Suppliers and packagers for flurandrenolide

flurandrenolide

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Padagis Israel	FLURANDRENOLIDE	flurandrenolide	LOTION;TOPICAL	207133	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-928-03	120 mL in 1 BOTTLE, PLASTIC (45802-928-03)	2016-10-06
Padagis Israel	FLURANDRENOLIDE	flurandrenolide	LOTION;TOPICAL	207133	ANDA	Bryant Ranch Prepack	63629-8657-1	1 BOTTLE, PLASTIC in 1 CARTON (63629-8657-1) / 120 mL in 1 BOTTLE, PLASTIC	2016-10-06
Padagis Israel	FLURANDRENOLIDE	flurandrenolide	LOTION;TOPICAL	207133	ANDA	Bryant Ranch Prepack	72162-1439-2	120 mL in 1 BOTTLE (72162-1439-2)	2016-10-06

Flurandrenolide: Supplier Landscape for Pharmaceutical-Grade Production

Last updated: April 24, 2026

Who manufactures flurandrenolide (API) and related intermediates?

Flurandrenolide is a long-established corticosteroid with a limited number of publicly trackable, internationally listed API suppliers. Public commercial listings tend to consolidate under “USP/EP grade flurandrenolide” and do not always disclose intermediate capabilities (e.g., steroid core synthesis versus final crystallization/analysis). The most defensible supplier approach for procurement is to source from companies that explicitly list flurandrenolide as a sellable item (API) and provide compliance artifacts such as CoA, DMF/CEP support statements (where applicable), and controlled manufacturing attestations.

Procurement targets (API / finished active substance):

• API sellers that list flurandrenolide as an active product (typically “flurandrenolide” or “flurandrenolide powder”).
• Intermediates suppliers that list steroid intermediate readiness for corticosteroid synthesis (only use when they also support flurandrenolide in the QA package, or when you can qualify their impurity profile to your specification).
• Contract manufacturers (CDMO) with steroid capability only if they also provide analytical method support and lot traceability for flurandrenolide manufacture.

Because supplier rosters change frequently, the correct diligence artifact is the supplier’s latest CoA, impurity profile, and stability package for flurandrenolide under your intended grade and particle/crystal form. Without that, buyer risk concentrates in supply continuity and out-of-spec impurity drift.

What supplier types exist for flurandrenolide, and how buyers should qualify them?

API manufacturers vs traders

• API manufacturers: can support batch traceability, full impurity set, and manufacturing route consistency.
• API traders/brokers: may provide CoA but often cannot provide process validation depth, which matters for corticosteroids due to impurity control and polymorph/crystal habit effects.

Regulatory documentation and technical proof points

For flurandrenolide, qualification typically depends on:

• Analytical deliverables: ID, assay, related substances/impurities, water content (if relevant), residual solvents, particle size/crystal form (if targeted).
• Manufacturing control: batch-to-batch consistency and impurity trend data across at least three consecutive lots.
• Supply continuity: minimum order quantities, lead times, and ability to support recurring stability updates.

Practical qualification checklist

• CoA accuracy against your target spec and method equivalency.
• Impurity profile alignment (not just total impurity).
• Crystal form or physical form control (if your dosage form sensitivity requires it).
• Stability data package: at least accelerated and long-term conditions for the grade you buy.

What procurement-ready specs typically drive flurandrenolide supplier selection?

Flurandrenolide is commonly sold for topical corticosteroid formulations; buyer specs usually map to pharmacopoeial requirements for:

• Identity and assay (HPLC method)
• Related substances (HPLC with defined reporting threshold)
• Residual solvents (GC where used)
• Water / loss on drying (depending on vendor package)
• Physical form (particle size and/or polymorph/crystal habit where relevant)

For tendering, you should demand from the vendor:

• A current CoA for the exact grade.
• The SDS for the purchased grade.
• Impurity list with reporting thresholds and method.
• Packaging spec (container closure integrity) and shipping condition guidance.

Which regions usually host flurandrenolide API suppliers?

Supplier availability concentrates in:

• India and China: broader listing frequency for steroid APIs in commercial catalogues.
• Europe and the US: fewer public listings for API only, with more emphasis on intermediates, tolling, or formulation-level supply chains.

For risk management, buyers typically prefer:

• Supplier with confirmed manufacturing site audits.
• Vendor able to provide batch history and impurity trend data.
• Option for dual sourcing where feasible.

How do you map supplier choice to commercial outcomes (cost, continuity, and qualification time)?

Cost

• Lowest unit price often correlates with longer qualification timelines if the vendor’s impurity package or crystal form control is not aligned to your spec.

Continuity

• Choose suppliers who can commit to periodic production slots and hold inventory for fast replenishment.

Qualification time

• Qualification accelerates when the supplier already supports the relevant impurity method and provides crystal form/physical form consistency.

What should buyers request before purchase orders for flurandrenolide?

Minimum procurement request package:

• Latest CoA (not sample-only)
• Impurity profile with method details
• SDS
• Manufacturing site and batch traceability
• Stability data (or a vendor letter with your stability plan alignment)
• Certificate of analysis includes residual solvents and water/L-o-D fields consistent with your spec

Key Takeaways

• Flurandrenolide API sourcing is constrained; supplier shortlists should be built around vendors that explicitly sell flurandrenolide API and can support full impurity and physical-form control, not only identity and assay.
• Qualification should be spec-led: impurity profile alignment and consistency of physical form typically determine acceptance for corticosteroids.
• For business continuity, buyers should target suppliers with batch traceability, current CoAs, and the ability to provide recurring lot data for impurity trend monitoring.

FAQs

1. Is flurandrenolide API widely available globally?
   Supplier listings exist, but qualified supply continuity is narrower than for more common APIs due to impurity and physical-form control needs.

2. Should I prioritize API manufacturers over brokers for flurandrenolide?
   Yes, because impurity trend data, lot traceability, and process consistency materially affect qualification speed and out-of-spec risk.

3. What technical documents matter most when qualifying flurandrenolide suppliers?
   The CoA with full related substances, impurity method details, residual solvent and water/L-o-D fields (as applicable), plus traceability and stability package alignment.

4. Do crystal form and particle size matter for flurandrenolide?
   They can, depending on your finished dosage form and formulation sensitivity. Vendors should support physical form control claims with evidence.

5. How do I reduce supply disruption risk for flurandrenolide?
   Use dual sourcing where possible and require recurring batch CoAs plus impurity trend reporting for ongoing lots.

References

[1] U.S. National Library of Medicine. “Flurandrenolide.” PubChem Compound Summary. (accessed 2026-04-25). https://pubchem.ncbi.nlm.nih.gov/
[2] European Directorate for the Quality of Medicines (EDQM). European Pharmacopoeia monographs (flurandrenolide-related listings, if applicable). (accessed 2026-04-25). https://www.edqm.eu/