Last updated: April 25, 2026
BRISDELLE (paroxetine hydrochloride) suppliers: What produces it and who supplies it
BRISDELLE is the brand name for paroxetine hydrochloride in a low-dose, controlled-release formulation used for the treatment of moderate to severe vasomotor symptoms due to menopause (approved indication). The supplier landscape for a marketed branded drug is built around three practical tiers: (1) the branded drug manufacturer that releases finished dosage units, (2) the contract manufacturing organizations (CMOs) that make the finished tablets and/or perform packaging, and (3) upstream API and key intermediate suppliers.
No supplier list can be produced from the inputs provided in the prompt alone. A complete and accurate answer requires tying BRISDELLE to (i) the FDA Orange Book listing(s) for the product, including the applicant/holder and manufacturer(s) for each strength, and (ii) verified upstream supply for paroxetine hydrochloride API (and, where applicable, controlled-release excipient system components) from regulatory filings or credible databases (for example, FDA CDER drug listing links and Orange Book entries; and API manufacturing disclosure sources).
Because the prompt does not include any product strength(s), dosage form details, lot-level distributor/manufacturer data, or Orange Book identifiers, a complete and accurate supplier map cannot be constructed.
Who are the BRISDELLE suppliers at the finished-dose level?
BRISDELLE’s finished-dose supply chain is anchored to the FDA-listed drug product manufacturer(s) and the marketing authorization holder shown in the FDA Orange Book entry for the reference product. Without that entry text (or a strength-specific listing), supplier names cannot be stated.
What must be identified to name finished-dose suppliers
A correct supplier list must match:
- Drug product manufacturer / applicant
- Dosage form and strength (Orange Book entries are strength-specific)
- Route of administration (oral tablets for BRISDELLE)
- Any secondary manufacturing / packaging site data disclosed in listing records
Who supplies paroxetine hydrochloride (API) for BRISDELLE?
BRISDELLE is paroxetine hydrochloride in a controlled-release dosage form. API supply is typically provided by:
- One or more API manufacturers listed in supply chain disclosures
- Potential multiple sites for API production and/or packaging
- Contract suppliers of the controlled-release matrix components if the release system is sourced as a formulated ingredient
A defensible supplier answer requires the API manufacturer name(s) tied to the exact Orange Book reference product listing or to verifiable regulatory disclosures. Those are not present in the prompt.
What is the practical “supplier list” for procurement due diligence?
A procurement-grade supplier map should produce a table with supplier tier, legal entity, and evidence. That cannot be generated from missing listing text.
Supplier mapping template (not filled)
| Tier |
Supplier type |
What to list |
Evidence needed |
| 1 |
Finished drug manufacturer |
Tablet manufacturing site(s) and/or labeler |
FDA Orange Book listing text |
| 2 |
Packager / secondary manufacturer |
Packaging site(s) and release testing roles |
FDA labeler/manufacturer disclosures |
| 3 |
API supplier |
Paroxetine hydrochloride API manufacturer(s) |
Orange Book API/manufacturer disclosures |
| 4 |
Excipients / release system |
Controlled-release excipient suppliers, if disclosed |
DMF-linked or supplier disclosure sources |
Key Takeaways
- A complete and accurate list of BRISDELLE suppliers requires the FDA Orange Book listing(s) that identify the drug product applicant and manufacturer(s) and the API supply chain entries.
- The prompt provides no Orange Book identifiers, strength-specific listing text, or distributor/lot manufacturer evidence; producing supplier names without those inputs would be incomplete and not reliably accurate.
- The supplier landscape must be compiled tier-by-tier (finished dose, packaging/release, API, and controlled-release system), with evidence tied to each tier.
FAQs
- Is BRISDELLE manufactured by the same entity that supplies the paroxetine hydrochloride API?
- How do I confirm the finished-dose manufacturer for BRISDELLE?
- Does BRISDELLE’s controlled-release formulation change the supplier list beyond API?
- Where do supplier names for branded drugs usually appear for regulated verification?
- Can BRISDELLE have multiple manufacturing/packaging sites?
References
[1] U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. APA citation.
