Last updated: June 2, 2026
ESTARYLLA Suppliers: Who manufactures, supplies, and distributes Estarylla (ethinyl estradiol/norgestimate) in the US?
Executive summary: Estarylla (ethinyl estradiol and norgestimate) is an FDA-approved combined oral contraceptive (COC). In the US supply chain, “suppliers” typically split into (1) the branded/marketing rights holder listed for the product in FDA systems, (2) finished-dosage manufacturers for Estarylla tablets, and (3) upstream API and excipient suppliers. Without specific FDA label/manufacturer-line items and the Orange Book listing details for the exact Estarylla strength(s) and NDCs, a complete, accurate supplier map cannot be produced.
Who is listed as the manufacturer or labeler for Estarylla (ethinyl estradiol/norgestimate)?
Featured snippet answer: The labeler/manufacturer details for Estarylla must be taken from FDA labeling (package insert “Manufactured for…” lines) and the FDA Orange Book listing for each Estarylla NDC/strength.
Which strength and NDC matter for Estarylla supplier attribution?
Estarylla exists across multiple presentations (tablet strengths and packaging configurations). Supplier identity can differ by:
- Strength (EE/norgestimate dose)
- Package type (count)
- NDC (10- or 11-digit format)
- Revision date of the label
What finished-dose manufacturers supply Estarylla tablets?
Featured snippet answer: Finished-dose manufacturing sites for Estarylla are identified in the product’s FDA labeling and Orange Book “Applicant” and “Manufacturer” fields for each NDC/strength.
How to trace finished-dose supply for Estarylla
A defensible finished-dose supplier map requires cross-checking:
- FDA label “Manufactured by/for” and address lines
- Orange Book listing associated with the same NDC
- Any “site of manufacture” changes reflected in label revisions
Who supplies the active pharmaceutical ingredients for Estarylla (API: ethinyl estradiol and norgestimate)?
Featured snippet answer: Estarylla’s upstream API suppliers are not consistently published at the branded level; API vendor attribution is usually not public unless disclosed via:
- FDA Drug Master Files (DMFs)
- Procurement disclosures in company filings
- Public regulatory submissions that enumerate DMF holders (not always indexed to the brand)
API sourcing differences that affect continuity
API suppliers can change due to:
- DMF transitions
- compliance and capacity constraints
- requalification of commercial lots
- site swaps approved via CBE-30 or PAS (depending on change type)
Which excipient and packaging suppliers are used for Estarylla?
Featured snippet answer: Excipient and packaging suppliers are generally not named in public FDA databases for branded oral contraceptives, but they can be inferred only from:
- vendor qualification documents (not public)
- supplier disclosures in regulatory submissions (often DMF/CMC-linked)
- label “packaged by” and “distributed by” lines when available
What packaging formats are typically involved
COC supply chains use:
- blister packaging or bottles
- desiccant/induction seals where applicable
- child-resistant and tamper-evident packaging variants
How can you identify Estarylla distributors and wholesale suppliers in the US?
Featured snippet answer: The public-facing distribution roles are usually captured as:
- “Distributed by” lines on the label
- wholesaler catalog entries tied to NDCs
- GPO contract listings
Wholesale distribution is NDC-specific
Distribution partners can vary by:
- NDC (even within the same strength)
- region and contract structure
- inventory and substitution rules
What supplier risks affect Estarylla availability (capacity, recalls, shortages)?
Featured snippet answer: Estarylla availability risk typically tracks:
- manufacturing site capacity and sterility/non-sterility line constraints (COCs are non-sterile)
- tablet compression coating line availability
- packaging line constraints
- regulatory action affecting a specific NDC strength/manufacturing site
Where shortage signals appear
Public shortage signals are typically communicated through:
- FDA Drug Shortages database (for finished product)
- voluntary manufacturer communications
- state-level pharmacy alerts (less consistent)
Which companies supply competing generics for ethinyl estradiol/norgestimate COCs versus Estarylla?
Featured snippet answer: Competitor supplier sets are inferred from generic manufacturers for each AB-rated product sharing the same active ingredients and dosage form (tablet). A precise comparison requires NDC-level Orange Book listing for each competitor.
Generic entry can shift the supplier landscape
When generic and authorized generics launch, finished-dose manufacturing and distribution rotate through:
- multiple generic applicants
- contract manufacturers
- alternate packaging configurations
How does Estarylla’s supplier chain compare with other EE/norgestimate brands?
Featured snippet answer: Other EE/norgestimate COCs may share upstream API supply but often differ at:
- finished-dose manufacturing sites
- packaging vendors
- distributor/labeler names
Most comparable dimension for procurement
Procurement teams benchmark:
- tablet manufacturing site
- batch-release testing sites
- packaging line sites
- regulatory inspection history per site (CMC compliance)
Key Takeaways
- Estarylla supplier identification must be grounded in NDC- and strength-specific FDA label and Orange Book listing fields.
- Public sources rarely disclose upstream API/excipient vendor names at the branded level.
- A complete supplier map requires manufacturer “site of manufacture” and labeler/distributor lines for each Estarylla NDC, plus Orange Book applicant/manufacturer linkage.
FAQs
- Does Estarylla’s labeler change by NDC or strength?
- How do DMFs link to the API suppliers for ethinyl estradiol and norgestimate?
- Can the same finished-dose manufacturer produce multiple COCs with shared packaging lines?
- What information on FDA labels helps identify “distributed by” vs “manufactured for”?
- How should procurement teams assess Estarylla manufacturing site risk during shortage periods?
References
- FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (n.d.). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
- FDA Drug Shortages. (n.d.). FDA. https://www.accessdata.fda.gov/scripts/drugshortages/
- FDA Labeling (DailyMed). (n.d.). National Library of Medicine. https://dailymed.nlm.nih.gov/
