Suppliers and packagers for ICLEVIA

ICLEVIA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma Ltd	ICLEVIA	ethinyl estradiol; levonorgestrel	TABLET;ORAL	206850	ANDA	Aurobindo Pharma Limited	65862-865-83	3 POUCH in 1 CARTON (65862-865-83) / 1 BLISTER PACK in 1 POUCH (65862-865-94) / 1 KIT in 1 BLISTER PACK	2018-06-29

ICLEVIA Suppliers: Who Manufactures and Supplies the Drug, Active Ingredient, and Finished Dosage Forms

Last updated: June 5, 2026

ICLEVIA’s supplier map depends on which “supplier” layer is meant: finished-dose manufacturer, active pharmaceutical ingredient (API) maker, packaging and distribution partners, or authorized wholesale distributors. With the single input “ICLEVIA,” no specific manufacturer, API source, contract manufacturing organization (CMO), or distributor can be identified from reliable, citable sources.

Who makes ICLEVIA finished drug product and supplies pharmacies?

No defensible answer can be produced because ICLEVIA lacks an unambiguous, citable identification in the provided data (for example, dosage form strength, application/labeler, or regulatory listing). “ICLEVIA” can also be a trade name used in different jurisdictions or for different products, which prevents a precise supplier attribution.

What finished-dose companies are listed on ICLEVIA labels?

Not available. Labeler and NDC-specific label data are required to identify the finished-dose manufacturer and the U.S. labeler of record, which is the baseline for supplier mapping.

Are there multiple ICLEVIA strengths with different suppliers?

Not available. Supplier status can differ by strength, presentation, and site of manufacture, so strength-level granularity is required to produce an accurate supplier roster.

Which companies supply the ICLEVIA active pharmaceutical ingredient (API)?

No defensible answer can be produced without the API identity and its manufacturer/vendor listing (typical sources: Drug Master File references, regulatory filings, or labeler/DMF linkages). “ICLEVIA” alone does not identify the active ingredient.

Does ICLEVIA source API from a single vendor or multiple sites?

Not available. The API supply chain is often multi-sourced, and the number of vendors cannot be determined without the API name and regulatory references.

Are there API-only suppliers that also do formulation/packaging?

Not available. Without API identity and site-level manufacturing disclosures, any supplier attribution would be speculative.

How do ICLEVIA distribution channels work: wholesale distributors and logistics suppliers?

No defensible answer can be produced. Wholesale distribution partner lists are tied to NDC and market-specific distribution arrangements, which require NDC-level identification and regulatory or commercial disclosures.

Which authorized wholesalers distribute ICLEVIA in the U.S.?

Not available. Authorized distributor rosters are not universal across products and require product-specific sourcing.

Are there specialty pharmacy networks for ICLEVIA?

Not available. Specialty distribution depends on indication, reimbursement, and REMS or distribution controls tied to the specific product.

What are the main CMO and packaging suppliers for ICLEVIA?

No defensible answer can be produced. CMO/packaging site selection is product- and site-specific and is not identifiable from “ICLEVIA” without dosage form and regulatory application identifiers.

Do packaging suppliers vary by dosage form (vials, tablets, capsules, prefilled pens)?

Not available.

Does ICLEVIA use sterile manufacturing and aseptic fill-finish suppliers?

Not available. Sterile requirements materially change the supplier set (aseptic fill-finish, cleanroom constraints, and quality system jurisdictions).

ICLEVIA supplier due diligence: what to verify before contracting or licensing?

Not available as a supplier list, but the due-diligence items that typically determine supplier feasibility for pharmaceuticals include:

• GMP compliance for finished-dose and API sites (inspection outcomes, scope, and product categories)
• Chain-of-custody controls (temperature excursions, re-sterilization, segregation)
• Batch traceability and yield performance
• Quality agreements (QMS, deviation handling, change control)
• Regulatory alignment (site registration status, labeling controls, pharmacovigilance covenants)
• Supply assurance (multi-sourcing, lead times, capacity reservation clauses)
• IP cleanliness (process patents, formulation patents, method-of-use constraints)

Key Takeaways

• A supplier roster for ICLEVIA cannot be constructed from the single term “ICLEVIA.”
• Supplier identification requires product-specific identifiers (at minimum: dosage form/strength and regulatory labeler/NDC, and ideally the active ingredient or application).
• Any attempt to name manufacturers, API vendors, CMOs, or distributors from “ICLEVIA” alone would be unreliable.

FAQs

1. What does “ICLEVIA” refer to (active ingredient, dosage form, and strength) for supplier mapping?
2. How do I identify ICLEVIA’s labeler of record and finished-dose manufacturer?
3. How can I find ICLEVIA’s API manufacturer using regulatory filings (DMF references, applicant statements, or labeling crosswalks)?
4. Which data fields show packaging and labeling contract partners for ICLEVIA?
5. How do I validate ICLEVIA supply chain eligibility for contracting (GMP scope, site registrations, and quality agreement terms)?

References

1. FDA. (n.d.). Drug shortages and drug product labeling resources. U.S. Food and Drug Administration.
2. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
3. FDA. (n.d.). NDC Directory. U.S. Food and Drug Administration.