VARUBI: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Tersera	VARUBI	rolapitant hydrochloride	TABLET;ORAL	206500	NDA	TerSera Therapeutics LLC	70720-101-02	2 TABLET in 1 BLISTER PACK (70720-101-02)	2015-10-07
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 23, 2026

Varubi (rolapitant) Suppliers, Contract Manufacturers, and API Players

Executive summary: Public supplier visibility for Varubi (rolapitant) is constrained by limited, regulator-indexed manufacturing disclosure in the US Orange Book and by common reliance on contracted drug substance and drug product manufacturing. The market-facing supply chain for Varubi is anchored by the marketing authorization holder (Bayer) and its authorized manufacturing network for the drug product. For upstream API and intermediate supply, the best actionable starting points are (1) the drug master files (DMFs) and (2) the listed manufacturing sites in FDA chemistry and manufacturing reviews that support rolapitant NDA approvals and supplements.

What matters for buyers and litigators: supplier decisions and IP diligence should be mapped in two layers: drug substance (rolapitant/API) supply and drug product (fill-finish, packaging) supply. Publicly searchable granularity is highest at the drug product manufacturing site level when it is reflected in regulatory documents and labeling, and highest for API when tied to DMF holders or cross-referenced regulatory filings.

Who manufactures Varubi (rolapitant) drug product and packaging?

Short answer: Varubi is sold under a Bayer label and is manufactured through Bayer’s approved manufacturing network for the finished drug product. The key commercial question for procurement is the specific finished-dose manufacturing site(s) referenced in FDA labeling/CMC documentation for the marketed dosage form.

Which dosage form is in scope for supplier mapping?

Varubi is marketed as rolapitant for oral use (brand product).
Supplier mapping depends on whether you are sourcing:
- clinical supply (NDA/BLA lots, often earlier sites)
- commercial supply (post-approval CMC and validated commercial sites)

What to look for in authoritative supplier sources

FDA product labeling and associated CMC sections that identify manufacturing/packaging sites.
FDA post-approval supplements that move manufacturing or update packaging labels.
Orange Book listing for manufacturing changes is limited; rely on FDA CMC updates and labeling revisions for actual site granularity.

Which companies supply rolapitant (API) for Varubi?

Short answer: Rolapitant API supply is typically provided by one or more qualified API manufacturers supporting the NDA through DMF and/or cross-referenced CMC. The most reliable supplier identification comes from DMF holders and the manufacturing sites credited in FDA review packages.

Drug substance supplier due diligence framework

Identify the rolapitant DMF holders referenced in FDA reviews supporting the NDA.
Confirm whether the DMF is used by Bayer (directly or via licensed distributors).
Track site change control: API manufacturers often change over time even when the brand remains constant.

API “supplier” meaning in procurement

DMF holder: legal entity controlling the disclosed manufacturing process.
Manufacturing contractor: the plant operator producing the material under contract.
Licensee/distributor: entity selling the API to Bayer or to a fill-finish partner.

Where can Varubi supplier data be found in the FDA Orange Book?

Short answer: Orange Book listings are optimized for patent and exclusivity, not for manufacturing site transparency. Orange Book data can confirm NDA/strength and help tie the correct application to FDA reviews where manufacturing sites and DMFs are referenced, but it usually does not list granular supplier identities.

What Orange Book entries do help with

Confirm the correct NDA associated with Varubi for rolapitant.
Anchor the litigation and regulatory record to the correct application and label.

What is the link between FDA reviews, DMFs, and the real Varubi supply chain?

Short answer: The “who supplies” answer is usually distributed across:

NDA/CMC review documentation (API manufacturer and intermediates),
DMF documentation (process and site),
labeling and packaging information (finished product sites).

Typical documentation map for Rolapitant

NDA approval package: rolapitant drug substance manufacturing and controls
CMC supplements: site transfers, process changes, scale-up validation
Labeling updates: packaging and distribution network

Which contract manufacturers and fill-finish players typically handle oral solid Varubi production?

Short answer: For oral solid drugs like rolapitant, the contracted chain usually includes:

tablet manufacturing or capsule/tablet assembly (depending on formulation form)
compression/coating (if applicable)
packaging line operations (blistering or bottle filling)

Public identification of specific contract manufacturers is driven by:

manufacturing site names appearing in labeling or annual product reports
CMC review attachments naming plant sites

How does manufacturing change control affect Varubi supplier continuity?

Short answer: Varubi supply may shift between qualified sites through CMC supplements without changing the brand, NDA, or Orange Book listing. Procurement planning and litigation discovery should treat “supplier” as a time-dependent variable.

Change events that typically trigger supplier substitution

scale-up changes or equipment changes
API site qualification updates
new secondary packaging lines
global logistics rerouting that results in approved packaging site changes

How many suppliers can support Varubi commercial supply and what are the bottlenecks?

Short answer: Commercial supply capacity usually requires at least:

one primary API manufacturing site and
one finished dose manufacturing/packaging site per validated configuration

Bottlenecks arise when:

only one API site is qualified for a specific intermediate set
API synthesis is constrained by hazardous reagent steps
analytical method validation ties the material to specific equipment or process controls

What patent estate risks exist for Varubi supply-chain replication (API vs formulation)?

Short answer: Supplier entry risk is driven by two independent IP vectors:

API process and composition patents (rolapitant drug substance)
drug product patents (formulation, polymorphs, coatings, excipients, and manufacturing methods)

Why IP matters for suppliers

A prospective API manufacturer must avoid infringing:
- rolapitant compound claims (composition of matter)
- protected synthetic steps or intermediates
- polymorph or salt form claims
A prospective fill-finish manufacturer must avoid infringing:
- protected formulation claims
- manufacturing method claims tied to specific process controls

What generic or biosimilar pathway changes affect Varubi supplier strategy?

Short answer: Rolapitant is a small-molecule antagonist, so “biosimilar” dynamics do not apply. Supplier strategy is affected by whether generic entry is pursued through Abbreviated New Drug Application (ANDA) and whether Para IV or design-around strategies target:

API composition/process
formulation details
method-of-use

What is the Orange Book status of Varubi and how does it relate to supplier switching?

Short answer: Orange Book status defines the competitive window for generic substitution, not the supplier’s operational identity. For supplier switching decisions, the practical linkage is:

whether a generic manufacturer can legally source equivalent API and manufacture equivalent dosage forms during exclusivity or patent constraints.

Supplier switching under patent pressure

If patents are active, suppliers serving generics face:
- freedom-to-operate constraints
- potential injunctive risk in ANDA litigation
If patents expire, the supply chain typically broadens via:
- additional qualified API sites
- new finished-dose contract manufacturers
- more packaging configurations

What supplier risks exist due to ANDA Paragraph IV disputes involving rolapitant?

Short answer: Supplier risk is indirect but material: ANDA challenges can trigger discovery that exposes:

manufacturing sites,
DMF usage,
process similarities and test method cross-over.

These discovery trails can constrain supplier options during litigation.

How do licensing deals typically structure Varubi supply for generics or authorized copies?

Short answer: Licensing structures for small-molecule drugs typically split:

API license (manufacturing rights to rolapitant),
formulation license (drug product rights),
distribution and commercialization rights.

Where rights are exclusive by field of use, supplier selection is constrained to the license network.

Supplier landscape comparison: branded Bayer supply chain vs generic entrants

Short answer: Generic entrants often start with a narrower set of qualified sites, then expand after:

regulatory approvals,
quality system maturity,
commercial ramp.

Brand supply chains frequently remain stable longer because they rely on established validated manufacturing and pre-established packaging relationships.

Key Takeaways

Varubi’s supplier identification at the “named company” level depends on FDA CMC records and DMF references, not Orange Book alone.
Treat the supply chain as two-layered: rolapitant API sourcing and finished-dose manufacturing/packaging.
Manufacturing sites can change via CMC supplements without altering the brand or Orange Book entry.
IP risk for suppliers is composition/process and formulation driven; procurement and licensing diligence must map both vectors.
ANDA litigation and Para IV activity can indirectly constrain supplier options through discovery and freedom-to-operate controls.

FAQs

Where do I find the rolapitant DMF holder for Varubi?
In FDA drug substance CMC review packages linked to the Varubi NDA and in DMF cross-references used for manufacturing controls.
Does Orange Book identify the contract manufacturer for Varubi tablets/capsules?
Usually no. Orange Book is patent and exclusivity focused; manufacturing sites are more reliably found in labeling/CMC documentation.
Can Varubi switch API suppliers without changing the NDA?
Yes, through CMC supplements that qualify additional sites and validate interchangeability under approved controls.
What manufacturing steps for oral solid rolapitant are most likely to be IP-protected?
Drug substance synthetic steps/intermediates and drug product formulation or manufacturing method steps tied to protected composition, polymorph, or excipient/process specifications.
How does ANDA Paragraph IV litigation affect sourcing of rolapitant API for generic launches?
It increases freedom-to-operate scrutiny and can lead to discovery that identifies manufacturing sites, processes, and test methods, constraining suppliers during disputes.

References

FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration. (Accessed via FDA Orange Book database).
FDA. Labeling and CMC review materials associated with the Varubi (rolapitant) NDA. US Food and Drug Administration. (Accessed via FDA NDA review document repositories where available).

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