Suppliers and packagers for AMPHETAMINE

AMPHETAMINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actavis Labs Fl Inc	AMPHETAMINE	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	209253	ANDA	Teva Pharmaceuticals, Inc.	0480-3315-65	30 BLISTER PACK in 1 CARTON (0480-3315-65) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	2025-12-08
Actavis Labs Fl Inc	AMPHETAMINE	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	209253	ANDA	Teva Pharmaceuticals, Inc.	0480-3316-65	30 BLISTER PACK in 1 CARTON (0480-3316-65) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	2025-12-08
Actavis Labs Fl Inc	AMPHETAMINE	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	209253	ANDA	Teva Pharmaceuticals, Inc.	0480-3317-65	30 BLISTER PACK in 1 CARTON (0480-3317-65) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	2025-12-08
Actavis Labs Fl Inc	AMPHETAMINE	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	209253	ANDA	Teva Pharmaceuticals, Inc.	0480-3318-65	30 BLISTER PACK in 1 CARTON (0480-3318-65) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	2025-12-08
Actavis Labs Fl Inc	AMPHETAMINE	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	209253	ANDA	Teva Pharmaceuticals, Inc.	0480-3319-65	30 BLISTER PACK in 1 CARTON (0480-3319-65) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	2025-12-08
Actavis Labs Fl Inc	AMPHETAMINE	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	209253	ANDA	Teva Pharmaceuticals, Inc.	0480-3320-65	30 BLISTER PACK in 1 CARTON (0480-3320-65) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	2025-12-08

Executive summary Amphetamine supply in the US is highly consolidated and tightly controlled due to DEA diversion controls and quota limits. For regulated commercial supply, buyers typically procure from DEA-registered manufacturers and their authorized distributors, with sourcing often tied to bulk API availability and finished-dose capabilities (tablet/capsule) plus validated cGMP packaging. The specific “suppliers” (company-level) and the exact products they sell depend on whether you mean (1) US FDA-approved finished dosage forms, (2) DEA-registered bulk amphetamine API, or (3) international sources for export or contract manufacturing.

If the supplier list is limited to companies that actually market FDA-approved amphetamine products in the US, then the universe is definable via FDA/NDC labeling and DEA registration status. If the supplier list includes amphetamine “API” and specialty contract manufacturers, it expands materially and must be cross-checked against DEA registration and quota administration.

No complete, accurate supplier set can be produced from the prompt alone, because “AMPHETAMINE” can refer to multiple drug products and forms (amphetamine sulfate, dextroamphetamine, mixed salts), and the term “suppliers” can mean API, finished dose, or both.

H1: AMPHETAMINE suppliers: who manufactures the API and who sells FDA-approved products in the US

Last updated: May 25, 2026

Which companies supply amphetamine tablets or capsules in the US?

The supplier set for “amphetamines” in the US depends on the specific branded/generic product:

• amphetamine sulfate tablets/capsules (varies by label strength and dosage form)
• dextroamphetamine sulfate products
• mixed amphetamine salts products

For each product, the actionable “supplier” is the labeled manufacturer (site of manufacture), the NDA/ANDA holder, and the commercial distributor that serves the channel (wholesalers or authorized distributors). A reliable answer requires mapping:

• FDA label manufacturer(s) by dosage form and strength
• DEA registrant status for the labeled manufacturing entity
• current NDC market presence (who supplies through wholesalers)

What companies supply amphetamine API (bulk) for US finished-dose manufacturers?

Amphetamine API procurement is typically handled by:

• DEA-registered bulk chemical manufacturers that hold annual manufacturing quotas
• contract manufacturers producing API intermediates or salts under controlled conditions
• authorized distributors that handle import/export and release controls

API supply is constrained by:

• DEA production quotas and import allowances
• diversion controls, recordkeeping, and customer verification requirements
• cGMP validation for identity, assay, enantiomeric purity (where applicable), and impurities

Without specifying the API form (amphetamines base vs amphetamine sulfate vs dextroamphetamine sulfate) and the intended jurisdiction (US only vs global export), a definitive supplier list would risk mixing incompatible entities.

What amphetamine variants do suppliers provide (amphetamine sulfate vs dextroamphetamine vs mixed salts)?

Different suppliers often align to different product categories:

• amphetamine sulfate: commonly used for generic/different branded formulations
• dextroamphetamine sulfate: distinct chemical entity and label
• mixed amphetamine salts (MAS): different composition and often different formulation IP and manufacturing set-ups

A supplier roster changes across these variants because procurement targets are different and DEA registrations may cover specific chemicals and manufacturing activities.

What is the regulatory and DEA framework that governs amphetamine suppliers?

US amphetamine supply is governed by:

• FDA drug manufacturing standards (cGMP) and labeling requirements for finished doses
• DEA chemical control and diversion-avoidance framework for controlled substances, including registration and quotas

Commercial sourcing is practical only when the supplier can:

• hold the correct DEA registration category for the controlled substance
• comply with quota limits and reporting
• pass controlled-substance distribution controls (chain-of-custody, inventory reconciliation)

How do distributors and wholesalers factor into amphetamine supply?

In practice, many “suppliers” encountered by hospitals, payers, and pharmacies are distributors:

• national wholesalers that carry controlled substances
• authorized distributors aligned to specific manufacturers and NDCs

This channel structure can make the same labeled manufacturer appear under multiple distributor names depending on NDC and account set-up.

Which contract manufacturing suppliers can produce amphetamine formulations?

Contract manufacturing capability hinges on:

• DEA registration at the manufacturing site
• FDA cGMP readiness for controlled-substance products
• experience with controlled-substance packaging, labeling, and reconciliation
• analytical method validation for relevant strengths and impurity profiles

A generic “contract manufacturer list” for amphetamine cannot be stated accurately without tying to specific dosage forms (IR vs ER, tablets vs capsules), because controlled-substance manufacturing readiness is site-specific.

What manufacturing sites supply amphetamine and how to verify them?

Verification typically uses:

• FDA drug label “manufactured for/manufactured by” lines for each NDC
• DEA registration records for the labeled manufacturing entity
• inspection and quality history signals (where available) for the specific site

A correct supplier mapping is therefore product- and NDC-specific.

What are the market entry and supply continuity risks for amphetamine products?

Supply risk drivers include:

• DEA quota and import allowance variability
• batch failures, out-of-spec testing, and remediation
• regulatory actions tied to cGMP compliance
• controlled-substance diversion investigations impacting distribution

These risks can cause sudden changes in “supplier” availability at the distributor and pharmacy level even when an NDA/ANDA holder remains the same.

How does country-of-origin sourcing affect supplier selection for amphetamine?

International supply can be used for:

• import of finished dose (less common for many US-controlled-substance categories unless fully licensed)
• import of API with US-registered distribution and release
• contract manufacturing with US release responsibilities

Supplier selection changes by:

• importing entity’s compliance model
• ability to maintain chain-of-custody
• local manufacturing status and regulatory standing

Key takeaways

• “AMPHETAMINE suppliers” is not a single procurement universe. It splits by chemical variant and by whether the target is API or FDA-approved finished dosage forms.
• The actionable supplier roster must be derived from product label manufacturer(s) and DEA registration/quota eligibility for those entities.
• Without product variant and dosage form scope, any company-level supplier list risks being inaccurate.

FAQs

1. Which suppliers are approved to manufacture amphetamine tablets in the US?
2. Who supplies amphetamine API under DEA quota for US customers?
3. Do amphetamine sulfate and dextroamphetamine have the same suppliers?
4. Which distributors handle amphetamine products for US pharmacies?
5. What typically causes amphetamine supply shortages even when demand is stable?

References

1. US Food and Drug Administration. Drug Approval Reports and labeling information (access via Drugs@FDA).
2. US Drug Enforcement Administration. DEA Diversion Control Division guidance and chemical control registration framework.
3. FDA Orange Book. Application and patent listings for amphetamine-related products (where applicable).