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Suppliers and packagers for generic pharmaceutical drug: PIMAVANSERIN TARTRATE
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PIMAVANSERIN TARTRATE
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: PIMAVANSERIN TARTRATE
Pimavanserin Tartrate Suppliers: What Companies Provide APIs, Intermediates, and Finished Dosage Forms?
Executive summary: Pimavanserin tartrate supply chain centers on the original developer Acadia Pharmaceuticals via commercial manufacturing and supply arrangements, with API/intermediate manufacturing concentrated among contract manufacturers supplying the active ingredient and solid oral dosage forms. Public procurement-level granularity (all named API suppliers at batch-level and finished-dose manufacturers across all markets) is not fully captured in open-source FDA/Orange Book extracts; however, commercial supply is anchored by the FDA-listed manufacturers and labeled sources of finished pimavanserin products and by the API manufacturers disclosed in drug master files and technical filings associated with NDA/ANDA submissions and manufacturing supplements.
Who supplies pimavanserin tartrate for U.S. commercial use?
Answer: U.S. pimavanserin tartrate commercial supply is provided through labeled finished-product manufacturers for NDA pimavanserin drug products (solid oral tablets) that appear on FDA labeling and are used to satisfy prescriptions under Acadia’s brand commercialization. API supply is typically produced by contract API and intermediate manufacturers whose names are not always fully public at the level needed to enumerate every supplier without access to DMR/DMF crosswalks.
What is the labeled finished-product manufacturing footprint?
For pimavanserin tartrate, the relevant U.S. branded product is NUPLAZID (pimavanserin tartrate) tablets. FDA labeling and Orange Book listings identify the applicant and manufacturing sites for the finished dosage form. In practice, the finished dosage manufacturer becomes the direct “supplier” to the U.S. channel (wholesalers, specialty distributors), while upstream API/intermediate manufacturers supply the finished-product site under commercial contracts.
What procurement documents typically disclose for “suppliers”?
- Finished dosage form manufacturer (sites listed on labeling/Orange Book)
- API manufacturer only when specifically disclosed in public regulatory documents or the labeling supply chain
- API and intermediate lists in DMFs are often not exhaustively visible in Orange Book alone
Which companies make the pimavanserin tartrate API and intermediates?
Answer: Pimavanserin tartrate API and intermediates are supplied by specialty chemical and API manufacturers using contract manufacturing (CMO) frameworks. Public sources commonly identify DMF holders or manufacturing partners for NDA-related filings, but not always every supplier that can legally manufacture under the approved process.
Common supplier profile in pimavanserin API
- Multi-step synthetic route handling chiral chemistry and late-stage salt formation to tartrate
- Facilities certified for cGMP and controlled for impurity specifications
- Experience with oncology/neurology small-molecule solid oral products
What “tartrate” changes in sourcing
Tartrate salt formation is usually controlled via:
- Salt formation step parameters
- Polymorph/hydrate control
- Crystallization and filtration capability at scale
These steps can be handled by the API site or by a specialized salt-formulation operation, depending on the approved manufacturing description.
What finished dosage form manufacturers supply NUPLAZID (pimavanserin tartrate tablets)?
Answer: Finished dosage form suppliers are the companies listed as manufacturers/distributors on FDA labeling for NUPLAZID tablets. These manufacturers ship finished product into U.S. wholesale distribution channels.
Why finished-product suppliers matter for continuity of supply
- Shortage risk is driven by tablet batch release capacity, packaging lines, and QA/QC release timelines.
- API constraints can appear later unless API lead times are long or synthesis is capacity constrained.
How do pimavanserin tartrate supply contracts typically work?
Answer: The commercial supply model for pimavanserin tartrate typically combines:
- Acadia as sponsor/applicant, setting the regulatory-quality requirements and sourcing strategy.
- One or more CMOs for API synthesis.
- One main and potentially backup finished-dose CMOs for tablet manufacture, packaging, and distribution.
Where substitutions are constrained
- Any change in API synthesis route, impurity profile, or salt/form crystallization must be handled through CMC comparability and regulatory filings.
- Packaging configuration changes also require label/regulatory alignment.
What is the Orange Book status of pimavanserin tartrate and how does it affect sourcing?
Answer: Orange Book listings for pimavanserin tartrate control generic entry timing and formulation/method-of-use protections, which indirectly affects supply landscape by limiting competitive offerings. For sourcing, this means the brand sponsor can keep supply constrained within approved commercial manufacturing networks longer than an early generic competitor would.
Do Orange Book listings identify manufacturing sites?
Orange Book entries primarily reflect:
- Patents related to drug product and methods
- Applicant and listed dosage forms
Manufacturing-site granularity can appear via FDA databases and labeling rather than being uniformly complete through Orange Book alone.
What generic entry risks exist for pimavanserin tartrate that could change supplier structure?
Answer: If any applicant secures approval for an ANDA covering pimavanserin tartrate tablets, supply would broaden to:
- Additional API producers
- Additional finished-dose manufacturers
- Higher buyer leverage at the wholesale level
The risk depends on the patent estate and any Paragraph IV litigation outcomes.
Supply-shifting triggers
- FDA approvals for generic pimavanserin tartrate tablets
- Established manufacturing readiness for solid oral tablets
- Successful CMC tech transfer and batch release in target commercial markets
How strong is the pimavanserin tartrate patent estate and what does it do to supplier diversification?
Answer: The strength and remaining term of listed patents can delay generic approvals, keeping the finished product manufacturing largely within the brand sponsor’s commercial network. Patent-driven delays tend to concentrate sourcing.
Typical patent categories that block generic entry
- Composition and/or salt-related patents
- Formulation and solid-state attributes
- Method-of-use claims aligned with the approved indication
What litigation and settlements could affect pimavanserin tartrate supply?
Answer: Any ANDA Paragraph IV litigation or settlement can:
- Delay generic launch dates
- Define “design-around” boundaries for formulation or manufacturing
- Affect which product versions (strengths, excipients) are commercially feasible
Supply impact mechanism
A settlement can preserve the brand’s commercial supply economics, maintaining:
- Brand sponsor contracting positions with CMOs
- Wholesaler buying patterns centered on brand supply
What FDA regulatory pathway issues matter for pimavanserin tartrate sourcing (NDA vs ANDA vs 505(b)(2))?
Answer: Source diversification tends to correlate with regulatory approvals:
- NDA for brand establishes initial CMC and manufacturing acceptance criteria.
- ANDA for generics forces CMC comparability for API and finished product.
- 505(b)(2) can create second-entry products but often uses partial reliance with specific CMC constraints.
How pathway affects supplier eligibility
- An approved ANDA can unlock additional CMOs for API and tablets if the submission’s manufacturing and controls are accepted.
- If the API is shared among multiple generics, it can intensify API competition and reduce cost.
When does pimavanserin tartrate lose exclusivity, and how does that change supplier competition?
Answer: Exclusivity loss timing determines when additional suppliers can realistically enter and compete as approved products. Without a full exclusivity and patent timeline for the specific strengths/forms and jurisdictions, a precise date-based supplier impact cannot be stated from the open-source record alone.
What to watch
- Patent expiration and last listed patent “bottlenecks”
- Any pediatric exclusivity modifiers
- Litigation stay effects from Paragraph IV cases
What is the market exposure for supply disruptions in pimavanserin tartrate?
Answer: Supply disruptions concentrate risk in:
- One or a small number of finished-product manufacturing sites
- Release testing capacity and tablet stability program timelines
- API lead times for multi-step synthesis and tartrate crystallization
Operational risk points
- Tablet compression and coating capacity
- Packaging lines for bottle filling
- Stability shelf life and deviation handling
Which geographic markets have different pimavanserin tartrate suppliers?
Answer: Supplier lists vary by jurisdiction due to:
- Local regulatory submissions and QP release requirements
- National distribution models
- Different sourcing contracts for API and finished product
U.S. supply is best reflected by FDA labeling and manufacturing listings. Non-U.S. markets may have parallel or additional licensed packers/manufacturers.
Key Takeaways
- Pimavanserin tartrate commercial supply in the U.S. is anchored by labeled finished-product manufacturers for NUPLAZID; upstream API/intermediate suppliers are typically CMOs whose public identification may be incomplete outside DMF-linked disclosures.
- Supplier diversification is heavily tied to generic entry timing and patent/litigation outcomes, which affect whether additional ANDA-approved products emerge and expand the manufacturing roster.
- Practical procurement risk concentrates at the finished-dose manufacturing and batch release level, with API and tartrate crystallization acting as upstream constraints.
FAQs
1) What contract manufacturers produce pimavanserin tartrate tablets under cGMP?
Finished-dose tablet manufacturers for NUPLAZID are identified on FDA labeling and are the practical suppliers to U.S. wholesalers.
2) Are there alternative pimavanserin tartrate API suppliers for shortages?
Often limited to qualified DMF-backed or approved process-capable API CMOs; swaps require regulatory acceptance and CMC bridging.
3) Does tartrate salt formation create additional sourcing bottlenecks?
Yes, salt crystallization controls (polymorph/hydrate/impurity profiles) can restrict eligible CMOs.
4) Will generic pimavanserin tartrate approval expand the number of API suppliers?
Typically yes, because each ANDA can qualify different manufacturing sites, increasing supply options.
5) Where can I confirm the actual manufacturing sites for pimavanserin tartrate products?
Use the FDA labeling and Orange Book/manufacturing listings for the specific pimavanserin tartrate dosage form and strength.
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- U.S. Food and Drug Administration. Drug Labeling for NUPLAZID (pimavanserin tartrate) tablets.
- U.S. Food and Drug Administration. FDA databases and drug approval records associated with pimavanserin tartrate NDA.
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