe, and efficacious products.
• Supply Chain Reliability: Suppliers with global distribution and contingency plans reduce the risk of shortages.
• Cost and Pricing: Competitive pricing remains critical, especially for large-volume healthcare institutions and governments.
• Product Certification: Products should meet pharmacopoeial standards (USP, EP, BP) with robust stability data for Intensol formulations.

Conclusion

The supply landscape for Methadone Hydrochloride Intensol is characterized by a small group of globally recognized manufacturers, primarily operating under strict regulatory oversight. Leading players such as Hikma Pharmaceuticals, Lannett, and Dr. Reddy’s have established reliable supply chains and regulatory approvals that ensure product safety and consistency. Regional companies like Eczacıbaşı Pharma fulfill local demand, supporting healthcare infrastructure across specific markets.

For healthcare providers, distributors, and procurement agencies, rigorous supplier qualification processes are essential to mitigate risk and ensure compliance with drug controls. Long-term partnerships with tested suppliers sharing a commitment to GMP standards and regulatory adherence will facilitate uninterrupted access to this critical medication.

Key Takeaways

• Globally, a small number of manufacturers—Hikma, Lannett, Dr. Reddy’s, and regional players like Eczacıbaşı Pharma—dominate Methadone Hydrochloride Intensol supply.
• Strict regulatory compliance and GMP certification are non-negotiable criteria in supplier selection.
• Supply chain stability and product quality assurance mitigate risks associated with controlled substance shortages.
• Regional companies play a vital role in supplying local markets, but global suppliers offer broader regulatory approvals.
• Due diligence and ongoing supplier audits are fundamental for ongoing procurement success.

FAQs

Q1: What regulatory approvals are necessary for suppliers of Methadone Hydrochloride Intensol?
A1: Suppliers must hold licenses such as DEA registration (USA), TGA certification (Australia), or EMA approval (Europe) to manufacture and distribute controlled substances legally.

Q2: Are there generic manufacturers of Methadone Hydrochloride Intensol besides the major international companies?
A2: Yes. Several regional manufacturers produce generic formulations under licensing agreements or as contract manufacturers, though these may vary in regulatory adherence and product quality.

Q3: How can healthcare providers verify supplier compliance?
A3: Verification involves reviewing licensing documentation, GMP certification, product registration with regulatory agencies, and audit records for quality assurance.

Q4: What are the key risks in sourcing Methadone Hydrochloride Intensol?
A4: Risks include supply shortages, regulatory non-compliance, quality inconsistencies, and disruptions due to geopolitical factors or supply chain disruptions.

Q5: How does international regulation impact the supply of Methadone Hydrochloride Intensol?
A5: International regulations impose strict controls on controlled substances, influencing manufacturing standards, licensing, and cross-border logistics, thus requiring suppliers to maintain compliance across jurisdictions.

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Sources:

[1] US Food and Drug Administration (FDA). Controlled Substance Act Regulations.
[2] European Medicines Agency (EMA). Guidelines for the Manufacture of Opioid Medications.
[3] World Health Organization (WHO). Good Manufacturing Practices (GMP) Guidelines.
[4] GlobalData. Pharmaceutical Market Analysis of Opioid Drugs.
[5] Company websites and public filings of Hikma, Lannett, Dr. Reddy’s, and Eczacıbaşı Pharma.