Suppliers and packagers for PROMACTA KIT

PROMACTA KIT

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	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027	NDA	Novartis Pharmaceuticals Corporation	0078-0697-61	1 CARTON in 1 KIT (0078-0697-61) / 30 PACKET in 1 CARTON (0078-0697-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0697-19)	2018-09-27
Novartis	PROMACTA KIT	eltrombopag olamine	FOR SUSPENSION;ORAL	207027	NDA	Novartis Pharmaceuticals Corporation	0078-0972-61	1 CARTON in 1 KIT (0078-0972-61) / 30 PACKET in 1 CARTON (0078-0972-23) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0078-0972-19)	2018-09-27

Suppliers and packagers for PROMACTA KIT

Last updated: June 2, 2026

PROMACTA Kit suppliers: Who manufactures and supplies eltrombopag for the US and EU?

Executive summary: Promacta (eltrombopag) is manufactured and supplied through a contracted global network centered on Novartis supply. The kit’s supply chain combines (1) eltrombopag drug substance and drug product manufacture, (2) packaging and kit assembly for the oral suspension presentation, and (3) distribution under Novartis’ commercial import and wholesale model in major markets. Who the “suppliers” are depends on whether you mean upstream API/drug-product manufacturers, or downstream packaging/kit-assembly contractors. The most reliable supplier identifiers come from regulatory dossiers (EMA/US), FDA inspection/manufacturing listings, and Orange Book/NDAs that tie each NDC to specific manufacturing sites.

What companies supply PROMACTA kit eltrombopag for the US?

Featured snippet answer: In the US, Promacta (eltrombopag) is marketed by Novartis; the kit’s manufacturing and packaging steps are performed at specific, site-identified contractors listed in FDA labeling and the drug’s application/CMC records.

Which companies appear as manufacturing sites for PROMACTA (eltrombopag)?

For supplier mapping, Promacta kit supply is typically split across:

• Drug product manufacturing sites (tablet and oral suspension presentations, where applicable)
• Packaging and kit assembly sites (for the powder-in-bottle and accompanying dosing components in the kit format)
• Drug substance manufacturers for eltrombopag

In practice, US market “suppliers” most often resolve to:

• The marketing authorization holder: Novartis
• The contract manufacturer(s) at the manufacturing sites tied to each NDC presentation

Note: exact site-to-supplier mapping is presentation- and NDC-specific (kit vs tablet).

Which manufacturers make the eltrombopag active ingredient used in PROMACTA kit?

Featured snippet answer: Eltrombopag (API) for Promacta is produced by contract and/or in-house manufacturing under Novartis’ supply chain, with site identifiers captured in regulatory documentation tied to the product.

Drug substance supplier identification: what to extract

To identify API suppliers with litigation and licensing relevance, track:

• API manufacturer names and addresses in CMC sections of the NDA/DMF references
• FDA manufacturing site listings tied to the same active ingredient and presentation
• Changes over time from supplements (site transfers, process tech transfers)

How is PROMACTA kit packaged and assembled for oral suspension?

Featured snippet answer: The Promacta kit is assembled into a dosing system that typically includes a bottle of eltrombopag powder and instructions for reconstitution (oral suspension). Packaging and kit assembly are handled at designated packaging/fulfillment manufacturing sites listed in regulatory documentation.

What packaging suppliers usually look like in regulatory records

When “kit suppliers” are listed, they typically include:

• Packaging site (primary packaging and labeling)
• Secondary packaging site (cartoning and kit bundling)
• Distribution/wholesale logistics entities, where separately disclosed in some market channels

What is the Orange Book status of PROMACTA kit, and who is listed as manufacturer?

Featured snippet answer: Orange Book listings tie each NDC strength/presentation to the holder and to patent numbers; they also reflect the FDA-accepted manufacturer labeling for that NDC.

Orange Book fields that determine supplier mapping

• Applicant/Holder (marketing authorization holder)
• Patents linked to the NDA (composition, method-of-use, and formulation where applicable)
• Listed manufacturers tied to the NDC
• Exclusivity periods that can affect generic supply timing

When does PROMACTA kit lose exclusivity and enable generic supply?

Featured snippet answer: For eltrombopag, generic entry risk is tied to the Orange Book patent estate and any relevant exclusivity (data exclusivity and any granted exclusivity extensions), rather than kit format alone.

What typically controls timing for kit vs tablet

• Patent expiry by claim scope (composition vs methods vs formulation)
• Potential Paragraph IV challenges affecting launch timing
• Exclusivity that can block FDA approval even after patent expiry

Which companies are challenging PROMACTA with Paragraph IV for eltrombopag?

Featured snippet answer: Patent challenges for eltrombopag are concentrated among generic applicants seeking FDA approval for eltrombopag products. The party list is best derived from FDA’s Paragraph IV and court dockets that reference the Orange Book patents.

Why “supplier” matters in litigation

In Paragraph IV disputes, supplier/CMC capacity matters because:

• An approved ANDA must prove bioequivalence and manufacturing compliance
• A launch-ready supply chain requires validated manufacturing and packaging capacity

How does PROMACTA kit compare with eltrombopag tablets on supplier sourcing?

Featured snippet answer: Tablet and kit (oral suspension) supply chains are often managed with shared API sourcing but different drug product manufacturing and packaging footprints. Kit presentation increases packaging/assembly specificity.

Common sourcing pattern

• Same API supplier(s) or API process family
• Different formulation and excipient handling for reconstitution powder
• Different packaging and labeling line contractors

What patent estate covers PROMACTA kit formulations and manufacturing methods?

Featured snippet answer: Promacta’s patent estate includes composition and method-of-use patents; formulation and process patents can also cover specific presentations and manufacturing methods. These patents determine whether generic suppliers can legally market a kit-formulation substitute.

How patent scope affects “who can supply”

• If formulation/process claims cover oral suspension kit composition parameters, a generic supplier may need design-around changes
• If manufacturing method claims apply, CMO process replication can be blocked even if composition is close

What FDA regulatory status applies to PROMACTA kit, and who is the sponsor?

Featured snippet answer: Promacta is FDA-approved, and the sponsor/holder on the approval record is Novartis. Kit manufacturing suppliers appear through NDC-specific labeling and manufacturing site listings in regulatory documentation.

Pathway and approval relevance to supply

• NDA-approved drug product
• Supplier credibility and inspection history are linked to manufacturing site inspection records and CMC compliance

Commercial exposure: how many markets rely on the PROMACTA kit supply chain?

Featured snippet answer: The relevant commercial exposure is determined by Promacta’s approved indications (chronic immune thrombocytopenia and other uses) and the share of patients using the oral suspension presentation versus tablets.

Why representation matters for supplier risk

• If oral suspension demand is concentrated in geographies with specific suppliers, supply disruptions are more acute
• Kit packaging capacity limits can affect delivery performance and substitution timelines

Key Takeaways

• PROMACTA kit is marketed under Novartis in major markets; supplier identification depends on whether you mean marketing holder vs upstream API and downstream kit assembly CMOs.
• Kit format typically changes packaging and drug product assembly suppliers, even when API sourcing is shared.
• Definitive supplier mapping requires tying the NDC/presentation to the FDA labeling/manufacturing site and the NDA/CMC documentation used for approvals and supplements.
• Patent status and exclusivity govern when alternative manufacturers can supply lawful generic/authorized products, but the “supplier list” is still NDC-specific.

FAQs

1. Who is the manufacturing site supplier for the PROMACTA oral suspension kit by NDC?
2. Are PROMACTA tablet and PROMACTA kit built from the same eltrombopag API suppliers?
3. Do kit assembly and labeling contractors differ from eltrombopag drug product manufacturers?
4. Which Orange Book patents most directly constrain generic substitution of PROMACTA kit formulations?
5. What Paragraph IV challenges have been filed for eltrombopag, and which applicants are tied to supplier entry risk?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Promacta, eltrombopag). U.S. Food and Drug Administration.
2. FDA. Drug Approval Package for Promacta (eltrombopag) (NDA records and labeling). U.S. Food and Drug Administration.
3. FDA. FDA Labeling and Manufacturing Site Information for Promacta (eltrombopag). U.S. Food and Drug Administration.