Last Updated: June 9, 2026

Suppliers and packagers for delestrogen


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delestrogen

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Ph Health DELESTROGEN estradiol valerate INJECTABLE;INJECTION 009402 NDA Par Health USA, LLC 42023-110-01 5 mL in 1 VIAL, MULTI-DOSE (42023-110-01) 2007-11-01
Ph Health DELESTROGEN estradiol valerate INJECTABLE;INJECTION 009402 NDA Par Health USA, LLC 42023-111-01 5 mL in 1 VIAL, MULTI-DOSE (42023-111-01) 2007-11-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Delestrogen (Estradiol Cypionate): Who Supplies What in the Supply Chain?

Last updated: April 25, 2026

No complete, reliable supplier roster can be produced for Delestrogen from the information available in this session. A supplier list for a branded injectable depends on the exact market (country), pack strength, and dossier references (drug product vs. API vs. sterile fill-finish) and on current contracts and regulatory listings. Without those inputs, any named “suppliers for Delestrogen” would be incomplete and likely incorrect.

Delestrogen is an estradiol cypionate injection. In pharma supply chains, sourcing typically splits into three layers:

  • API manufacture (estradiol cypionate)
  • Sterile drug product manufacturing (aseptic filling, sterilization, labeling/packaging)
  • Ancillary component sourcing (solvents, vials, stoppers, syringes, labels, cartons)

A defensible supplier answer requires linkage to the specific regulatory product dossier and current label holder by jurisdiction.


What counts as a “supplier” for Delestrogen?

For decision-grade procurement and diligence, “supplier” should mean one of the following, each with different documentation:

  • API supplier: provides the estradiol cypionate active ingredient under controlled specifications and typically referenced in DMF/CEP or dossier tables.
  • Drug product manufacturer (sterile fill-finish): performs compounding, aseptic processing, filling, inspection, and sterile release.
  • Labeler/holder (market authorization holder): owns the marketing authorization and contracts manufacturing and packaging.

Without the jurisdiction and product presentation, the “supplier” set is not determinable with accuracy.


Which supply chain roles matter for an injectable steroid like Delestrogen

Delestrogen (estradiol cypionate) is an oil-based injectable. That typically drives procurement focus around:

  • Sterile fill-finish capability (aseptic processing, container closure integrity testing, sterility assurance)
  • Oil vehicle and formulation components (depending on the label and strength)
  • Primary packaging (glass vial type, elastomer stopper grade, crimp seals)
  • Analytical release (HPLC assay, impurities, water content where applicable)

These roles map to different supplier types and different regulatory evidence.


What supplier evidence is required to produce a real list

A complete supplier list for Delestrogen must cite at least one of:

  • Regulatory product information (marketing authorization holder, manufacturing sites)
  • Drug master file (DMF) references for the API
  • CEP or other API certificates identifying manufacturer(s)
  • Current US/EU labeling/manufacturing statements listing the drug product manufacturer(s) and packager(s)

No such jurisdiction-specific dossier data is available in this chat.


Key Takeaways

  • A correct, complete “suppliers for Delestrogen” list cannot be produced from the information provided in this session.
  • For injectables, suppliers must be defined by supply-chain role (API manufacturer, sterile fill-finish/drug product maker, and label/authorization holder).
  • A defensible supplier roster requires jurisdiction- and presentation-specific regulatory evidence.

FAQs

  1. What is Delestrogen’s active ingredient?
    Estradiol cypionate.

  2. Do API and sterile fill-finish suppliers usually overlap?
    They are typically different entities because API and sterile aseptic manufacturing require distinct capabilities and approvals.

  3. What documentation normally identifies Delestrogen suppliers?
    Marketing authorization/manufacturer statements, plus API dossier references (DMF/CEP) tied to the exact product and market.

  4. Why does “supplier” vary by country?
    The labeler and contracted manufacturers differ by jurisdiction, and product strengths and packaging presentations also vary.

  5. Can a supplier list be accurate without regulatory sources?
    No. For branded injectables, accuracy depends on mapping the product to current regulatory listings.


References

No sources were provided in the session, and no jurisdiction-specific Delestrogen dossier or label documentation was available to cite.

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