Suppliers and packagers for SYEDA

SYEDA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Xiromed	SYEDA	drospirenone; ethinyl estradiol	TABLET;ORAL-28	090114	ANDA	Bryant Ranch Prepack	63629-2335-1	3 BLISTER PACK in 1 CARTON (63629-2335-1) / 1 KIT in 1 BLISTER PACK	2017-12-01
Xiromed	SYEDA	drospirenone; ethinyl estradiol	TABLET;ORAL-28	090114	ANDA	Xiromed, LLC.	70700-115-85	3 BLISTER PACK in 1 CARTON (70700-115-85) / 1 KIT in 1 BLISTER PACK	2017-12-01

Suppliers and packagers for SYEDA

Last updated: June 1, 2026

Syeda (drospirenone/ethinyl estradiol) suppliers: API, contract manufacturers, and branded packaging sources

Syeda is a brand of a combined oral contraceptive (COC) containing drospirenone and ethinyl estradiol. Market supply typically depends on upstream hormone API sourcing plus finished-dose/tablet manufacturing and secondary packaging. Specific supplier identity for Syeda’s finished product is not consistently published in public regulatory dossiers or routinely visible in FDA drug labeling, so supplier mapping is usually done via corporate manufacturing ownership, contract manufacturing relationships shown in public filings, and the Drug Master File (DMF) ecosystem for steroid intermediates and APIs.

What suppliers make drospirenone and ethinyl estradiol for Syeda?

Syeda’s active pharmaceutical ingredients are drospirenone (USP) and ethinyl estradiol (USP). For COCs, API supply generally comes from a small set of specialty steroid manufacturers and their downstream CMOs.

Typical supplier categories

• Drospirenone API manufacturers (steroid active ingredient)
  Commonly supplied by steroid-specialty producers and their CMOs’ API divisions.
• Ethinyl estradiol API manufacturers (steroid active ingredient)
  Often supplied by established steroid API producers with long-running commercial supply chains.
• Intermediates suppliers
  Steroid intermediates and key precursors can be supplied under separate contracts and later converted into final APIs at the API site.

API sourcing model used in COC supply chains

• Hormone APIs are sourced via:
  • Direct commercial API purchase from licensed API holders, or
  • DMF-linked supply, where the API site holds a DMF and finished-dose manufacturers reference it.
• Finished-dose tablet manufacturers then perform:
  • Tablet compression/granulation (if applicable),
  • Film coating,
  • Blistering or bottle filling,
  • Secondary packaging and labeling.

Which contract manufacturing organizations (CMOs) produce Syeda tablets and packaging?

Finished-dose COC tablets are manufactured by pharmaceutical tablet CMOs that handle:

• Blister or bottle packaging,
• Labeling and cartoning,
• Serialization where required.

What to look for when identifying Syeda CMO/packagers

• FDA manufacturing site listings in the drug’s labeling and in FDA’s product/establishment records.
• Ownership links between the brand holder and manufacturing entities (some brands are produced at internal sites).
• Submission trail: site changes show up in supplements and manufacturing updates, often reflecting CMOs rather than API-only suppliers.

What is the Orange Book status of Syeda and does it affect supplier mapping?

Syeda is a branded, prescription COC product. Orange Book data typically:

• Confirms listed patents and exclusivity,
• Identifies application and dosage form,
• Sometimes provides manufacturing information through related FDA records.

Why Orange Book status matters for suppliers

• When patents expire, generic competition can shift supply to additional finished-dose manufacturers.
• A “single brand” period often correlates with a tighter set of manufacturing sites.

How do generic and authorized-duplicate COCs change supplier landscape for Syeda?

When Syeda faces competition from generic drospirenone/ethinyl estradiol products:

• More finished-dose manufacturers enter the market.
• Tablets may move across multiple CMO sites.
• API procurement can broaden because generic approvals reference different DMF/API holders.

What formulation and manufacturing steps control Syeda supply risk?

COC tablet supply risk is usually driven by:

• API potency and particle specification consistency,
• Coating and dissolution performance,
• Packaging line throughput (blisters are high-touch for printers and line balancing).

Key manufacturing controls

• Granulation and blending for uniformity of low-dose hormones.
• Film-coating to control dissolution and stability.
• Stability management for steroid hormones under ICH storage conditions.
• Packaging integrity for moisture sensitivity.

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Practical supplier map (how procurement teams source Syeda-ready COC supply)

Because “Syeda suppliers” are not listed in a single authoritative public table, procurement teams build a mapping that typically separates:

1. API suppliers
   • Drospirenone API holder(s)
   • Ethinyl estradiol API holder(s)
   • Intermediate suppliers (precursors)
2. Finished-dose manufacturer
   • Tablet production site(s) using referenced APIs
3. Packaging and labeling
   • Blistering/bottling site
   • Secondary packaging and distribution label printers (sometimes internal, sometimes subcontracted)

This separation supports parallel sourcing strategies if one API or coating line becomes constrained.

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Key Takeaways

• Syeda depends on two steroid APIs: drospirenone and ethinyl estradiol.
• Publicly identifiable “suppliers” for Syeda are most reliably mapped by combining FDA manufacturing site records, establishment listings, and DMF-linked API supply patterns.
• Supplier risk is tied to API specialty capacity, tablet coating/dissolution performance controls, and packaging line constraints.

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FAQs

1. Which DMF holders supply drospirenone and ethinyl estradiol for COCs?
2. How can procurement confirm the manufacturing site for Syeda tablets?
3. Do Syeda generics use the same CMO sites as the branded product?
4. What packaging constraints most often limit combined oral contraceptive supply?
5. How do steroid API changeovers affect dissolution and bioequivalence for COC products?

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References

1. U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. FDA. Drug Establishment Registration and Drug Listing (DE/R).
3. U.S. FDA. Electronic Orange Book and related application records.