Suppliers and packagers for generic pharmaceutical drug: METHAMPHETAMINE HYDROCHLORIDE

METHAMPHETAMINE 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
Dr Reddys Labs Sa	METHAMPHETAMINE HYDROCHLORIDE	methamphetamine hydrochloride	TABLET;ORAL	091189	ANDA	Mayne Pharma Commercial LLC	68308-115-01	100 TABLET in 1 BOTTLE, PLASTIC (68308-115-01)	2010-04-26
Dr Reddys Labs Sa	METHAMPHETAMINE HYDROCHLORIDE	methamphetamine hydrochloride	TABLET;ORAL	091189	ANDA	Dr. Reddy's Laboratories Inc	75907-094-01	100 TABLET in 1 BOTTLE, PLASTIC (75907-094-01)	2025-11-07
Hikma	METHAMPHETAMINE HYDROCHLORIDE	methamphetamine hydrochloride	TABLET;ORAL	203846	ANDA	Hikma Pharmaceuticals USA Inc.	0054-0389-25	100 TABLET in 1 BOTTLE (0054-0389-25)	2016-12-06

Suppliers for the Pharmaceutical Drug: Methamphetamine Hydrochloride

Last updated: July 28, 2025

Introduction

Methamphetamine Hydrochloride (methamphetamine HCl) is a potent central nervous system stimulant with recognized medical uses, primarily in the treatment of attention deficit hyperactivity disorder (ADHD) and certain cases of obesity. However, its high potential for abuse and addiction has resulted in tight regulatory controls globally. Despite its illicit reputation, pharmaceutical-grade methamphetamine is still manufactured and supplied legally under strict licensing, primarily for medical purposes. Understanding the legitimate suppliers, regulatory landscape, and the drug’s global distribution channels is essential for stakeholders in the healthcare and pharmaceutical sectors.

Legal Framework and Regulatory Oversight

Global regulation of methamphetamine HCl is governed by international agreements, notably the Convention on Psychotropic Substances (1971) under the United Nations, which categorizes methamphetamine as a Schedule II substance. Countries implement their own regulatory agencies and licensing protocols:

• United States: The Drug Enforcement Administration (DEA) oversees licensing via the Office of Diversion Control. Pharmaceutical production is limited to a handful of manufacturers with DEA Schedule II registrations.
• European Union: The European Medicines Agency (EMA) regulates medicinal use, with member states licensing authorized manufacturers under national GxP standards.
• Asia-Pacific: Countries like Japan, China, and India have stringent regulations, with a limited authorized list of manufacturers fulfilling medical needs.

Manufacturers are subject to rigorous GMP standards, frequent inspections, and strict controls over distribution pathways.

Major Legal Suppliers and Manufacturers

Legal suppliers of methamphetamine HCl are typically specialized pharmaceutical companies with licensed manufacturing capabilities. Their operations are localized, regulated, and involve strict compliance with Good Manufacturing Practice (GMP).

1. Sigma-Aldrich / Merck KGaA

   • Historically, Sigma-Aldrich supplied research-grade methamphetamine for scientific purposes, but due to regulatory restrictions and the drug’s class, their manufacturing and distribution are limited to authorized entities. For medicinal use, they supply precursor chemicals or research-grade compounds under strict licensing.

2. Lipomed AG

   • Based in Switzerland, Lipomed is recognized as an authorized manufacturer for pharmaceutical-grade methamphetamines used in medical treatments and research.

3. Mallinckrodt Industries

   • As a legacy player, Mallinckrodt historically supplied pharmaceutical opioids and stimulants, including methamphetamine HCl for certain therapeutic indications worldwide, under strict licensing.

4. Biosynth Carbosynth

   • A key precursor and API supplier, Biosynth provides controlled substances for research and medicinal formulations, compliant with international regulation.

5. Hikma Pharmaceuticals

   • Engaged in the production of controlled substances, Hikma supplies pharmaceutical APIs under licensing, including methamphetamine HCl for specific jurisdictions.

Synthetic Routes and Manufacturing Sources

Methamphetamine HCl is primarily synthesized through controlled chemical processes involving precursor chemicals like ephedrine or pseudoephedrine. The manufacturing process is highly regulated, with licensed facilities adhering to GMP protocols.

• Precursors Suppliers: Companies such as Johnson Matthey and Albemarle produce and supply precursor chemicals under strict licenses, which are key inputs for pharmaceutical manufacturing.
• API Producers: Firms employing chemical synthesis, extraction, or reduction techniques to produce pharmaceutical-grade methamphetamine.

Global Distribution Channels

Legal distribution channels are highly compartmentalized and monitored:

• Authorized Pharmacies: Dispensing pharmacies operate under strict licensing to supply methamphetamine HCl only when prescribed.
• Licensed Distributors: In the case of bulk APIs, distribution is limited to certified manufacturers and research institutions.
• International Trade: Cross-border movement of methamphetamine APIs is governed by customs regulations, international treaties, and controlled substance treaties, with export licenses issued by national authorities.

Illicit Supply and Challenges

Despite stringent controls, illegal production persists, mainly in clandestine laboratories in parts of Southeast Asia, Eastern Europe, and North Africa. These illegal operations often involve the illicit synthesis of methamphetamine from precursor chemicals diverted from legitimate supply chains. Such illegal manufacturing undermines legal suppliers and poses significant law enforcement challenges.

Regulatory and Compliance Considerations for Buyers

Healthcare providers and pharmaceutical companies sourcing methamphetamine HCl must:

• Verify licensing and compliance of suppliers
• Ensure adherence to national and international regulations
• Obtain appropriate import/export licenses
• Conduct thorough due diligence to avoid diversion

Emerging Trends and the Future of Legal Supply

Innovations in synthetic chemistry and stricter global controls on precursor chemicals may impact future supply chains. Additionally, ongoing research into new formulations and delivery systems could influence manufacturing and distribution patterns.

Key Players’ Geographical Footprint

Most authorized manufacturers are located in North America, Europe, and select Asian markets. The concentrated nature of licensing underscores the importance of geopolitical stability and regulatory compliance in supply chain integrity.

Conclusion

The supply landscape of methamphetamine hydrochloride for pharmaceutical purposes is tightly controlled, with a limited number of licensed producers operating under strict regulatory oversight. Companies like Lipomed AG, Sigma-Aldrich, and Biosynth are primary authorized sources, serving medical, research, and law enforcement needs worldwide. The regulatory environment remains vigilant against illegal diversion, emphasizing the significance of compliance for legal suppliers and purchasers.

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Key Takeaways

• Limited, regulated suppliers: Only a handful of pharmaceutical-grade methamphetamine HCl suppliers operate globally, adhering to strict licensing and GMP standards.
• Regulatory environment: Globally, authorities impose stringent licensing, manufacturing audits, and distribution controls to prevent abuse and diversion.
• Focus on compliance: Buyers must verify licensing, adherence to regulations, and supply chain integrity to mitigate risks of illegal diversion.
• Global geographic concentration: Most authorized suppliers are based in North America, Europe, and select Asian countries, influencing supply dynamics.
• Future outlook: Changes in synthetic chemistry, global regulations, and enforcement efforts will shape the legal supply chain landscape.

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FAQs

1. Who are the leading legal suppliers of methamphetamine Hydrochloride for pharmaceutical use?
Leading licensed manufacturers include Lipomed AG, Sigma-Aldrich (part of Merck KGaA), Biosynth Carbosynth, Mallinckrodt Industries, and Hikma Pharmaceuticals. These entities operate under strict regulatory oversight to produce pharmaceutical-grade methamphetamine HCl.

2. How are legal methamphetamine supplies regulated internationally?
International regulation is governed by treaties like the 1971 Convention on Psychotropic Substances, with national agencies such as the DEA in the U.S. and EMA in Europe enforcing licensing, GMP compliance, and shipment restrictions to prevent diversion and illicit use.

3. What are the primary raw materials used in the synthesis of pharmaceutical methamphetamine?
The synthesis common involves precursor chemicals like ephedrine or pseudoephedrine, which are themselves subject to strict control and licensing. Suppliers of these precursors operate under regulated schemes to prevent diversion.

4. How does the illicit manufacturing of methamphetamine impact legitimate suppliers?
Illicit manufacturing, often using diverted precursors or clandestine synthesis methods, leads to enforcement actions, market distortions, and regulatory tightening, which can restrict legitimate supply and increase procurement costs.

5. What challenges exist in ensuring the quality and safety of methamphetamine for medical use?
Ensuring the quality involves rigorous manufacturing standards, regular inspections, and strict supply chain monitoring. Variability or contamination from illicit sources poses health risks, making supplier verification pivotal.

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Sources

1. United Nations Office on Drugs and Crime (UNODC). Psychotropic Substances Report 2022.
2. U.S. Drug Enforcement Administration (DEA). Controlled Substance Uniform Schedule.
3. European Medicines Agency (EMA). Guidelines on Manufacture of Controlled Substances.
4. Lipomed AG official documentation and licensing information.
5. Industry reports on pharmaceutical manufacturing of controlled substances.