Last updated: May 27, 2026
Amphetamine salts in the US market are supplied through a mix of US specialty generics and branded holders, with upstream API typically produced by specialized chemical/API manufacturers and then finished by NDA/ANDA holders under GMP. Exact “supplier lists” vary by labeler, dosage form, and strength because the same salt can be sourced from multiple API sites across time. A defensible supplier map requires Orange Book labeler and FDA registration-linked API site data, which is not provided here.
Sources used below are limited to publisher-reported labelers and regulatory identifiers that can be deterministically tied to specific products. No complete, verifiable supplier roster across all amphetamine salt SKUs can be produced from the information provided.
Who supplies amphetamine sulfate and dextroamphetamine sulfate in the US market?
Answer (market structure): US amphetamine sulfate and dextroamphetamine sulfate products are supplied by (1) FDA labelers with controlled-substance manufacturing permissions and (2) contract API and finished-dose suppliers. For each drug, the active ingredient supplier is usually not disclosed in public FDA product labeling; the “supplier” that is auditable from public records is the FDA labeler/manufacturer of record for the finished dosage form.
Product-level supply chain map (finished dose manufacturers)
A complete, product-level map requires the specific ANDA/NDA labelers for each salt and dosage form, plus their registered manufacturing sites (FDA Establishment Registration and Listing). Without those inputs, no accurate roster can be listed.
What companies are the API suppliers for amphetamine aspartate and amphetamine sulfate?
Answer (API reality): Public sources generally identify API manufacturers at the level of ANDA product manufacturing sites or through confidential drug master file relationships, not through a public “API supplier” field. For amphetamine salts, API supply is also constrained by regulatory and controlled-substance compliance, which keeps many upstream relationships private.
Where supplier disclosure is observable
- FDA Drug Product Listing / Establishment Registration links labelers to manufacturing locations.
- Some industry disclosures (site changes, annual reports, or inspection outcomes) can imply API sites, but they do not yield a full, current supplier roster.
- Patent and licensing documents may name manufacturers at a specific stage, but not consistently for all salts.
Which manufacturers supply dextroamphetamine saccharate and dextroamphetamine sulfate generics?
Answer (what can be listed reliably): The reliably listable entities are the labelers (companies holding the approved application for each finished-dose NDA/ANDA) and their site-of-manufacture registrations. Upstream API suppliers are often not publicly stated.
How to build a defensible “supplier list” in practice
- Start from each approved product’s application number (NDA/ANDA).
- Retrieve the labeler and manufacturing sites from FDA listing.
- Tie those sites to API capability through DMF references where publicly available.
No such product-application inputs are included here, so no deterministic manufacturer roster can be produced.
How do suppliers differ by salt form: amphetamine sulfate vs dextroamphetamine sulfate vs saccharate vs aspartate?
Answer: Supplier networks change by salt because:
- Different crystallization and counterion processes require different API intermediates and salt-forming steps.
- Finished-dose lines need verified segregation and validated controls for each salt.
- Regulatory submissions for each salt can lock in specific manufacturing processes and sites.
Still, a “supplier-by-salt” table cannot be completed without product-level listing data.
What Orange Book listings identify the manufacturers for amphetamine salts?
Answer: Orange Book lists the approved products and application holders, plus related patents. It does not provide a comprehensive upstream API supplier list.
What Orange Book can support for supplier analysis
- Application holder and drug product entry
- Patent family boundaries affecting process and formulation
- Potentially relevant licensing agreements
No Orange Book product identifiers are provided, so listings cannot be enumerated.
Which supplier risks matter for amphetamine salts (controlled substance manufacturing, API supply, and QC)?
Answer: The dominant risks for amphetamine salts are site qualification and controlled-substance supply continuity:
- API site qualification and validated synthesis of each isomer and salt form
- Salt conversion and solid-state QC (polymorph, particle size distribution, assay)
- Finished-dose GMP controls and diversion-prevention systems
A supplier risk ranking requires specific supplier sites, which are not provided.
Key Takeaways
- The public, auditable “supplier” for amphetamine salts is typically the FDA labeler and site-of-finished-dose manufacture, not the upstream API supplier.
- A complete supplier roster for amphetamine aspartate, amphetamine sulfate, dextroamphetamine saccharate, and dextroamphetamine sulfate cannot be generated from the information provided.
- Any defensible supplier table must be built from FDA application and establishment registration data tied to specific NDA/ANDA products for each salt and dosage form.
FAQs
- Which US companies are the labelers for amphetamine sulfate tablets and capsules?
- How do I identify the manufacturing site for a specific dextroamphetamine sulfate NDC?
- Do Orange Book patents for amphetamine salts indicate API suppliers?
- Can dextroamphetamine saccharate and dextroamphetamine sulfate share the same manufacturing line?
- What FDA data fields show controlled-substance manufacturing registrations for amphetamine products?
References (APA)
No sources were cited because no deterministic FDA labeler/application/site data for the specific amphetamine salt products was provided in the prompt.
