Last updated: May 25, 2026
Auvelity suppliers: Who manufactures dextromethorphan-bupropion and what upstream vendors support it?
Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) is supplied through a tightly controlled, branded manufacturing and packaging supply chain. Supplier identification for the finished dosage form (tablets), plus upstream suppliers for active pharmaceutical ingredients (APIs) and critical intermediates, depends on the exact NDC, dosage strength, and label configuration listed on the FDA label and in commercial trade channels.
No complete, verifiable supplier list (finished-product manufacturer, API manufacturers, and key excipient/packaging suppliers tied to specific NDCs and lots) is available in the input provided.
What companies supply Auvelity tablets (finished dosage form) for each NDC?
Featured snippet answer: The finished-dose supplier is not identified here with enough verifiable specificity to map to each Auvelity NDC.
How to identify Auvelity finished-product suppliers (NDC, labeler, repackager)
A complete supplier map for Auvelity requires cross-referencing:
- FDA label “Manufactured for” / “Distributed by” lines
- NDC directory labeler and product packaging/labeler identifiers
- Current GMP manufacturing site associated with the labeled strength and dosage form
Why NDC-level supplier mapping matters
Auvelity has multiple strengths and packaging configurations. Contract manufacturing and packaging arrangements can shift by lot, geography, or contract update, changing the supplier recorded by labeler versus the true GMP site.
Which suppliers provide the Auvelity APIs: dextromethorphan hydrobromide and bupropion hydrochloride?
Featured snippet answer: API supplier identities are not specified here with verifiable traceability.
API supply chain structure
Auvelity’s API supply typically breaks into:
- Dextromethorphan hydrobromide API supplier and corresponding upstream synthesis/intermediate vendors
- Bupropion hydrochloride API supplier and corresponding upstream synthesis/intermediate vendors
- Any contracted salt-forming, purification, and drying vendors tied to specific DMF/ASMF filings
What “supplier” usually means in diligence
In commercial and litigation contexts, “supplier” can mean:
- GMP site that manufactures the API
- Trading entity listed on the labeler’s chain
- Intermediates supplier (which often remains undisclosed publicly)
What excipient and packaging suppliers support Auvelity tablets?
Featured snippet answer: Excipient and packaging suppliers are not provided here with verifiable linkage to Auvelity strengths and packaging configurations.
Key Auvelity supply-chain inputs
Tablet manufacturing requires:
- Binders, disintegrants, and controlled-release polymers (depending on formulation design)
- Colorants and film-coating components
- Packaging components (blister or bottle, desiccants, induction seals)
Packaging supply dependencies
Packaging vendors are often shared across branded portfolios and may vary by NDC and fulfillment partner.
How do Auvelity supplier changes affect FDA compliance and continuity of supply?
Featured snippet answer: Supplier swaps can trigger CMC comparability and qualification requirements, but supplier identification is not available here to tie specific changes to Auvelity.
Typical regulatory/commercial triggers
- Site change for API or finished product
- Line move for packaging
- Excipient substitution and equivalence qualification
- Stability bridging and lot release impacts
Operational risk
Without named suppliers by NDC and site, the supply continuity risk cannot be quantified.
What supplier information is visible from the FDA label and Orange Book for Auvelity?
Featured snippet answer: This input does not include the FDA label or Orange Book listing details needed to extract supplier and manufacturer lines.
What to extract if label/Orange Book text is available
From label/Orange Book text, diligence normally pulls:
- Listed manufacturer of record
- Strength-specific marketing authorization details
- Revisions that indicate manufacturing site changes
Which contract manufacturers and packagers are commonly involved for NCE CNS combinations like Auvelity?
Featured snippet answer: No verifiable mapping to Auvelity’s specific contracts is available in the input provided.
Why direct mapping is required
Many large CDMOs work across CNS brands. Without Auvelity-specific label-site mapping, any list would be non-actionable.
What licensing or supply agreements can constrain alternative sourcing for Auvelity?
Featured snippet answer: No licensing or supply-constraint terms are provided here to identify specific contract restrictions.
Typical constraints to check in diligence
- Exclusivity linked to formulation or manufacturing know-how
- Supply agreements tied to trade dress, coating, or process parameters
- API sourcing controls tied to DMF/ASMF cross-referencing
Revenue exposure: How much supply interruption risk exists for Auvelity based on supplier concentration?
Featured snippet answer: Supplier concentration cannot be calculated here because suppliers and sites are not listed in the input.
Key Takeaways
- A complete, NDC-accurate supplier list for Auvelity tablets, plus API and upstream vendor identifications, is not available in the provided information.
- Supplier diligence for Auvelity requires extracting labeler/manufacturing-site data and mapping it to NDCs, then validating API and excipient/packaging supply through regulatory and commercial records.
- Without those records in the input, producing an actionable supplier table would be speculative.
FAQs
- Who is the manufacturer of record for Auvelity on the FDA label?
- Which suppliers make dextromethorphan hydrobromide and bupropion hydrochloride for Auvelity?
- Are Auvelity suppliers listed by NDC in the FDA NDC Directory?
- Do Auvelity manufacturing site changes show up in label revisions or supplements?
- What packaging formats does Auvelity use, and which suppliers support them?
References
None provided in the input.
