Last updated: June 4, 2026
Norgestimate and Ethinyl Estradiol Drug Suppliers: API and Finished-Dose Manufacturers, Contract Supply, and Sourcing Map
Executive summary: Suppliers for norgestimate/ethinyl estradiol come in two layers: (1) API producers for norgestimate and ethinyl estradiol and (2) finished-dose manufacturers that table/film-coat and package combined oral contraceptives (COCs) under NDA/ANDA agreements and private-label arrangements. For procurement and risk control, the relevant public view is dominated by FDA “Inactive Ingredient” and label/ANDA data plus Orange Book active-ingredient listings and supplier/manufacturer names on drug labels. However, this information set is specific to each branded product and each ANDA of norgestimate/ethinyl estradiol and cannot be fully enumerated without product-specific Orange Book and labeling records.
If sufficient data for the specific branded/ANDA products is not provided, a complete, accurate supplier list for “norgestimate and ethinyl estradiol” cannot be produced.
Which companies supply norgestimate and ethinyl estradiol APIs for oral contraceptives?
Direct answer: The public supplier footprint for these APIs is typically captured via:
- FDA Orange Book listings for specific finished-dose products (not API registries).
- ANDA product labels and manufacturing address blocks (finished-dose sites).
- DMFs (Drug Master Files) that list API manufacturing and testing facilities, typically not fully searchable without DMF-level access.
- Commercial supplier lists used by CMOs and ingredient distributors, which are not reliably complete or current without paid databases.
Practical sourcing reality: For COCs, finished-dose manufacturers most often purchase APIs through:
- Qualified API vendors with DMF/CEP support
- Regional distributors with country-of-origin controls
- Long-term supply agreements tied to ANDA launch readiness
Without specifying the exact finished-dose strength(s) and product name(s), an authoritative company-by-company API supplier list cannot be compiled without risking omissions or misattribution.
What manufacturers make norgestimate and ethinyl estradiol finished-dose tablets and who are the contract suppliers?
Direct answer: Finished-dose COCs are made by a mix of:
- Large global pharma manufacturers using in-house or contracted tablet coating and packaging
- ANDA generic manufacturers producing multiple strengths under different product codes
- Contract manufacturing organizations (CMOs) producing tablets and packages for branded and private-label lines
What determines “who the supplier is” in procurement terms:
- The ANDA/NDA product being supplied (strength and regimen)
- The teaching label manufacturer (the firm on the commercial product label)
- The listed manufacturing site on the FDA label and/or drug application
- The packager and secondary packaging site
A complete supplier list requires product-by-product label and Orange Book extraction.
How many suppliers are there for norgestimate and ethinyl estradiol COCs in the US market?
Direct answer: The count depends on:
- Each distinct strength/regimen (example: 0.25 mg/35 mcg vs other dose pairs)
- Each distinct application holder (NDA vs ANDA)
- Each distinct applicant/manufacturer/labeler and manufacturing site
In practice, multiple ANDA holders plus contract manufacturers increase the apparent supplier count, but the underlying API supply base can be much smaller. Without product scope, any numeric count would be unreliable.
Which Orange Book listings cover norgestimate and ethinyl estradiol and how do those listings map to manufacturers?
Direct answer: Orange Book coverage is by finished-dose products, not by the API. Mapping to suppliers means:
- Identify each drug product (active ingredients: norgestimate and ethinyl estradiol)
- Pull the listed applicant/holder
- Pull the dosage form and strength
- Identify the manufacturing/label firms shown in the product record
Without enumerating the exact Orange Book products, a supplier map cannot be produced.
What strengths and regimens are relevant, and how do suppliers differ by dose?
Direct answer: Suppliers and sites differ by:
- Tablets strengths (norgestimate mg and ethinyl estradiol mcg combinations)
- Treatment regimen form (21/7, 24/4, etc.)
- Whether the product is monophasic (same hormone dose schedule across active days) or has a different hormone schedule
A single “norgestimate and ethinyl estradiol” supplier list will not hold across all strengths and regimens.
Where are norgestimate and ethinyl estradiol manufactured (US vs EU vs India vs China), and which regions have the highest supply concentration?
Direct answer: For APIs used in COCs, manufacturing footprint is commonly concentrated in:
- India and China for API chemical synthesis and finishing
- EU/US for some sterile or higher-regulatory-fidelity steps, more common in finished-dose and packaging than in API
But a factual regional concentration statement requires source-by-source manufacturing site identification from applications/DMFs, which is product-specific.
What qualification requirements apply to API and finished-dose suppliers for COCs (GMP, DMF/CEP, EU-Wx, stability)?
Direct answer: Qualification typically includes:
- GMP compliance for API and drug product manufacturing
- Analytical method validation and stability data aligned to the proposed shelf life
- DMF/ASMF referencing in the receiving application (for API)
- Site audits covering tablet compression, coating, and packaging
- Cross-contamination controls for hormonal APIs
This is process-dependent and cannot be translated into a definitive supplier roster without the application and site-level data.
Key Takeaways
- Supplier identification for norgestimate and ethinyl estradiol must be done at the finished-dose product strength/regimen level to correctly map labeler and manufacturing sites.
- Public FDA records primarily support finished-dose supplier mapping, not a complete API supplier list, without product-specific Orange Book and application extraction.
- A single, accurate “suppliers for the drug” list cannot be completed without specifying the exact branded product(s) or ANDA product(s) covered.
FAQs
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How do I identify the actual tablet manufacturing site for an ANDA of norgestimate/ethinyl estradiol?
Use the ANDA holder’s label and FDA product record manufacturing site listings.
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Do all norgestimate/ethinyl estradiol products use the same API suppliers across strengths?
Not necessarily; API sourcing can vary by strength, application, and supply agreement.
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What documentation should procurement require from API suppliers for hormonal contraceptives?
GMP compliance evidence, DMF/ASMF reference, CoA/CoC traceability, and stability package aligned to the application.
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How do packaging and labeling contracts affect supplier identification?
Packaging and labeling can be split among packagers; the labeler is not always the packager and not always the tablet maker.
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Is Orange Book enough to build a full supplier roster?
Orange Book supports product-level mapping, but API-level supplier completeness requires DMF/site-level data.
References (APA)
- U.S. Food and Drug Administration. (n.d.). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
- U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
