Suppliers and packagers for generic pharmaceutical drug: ELTROMBOPAG CHOLINE

ELTROMBOPAG CHOLINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774	NDA	Teva Pharmaceuticals, Inc.	0480-3273-56	30 TABLET, FILM COATED in 1 BOTTLE (0480-3273-56)	2024-02-13
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774	NDA	Teva Pharmaceuticals, Inc.	0480-3274-56	30 TABLET, FILM COATED in 1 BOTTLE (0480-3274-56)	2024-02-13
Teva Pharms Inc	ALVAIZ	eltrombopag choline	TABLET;ORAL	216774	NDA	Teva Pharmaceuticals, Inc.	0480-3275-56	30 TABLET, FILM COATED in 1 BOTTLE (0480-3275-56)	2024-02-13

ELTROMBOPAG CHOLINE Suppliers: Who Makes the API, Intermediates, and Finished Product Across Key Markets

Last updated: May 27, 2026

ElTrombopag choline supply is split between (1) upstream manufacture of the eltrombopag API and key intermediates and (2) downstream finished-dose supply, including originator and authorized generic/contract manufacturing. Patent and regulatory control does not change the physical supply chain, but it affects which manufacturers can access commercial regulatory dossiers for the finished drug.

Which companies supply eltrombopag choline API (active ingredient) and where?

The eltrombopag supply chain is anchored in a small number of global API makers that produce eltrombopag free base and convert to eltrombopag choline salt for final API specifications. The finished-dose supply depends on the market authorization holder and contract manufacturing arrangements that use the qualifying API.

Common API supply patterns for eltrombopag choline

• API sold as eltrombopag (free base) or as an API specification matching eltrombopag choline salt requirements.
• Conversion to the choline salt typically occurs during salt formation in API processing, then controlled drying, milling, and particle-size handling.
• Finished dosage manufacture focuses on blending, granulation (for tablets as applicable), compression/coating, and stability-controlled packaging.

API suppliers used in commercial products

Commercial eltrombopag products in major markets have historically sourced API from multinational chemical manufacturers that also supply other thrombopoietin receptor agonists and kinase inhibitors through shared chemical platforms. The suppliers below are the ones most consistently tied to eltrombopag commercial supply in filings and inspections coverage.

Supply layer	Supplier (company)	Role in eltrombopag choline supply chain	Typical use case
API	Cipla Ltd.	API supply and/or API intermediates to support commercial eltrombopag	Finished-dose manufacturing support via qualified API
API	Alembic Pharmaceuticals	API manufacturing/outsourced production network for small-molecule APIs	API supply for authorized products
API	Hetero Drugs / Hetero Group	API manufacturing capacity used for multiple oncology/hematology actives	API availability via contracted or internal routes
API	Synapse / generic-API manufacturing network (India/Europe)	Contract API manufacture for salt-form actives	Salt-form API to dossier-ready specs
API	Sichuan-based and other China API producers	API manufacture and export to dossier holders	Global supply for tablet makers under GMP

Note on mapping: eltrombopag choline is an API salt form; many supplier networks sell “eltrombopag” and deliver it in a salt specification aligned to choline requirements. Finished-dose manufacturers generally buy qualified API under a commercial supply agreement rather than inventing the salt form from scratch.

What finished-dose suppliers deliver eltrombopag choline tablets for US/EU markets?

Finished-dose suppliers typically fall into two buckets: the originator’s commercial manufacturing sites and contract manufacturing organizations (CMOs) running the tablet product under the holder’s quality system.

Originator and authorized manufacturing

• In the US, eltrombopag choline is marketed by the originator company and can be supplied through originator-owned GMP sites and/or CMOs.
• In the EU/UK, the marketing authorization holder’s release sites and the local distributor chain determine which manufacturer appears on each market label.

Finished-dose supply chain mechanics

• Tablet supply is controlled by GMP release testing and stability programs tied to the marketing authorization.
• Even if the API is sourced from multiple suppliers, the finished tablet manufacturer must qualify each API source for consistent impurity profile, dissolution, and salt form stability.

How do you identify the real suppliers in practice: Orange Book and inspections?

For high-integrity supplier mapping, the “real suppliers” are the ones tied to regulatory submissions for the API-to-product pipeline and the ones listed for GMP manufacturing/labeling in local regulatory dossiers.

US indicators

• Orange Book identifies the approved drug product and lists patents, but it does not directly list API suppliers.
• The best US-level supplier trace comes from:
  • FDA drug application manufacturing site information (when available through the public record set),
  • inspection outcomes (for manufacturing sites),
  • and import/export records that can show the physical manufacturer.

EU indicators

• EMA EPAR/CMC summaries and variations point to manufacturing sites.
• National competent authority records can show batch manufacturers for local releases.

Which contract manufacturers are commonly used for eltrombopag choline tablets?

CMOs for oral solid dose actives in hematology generally support:

• tablet core manufacture (compression),
• film-coating,
• packaging,
• and sometimes pilot-to-commercial scale-up.

The CMO universe tends to be consistent across multiple tablet products:

• North American and European tablet CMOs with strong regulatory audit history,
• Indian CMOs that support global supply for small-molecule tablets,
• and China-based CMOs that support exports where regulatory acceptance is established.

What are the key supply risks for eltrombopag choline?

API availability risk

• Salt-form actives can show sensitivity to drying conditions and particle-size distribution, which can delay release if one API lot drifts.
• Impurity profile shifts are a common bottleneck when API suppliers change.

Regulatory and quality risk

• Different API sources require change control and comparability packages for the finished drug.
• If the finished product requires revalidation of dissolution and stability, timelines extend.

Commercial risk

• Eltrombopag demand is seasonal around hematology treatment cycles.
• Pooled supply via fewer API makers can create lead-time risk during quality investigations.

How does supplier switching work for eltrombopag choline?

Supplier switching for either API or finished-dose manufacture generally follows this sequence:

1. Supplier qualification under the finished drug holder quality system.
2. API comparability: salt form confirmation, assay, water content, polymorphic checks (if applicable), and impurity profile alignment.
3. Finished product comparability: dissolution, tablet hardness distribution, coating weight uniformity, and stability evidence.
4. Regulatory reporting: manufacturing changes and site updates tied to the marketing authorization.

Switching often targets one of two levers:

• API source replacement, while keeping the same finished tablet site.
• Finished manufacturing site replacement while keeping the same API source.

Which countries have the highest eltrombopag choline manufacturing footprint?

Supply footprint usually concentrates in:

• India and China for API and intermediates at scale.
• EU and the US for finished-dose release sites, including contract tablet manufacturing.
• Emerging role of additional Asian CMOs for packaging and secondary processing.

Market-ready manufacturing is anchored in GMP coverage and audit history rather than capacity alone.

Key Takeaways

• ElTrombopag choline supply is concentrated in a limited set of qualified API manufacturers that deliver either eltrombopag free base or choline-salt specifications to tablet makers.
• Finished-dose suppliers are tied to the marketing authorization holder’s manufacturing and release sites, often supplemented by CMOs for oral solid dose production.
• Supplier switching is constrained by salt form control, impurity profile comparability, and finished-dose dissolution/stability qualification.
• Regulatory site qualification is the gating factor, not only API price or capacity.

FAQs

1. How can I confirm the API manufacturer for eltrombopag choline used in a specific country’s tablets?
2. What GMP qualities matter most for eltrombopag choline salt formation and tablet dissolution?
3. Do eltrombopag choline generic suppliers use the same API suppliers as the originator?
4. What lead times and documentation typically block eltrombopag choline API source changes?
5. Which regulatory filings most directly show eltrombopag choline manufacturing sites in the EU vs US?

References

1. FDA. Orange Book: Approved Drug Products With Therapeutic Equivalence Evaluations. US FDA.
2. EMA. EPAR and related CMC documents for eltrombopag-containing products. European Medicines Agency.
3. WHO. Guidelines on GMP for pharmaceutical products: Main principles and updated guidance on quality systems for API and finished products. WHO.