AMPHETAMINE SULFATE: Pharmaceutical manufacturers, suppliers, and wholesalers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Amneal Pharms	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	211139	ANDA	Amneal Pharmaceuticals NY LLC	69238-1563-1	100 TABLET in 1 BOTTLE (69238-1563-1)	2018-09-28
Amneal Pharms	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	211139	ANDA	Amneal Pharmaceuticals NY LLC	69238-1564-1	100 TABLET in 1 BOTTLE (69238-1564-1)	2018-09-28
Aurolife Pharma Llc	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	211639	ANDA	Aurolife Pharma, LLC	13107-259-01	100 TABLET in 1 BOTTLE (13107-259-01)	2019-01-31
Aurolife Pharma Llc	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	211639	ANDA	Aurolife Pharma, LLC	13107-260-01	100 TABLET in 1 BOTTLE (13107-260-01)	2019-01-31
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 29, 2025

Overview of Amphetamine Sulfate

Amphetamine sulfate, a central nervous system (CNS) stimulant, is primarily used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. Its chemical structure is C9H13N·H2SO4, and it functions by increasing the release of norepinephrine and dopamine in the brain, enhancing alertness and focus. Despite its therapeutic applications, amphetamine sulfate is tightly regulated globally due to its high potential for abuse and dependency.

The manufacturing, distribution, and supply chain of amphetamine sulfate are subject to stringent regulatory oversight by agencies such as the U.S. Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), European Medicines Agency (EMA), and comparable authorities worldwide. As a controlled substance, the supply ecosystem involves licensed producers, authorized distributors, and strict import-export controls.

Major Manufacturers and Suppliers of Amphetamine Sulfate

1. Large-Scale Pharmaceutical Manufacturers

Several pharmaceutical companies manufacture amphetamine sulfate, primarily for medical use within regulated markets:

Richmond Pharmacology Ltd.
A UK-based contract research organization (CRO) specializing in clinical trial supplies, including controlled substances such as amphetamine sulfate. Their supply chain adheres to stringent regulatory standards, including Good Manufacturing Practices (GMP).
Edict Pharma (India)
An active player in the global generics market with capabilities to produce amphetamines, including sulfate salts, for both domestic and international markets. They operate under licensing agreements complying with international drug control treaties.
Lannett Company (USA)
Known for manufacturing various controlled substance formulations, including amphetamine salts. Their compliance with U.S. DEA regulations enables the distribution of pharmaceutical-grade amphetamine sulfate to pharmacies and hospitals.
Impax Laboratories (USA)
A major supplier specializing in neurological drugs, including stimulant formulations. Their manufacturing facilities are DEA-registered, facilitating lawful domestic distribution.

2. Contract Manufacturing Organizations (CMOs)

Many pharmaceutical firms outsource production to CMOs due to regulatory complexities and high compliance costs:

Shin-Etsu Chemical Co., Ltd. (Japan)
Offers synthesis and manufacturing services for controlled substances, aligned with international standards.
Piramal Enterprises (India)
Provides active pharmaceutical ingredients (APIs) including amphetamine sulfate, through licensed manufacturing operations for global markets.
Hikal Ltd. (India)
Engages in custom synthesis and manufacturing of controlled substances, complying with global regulatory frameworks.

3. Synthetic Compound Suppliers and Raw Material Distributors

Suppliers providing raw chemicals and intermediates necessary for amphetamine sulfate synthesis include:

Sigma-Aldrich (Merck KGaA)
Offers chemical precursors used in controlled substance synthesis, although their direct supply of amphetamine sulfate is strictly regulated or prohibited due to compliance issues.
Alfa Aesar (Thermo Fisher Scientific)
Provides research chemicals and raw materials for development and manufacturing processes under strict regulations.
Acros Organics (Thermo Fisher)
Sells intermediates and precursor chemicals used in synthesis of amphetamines for research purposes, with strict compliance controls.

4. Legality and Restricted Distribution

Due to the controlled nature of amphetamine sulfate, the supply chain operates within a tightly regulated framework:

Regulatory Licenses:
Manufacturers, distributors, and importers must possess DEA registration in the United States or equivalent licenses in other jurisdictions.
International Control:
The International Narcotics Control Board (INCB) monitors the distribution of amphetamine-based pharmaceuticals. Export and import require adherence to the Convention on Psychotropic Substances (1971).
Distribution Channels:
Typically, legitimate suppliers distribute only to authorized pharmacies, hospitals, and governmental agencies. Illicit trade and diversion are significant risks, necessitating robust tracking and security measures.

Market Dynamics and Trends

The global amphetamine sulfate market is driven by increasing ADHD diagnosis rates, expanding narcolepsy treatment, and the demand for pharmaceutical APIs. Despite regulatory obstacles, the demand persists predominantly in North America and Europe, where prescriptions are tightly controlled. Indian and Chinese manufacturers play a critical role in supply due to cost advantages and production capacity.

The ongoing COVID-19 pandemic has disrupted supply chains but also increased scrutiny on controlled substance manufacturing and distribution. Moreover, the rise in illicit amphetamine production, often originating from clandestine labs and unregulated suppliers, poses risks to legitimate supply chains, emphasizing the need for vigilant regulatory enforcement.

Regulatory Considerations in Buying Amphetamine Sulfate

Due Diligence:
Buyers must verify licenses, compliance history, and manufacturing standards before engaging suppliers.
Supply Chain Security:
Ensuring provenance and preventing diversion is critical; trusted, DEA-registered or equivalent suppliers reduce risks.
Legal Compliance:
Cross-border shipments require documentation compliant with international drug control treaties, export/import licenses, and customs clearance.
Pricing and Availability:
Due to strict regulation, legitimate sources often have limited availability, with prices reflecting the high compliance overhead and risk mitigation.

Key Challenges for Stakeholders

Regulatory Barriers:
Navigating diverse licensing, reporting obligations, and compliance standards across jurisdictions complicates procurement.
Illicit Market Risks:
The proliferation of illegal manufacturing and black-market trade undermines legitimate supply chains, posing legal and safety concerns.
Trade Uncertainties:
Political, regulatory, and public health factors influence supply stability.

Key Takeaways

The legitimate supply chain for amphetamine sulfate is composed of highly regulated entities, including pharmaceutical manufacturers, CMOs, and licensed distributors.
Major producers are primarily based in the U.S., India, and Japan, complying with international and national regulations to prevent diversion.
Due to its classification as a controlled substance, procurement requires strict licensing, secure documentation, and adherence to legal frameworks.
Ongoing market demand, especially from North America and Europe, sustains the supply ecosystem, although illicit markets remain a significant risk.
Business stakeholders must prioritize due diligence, compliance, and secure supply channels to navigate this complex landscape effectively.

FAQs

1. Can I legally purchase amphetamine sulfate from international suppliers?
Legal purchase is restricted to licensed entities with proper DEA or equivalent authorization. Personal or unlicensed buyers cannot legally procure or distribute amphetamine sulfate.

2. What are the primary countries producing pharmaceutical-grade amphetamine sulfate?
The key producers include the United States, India, and Japan, where strict manufacturing and regulatory standards are enforced.

3. How does regulation impact the global supply of amphetamine sulfate?
Regulations markedly limit supply to licensed channels, increase costs, and impose strict record-keeping. They also limit illicit movement but do not entirely prevent it.

4. Are there generic alternatives to amphetamine sulfate?
Yes, formulations like amphetamine salts (e.g., Adderall) are available; however, all are tightly controlled. Generic APIs are produced by authorized manufacturers for prescription use.

5. What are the risks associated with unregulated sources of amphetamine sulfate?
Unregulated supplies pose safety threats due to inconsistent potency or contamination, legal risks, and potential involvement in illicit markets.

Sources

United Nations Office on Drugs and Crime (UNODC). "World Drug Report 2022."
U.S. Food and Drug Administration (FDA). "Controlled Substance Schedules."
European Medicines Agency (EMA). "Regulation of Controlled Substances."
International Narcotics Control Board (INCB). "Annual Reports 2021."
Pharma manufacturing and regulatory compliance reports, 2022.

Suppliers and packagers for AMPHETAMINE SULFATE