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Suppliers and packagers for FENOFIBRATE (MICRONIZED)
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FENOFIBRATE (MICRONIZED)
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ajanta Pharma Ltd | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 210705 | ANDA | Ajanta Pharma USA Inc. | 27241-118-04 | 100 CAPSULE in 1 BOTTLE (27241-118-04) | 2018-09-10 |
| Ajanta Pharma Ltd | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 210705 | ANDA | Ajanta Pharma USA Inc. | 27241-118-05 | 500 CAPSULE in 1 BOTTLE (27241-118-05) | 2018-09-10 |
| Ajanta Pharma Ltd | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 210705 | ANDA | Ajanta Pharma USA Inc. | 27241-119-04 | 100 CAPSULE in 1 BOTTLE (27241-119-04) | 2018-09-10 |
| Ajanta Pharma Ltd | FENOFIBRATE (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 210705 | ANDA | Ajanta Pharma USA Inc. | 27241-119-05 | 500 CAPSULE in 1 BOTTLE (27241-119-05) | 2018-09-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Fenofibrate (Micronized) Suppliers: Who Manufactures Bulk API, Micronized Active, and Finished Dosage in Key Markets
Fenofibrate (micronized) supply chains split into three layers: fenofibrate API, micronization services or micronized fenofibrate intermediates, and finished-dose tablet/capsule manufacturers. The supplier universe is dominated by a small set of global API producers plus a separate set of tablet/capsule OEMs that qualify for FDA/EDQM listings and supply national markets under product-specific registrations.
Who supplies fenofibrate (micronized) API and what is the supplier map?
Answer: The API supplier map is global and tends to be concentrated in China and India for bulk fenofibrate manufacture, with downstream micronization and formulation performed by manufacturers that can meet particle-size specifications, moisture control, and tablet/capsule performance targets.
API manufacturing and micronization handoff
Fenofibrate supply for “micronized” labeling commonly involves:
- Bulk fenofibrate API or an intermediate produced in one facility.
- Micronization of the API (or a micronized API intermediate) under controlled jet-mill or similar comminution processes.
- Finished-dose production by the product manufacturer (or a contract manufacturer) with compression or encapsulation steps that preserve bioavailability targets.
Key supplier categories (by function)
| Supply layer | Typical role in fenofibrate (micronized) | What to validate |
|---|---|---|
| Fenofibrate API manufacturer | Produces bulk API under GMP | DMF/EDMF status, impurity profile, polymorph control, residual solvents |
| Micronized fenofibrate intermediate producer | Performs micronization and sizing | Particle size distribution (D10/D50/D90), PSD stability, moisture uptake |
| Finished-dose manufacturer | Manufactures tablets/capsules using micronized material | FDA/EDQM registrations, bioequivalence support, stability data, packaging controls |
Which companies produce micronized fenofibrate intermediates and finished tablets or capsules?
Answer: Fenofibrate micronized is supplied by both brand-generic incumbent manufacturers and contract manufacturers. The “micronized” attribute attaches to the formulation and/or particle-size specification, so the same API supplier can feed multiple finished-dose products.
How to identify the true supplier in practice
In fenofibrate (micronized), the practical way to map suppliers is through:
- FDA labeling and product manufacturing/packaging claims for specific NDCs.
- Orange Book listings tied to NDA/ANDA registrations, then tracing facility information.
- DMF cross-references for API suppliers where accessible.
- Public contract manufacturing profiles (OEM tablets/capsules) used by multiple marketing authorizations.
Supplier map by distribution model
| Distribution model | Typical suppliers visible to buyers |
|---|---|
| Direct API + CMO formulation | API producer + micronized intermediate maker + CMO tablet/capsule maker |
| Brand or global generics platform | NDA/ANDA marketing authorization holder with in-house or contracted manufacturing |
| Regional generics distributors | Licensed wholesalers and local assemblers using qualified manufacturers |
What are the FDA and regulatory constraints that limit fenofibrate (micronized) suppliers?
Answer: Suppliers must align with FDA regulatory pathways for drug substance and drug product. For micronized fenofibrate products, the particle-size specification and resulting performance are treated as quality-critical attributes.
FDA quality expectations that affect supplier qualification
- Consistent particle size distribution and batch-to-batch control for “micronized” grade.
- Control of polymorphic form and moisture effects.
- Impurity controls and residual solvent limits.
- Stability under packaging and storage conditions consistent with the ANDA or NDA submission.
DMF vs. supplier in finished product
Many buyers qualify API via DMF or via direct quality agreements. For micronized products, they also qualify the micronization step or the micronized intermediate itself, because particle size is a core parameter that can influence dissolution and bioavailability.
What is the Orange Book status for fenofibrate (micronized), and why does it matter for suppliers?
Answer: Orange Book status affects which manufacturers can market a generic or reference product, and it drives who can supply product at scale without triggering patent litigation or exclusivity constraints.
Why Orange Book matters for procurement
- If a supplier’s marketed product is tied to a specific NDA/ANDA, availability depends on regulatory status and exclusivity.
- Patent estate and litigation outcomes affect re-launch timing for certain formulations and strengths.
How do fenofibrate (micronized) supplier choices impact bioavailability and quality?
Answer: For micronized fenofibrate, the key procurement risk is PSD drift or changes in the micronization process that can alter dissolution and exposure.
Quality attributes buyers should anchor to purchase specs
- Particle size distribution (PSD): D10/D50/D90 and percent within target ranges.
- Bulk density and flow properties for manufacturing.
- Moisture content and hygroscopic behavior.
- Polymorph or solid-state form control.
- Impurity profile versus the approved API specification.
Which generic manufacturers are active suppliers in the US market for micronized fenofibrate?
Answer: The US supply base for fenofibrate micronized includes multiple ANDA holders and packagers across strengths. Actual “supplier” for a given buyer is the finished-dose manufacturer tied to NDCs, not just the API producer.
Procurement-grade mapping approach
To identify the finished-dose supplier for “fenofibrate (micronized)”:
- Select the target strength (commonly 54 mg, 67 mg equivalent, and 145/150 mg-class strengths depending on local labeling conventions).
- Identify NDCs marketed as “micronized.”
- Extract the listed manufacturer (labeler) and packaging/manufacturing sites from FDA labeling.
- Cross-reference with ANDA or NDA entries and associated patents.
What contract manufacturing capacity exists for fenofibrate (micronized) tablets and capsules?
Answer: Fenofibrate tablets are commonly produced by regional and global CMO networks that support compression and controlled dissolution performance. Capsule formats are less typical for fenofibrate micronized, but they exist depending on the marketed product.
Where manufacturing bottlenecks typically occur
- Micronization capacity with validated PSD control.
- Powder handling under low-humidity conditions.
- Bioequivalence-linked formulation process parameters.
What manufacturing/IP barriers affect new entrants to fenofibrate (micronized) supply?
Answer: Barriers are driven by:
- Regulatory filings and facility qualifications (FDA/EDQM).
- Patent estate covering formulations, particle-size specifications, and method-of-use.
- Ongoing patent litigation or settlement agreements that can delay market entry.
Typical patent categories relevant to procurement risk
- Formulation patents covering micronized particle size, excipients, and processing.
- Method-of-use patents for lipid-modifying regimens.
- Manufacturing method patents tied to particle size reduction or solid-state control.
Commercial implications: who can supply reliably at scale?
Answer: Procurement reliability tends to track with:
- Vertically integrated or tightly managed supply chain (API to micronization to finished-dose).
- Historical DMF/ANDA supply continuity.
- Access to validated micronization equipment and batch QA data.
Buyer decision criteria
| Criterion | Why it matters for fenofibrate (micronized) |
|---|---|
| Confirmed PSD capability | Protects dissolution and exposure performance |
| Documented solid-state controls | Reduces variability risk |
| Facility inspection history | Drives approval and re-supply continuity |
| Quality system maturity | Limits deviation and batch rejection risk |
Key Takeaways
- Fenofibrate (micronized) supply is a three-layer chain: API, micronization/intermediate, and finished-dose manufacturing.
- “Micronized” is a quality-critical attribute tied to PSD control and downstream dissolution performance, so procurement must qualify micronization or micronized intermediate, not only bulk API.
- Supplier eligibility for commercial sale depends on FDA/EDQM regulatory status for specific finished-dose products and their associated patent/exclusivity landscape.
- The most actionable way to identify the real finished-dose supplier for procurement is NDC-based mapping of manufacturers tied to ANDA/NDA entries, then tracing back to API/micronization sources through DMF cross-references and quality agreements.
FAQs
1) What is the difference between micronized fenofibrate and non-micronized fenofibrate in sourcing?
Micronized fenofibrate requires validated particle-size specifications and tighter controls during comminution and downstream manufacturing; non-micronized grades can use different dissolution characteristics and may not meet the same PSD targets.
2) How do I identify the actual finished-dose manufacturer behind an NDC marketed as “micronized fenofibrate”?
Use FDA labeling/NDC records for the product to capture the listed manufacturer and packaging sites, then link that to the ANDA/NDA entry.
3) Are API suppliers the same as micronized fenofibrate intermediate suppliers?
Often not. Bulk API production and micronization are frequently performed by different facilities, even when supply agreements are bundled.
4) What quality tests are most important for qualifying micronized fenofibrate?
Particle size distribution, moisture content, solid-state form verification, impurity profile, and dissolution performance consistency against the approved specification.
5) What risks exist if micronization suppliers change milling equipment or process parameters?
PSD drift can shift dissolution and exposure, which can trigger batch failures, regulatory nonconformance, or bioequivalence concerns for a product tied to a specific grade and specification.
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. Drug Approval Reports and FDA labeling resources (FDA Orange Book and labeling database). https://www.accessdata.fda.gov/
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