Suppliers and packagers for DAYBUE

DAYBUE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Acadia Pharms Inc	DAYBUE	trofinetide	SOLUTION;ORAL	217026	NDA	Acadia Pharmaceuticals Inc.	63090-660-01	1 BOTTLE, PLASTIC in 1 CARTON (63090-660-01) / 450 mL in 1 BOTTLE, PLASTIC	2023-03-10

DAYBUE (trofinetide) Suppliers: Who Manufactures Drug Substance, Drug Product, and Key Contract Partners

Last updated: June 5, 2026

DAYBUE (trofinetide) supply chain is built around a centralized commercial manufacturing model common to rare-disease launches: a primary drug-product contract manufacturer produces commercial lots under the marketing authorization holder’s quality system, while API is sourced through qualified drug-substance suppliers and controlled through material transfer, release specifications, and batch record governance. The specific named suppliers for DAYBUE are not provided in the available source set for this request.

Who supplies trofinetide for DAYBUE drug product?

The drug-product supplier for DAYBUE determines fill-finish capacity, packaging configuration, and batch release timing. For rare-disease CNS therapies, contract manufacturing is typically the execution point for commercialization-scale demand, while the marketing authorization holder retains responsibility for:

• GMP oversight and quality agreement terms
• Stability program management and shelf-life assignment
• Finished-goods release testing (assay, impurities, uniformity, dissolution/related tests where applicable)

No named contract manufacturing organization for DAYBUE drug product is included in the available source set.

Which companies handle fill-finish and packaging for DAYBUE?

Packaging partners are usually selected for:

• Bottle vs blister configuration
• Child-resistant packaging compliance
• Labeling at scale to support multi-market distribution

No packaging or fill-finish vendor names for DAYBUE appear in the available source set.

Who supplies trofinetide API (drug substance) for DAYBUE?

API suppliers provide trofinetide drug substance manufactured under GMP using validated synthetic routes and impurity controls aligned with drug-product specifications. API sourcing is typically governed by:

• Supplier qualification, audit cadence, and change notification
• Control of critical process parameters
• Impurity profile matching to the reference material used for clinical lots

No specific trofinetide API suppliers are named in the available source set.

What contract manufacturers are used for trofinetide drug substance?

Drug-substance manufacturing for small-molecule CNS drugs often involves a specialist chemical manufacturer paired with a GMP release testing organization. No trofinetide drug-substance contract manufacturer names are included in the available source set.

What Orange Book or FDA listing data shows DAYBUE suppliers?

For branded small molecules, the FDA’s publication sets that sometimes help identify manufacturers include:

• Labeling “Manufactured for” and “Distributed by” statements
• Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) listings (where applicable)
• Drug Master File or facility references (indirect and not consistently supplier-specific)

For DAYBUE, no supplier-identifying data is provided in the available source set.

What manufacturing and quality partners support DAYBUE release testing?

Commercial release testing is often executed at:

• The marketing authorization holder’s quality labs
• A contract testing laboratory for specific analytical modules
• Regional batch release sites aligned with distribution

No specific release-testing or quality partner names for DAYBUE are included in the available source set.

How does supply chain governance work for a rare-disease drug like DAYBUE?

A typical governance stack for products in limited patient populations includes:

• Safety stock and constrained lot dispatching aligned with forecast updates
• Lifecycle change control for API synthesis and drug-product processing
• Batch record review controls and OOS/OOT investigation paths

No DAYBUE-specific governance documents or partner names are provided in the available source set.

Which suppliers matter most for DAYBUE availability risk?

Availability risk concentrates in three supplier-dependent bottlenecks:

1. Drug substance lot availability (API synthesis capacity, impurity compliance)
2. Drug product bottlenecks (compression/powder handling, mixing, filtration, sterilization if applicable, aseptic steps if present)
3. Packaging line constraints (labeling configuration changes tied to market/lot)

No named supplier set for DAYBUE is available in the available source set, so no company-specific risk ranking can be produced.

Key Takeaways

• DAYBUE (trofinetide) supply chain structure is consistent with contract manufacturing plus qualified API sourcing, but the specific named suppliers are not available in the provided source set.
• No FDA labeling, Orange Book listing fields, or source-cited supplier names for DAYBUE drug substance, drug product, fill-finish, or packaging are present in the available materials for this request.

FAQs

1. Does DAYBUE have multiple API suppliers or a single drug-substance source?
   The supplier count is not stated in the available source set.

2. Who is listed on the DAYBUE label as “manufactured for” and “distributed by”?
   Label supplier identification is not included in the available source set.

3. What contract manufacturing organizations typically produce rare-disease small molecules like trofinetide?
   General practice is contract GMP manufacturing, but no DAYBUE-specific firm list is provided.

4. How do API impurity controls affect trofinetide supply continuity?
   Impurity profile matching and specification compliance govern release, but DAYBUE-specific details are not in the available source set.

5. Can supplier identities be inferred from FDA facility listings for DAYBUE?
   Supplier-facility mapping for DAYBUE is not provided in the available source set.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-06-05).
2. FDA. Drug labeling and prescribing information database. (Accessed 2026-06-05).