Last Updated: June 25, 2026

Suppliers and packagers for FYAVOLV


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FYAVOLV

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Lupin FYAVOLV ethinyl estradiol; norethindrone acetate TABLET;ORAL 204213 ANDA Lupin Pharmaceuticals, Inc. 68180-827-09 90 TABLET, FILM COATED in 1 BOTTLE (68180-827-09) 2016-03-15
Lupin FYAVOLV ethinyl estradiol; norethindrone acetate TABLET;ORAL 204213 ANDA Lupin Pharmaceuticals, Inc. 68180-827-73 3 POUCH in 1 CARTON (68180-827-73) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK 2016-03-15
Lupin FYAVOLV ethinyl estradiol; norethindrone acetate TABLET;ORAL 204213 ANDA Lupin Pharmaceuticals, Inc. 68180-828-09 90 TABLET, FILM COATED in 1 BOTTLE (68180-828-09) 2016-03-15
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

FYAVOLV suppliers: what companies manufacture, fill, and package the pembrolizumab-based product?

Last updated: May 28, 2026

No sufficient information was provided to identify Fyavolv’s active ingredient, dosage forms, FDA marketing authorization type, or current manufacturing/secondary packaging partners. Without that, it is not possible to produce a complete, accurate supplier map.

What is Fyavolv and who are its listed suppliers?

No supplier list can be produced from the information available.

What information is required to determine suppliers (direct manufacturer, CMOs, packagers)?

A defensible supplier answer requires, at minimum, one of the following: FDA label “Manufactured for/By” strings, the Orange Book listing for the exact NDA(s), or current package inserts and commercial packaging that name the manufacturer of record and packager.

Which companies manufacture Fyavolv (drug substance and drug product)?

No supplier identification available.

Drug product manufacturing, filling, and packaging

No data available to map:

  • primary manufacturing site (drug product)
  • sterile vs non-sterile process class
  • fill-finish/secondary packaging partners
  • labeler-of-record versus manufacturer-of-record

How many suppliers cover Fyavolv across dosage strengths and presentations?

No supplier identification available.

Strength and presentation split

No information available on:

  • tablet vs capsule vs film-coated vs extended release
  • number of NDCs and strength-specific manufacturers

What does the FDA Orange Book list for Fyavolv?

No Orange Book data available.

Patent and exclusivity tie-in to supplier chains

Supplier mapping normally uses the exact NDA and manufacturer names tied to:

  • active ingredient and dosage form
  • BLA/NDA labeler
  • exclusivity period start/end
  • listed drug status (RLD)

What generic or biosimilar entry risks exist that would change Fyavolv suppliers?

No entry or market-structure data available.

Paragraph IV and “same manufacturer” risks

No data available on:

  • ANDA/RLD relationship
  • approved generics and their manufacturing/packaging sites
  • litigation settlements that shift supply

Who are the CMOs for Fyavolv manufacturing and packaging?

No CMO identification available.

Common CMO work types (what would be cited if data existed)

A supplier answer would typically enumerate:

  • formulation development and scale-up
  • compression/coating or capsule fill
  • blistering or bottle fill
  • secondary packaging and labeling
  • distribution qualification and cold-chain (if relevant)

Key Takeaways

  • No supplier dataset can be generated for “Fyavolv” from the information provided.
  • Supplier identification for pharmaceuticals requires FDA-label or Orange Book/NDC-level manufacturer-of-record data tied to the exact product.

FAQs

  1. What does the Fyavolv label say about who manufactures and packages it?
  2. Where can I find the manufacturer-of-record for Fyavolv by NDC?
  3. Does Fyavolv have multiple suppliers for different strengths or packaging types?
  4. How do Orange Book “listed drug” entries map to the labeler and manufacturing sites?
  5. Do Fyavolv supply chains change after generic approvals or patent settlements?

References

No sources were cited because no factual supplier data was available in the prompt.

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