Last updated: May 24, 2026
Tasimelteon (Hizentraq/Kronasal category; marketed as Hetlioz in the US) is sourced through a small set of vertically integrated or long-term supply relationships for active pharmaceutical ingredient (API) and finished dosage tablets. Contract manufacturing and secondary sourcing are typically handled via CDMOs that support tablet compression, coating, packaging, and regulatory/quality documentation under established commercial supply agreements.
No complete, authoritative supplier roster can be produced from the information provided.
What suppliers provide tasimelteon API and who manufactures the finished tablets?
Answer (high level): Tasimelteon supply is typically split between (1) API manufacturers and (2) finished dosage manufacturers (tablet and packaging). In commercial practice, the finished product is often produced by a small number of CMOs under drug master file (DMF) linkages and/or quality agreements aligned to the marketing authorization holder and US FDA listing.
How API supply chain typically works for tasimelteon
- API is supplied under DMF or CEP-linked quality systems, then transferred to tablet manufacturing sites through controlled intermediates, defined polymorph specs, and validated impurity profiles.
- Finished dosage manufacturers handle tablet press, coating, in-process controls, and batch release testing, then package into commercial bottle/blister formats depending on label configuration.
What finished-dose manufacturing components are implicated
- Tablet core compression
- Film coating
- Encapsulation/form factor controls
- Primary packaging (bottle/blister)
- Labeling and secondary packaging
Which companies are the tasimelteon API manufacturers?
Answer: Supplier identification requires Orange Book and/or FDA DMF-linked filings, label manufacturer statements, and verified commercial procurement disclosures. Those inputs are not present here.
What evidence sources normally identify tasimelteon API and CMO sites
- FDA Orange Book “Manufacturer” and “Applicant” entries tied to US marketing authorization
- FDA drug product labeling (package insert) listing “manufactured for”/“manufactured by” sites
- DMF holder names associated with tasimelteon API
- Site-specific FDA inspection history tied to the listed manufacturers (non-exhaustive)
- Procurement disclosures in settlement agreements, licensing deals, or consent decrees
What is the Orange Book status of tasimelteon and how does it map to suppliers?
Answer: Orange Book mappings identify the NDA applicant/holder and the listed “manufacturers” for drug product and sometimes the labeler that controls supply. Supplier names cannot be enumerated without the specific Orange Book record for the relevant US product listing.
Orange Book fields that typically drive supplier identification
- NDA number and applicant/holder
- Drug product dosage form (tablets/capsules)
- “Applicant” and “Manufacturer” name fields
- Patent/Exclusivity metadata (not supplier-specific but can help validate the exact product listing)
When does generic or competitor supply change tasimelteon sourcing risks?
Answer: Generic entry changes supply concentration when ANDA approvals appear, Para IV challenges resolve, or exclusivity expires. This is tied to the Orange Book patent estate and FDA approval timeline for competing products. Supplier risk cannot be timed without the specific exclusivity and patent expiration data for tasimelteon.
What supplier risk looks like in practice during exclusivity windows
- Reduced secondary sourcing for API and finished dosage due to validated process lock-in
- Higher risk of allocation during disruptions
- Higher leverage for CDMOs with validated lines and QA infrastructure
What manufacturing scale and capabilities matter for tasimelteon tablet supply?
Answer: Tasimelteon tablet supply requires a CDMO with:
- validated tablet compression/coating processes for controlled dissolution
- impurity control and residual solvent management suited to tasimelteon chemistry
- analytics capacity for stability-indicating HPLC/LC-MS workflows
- sterile-free non-injectable production quality systems (typical for tablets)
- packaging line qualification for the specific format
Technical areas that constrain supplier substitution
- Particle size distribution sensitivity and blend uniformity for tablets
- Coating formulation control to hit dissolution specification
- Hold-time and temperature/humidity controls in blending and coating stages
- Impurity qualification strategy and batch-to-batch consistency
How do tasimelteon suppliers handle regulatory quality documentation?
Answer: Suppliers in commercial supply typically operate under:
- GMP compliance with site qualification audits
- controlled change management (process and formulation)
- batch release testing aligned to specifications
- document readiness for FDA inspections (CMC sections, stability protocols, CoA formats)
What documents commonly anchor supplier onboarding
- DMF (API) or ASMF linkages where applicable
- CoA templates and method transfer packages
- validation packages for cleaning, dissolution, and packaging
- stability protocols (long-term and accelerated)
Key Takeaways
- Tasimelteon supply is usually governed by a limited number of API and finished dosage manufacturers operating under linked FDA regulatory files and quality systems.
- A complete supplier list cannot be reliably generated without the specific FDA/Orange Book record and label/DMF-linked manufacturing site data for the tasimelteon product in scope.
- Supplier substitution is constrained by tablet process validation, dissolution targets, impurity control, and regulatory documentation readiness.
FAQs
- Who is the NDA holder for tasimelteon in the US and which sites manufacture the commercial drug product?
- Which DMF holders are associated with tasimelteon API?
- Can CDMOs produce tasimelteon tablets for third-party distribution under an NDA/labeler arrangement?
- What CMC elements typically block replacement of a tasimelteon API supplier in a marketed ANDA or branded supply chain?
- How do FDA inspections and warning letters at specific tablet manufacturing sites affect tasimelteon availability and allocation risk?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026).
- FDA. Drugs@FDA. (Accessed 2026).
