Last updated: April 23, 2026
Who Supplies Buspirone Hydrochloride (API and Finished Dosage) and How to Vet Them
Buspirone hydrochloride is a widely used generic active pharmaceutical ingredient (API) for anxiety disorders. The supply base is typically split across (1) API manufacturers and (2) finished-dose (FDF) producers and re-packers that source API and sell tablets under multiple labelers. Below is the supplier map that is supportable from public, citable records and is actionable for due diligence.
Is there a reliable public supplier list for buspirone hydrochloride?
Yes. The US FDA’s Orange Book records list marketing applicants (labelers) for buspirone hydrochloride products, which is the most direct public index of finished-dose supply. For API, the most defensible approach is to anchor on FDA drug establishment and application records linked to listed products, and corroborate via cGMP supplier documentation during procurement.
Which companies are publicly listed as market suppliers (labelers) in the US Orange Book?
The Orange Book lists multiple marketing applicants across strengths and dosage forms for buspirone hydrochloride tablets. The practical takeaway for sourcing is that the “supplier” you buy from is often the labeler (or its distributor) for FDF, while the upstream API supplier is identified only through procurement qualification, DMFs, or manufacturer statements.
US market labelers (Orange Book marketing applicants for buspirone hydrochloride tablets):
- Apotex
- Actavis / Teva
- Amneal
- Aurobindo
- Mylan / Viatris
- Sandoz
- Teva
- Watson
- Par Pharmaceutical
- Camber
- Lupin
- Torrent
Actionable note: these entities appear as marketing applicants for specific strengths and packaging configurations in the Orange Book; the exact mapping of labeler-to-product requires selection by NDC, strength, and dosage form during procurement.
Where do buspirone hydrochloride products get manufactured (finished dosage supply chain)?
US-labeled products are often manufactured at one or more FDA-inspected domestic or foreign drug manufacturing sites under the applicant’s quality system. For finished-dose supply chain verification, procurement teams should trace:
- the Orange Book applicant (labeler),
- the FDA establishment registration matching the dosage form manufacturing site,
- and, where available, the DMF or manufacturing authorization tying the API source to the application.
Which APIs are used and how do you identify the API supplier?
Buspirone hydrochloride API suppliers are not consistently enumerated in a single public table like Orange Book for FDF labelers. Instead, API supplier identification is handled by:
- DMF referencing in the application (when disclosed through regulatory filings and citable references),
- procurement documentation (supplier GMP certificates, CoA traceability, and batch records),
- regulatory inspection history for the manufacturing site (FDA establishment lookups and inspection outcomes).
How to vet an API or FDF supplier for buspirone hydrochloride (quality and compliance)
Use a procurement qualification checklist that matches the risk profile for a generic API:
1) Confirm regulatory status tied to the product
- Match strength and dosage form to the correct Orange Book entry by NDC.
- Confirm the marketing applicant and corresponding application holder.
2) Validate the manufacturing chain
- For API: request CoA for buspirone hydrochloride with manufacturing site, batch, specs, and test methods.
- For FDF: request CoA and site-of-manufacture documents and confirm alignment with the labeler’s quality system.
3) Require cGMP and quality documentation
- Recent GMP certificate and audit letter (if applicable).
- Full specification sheet and analytical method summaries for identity, assay, impurities, and residual solvents (where applicable).
- Stability data aligned to the shelf life claim.
4) Impurities and particle profile
Buspirone hydrochloride supply must control:
- known related substances,
- residual solvents (as per ICH Q3C),
- polymorphic or particle size effects that can impact dissolution for tablets.
How does supplier availability typically break down in buspirone hydrochloride?
Because buspirone hydrochloride is off-patent and available widely as a generic, procurement usually finds:
- multiple concurrent FDF suppliers per strength,
- a limited set of API manufacturers that supply multiple tablet makers through intermediates or direct contracts.
The key business point is that the “supplier list” you can use operationally depends on what you are buying:
- If you buy finished tablets, you target Orange Book labelers and their contract manufacturers.
- If you buy API, you target API manufacturers via DMF/traceability and GMP documentation, not just distributor catalogs.
What are the most actionable sourcing targets?
If you are building a vendor roster for buspirone hydrochloride, anchor it in:
- Orange Book marketing applicants for finished-dose supply (NDC-strength specific),
- FDA registered manufacturing sites behind each applicant for FDF,
- API suppliers identified through DMF and CoA traceability for API.
Supplier mapping table (practical procurement view)
| Sourcing need |
Supplier category |
Public index to anchor |
What you should confirm in diligence |
| Finished tablets |
Marketing applicant / labeler |
FDA Orange Book |
Applicant, NDC-strength, manufacturing site, CoA traceability |
| Finished tablets |
Contract manufacturer |
FDA establishment records linked to applicant |
Site cGMP status, batch release process, deviation history |
| API |
API manufacturer |
DMF/applications + CoA traceability |
Manufacturing site, impurity profile control, residual solvents, stability support |
| Intermediates / distributors |
Distributor / reseller |
Purchase-order history and documentation |
Source chain integrity, CoA batch matching, recall handling |
Key Takeaways
- US finished-dose supply for buspirone hydrochloride is trackable via the FDA Orange Book by marketing applicant and NDC-strength.
- API supplier identification is not reliably centralized in a single public table; procurement should use DMF referencing and CoA traceability tied to batch manufacturing sites.
- Your fastest, most defensible sourcing route is to start with Orange Book labelers for tablets, then trace the manufacturing sites via FDA records and document-based verification.
- Vendor qualification should focus on spec compliance, impurity control, residual solvents, and site-of-manufacture alignment across API and FDF.
FAQs
1) Can I source buspirone hydrochloride API from the same companies that label finished tablets?
Yes in some cases, but not reliably. Many tablet labelers contract out to one or more API and FDF manufacturing sites. Confirm via DMF/traceability and batch CoA documentation.
2) What public source best identifies suppliers for buspirone hydrochloride tablets in the US?
The FDA Orange Book. It lists marketing applicants for buspirone hydrochloride products by NDC and strength. [1]
3) How do I identify the API manufacturer behind a tablet product?
Use DMF references when available and confirm via CoA batch traceability back to the API manufacturing site. Orange Book itself does not consistently list the API manufacturer. [1]
4) What should I require to qualify an API supplier for buspirone hydrochloride?
At minimum: cGMP evidence, full specification sheet, CoA with batch traceability, impurity and residual solvent controls, and stability documentation aligned to the intended retest shelf life.
5) What is the most efficient way to build a dual-sourcing plan?
Build two complete supply paths: (1) two FDF labelers/manufacturing sites at each strength you need, and (2) two independent API source paths for those FDF sites, validated by batch CoA traceability.
References
[1] FDA. Drugs@FDA: Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations). US FDA. https://www.accessdata.fda.gov/scripts/cder/ob/
