Suppliers and packagers for VOTRIENT

VOTRIENT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis	VOTRIENT	pazopanib hydrochloride	TABLET;ORAL	022465	NDA	Novartis Pharmaceuticals Corporation	0078-1077-66	120 TABLET, FILM COATED in 1 BOTTLE (0078-1077-66)	2016-07-12

Suppliers and packagers for VOTRIENT

Last updated: June 1, 2026

Votrient (pazopanib) Supplier Landscape: Which Companies Manufacture, Package, and Supply the Drug Substance and Drug Product?

Votrient is a brand of pazopanib used for oncology indications. Publicly accessible supplier and manufacturing information is typically split across (1) the drug substance (API) supply chain and (2) the finished drug product (drug product) manufacturing, packaging, labeling, and distribution network. Without a specific dossier for the exact dosage form, strength, and market (US vs ex-US), supplier lists cannot be compiled accurately to a defensible standard.

Who manufactures Votrient (pazopanib) drug product for the US market?

Votrient’s US product is marketed by GSK (GlaxoSmithKline). The drug product manufacturing and packaging entities are usually identified in:

• FDA’s Orange Book (listed applicant/holder; not always the manufacturing site)
• FDA labeling and NDAs (manufacturer statements)
• FDA inspections (site-level manufacturing) and drug establishment registration data

A complete, correct “who supplies Votrient drug product” list requires matching the marketed NDCs to the associated manufacturing/packaging sites for that specific strength and dosage form, then cross-checking those sites to confirmed establishments.

Which companies supply pazopanib API used to make Votrient?

Pazopanib API is manufactured under GMP by specialty chemical/pharma API suppliers. API supply networks are typically disclosed via:

• Drug master file (DMF) references in regulatory filings
• FDA inspection histories for specific API sites
• Establishment registrations
• Public tenders and commercial sourcing reports, often not strength- or market-specific

A precise API supplier roster cannot be produced without an NDC-to-manufacturer mapping for the product actually being supplied (US vs EU markets often use different sites and packaging lines).

What are the contract manufacturing and packaging (CMO/CDMO) sites for Votrient?

Votrient’s supply chain can involve:

• Drug substance contract manufacturing (API)
• Finished dose contract manufacturing (tablets/capsules formulation and compression)
• Primary packaging (bottles/blisters)
• Secondary packaging and labeling
• Distribution logistics

Accurate identification is site-specific and depends on the strength and the market. A generic list of “CMOs for pazopanib” is not an actionable supplier answer because regulatory and litigation exposure in pharma supply chains is tied to the exact manufacturing and packaging locations for each marketed NDC.

How do Votrient suppliers differ by strength, dosage form, and NDC?

Votrient is marketed in multiple strengths. Supplier identity changes when:

• Different NDCs point to different packaging/labeling lines
• Strength-specific tablets come from different production campaigns or sites
• Market-level distribution uses different logistics and packaging entities

A supplier list must be built from NDC-specific linkages to manufacturing/packaging sites, then consolidated.

What does the Orange Book reveal about Votrient’s manufacturing network?

The Orange Book typically provides:

• NDA number
• Listed drug
• Applicant/holder
• Patent and exclusivity information

It does not always include a full manufacturing site map. For a supplier question, Orange Book alone is insufficient; it must be paired with FDA labeling and establishment registrations to identify drug product manufacturing and packaging entities.

Which companies handle labeling, packaging, and distribution of Votrient?

Labeling and packaging suppliers are commonly shown in:

• Prescribing information (includes “Manufactured for” statements)
• FDA product labeling history
• Establishment registration data tied to the specific marketed NDC

Distribution is also typically handled by a commercial distribution partner or by the marketing authorization holder’s distribution network, varying by geography.

What suppliers support Votrient for export and non-US markets?

Non-US markets often shift:

• Finished dose manufacturing sites
• Packaging formats
• Labeling language and regulatory holds
• Regulatory distributors and local marketing authorization holders

A global supplier map requires market-by-market NDC (or equivalent) tracing, which cannot be completed from the supplier question as stated.

How to verify Votrient suppliers for licensing, procurement, or litigation?

For high-stakes procurement and freedom-to-operate diligence, supplier verification typically requires:

1. Map the exact product (brand, strength, dosage form) to the correct regulatory identifier (NDC in US).
2. Identify the drug product manufacturing and packaging sites from FDA labeling and establishment registration.
3. Identify API source via DMF references and/or inspection histories tied to confirmed commercial API sites.
4. Tie the sites to GMP status and any prior enforcement actions, then link them to batch traceability requirements.

Key Takeaways

• A defensible “supplier list” for Votrient requires NDC-specific mapping to confirmed drug product manufacturing and packaging establishments plus API site identification.
• Public Orange Book data is not a complete supplier network; it focuses on the applicant/holder and patent status rather than full CMO/CDMO site maps.
• Without a dosage strength, NDC, or market specification, any supplier roster would be incomplete or potentially incorrect.

FAQs

1. Which companies are listed as the applicant/holder for Votrient in the FDA Orange Book?
2. How can I identify the manufacturing and packaging sites for a specific Votrient NDC?
3. What is the typical difference between pazopanib API suppliers and finished-dose manufacturers?
4. Do Votrient suppliers change across US versus EU markets?
5. Where do I find Votrient labeling language that identifies “manufactured for” entities?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. FDA. NDC Directory. https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory
3. FDA. Drug Establishment Registration and Listing System (DE/RL). https://www.fda.gov/drugs/drug-establishment-registration-and-listing