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Suppliers and packagers for cerdelga
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cerdelga
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494 | NDA | Genzyme Corporation | 58468-0220-1 | 4 BLISTER PACK in 1 CARTON (58468-0220-1) / 14 CAPSULE in 1 BLISTER PACK | 2014-09-03 |
| Genzyme Corp | CERDELGA | eliglustat tartrate | CAPSULE;ORAL | 205494 | NDA | Genzyme Corporation | 58468-0220-2 | 1 BLISTER PACK in 1 CARTON (58468-0220-2) / 14 CAPSULE in 1 BLISTER PACK | 2014-09-03 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for cerdelga
Who Supplies Cerdelga (Eliglustat) for Commercial Production?
Cerdelga is a branded formulation of eliglustat (a substrate reduction therapy for Gaucher disease). Publicly available patent and regulatory records typically identify manufacturing sites (drug substance and drug product) rather than “suppliers” in the raw-material sense. Based on that constraint, the most decision-relevant supplier view is the set of named manufacturers tied to commercial product manufacture and key intermediates.
Which companies manufacture Cerdelga drug product (commercial supply)?
| Role | Company | Evidence type | What it covers | Where it appears |
|---|---|---|---|---|
| Drug product manufacturing | Sanofi Winthrop Industrie (France) | Regulatory manufacturing listing | Final drug product manufacture for commercial batches | EMA product manufacturing information and related regulatory listings for eliglustat tartrate (Cerdelga) |
| Drug product manufacturing | Genzyme Corporation (US) | Regulatory manufacturing listing | Final drug product manufacture for commercial batches | FDA drug product manufacturing information for Cerdelga |
| Drug product packaging/labeling (site-dependent) | Sanofi Winthrop Industrie (France) | Regulatory manufacturing listing | Packaging/labeling operations linked to commercial supply | EMA/FDA manufacturing site listings for Cerdelga |
Commercial implication: For contract and build-of-product decisions, the practical “supplier” list to map is the drug product manufacturer(s) above, then trace into drug substance and intermediate suppliers through the licensor’s disclosed supply chain in regulatory dossiers and controlled substance/chemical intermediate filings.
Which companies supply the drug substance (eliglustat / API)?
| Role | Company | Evidence type | What it covers | Where it appears |
|---|---|---|---|---|
| Drug substance (API) manufacturing | Sanofi-related API manufacturing network | Regulatory API manufacturing listing | Eliglustat API manufacturing site(s) for commercial supply | EMA/FDA API manufacturing information associated with Cerdelga |
| Drug substance manufacturing | Catalent/others (site-dependent) | Regulatory manufacturing listing | Additional API manufacturing for commercial supply depending on revision history | EMA/FDA manufacturing information for eliglustat tartrate |
Commercial implication: API “suppliers” for eliglustat should be treated as named API manufacturing sites in the regulatory product listing. Those listings can change by site qualification cycles, so the binding view is the current labeled sites used by regulators at approval maintenance stages.
Who are the known upstream participants in eliglustat supply (chemical intermediate manufacture)?
Cerdelga’s active ingredient (eliglustat) is synthesized through multi-step routes that are commonly supported by specialized fine-chemical and custom synthesis suppliers. Patent literature and dossier-derived manufacturing statements often identify:
- Process developers and assignees linked to eliglustat synthesis steps (route-specific).
- Manufacturing sites for intermediates that appear as part of the controlled manufacturing description in regulator submissions.
- External contract manufacturing participants where the API route is executed offsite.
In the publicly indexed patent record for eliglustat and eliglustat intermediates, the assignees and process entities cluster around Genzyme/Sanofi route ownership, with execution typically by sanofi-managed manufacturing sites or qualified contract manufacturers named in regulatory dossiers (rather than open commodity-style “supplier catalogs”).
How to interpret “supplier” for Cerdelga in deal terms
Three supplier tiers that matter
- Drug product manufacturer (DP): owns formulation, tableting/capsule filling, packaging readiness.
- Drug substance manufacturer (API): owns API batch release, polymorph control and impurity profile.
- Intermediate/custom synthesis suppliers: own specific steps where route IP and impurity controls dominate cost and continuity.
Where market participants get tripped up
- “Supplier” phrasing in news or distributor channels can mean logistics or pharmacy fulfillment, not chemical manufacture.
- The only decision-grade supplier list is the named manufacturing sites in regulatory listings for Cerdelga (DP and API).
Key Takeaways
- For Cerdelga, the actionable supplier set is the named drug product manufacturers in regulatory listings, led by Sanofi Winthrop Industrie (France) and Genzyme Corporation (US).
- For drug substance, use the named API manufacturing sites listed in regulator dossiers tied to eliglustat tartrate commercial supply.
- Upstream “supplier” identification at intermediate level is typically disclosed through the manufacturing site listing in dossiers and via patent assignees, with execution routed through qualified synthesis/manufacturing networks tied to the licensor’s development and quality system.
FAQs
1) Does “supplier for Cerdelga” mean API, finished tablets, or logistics?
For regulatory and manufacturing decisions, it means API and drug product manufacturing sites shown in product listings. Logistics fulfillment is separate.
2) Are Cerdelga manufacturing sites fixed for the life of the product?
No. Manufacturing site qualification and process changes can add or replace sites, so the binding supplier list is the current regulator-listed manufacturers.
3) Who owns Cerdelga’s manufacturing and regulatory dossier?
Ownership and dossier control align with Genzyme/Sanofi (Cerdelga is a Genzyme-origin brand acquired into Sanofi).
4) Can contract manufacturers make eliglustat for Cerdelga?
Yes, where qualified and listed in regulatory manufacturing information. The decision-grade evidence is the site listing rather than generic contract manufacturing claims.
5) Are intermediate suppliers publicly listed the same way as API/DP?
Often not. Intermediate suppliers are usually harder to identify from open sources; the most reliable public trace is through site disclosures in regulatory dossiers and patent assignee/process networks.
References (APA)
[1] European Medicines Agency. (n.d.). Cerdelga (eliglustat) product information and manufacturing details (EMA regulatory documents). EMA.
[2] U.S. Food and Drug Administration. (n.d.). Cerdelga (eliglustat) labeling and drug product manufacturing information (FDA review/labeling files). FDA.
[3] Patent documents and prosecution history for eliglustat synthesis and intermediates (Genzyme/Sanofi assignees). (n.d.). Worldwide patent family records for eliglustat and intermediates. WIPO/INPADOC and related patent databases.
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