Suppliers and packagers for generic pharmaceutical drug: AMPHETAMINE SULFATE

AMPHETAMINE SULFATE

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

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
Epic Pharma Llc	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	213980	ANDA	Epic Pharma LLC	42806-029-01	100 TABLET in 1 BOTTLE (42806-029-01)	2020-09-18

Who Supplies Amphetamine Sulfate to Pharma and Distribution Chains?

Last updated: April 25, 2026

What is the supply base for amphetamine sulfate?

Amphetamine sulfate is a controlled active pharmaceutical ingredient (API) used to manufacture prescription stimulant medicines (for example, ADHD and narcolepsy indications). Supply is typically concentrated among a small number of licensed API manufacturers and chemical suppliers with regulatory authorizations for manufacture, import, and distribution of controlled substances.

Because amphetamine sulfate is a regulated substance in the US and other jurisdictions, procurement is not a general “catalog” exercise. It is governed by licensing, import/export paperwork, and chain-of-custody requirements for controlled substances. In practice, pharmaceutical manufacturers and branded-generic makers source through:

• Licensed API manufacturers (domestic or foreign) that produce amphetamine sulfate or immediate precursors to it.
• Specialty chemical distributors that have controlled-substance handling permits.
• Contract manufacturing and repackaging channels for clinical and commercial lots, depending on the buyer’s market and regulatory strategy.

Which regions and supplier profiles dominate amphetamine sulfate sourcing?

Amphetamine sulfate supply is dominated by jurisdictions with mature controlled-substance compliance infrastructure and established chemical manufacturing capacity. The practical supplier profile usually falls into four buckets:

1. Regulated API manufacturers with direct controlled-substance licensing for production and export.
2. Derivative manufacturers that supply close intermediates and deliver amphetamine sulfate through finished API conversion under contract.
3. Licensed distributors that aggregate supply from one or more API manufacturers and provide controlled logistics.
4. Contract packagers / releasers for finished dosage supply chains, where amphetamine sulfate handling and lot release are coordinated to meet regulatory timelines.

Procurement typically prioritizes suppliers that can document consistent impurity profiles, provide validated CoAs, support DMF/CEP relationships where relevant, and run batch traceability suitable for controlled-substance audits.

What procurement documentation controls amphetamine sulfate purchasing?

Amphetamine sulfate sourcing is controlled by regulatory and licensing controls, which translate into standardized documentation requirements in procurement workflows. Typical documentation packages requested by regulated buyers include:

• Certificate of Analysis (CoA) per lot (assay, impurities, residual solvents if relevant, physical tests)
• GMP compliance documentation for manufacturing sites (facility licenses, inspection status)
• Batch/lot traceability and deviation/CAPA reporting access
• Regulatory status evidence for importation, distribution, and controlled-substance handling
• Chain-of-custody records for every custody transfer in the supply chain

How do pharmaceutical buyers qualify amphetamine sulfate suppliers?

Qualification is driven by compliance plus quality system fit. For a regulated buyer (brand, generic, or contract manufacturer), supplier qualification typically requires:

• GMP-grade API production at an approved site
• Analytical method verification support (or method transfer packages) for compendial and internal specifications
• OOS/OOT historical transparency for impurity drift and batch variability
• Stability and retest period evidence aligned to the intended dosage form and shelf life
• Controlled-substance logistics readiness, including storage security, shipment monitoring, and audit trail

What API specifications do suppliers typically need to match?

Amphetamine sulfate specifications vary by pharmacopeia and market, but for regulated manufacture the key items that buyers screen for are:

• Assay within a pharmacopeial range
• Impurity profile (including related substances and controlled impurity thresholds)
• Physical characteristics for downstream processing (particle size behavior is frequently relevant for tableting and formulation)
• Residual solvent and manufacturing process controls where relevant for the synthetic route used
• Water content and/or loss on drying depending on pharmacopeial requirements and internal specs

For business procurement, the decision is usually less about whether a supplier can name a spec and more about whether the supplier can sustain it across multiple consecutive lots under validated process conditions.

Where can amphetamine sulfate suppliers be found in the market?

Suppliers are typically discoverable through one of three practical channels:

1. Regulatory filings and registrations
   • Active filings that list the manufacturer of the API and relevant sites
2. GMP and controlled-substance licensing registries
   • Industry and government sources that show permitted controlled-substance manufacturing and handling
3. Commercial sourcing frameworks
   • Supplier networks used by CDMOs and branded-generic manufacturers under master supply agreements

Which vendors supply amphetamine sulfate?

Only suppliers with publicly verifiable evidence of manufacturing or distributing amphetamine sulfate for regulated pharmaceutical use should be listed. Without that verifiable basis, listing specific company names would create a high risk of inaccuracies (wrong product form, wrong controlled-substance status, wrong jurisdiction, or outdated manufacturing status). Under the operating constraints here, no vendor list can be produced without adequate evidence.

What is actionable for procurement planning?

If the objective is to secure supply for amphetamine sulfate-based manufacturing, the procurement playbook should center on:

• Controlled-substance compliance fit (licenses, import/export permissions, and audit trail maturity)
• Batch-to-batch consistency (impurity profile stability over time)
• Documentation speed (CoA lead times and responsiveness for deviation investigations)
• Route and impurity strategy (the supplier’s process controls and analytical comparability)
• Sustained capacity (ability to meet forecasted demand, not just qualification-stage volume)

What risks should buyers price into supplier selection?

Amphetamine sulfate supply chains carry predictable risk drivers:

• Regulatory and quota constraints tied to controlled-substance approvals
• International logistics delays for controlled shipments
• Batch impurity excursions that force holds under internal specifications
• Site-level GMP issues that can stop supply quickly
• Concentration risk when the supplier base is narrow and qualification cycles are long

What do contracts usually require?

For controlled APIs, buyers typically harden contracts around:

• Quality agreements defining CoA requirements, deviation handling, and comparability support
• Right-to-audit and inspection support for regulatory readiness
• Supply commitment terms (lot availability windows, forecast adherence)
• Change control (process changes, analytic method changes, site changes)
• Recall and investigation obligations mapped to controlled-substance handling

How should firms evaluate alternative sources?

“Second-source” strategies for amphetamine sulfate are typically built by:

• Identifying suppliers with documented controlled-substance capabilities in the target geography
• Running qualification comparability to ensure impurity and performance alignment
• Securing commercially meaningful safety stock through master agreements, given controlled logistics constraints
• Establishing regulatory file linkage (DMF/CEP-like documentation where applicable) to shorten time-to-launch

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Key Takeaways

• Amphetamine sulfate supply is concentrated in licensed, controlled-substance-capable API manufacturing and distribution channels.
• Supplier evaluation is dominated by controlled-substance compliance, batch traceability, and analytical/impurity consistency.
• A vendor list cannot be produced here without publicly verifiable sourcing evidence tied to regulated pharmaceutical supply; procurement planning should focus on qualification readiness, documentation, and contract quality terms.
• Key risks include quota/regulatory constraints, international controlled logistics, impurity excursions, and site-level GMP disruptions.

FAQs

1. Is amphetamine sulfate sourced through normal chemical procurement channels?
   No. It is a controlled-substance API, so procurement relies on licensed handling, chain-of-custody documentation, and regulated import/export processes.

2. What matters most in qualifying an amphetamine sulfate API supplier?
   Controlled-substance licensing and audit trail maturity, plus sustained impurity/assay consistency across multiple lots and responsive CoA and deviation handling.

3. Can a distributor supply amphetamine sulfate if it does not manufacture it?
   Sometimes, if it holds the required controlled-substance handling permits and can provide full traceability and CoAs tied to the underlying manufacturing site.

4. What contract elements are most important for controlled API supply?
   A quality agreement, right-to-audit, change control, deviation and recall obligations, and supply commitment terms mapped to lot release timing.

5. How do firms reduce supply interruption risk for amphetamine sulfate?
   Use second-source qualification, secure master supply agreements with quality-defined responsibilities, and build controlled-stock strategies aligned to forecast and licensing lead times.

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References

[1] U.S. Drug Enforcement Administration (DEA). (n.d.). Controlled Substances Act and DEA regulations (Controlled substance requirements and registrations overview). https://www.dea.gov/