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Suppliers and packagers for generic pharmaceutical drug: elafibranor
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elafibranor
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ipsen | IQIRVO | elafibranor | TABLET;ORAL | 218860 | NDA | Ipsen Biopharmaceuticals, Inc. | 15054-0080-1 | 1 BOTTLE in 1 CARTON (15054-0080-1) / 30 TABLET, FILM COATED in 1 BOTTLE | 2024-06-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: elafibranor
Elafibranor Suppliers: Who Manufactures API, Drug Product, and Contract Services for This PPARα/δ Agonist?
Elafibranor is a development-stage, orally administered PPARα/δ agonist. Public, purchase-ready supplier intelligence for elafibranor (API and finished dose) is limited in scope, and most availability described in the market is for research quantities or for manufacturing under NDA through CRO/CDMO relationships rather than open catalog supply.
Practical sourcing reality: for business timelines tied to tox/IND-enabling and Phase 1–2 dosing, elafibranor is typically obtained through (1) a rights holder or development sponsor, or (2) controlled procurement through CDMOs supporting preclinical and clinical batches under contract manufacturing agreements. Open web “suppliers” often sell only small quantities and may not support GMP clinical or commercial drug product supply.
Who supplies elafibranor API (active pharmaceutical ingredient) for GMP clinical manufacturing?
Answer: GMP elafibranor API supply is usually provided via specialized CDMOs and intermediates manufacturers under sponsor-controlled procurement, not through broadly listed distributors.
Common supply channel patterns for elafibranor
- Sponsor-controlled API procurement: development sponsor or rights holder selects an API manufacturer; downstream manufacturing slots are reserved contractually.
- CDMO-managed intermediates and API synthesis: elafibranor API is produced with validated routes and impurity controls; scale-up and tech transfer are handled inside the program.
- Research-quantity vendors: small-lot elafibranor is sometimes offered for in vitro work, but these suppliers generally do not guarantee GMP batch documentation required for IND-enabling tox and human dosing.
What buyers typically verify before contracting
- GMP status and CoA format for intended stage (pre-IND vs Phase 1 vs Phase 2/3)
- impurity profile control strategy (process-related impurities and residual solvents)
- analytical package completeness (NMR, LCMS, chiral assay if applicable)
- tech transfer readiness (DMF/ASMF linkage, if used)
- supply chain traceability for intermediates
Which CDMOs or contract manufacturers are most likely capable of elafibranor drug substance and drug product?
Answer: Capability is often tiered: companies that can supply validated API steps are not always the same firms that can dose-formulate and produce finished tablets or capsules under clinical cGMP.
Drug product manufacturing scope to confirm
- dosage form feasibility (tablet vs capsule)
- solubility and dissolution strategy (salt form, amorphous dispersion, particle size control)
- stability program design (ICH conditions, forced degradation)
- packaging configuration aligned to clinical labeling
Where sponsor-led selection matters
Elafibranor programs typically require NDA-level disclosure of:
- synthetic route and impurity targets
- analytical method validation approach
- stability-indicating methods
- in-process controls and batch genealogy requirements
This drives procurement through established program CDMOs rather than open-market sourcing.
What suppliers provide elafibranor intermediates and building blocks for scale-up?
Answer: Elafibranor supply chains commonly split into intermediates and final API manufacturing.
Intermediate procurement drivers
- route robustness at scale
- control of genotoxic or highly regulated impurities
- supply continuity for a single critical intermediate step
- cost and lead-time optimization during process development
Buyer diligence checkpoints
- impurity carry-through risk from intermediate to API
- suitability of intermediate grade for GMP conversion
- compliance with residual solvent and reagent spec limits
Can you buy elafibranor from online chemical vendors, and will that work for IND/clinical?
Answer: Online vendors can supply elafibranor for research use, but most do not provide clinical-grade GMP documentation or manufacturing controls required for human studies.
Typical mismatch between research and GMP supply
- missing GMP batch records and full CoA for human-use qualification
- impurity specifications not aligned to ICH thresholds used in clinical CMC packages
- limited documentation on stability, method transfer, and traceability
When it can still be used
- in vitro assays and early-stage screening
- method development and reference standard work
- non-clinical model studies where sponsor documentation requirements are lower
What patent and exclusivity factors affect elafibranor CDMO sourcing and supplier onboarding?
Answer: For a development-stage compound like elafibranor, supplier access is typically constrained less by “generic exclusivity” and more by process IP control, tech transfer gates, and sponsor/rights-holder procurement rights.
How IP affects supplier selection
- API route IP and proprietary intermediates may be protected by process patents and trade secrets
- sponsor may require NDA and impose permitted-use restrictions on the API
- tech transfer is often limited to pre-qualified CDMOs
What is the most realistic timeline to secure elafibranor supply for IND-enabling batches?
Answer: Supplier onboarding for a non-catalog API usually follows a staged procurement plan:
- early validation material supply (reference and method development)
- IND-enabling GMP batch manufacturing (often pilot scale with tox-grade spec)
- clinical-scale batches after process lock and method validation
Time risk usually comes from
- analytical method establishment and impurity profiling alignment
- stability and packaging studies
- tech transfer and process validation cycles
What is the FDA regulatory status of elafibranor that influences supplier documentation requirements?
Answer: Elafibranor is not a widely marketed, approved drug with a mature FDA listing footprint comparable to commercial APIs. That means supplier documentation for IND/clinical typically must be built program-by-program, and buyers must plan for CMC package alignment with IND expectations.
Documentation that procurement teams usually need
- GMP manufacturing record packages suitable for IND
- CoAs tied to release specs used in the clinical program
- stability protocols and initial data for the drug product form
- method validation reports and qualification of analytical instruments
How does elafibranor formulation and dosage form affect supplier selection?
Answer: Formulation risk often determines whether a supplier can support the program beyond API.
Key formulation supplier capabilities
- scalable manufacturing process for the intended dosage form
- dissolution specification and bio-relevant dissolution development
- solid-state characterization and control of polymorph/particle-size
- ability to run stability studies and provide data packages on schedule
Competitive landscape: how do elafibranor suppliers compare with other PPAR agonists?
Answer: For the class of PPAR agonists, supplier networks often reuse formulation know-how (solid dose, dissolution enhancement approaches), but API capability is not interchangeable because synthesis routes and impurity controls differ.
Procurement implications
- You may find more overlap in finished-dose CDMO networks than in API synthesis capability.
- Even if a CDMO has experience with related compounds, onboarding still requires route-specific impurity strategy and analytical method work.
Supplier due diligence checklist specific to elafibranor procurement
Use this as a decision filter for contracting API and drug product supply:
| Category | What to request/confirm | Why it matters |
|---|---|---|
| GMP readiness | clinical cGMP capability and batch documentation format | prevents CMC gaps for IND/clinical |
| Analytical package | validated methods for assay and impurities | supports release and stability |
| Impurity strategy | impurity limits aligned to route and tox needs | controls compliance and patient risk |
| Tech transfer | history of successful tech transfers for small-molecule APIs | de-risks lead time |
| Stability capability | accelerated and long-term program execution | supports shelf-life and packaging |
| Supply continuity | intermediate supply redundancy | avoids batch failures mid-program |
| QA contracting | audit rights and change control | protects consistency across lots |
Key Takeaways
- Elafibranor supply is typically sponsor-CDMO/CDMO-CDMO controlled rather than open-market “catalog” purchasing for clinical use.
- Online chemical vendors may sell reference quantities but are usually not suitable for GMP IND/clinical without verification of GMP documentation and impurity specs.
- API and drug product suppliers are often different; formulation readiness can be the limiting factor for clinical timelines.
- Supplier onboarding is driven by tech transfer, analytical impurity control, and stability data needs, not just general chemical manufacturing capacity.
FAQs
1) Are elafibranor generics or bulk distributors available in the same way as approved drugs?
No. Elafibranor is development-stage, so supplier access is generally controlled through sponsor procurement and CDMO qualification rather than via mature generic distribution networks.
2) What documents should a sponsor expect from a GMP elafibranor API manufacturer?
GMP batch records, CoAs aligned to release specifications, impurity and residual solvent documentation, and analytical method data adequate for CMC review.
3) Can the same supplier provide both elafibranor API and tablets/capsules?
Sometimes, but program practice often splits responsibilities. Buyers should confirm both API capability and formulation/dosage form manufacturing under cGMP.
4) How do impurity controls affect elafibranor supplier qualification?
Impurity profiling and control strategy must match the sponsor’s intended tox/clinical release specs. Lack of a validated impurity framework is a common onboarding blocker.
5) What is the biggest lead-time risk when sourcing elafibranor?
Analytical method alignment, impurity profiling, and tech transfer completion, followed by stability generation and packaging validation for the intended dosage form.
References
No sources were cited because no eligible, verifiable supplier lists or regulatory/CMC documentation for elafibranor were provided in the input and no compliant sources could be confirmed.
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