Last updated: May 31, 2026
CRYSELLE supplier landscape: who manufactures and supplies CRYSELLE (ethinyl estradiol + levonorgestrel) for US market?
CRYSELLE is an oral contraceptive product (ethinyl estradiol + levonorgestrel) marketed in the US under a brand name. The supplier picture hinges on the manufacturer listed on the FDA label and the FDA “drug product” registration data, which determine the company manufacturing the finished dosage form and the company responsible for distribution/manufacturing site coverage.
Who are the approved manufacturers and distributors for CRYSELLE?
Direct answer: CRYSELLE’s US “supplier” is the finished dosage form manufacturer (and/or labeler/distributor) shown on the FDA drug label and FDA listing records for CRYSELLE (NDC-specific). Those entries are the legally relevant sourcing points for wholesaler supply and for anyone assessing supply reliability or regulatory/quality accountability.
How “supplier” is determined for CRYSELLE in compliance terms
For US pharmaceutical supply work, “supplier” usually maps to one of these roles on the FDA listing:
- Labeler / applicant (who holds the NDA/ANDAs listing responsibility for the product listing)
- Finished drug manufacturer (site that manufactures the tablet and packages the product)
- Repackager/distributor (if applicable, less common for brand oral contraceptives vs. direct manufacturing sites)
The most actionable approach for downstream due diligence (GxP, supply chain integrity, litigation discovery, and FDA inspections) is to use the FDA labeler and manufacturing site for the specific NDC strength/form.
Which companies supply the ingredients for CRYSELLE (ethinyl estradiol and levonorgestrel)?
Direct answer: For CRYSELLE, the upstream chemical suppliers for ethinyl estradiol and levonorgestrel are not consistently disclosed as named API vendors in public brand packaging or FDA labeling. The practical “supplier” set for ingredient risk work is instead derived from:
- API manufacturer identity via DMF referencing (where available) and associated FDA DMF-to-product linking
- cGMP manufacture confirmation via drug substance DMF/CEP records
- quality agreements and audit reports (commercially available only through licensing or diligence)
Because the question asks for “suppliers” without restricting to finished dosage form versus API, the only legally grounded supplier set without a company-by-company claim is the finished dosage form manufacturer(s) and labeler/distributor shown in FDA listing data for CRYSELLE NDCs.
What is CRYSELLE’s manufacturing site coverage and what does it mean for supply risk?
Direct answer: CRYSELLE supply resilience depends on whether there are multiple finished dosage form manufacturing sites for the same NDC/strength. When only one site supports the full market, supply disruption risk concentrates in:
- tablet pressing/coating line downtime
- packaging line constraints (blistering and carton pack-out)
- primary packaging resin availability (if site-specific)
Supply chain risk checklist used for oral contraceptives
- Single vs multi-site manufacturing for the exact NDC
- Commonality of packaging components across strengths
- Whether manufacturing is outsourced to a third-party CDMO with dedicated lines
How do you identify CRYSELLE suppliers for each NDC strength and dosage form?
Direct answer: CRYSELLE has multiple NDC listings by strength and presentation. Supplier identity can change by NDC due to different labelers, packagers, or manufacturing sites.
Hardened process used in diligence
- Match the CRYSELLE SKU to its exact NDC
- Pull the FDA labeler/manufacturer for that NDC
- Pull the manufacturing site registered with the FDA for that product listing
- Use that manufacturing site for:
- inspection history review
- change notification tracking (FDA supplement patterns)
- raw material traceability expectations
What Orange Book listings show about CRYSELLE supply responsibility?
Direct answer: CRYSELLE’s Orange Book status is relevant for IP but does not reliably list upstream suppliers. Orange Book is used for:
- branded product identification for the NDC
- patent and exclusivity status tied to the product
- generic entry risk
Supplier identification is typically better sourced from:
- FDA labeler/manufacturer listing records
- FDA drug listing databases tied to NDCs
- inspection and registration databases by manufacturing site
Which companies could become CRYSELLE suppliers if generics launch?
Direct answer: If a generic enters, the supplier profile expands to:
- generic finished drug manufacturers for the generic NDC
- firms that hold the Abbreviated New Drug Application (ANDA) and associated manufacturing sites
In oral contraceptives, generic launches often involve:
- established CDMOs that already supply other ethinyl estradiol/levonorgestrel products
- packaging specialists for blister or tablet-carton formats
Without the specific generic ANDA(s) tied to CRYSELLE on the Orange Book, naming companies would be speculative.
Key takeaways
- The only firm, compliance-usable definition of “CRYSELLE suppliers” is the FDA labeler and finished dosage form manufacturer(s) for the specific CRYSELLE NDC(s).
- Upstream API supplier names for ethinyl estradiol and levonorgestrel are typically not public in brand labeling and require DMF-linked diligence.
- Supply risk is best evaluated by checking how many finished dosage form manufacturing sites support each CRYSELLE NDC/strength.
FAQs
1) Is the CRYSELLE supplier the same across all NDCs?
No. Supplier identity can differ by NDC/strength due to different labeler or manufacturing site registrations.
2) Are API suppliers for CRYSELLE listed on the CRYSELLE FDA label?
Typically no. Public labeling usually identifies the finished drug manufacturer, not the named API vendors.
3) Does Orange Book list CRYSELLE’s manufacturing sites?
Orange Book primarily lists drug product identity and patent/exclusivity information, not manufacturing site suppliers.
4) How do I confirm which company manufactures CRYSELLE tablets?
Use the FDA product listing information for the exact CRYSELLE NDC and manufacturing site registration associated with that listing.
5) If a CRYSELLE generic launches, who becomes the new supplier?
The generic ANDA applicant and its registered finished-dose manufacturing sites become the suppliers for that generic NDC.
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. Drug Registration and Listing System (DRLS) and related product listing data (NDC labeler/manufacturer and manufacturing site records). FDA. https://www.fda.gov/
