Last updated: June 5, 2026
Enskyce (desogestrel and ethinyl estradiol) suppliers: Who manufactures and packages the drug and its components?
Executive summary: Enskyce is a branded combined oral contraceptive (COC) containing desogestrel 0.15 mg and ethinyl estradiol 0.03 mg. Its U.S. supply chain includes the Marketing Authorization Holder/labeler (manufacturer-of-record on FDA labeling and Orange Book listings) and contract suppliers that produce finished tablets and/or contract-packaged lots. Without the exact Enskyce NDC(s) and dosage form strength listed in FDA’s Orange Book, a supplier list cannot be completed accurately.
What companies supply Enskyce (desogestrel/ethinyl estradiol tablets) in the U.S.?
Short answer: The “supplier” for Enskyce in regulatory terms is the entity listed as the applicant/holder and manufacturer for each Orange Book listing and NDC. Contract manufacturing and packaging suppliers may appear on packaging labels, manufacturing site databases, or product listing databases, but a definitive supplier roster requires NDC-level identification.
How to identify the actual supplier behind Enskyce
- Orange Book listing “Applicant/Proprietor” and manufacturer fields (per listed NDA).
- NDC labeler and manufacturing site shown on the product label.
- cGMP manufacturing sites connected to the NDA via FDA sources and commercial listing systems.
What suppliers typically do for Enskyce
- Finished dose tablet manufacturing (blending, compression, coating).
- Packaging and labeling (bottles and blister packs).
- API and intermediate supply for:
- Desogestrel
- Ethinyl estradiol
Which Enskyce NDCs and labelers indicate the finished-product supplier?
Short answer: Enskyce may be distributed under multiple NDCs (different package configurations, packaging plants, or re-labeling). The supplier changes at the NDC level.
NDC-level supplier changes to expect
- Different labelers can exist across:
- Bottles vs blister packs
- Different package sizes
- Different manufacturing sites within the same NDA
- Orange Book data should be matched to the exact NDC used for procurement.
What raw material suppliers exist for desogestrel and ethinyl estradiol used in Enskyce?
Short answer: Raw-material sourcing for desogestrel and ethinyl estradiol is typically handled by API producers and intermediate manufacturers with global procurement. A precise supplier list for Enskyce cannot be produced without the underlying API vendor statements tied to Enskyce’s NDA manufacturing process or site-specific manufacturing disclosures.
What you can infer (and what you cannot)
- You can confirm the API identities (desogestrel and ethinyl estradiol).
- You cannot reliably name Enskyce-specific API suppliers without linking Enskyce’s manufacturing sites and/or NDA traceability at the NDC level.
How does Enskyce’s supply chain typically split: API vs finished-dose manufacturing vs packaging?
Short answer: Standard COC supply chains separate into:
- API supply (desogestrel, ethinyl estradiol)
- Finished-dose tablet manufacturing (mixing, blending, compression, coating)
- Secondary packaging (unit-dose packaging into labeled cartons)
Common contracting patterns
- Brand holders often use:
- Contract manufacturing for tablets
- Contract packaging for distribution-ready packs
- Labeling may reflect the U.S. market authorization holder even if tablets are made by a different contract manufacturer.
Is Enskyce supplied by the same manufacturer as other desogestrel/ethinyl estradiol brands?
Short answer: It is possible but not assured. Many COCs share the same API combination, while suppliers differ by:
- NDA manufacturing site assignments
- NDC packaging configuration
- Post-approval manufacturing transfers
What to compare
- Orange Book manufacturer-of-record for each brand/NDA
- Same plant, different labeler scenarios
- Different plant, same API supplier scenarios
What regulatory sources list Enskyce manufacturers and suppliers?
Short answer: In the U.S., the key regulatory sources for identifying the company responsible for market supply are:
- FDA Orange Book entries for the NDA containing desogestrel/ethinyl estradiol
- FDA labeler and manufacturing site information tied to specific NDCs
Key fields to use in regulatory listings
- NDA number and labeler/applicant
- Manufacturer name
- Dosage form and strength
- NDC-to-manufacturer mapping
Key takeaways
- Enskyce supply is NDC-dependent. Supplier identification must be tied to the specific NDC listing and the Orange Book manufacturer/applicant fields.
- A credible supplier list requires Orange Book NDC-level mapping to finished-product manufacturing and labeling sites.
- API supplier attribution (desogestrel, ethinyl estradiol) cannot be stated for Enskyce without NDA-linked manufacturing disclosures at the site/vendor level.
FAQs
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How do I find the manufacturer-of-record for Enskyce?
Use the Orange Book listing for the Enskyce NDA and match to the specific NDC you procure.
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Does Enskyce use multiple manufacturing sites across different package sizes?
Yes. COCs often vary by bottle vs blister and package size, which can shift labeler or manufacturing sites at the NDC level.
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Are desogestrel and ethinyl estradiol APIs interchangeable across COCs?
The drugs are chemically defined, but procurement and supplier qualification are product- and site-specific, so interchange does not imply the same vendor chain.
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Where can contract packaging suppliers be identified for Enskyce?
Contract packaging suppliers are most reliably identified via the labeler/manufacturing site on the product label matched to the NDC.
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What is the fastest way to confirm the supplier for a specific Enskyce order?
Verify the NDC on the lot/pack and cross-check with FDA listing fields tied to that NDC.
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book database).
