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Suppliers and packagers for ANTARA (MICRONIZED)
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ANTARA (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 |
|---|---|---|---|---|---|---|---|---|---|
| Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695 | NDA | Lupin Pharmaceuticals, Inc. | 27437-109-06 | 30 CAPSULE in 1 BOTTLE (27437-109-06) | 2009-09-25 |
| Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695 | NDA | Lupin Pharmaceuticals, Inc. | 27437-110-06 | 30 CAPSULE in 1 BOTTLE (27437-110-06) | 2009-09-25 |
| Lupin | ANTARA (MICRONIZED) | fenofibrate | CAPSULE;ORAL | 021695 | NDA AUTHORIZED GENERIC | Lupin Pharmaceuticals, Inc. | 68180-130-06 | 30 CAPSULE in 1 BOTTLE (68180-130-06) | 2013-02-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for ANTARA (MICRONIZED)
ANTARA (micronized) supplier landscape: who makes and supplies the product, intermediates, and key inputs
ANTARA (micronized) is a brand for fenofibrate. The supplier landscape is split across (1) API manufacturers for fenofibrate, (2) formulation/finished-dosage manufacturers for micronized fenofibrate, and (3) excipients and processing inputs used to achieve particle size and crystallization targets.
No complete, actionable supplier list (by named company, site, and product-specific supply chain role) can be produced from the information available here.
What companies supply the fenofibrate API used for ANTARA (micronized)?
Featured snippet answer: The fenofibrate API supply chain typically includes multi-product chemical/API producers that manufacture fenofibrate bulk drug substance under GMP, then sell to finished-dose manufacturers or brand licensees.
API supplier categories
- Bulk API producers: chemical synthesis of fenofibrate with GMP release for customers.
- Contract manufacturers: toll manufacturing or API contract production for branded applicants.
- Intermediates makers: suppliers of key synthesis intermediates that feed fenofibrate manufacturing.
Common API sourcing patterns in fenofibrate
- Multiple global sources for bulk fenofibrate to reduce supply risk.
- Use of the same API grade across branded and generic micronized products when specs match particle size distribution and impurity profiles.
Which finished-dose manufacturers make micronized fenofibrate capsules/tablets like ANTARA?
Featured snippet answer: Finished-dose suppliers are typically contract development and manufacturing organizations (CDMOs) that handle micronization, blending, and capsule/tablet filling under cGMP.
Manufacturing steps that drive supplier selection
- Jet milling or comminution to achieve micronized particle size distribution.
- Controlled crystallization and milling aids that preserve moisture/flow properties.
- Blending with excipients sized for consistent dose uniformity.
- Filling/packaging line qualification for micronized powders.
Key qualification signals buyers use
- Demonstrated control of particle size and polymorph/solid-state form.
- Analytics package: laser diffraction PSD, XRPD, DSC, impurity panel.
- Batch traceability and change-control history for micronization process.
What suppliers provide the excipients and micronization-processing inputs for ANTARA?
Featured snippet answer: Excipients are commonly sourced from large, global excipient suppliers, while micronization-process inputs are mostly specialized milling aids, lubricant systems, and packaging materials that meet particle, moisture, and extractables requirements.
Typical excipient categories in fenofibrate solid oral products
- Binders and diluents selected to maintain granulation and flow.
- Lubricants for capsule/tablet manufacturing.
- Glidants/anti-caking agents for micronized powders.
- Packaging components designed to manage humidity and prevent PSD drift.
Packaging supply relevance
- Primary packaging that limits moisture ingress can be a critical supplier constraint for micronized formulations.
How does the micronized fenofibrate supplier chain differ from non-micronized fenofibrate?
Featured snippet answer: Micronized products increase supplier scrutiny around particle size control, milling equipment qualification, and solid-state analytics.
Differences that affect sourcing
- More stringent PSD specifications and sampling strategies.
- Greater process sensitivity to milling parameters and storage conditions.
- Higher risk of PSD drift across batches if milling or excipient handling varies.
What Orange Book listings imply about ANTARA (micronized) manufacturers and supply?
Featured snippet answer: Orange Book listings typically show the NDA holder and listed patents tied to the drug product. That helps identify the brand holder and the formulation IP, not necessarily the named factory or API site.
What listings normally provide
- NDA number and dosage forms.
- Patent numbers and expiration schedules.
- Applicant/manufacturer field that can differ from the actual manufacturing sites.
Which companies are potential contract partners for micronized fenofibrate manufacture in the US/EU?
Featured snippet answer: Potential partners are usually established CDMOs with proven micronization and solid-dose experience, plus API sites able to meet impurity and particle spec demands.
How to shortlist candidates (procurement lens)
- Prior track record with micronized particle size specs in oral solids.
- Analytical capability for solid-state characterization.
- GMP history with comparable APIs and controlled substance handling not applicable here.
What manufacturing and IP barriers constrain alternate suppliers of ANTARA (micronized)?
Featured snippet answer: Barriers are mainly practical and regulatory: particle-size control, analytical comparability, and process validation under cGMP.
Typical constraints
- Solid-state control and impurity control can limit straightforward substitution.
- Tight DMF linkage and supplier qualification requirements for APIs and key excipients.
- Process changes require comparability and stability revalidation.
How strong is the supplier concentration risk for fenofibrate micronized products?
Featured snippet answer: Fenofibrate generally has multiple API sources, but micronized product performance depends on formulation/process know-how that can concentrate capacity in fewer finished-dose facilities.
Concentration drivers
- Milling capacity and validated PSD control.
- Packaging and humidity-protective qualification.
- CDMO throughput for high-volume oral solid products.
Key Takeaways
- ANTARA (micronized) is a fenofibrate micronized solid oral drug; supplier selection depends on fenofibrate API GMP supply and finished-dose micronization and PSD control.
- The supplier ecosystem has three layers: API producers, finished-dose micronization/filling manufacturers, and excipients/packaging suppliers that support humidity and PSD stability.
- A named, complete supplier list (company-by-company for API and finished-dose roles) cannot be generated from the information provided in this prompt.
FAQs
- Who makes fenofibrate API under DMF for micronized fenofibrate products?
- What excipients are used to maintain micronized fenofibrate powder flow and stability?
- How is micronized particle size specified and released for oral fenofibrate products?
- What factors drive supplier qualification for milling and micronization of fenofibrate?
- Does the Orange Book list the actual manufacturing sites for ANTARA (micronized)?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-06-02).
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