Suppliers and packagers for NUPLAZID

NUPLAZID

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	NUPLAZID	pimavanserin tartrate	CAPSULE;ORAL	210793	NDA	Acadia Pharmaceuticals Inc.	63090-340-30	30 CAPSULE in 1 BOTTLE, PLASTIC (63090-340-30)	2018-06-28
Acadia Pharms Inc	NUPLAZID	pimavanserin tartrate	TABLET;ORAL	207318	NDA	Acadia Pharmaceuticals Inc.	63090-100-30	30 TABLET, COATED in 1 BOTTLE, PLASTIC (63090-100-30)	2018-06-28

Suppliers and packagers for NUPLAZID

Last updated: May 25, 2026

NUPLAZID Suppliers: Who Manufactures Pimavanserin and What Companies Supply It for US Launch, Formulation, and Distribution

NUPLAZID (pimavanserin) is supplied in the US by Acadia Pharmaceuticals via its commercial supply chain, with drug substance and finished dose manufacturing attributed to specific contract manufacturers listed across FDA product/labeling sources and corporate manufacturing disclosures. The key business-risk question for licensing, formulary access, and generic/biosimilar planning is whether any discrete manufacturing steps (tablet cores, film coating, packaging, or specific batch release sites) are tied to non-transferable IP or regulatory constraints, and which contract manufacturers are bound to Acadia’s commercial supply.

Who supplies NUPLAZID (pimavanserin) tablets in the US?

NUPLAZID is a small-molecule, oral drug product (tablet). In practice, “suppliers” splits into three categories: (1) label-listed manufacturing sites for drug product release, (2) contract manufacturing for drug substance, and (3) logistics and distribution entities.

US supply-chain entities are typically evidenced by:

• FDA label “Manufactured for” / “Distributed by” lines and associated manufacturing site language.
• FDA’s current NDC labeler/manufacturer fields (DailyMed and FDA product listings).
• Public filings by Acadia and its manufacturing partner disclosures in corporate presentations and regulatory submissions.

Drug product manufacturing and release (tablet)

NUPLAZID is manufactured at one or more facilities under commercial contract arrangements. The “manufactured for” line on the most current prescribing information and the labeler/manufacturer fields in FDA-linked product listings identify the finished-dose manufacturer(s) responsible for batch release.

Drug substance manufacturing (pimavanserin API)

Pimavanserin API supply is typically provided by contract manufacturers supporting commercial production. API sourcing is usually not visible in consumer-facing labeling but can be inferred from chemistry, manufacturing, and controls (CMC) descriptions in regulatory dossiers and from repeat manufacturer listings in FDA/Orange Book contexts where available for the specific listing.

Distribution

Acadia’s distribution model for NUPLAZID is controlled for chain-of-custody and reimbursement handling. Distributor entities are shown on the label and in pharmacy supply systems tied to the product’s NDC labeler.

What companies manufacture pimavanserin (NUPLAZID) API?

Pimavanserin is the active ingredient in NUPLAZID. API suppliers are typically contract manufacturers.

Business relevance:

• API supplier lock-in can affect contract exit risk during supply interruptions.
• API controls affect batch consistency and regulatory batch release.

However, supplier identification requires reliable, current manufacturer site attribution from FDA-linked sources or labeler/manufacturer listings. If you only need “who supplies to pharmacies,” the labeler/manufacturer on the NDC records is usually the actionable answer; if you need “who makes the API,” the evidence is CMC-linked and site-specific and is not reliably captured without the exact labeler and NDC-level product record set.

Which contract manufacturing organizations supply NUPLAZID tablets?

For a tablet like NUPLAZID, contract manufacturing organization (CMO) involvement usually covers:

• Tablet core production (compression)
• Film coating
• Packaging (bottles, cartons)
• Quality control and batch release

Actionable supplier target list in litigation and licensing:

• The finished-dose manufacturing site(s) tied to batch release responsibilities.
• Any disclosed second-site backup arrangements used for continuity.

This requires FDA label/NDC manufacturer-site matching. Without the specific NDC record(s) for your market, the supplier set cannot be stated as a complete, verifiable list.

What is the Orange Book status of NUPLAZID that indicates supplier and manufacturing listings?

NUPLAZID is listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) with patent and exclusivity status relevant to generic entry. Orange Book listings do not directly name CMOs but they tie:

• the approved dosage form(s),
• applicants/holders,
• and patent-covered claims.

For supplier mapping, Orange Book is best used to confirm:

• which specific strengths/formulations correspond to each NDC
• and the application/holder behind those listings

Then, the NDC-linked labeler/manufacturer data is used to identify commercial suppliers.

How does NUPLAZID supply compare with other pimavanserin brands or competitors?

NUPLAZID is the main commercial pimavanserin brand for schizophrenia and Parkinson’s disease psychosis indications. Direct supply comparison with competitors is typically not meaningful because:

• competitors use different APIs or different product designs,
• and supplier rosters vary by NDC and strength.

A defensible comparison requires mapping each product’s NDC labeler and manufacturer site list.

When do NUPLAZID manufacturing suppliers change, and what signals a supplier switch?

Supplier switch signals usually show up through:

• label updates (manufactured for and site language changes),
• NDC changes for labeler/manufacturer,
• variation filings tied to manufacturing site changes,
• and batch release site updates in CMC supplements.

For commercial risk monitoring, track:

• DailyMed or label revision history
• NDC “revised” dates and manufacturer changes
• FDA supplements tied to manufacturing changes

What manufacturing/IP barriers affect NUPLAZID generic entry and supplier substitution?

NUPLAZID’s IP position affects generic timelines and the ability of outside manufacturers to supply authorized generic or non-interchangeable versions. The practical supplier barrier in small-molecule products is usually:

• patent-protected formulations, methods of use, or process claims
• coupled with regulatory readiness of ANDA manufacturing and QC systems

If IP blocks generic launches, Acadia’s commercial supply chain remains a bottleneck for competition, increasing supplier relevance to pricing power and continuity.

Key Takeaways

• NUPLAZID “suppliers” split into finished-dose manufacturers, API suppliers, and distribution entities.
• The only fully actionable supplier identification is the NDC-linked manufacturer/labeler and the label “manufactured for/distributed by” lines.
• Orange Book confirms product/dosage-form scope and exclusivity context; it does not, by itself, enumerate CMOs.
• Supplier switching is observable through label and NDC manufacturer-site updates, typically tied to CMC supplements.

FAQs

1. Where on the NUPLAZID label can I find the finished-dose manufacturer responsible for batch release?
2. How do I identify the NDC(s) for NUPLAZID strengths to pull the correct manufacturer from FDA/DailyMed records?
3. Do pimavanserin API suppliers change more often than tablet suppliers for NUPLAZID?
4. What manufacturing site changes are typically tied to FDA CMC variations for tablet drugs like NUPLAZID?
5. How does Orange Book exclusivity affect the ability of third-party manufacturers to supply generic versions of pimavanserin?

References (APA)

1. Acadia Pharmaceuticals. NUPLAZID Prescribing Information (current label on FDA/DailyMed).
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations for NUPLAZID (pimavanserin).
3. FDA / DailyMed. NUPLAZID drug product labeling and NDC listing records.