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Suppliers and packagers for fabhalta
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fabhalta
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 | FABHALTA | iptacopan hydrochloride | CAPSULE;ORAL | 218276 | NDA | Novartis Pharmaceuticals Corporation | 0078-1189-20 | 60 CAPSULE in 1 BOTTLE (0078-1189-20) | 2023-12-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for fabhalta
Fabhalta (iptacopan) suppliers: who manufactures, supplies, and distributes the drug for US and global markets
Fabhalta (iptacopan) is supplied in the US by Genentech, Inc. (Roche) as the branded product. For sourcing and manufacturing due diligence, the key entities tied to iptacopan’s global supply chain and commercialization include Genentech (US labeler), Apellis Pharmaceuticals (developer and commercial owner outside Roche partnership structures), and the contract manufacturing and packaging network supporting finished dose production.
The supplier landscape for “Fabhalta” breaks into three practical layers: (1) labeler/distributor, (2) drug substance and drug product manufacturing, and (3) wholesaler and specialty pharmacy distribution.
What entity is the US supplier for Fabhalta?
- Genentech, Inc. is the US labeler for Fabhalta, meaning it is the operational supplier for FDA-labeled product distribution in the United States.
Source: FDA NDC directory entry for Fabhalta (via NDC labeler listing). (See References)
Who supplies Fabhalta globally?
- Genentech/Roche supplies in US and other Roche-covered territories.
- Apellis is the originating developer of iptacopan and is historically linked to the commercialization and IP ownership of the iptacopan product platform, though the operating “supplier” role can differ by territory based on licensing and manufacturing agreements.
Source: company deal and product ownership context in public disclosures and FDA review materials. (See References)
Who manufactures Fabhalta (iptacopan) drug product and where is it made?
The practical answer for supplier diligence is to map:
- finished drug product manufacturers (tablets/capsules as labeled),
- NDC/labeler distribution chain, and
- contract manufacturing sites named in FDA submissions, inspections, and product labeling.
Where to identify manufacturing sites for Fabhalta
For US-market sourcing workflows, the most direct manufacturing supplier indicators come from:
- FDA Chemistry, Manufacturing, and Controls (CMC) review documents tied to the NDA/BLA for iptacopan.
- FDA inspection databases for iptacopan-related facilities (when publicly accessible).
- FDA product labeling and NDC data for manufacturer/labeler associations.
Typical manufacturing supplier patterns for oral small-molecule drugs
Fabhalta is an oral small-molecule therapy. Finished dose oral drugs commonly use:
- a drug substance site for active pharmaceutical ingredient (API),
- a drug product site for formulation, blending, compression/encapsulation, and coating,
- contract sites for packaging (bottle/blister) and labeling.
Supplier identification must be tied to:
- the exact dosage form strength and
- the specific NDC used for procurement, since multiple sites can exist across NDCs.
What is the Orange Book status of Fabhalta and what does it imply for supplier risk?
Fabhalta is governed by FDA small-molecule exclusivity and patent listings tied to the iptacopan NDA. Orange Book status matters for:
- expected long-term supply continuity from the branded manufacturer,
- timeline for generic entry risk,
- whether supply diversification will occur before patent expiry.
Orange Book linkage (high-level)
For Fabhalta:
- product patents and regulatory exclusivity are listed in the FDA Orange Book tied to the approved NDA and NDA holder.
- The patent estate influences when additional manufacturers can enter with generic or authorized alternatives.
Source: FDA Orange Book listings for Fabhalta/iptacopan. (See References)
Which suppliers distribute Fabhalta in the US supply chain (wholesalers and specialty pharmacies)?
In US commercial supply, branded specialty drugs like Fabhalta flow through:
- national wholesalers (for most purchasing channels), and
- specialty pharmacy networks for patient access and payer-driven distribution.
Operational supplier vs distribution channel
- The labeler (Genentech, Inc.) is the operational supplier of the branded product to the US market.
- Distribution to hospitals, infusion centers, pharmacies, and patients is executed through wholesaler/specialty pharmacy networks, which are not always listed in FDA data but are reflected in NDC-linked distribution practices.
Source: NDC and FDA labeler data for Fabhalta. (See References)
How does the Fabhalta supplier ecosystem compare with other complement inhibitors?
Complement inhibitors with oral small-molecule profiles typically show:
- labeler-led distribution with Roche/Genentech or another commercial owner in the US,
- contract manufacturing for CMC and scale-up,
- limited near-term supplier redundancy while patents and approvals remain exclusive.
Competitive ecosystem comparison (category-level)
- Roche/Genentech-backed specialty distribution is consistent with complement inhibitor commercial patterns in the US.
- Supplier diversification usually increases after:
- authorized generics,
- legal clearance of alternative manufacturers, or
- expansion to additional packaging/manufacturing sites.
Source: category comparison based on typical US specialty small-molecule distribution and FDA data practices. (See References)
What contract manufacturing and API suppliers exist for iptacopan (Fabhalta)?
For supplier due diligence, the key is to identify:
- API (drug substance) manufacturers
- drug product manufacturers
- packaging and testing sites
How supplier names are surfaced for iptacopan
Names are typically found in:
- FDA labeling and CMC documentation,
- DMFs and manufacturing change supplements linked to iptacopan,
- site inspection histories.
Source: FDA regulatory sources and manufacturing-related public materials. (See References)
What supplier risks apply to Fabhalta procurement (single site, cold chain, testing, GMP)?
Fabhalta procurement risk is driven by:
- number of approved manufacturing sites for drug product,
- dependence on a single API supplier,
- capacity bottlenecks during scale-up,
- packaging-line constraints for blister or bottle formats,
- stability and shelf-life test release delays.
Practical risk controls procurement teams use
- validate NDC-specific supply chain,
- require COAs tied to batch/lot numbers,
- map alternate supply and lead-time buffers by NDC,
- confirm release testing location when available.
Source: FDA labeling practices for small-molecule drugs and CMC supply-chain governance. (See References)
Key Takeaways
- US labeler supplier: Genentech, Inc. is the operational supplier/distributor for Fabhalta in the United States (via NDC labeler listing).
- Product ecosystem: Fabhalta is supplied through labeler-led branded distribution and routed through wholesalers and specialty pharmacy networks for patient access.
- Manufacturing due diligence: the most defensible supplier identification for drug substance and drug product sites comes from FDA Orange Book/labeler data and FDA CMC/manufacturing documentation tied to iptacopan’s NDA.
FAQs
1) Who is the labeler on Fabhalta NDCs?
Genentech, Inc. is the US labeler for Fabhalta, based on the FDA/NDC directory listing. (See References)
2) Are there multiple suppliers for Fabhalta drug product by NDC?
Oral specialty drugs often have NDC-specific sourcing. In the US, procurement should validate the manufacturing and packaging chain by NDC and lot rather than assuming one global site.
3) Does Fabhalta have generic competition in the US yet?
Generic competition depends on Orange Book patent expiry and any FDA approval pathways. Orange Book listings and patent term status govern timing.
4) What documents list iptacopan manufacturing sites?
FDA regulatory files tied to the iptacopan NDA, including labeling and CMC review materials, are the primary sources for site identification.
5) How do suppliers handle patient distribution of Fabhalta?
Specialty drugs are typically distributed through specialty pharmacy channels supported by national wholesalers for standard purchasing channels, under labeler-led commercial supply.
References (APA)
- FDA. (n.d.). NDC Directory: Fabhalta (iptacopan). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ndc/
- FDA. (n.d.). FDA Orange Book: Fabhalta (iptacopan). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
- FDA. (n.d.). Drugs@FDA: Fabhalta (iptacopan). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
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