Last Updated: May 10, 2026

Suppliers and packagers for generic pharmaceutical drug: ESTRADIOL ACETATE


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ESTRADIOL ACETATE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Millicent Mfg Pr FEMRING estradiol acetate INSERT, EXTENDED RELEASE;VAGINAL 021367 NDA Millicent US, Inc. 72495-201-05 1 POUCH in 1 CARTON (72495-201-05) / 90 d in 1 POUCH 2018-12-10
Millicent Mfg Pr FEMRING estradiol acetate INSERT, EXTENDED RELEASE;VAGINAL 021367 NDA Millicent US, Inc. 72495-202-10 1 POUCH in 1 CARTON (72495-202-10) / 90 d in 1 POUCH 2018-12-10
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for generic pharmaceutical drug: ESTRADIOL ACETATE

Last updated: April 23, 2026

Who Supplies Estradiol Acetate for Pharmaceutical Manufacturing?

Estradiol acetate is a specialty steroidal API and intermediate used in hormone therapy and related dosage forms. Supplier coverage in the market is dominated by (1) API manufacturers that sell estradiol acetate as a finished API grade, and (2) bulk chemical manufacturers supplying steroidal intermediates that are converted to estradiol acetate upstream.

Which companies supply estradiol acetate as an API (commercial-grade)?

The following suppliers list estradiol acetate for sale to pharmaceutical manufacturers, labs, or industrial customers. These entities typically provide API specifications, CoA documentation, and regulatory paperwork aligned to GMP or commonly supported quality systems.

Supplier Supply role Common positioning in market Evidence type
Global Calcium Laboratories API distributor Steroid API sales catalog Product listing
MedChemExpress (MCE) Chemical supplier (research/industrial) Estradiol acetate in bulk for non-clinical uses Product listing
TCI Chemicals Chemical supplier Steroid catalog supply Product listing
Cayman Chemical Chemical supplier Steroid catalog supply Product listing
Toronto Research Chemicals (TRC) Chemical supplier Estradiol acetate catalog supply Product listing

Which companies supply estradiol acetate for research and process use (bulk chemicals)?

For R&D, analytical development, and process trials, many buyers source estradiol acetate through established catalog chemical suppliers. These suppliers frequently carry multiple grades and provide typical certificates suitable for internal qualification work.

Supplier Supply role What they typically provide Evidence type
MedChemExpress Bulk chemical Lot documentation, product specs Listing
TCI Chemicals Bulk chemical Product specs, batch info Listing
Cayman Chemical Bulk chemical CoA/spec package per lot Listing
Toronto Research Chemicals Bulk chemical Spec sheet and lot CoA Listing

What procurement data matter most for estradiol acetate?

Regulatory and quality artifacts to demand

Buyers of estradiol acetate typically evaluate suppliers using the same quality gate across steroidal APIs:

  • GMP status: whether the supplier manufactures under GMP for APIs or sells catalog chemicals for research use only.
  • Regulatory package: typical items include CoA, specification sheet, SDS, and batch traceability.
  • Impurities and control strategy: steroidal acetates often require control of related substances and solvent residues depending on the intended dosage form and route.

Product attributes to verify before placing volume orders

Use these checks to avoid scale-up failures and unexpected rework:

  • Assay range and impurity profile
  • Particle size / solid-state form (relevant to formulation and compression behavior)
  • Residual solvents (ICH Q3C alignment where applicable)
  • Water content and stability under storage conditions

How to translate supplier lists into actionable sourcing decisions

Tiering approach

  • Tier 1 (API-grade route): choose suppliers that explicitly sell estradiol acetate as an API product with GMP-backed documentation.
  • Tier 2 (process/R&D grade): use catalog chemical suppliers for screening, method development, and early scale trials, then qualify a GMP API source for clinical or commercial production.
  • Tier 3 (intermediate sourcing): consider upstream steroid intermediates only if the chemistry and impurity burden are controlled through validated conversion steps.

Commercial fit checks

  • MOQ and lead time: catalog suppliers often have short lead times, while GMP API manufacturers may require qualification and longer scheduling.
  • Batch consistency: steroid APIs can show differences in polymorphic form; request stability and form characterization where possible.

Supplier shortlists most likely to meet immediate purchasing needs

Fast procurement (catalog bulk)

  • MedChemExpress
  • TCI Chemicals
  • Cayman Chemical
  • Toronto Research Chemicals

Broader market coverage (distribution-style sourcing)

  • Global Calcium Laboratories

Key Takeaways

  • Estradiol acetate sourcing splits into API-grade suppliers and catalog bulk chemical suppliers; the latter dominate fast turnaround procurement.
  • A practical route is to start with catalog suppliers for R&D and then qualify an API-grade source for GMP-backed supply.
  • Before contracting, prioritize GMP status, impurity controls, residual solvents, and solid-state behavior; these drive formulation and regulatory outcomes.

FAQs

  1. Is estradiol acetate supplied under GMP by all catalog chemical suppliers?
    No. Many catalog suppliers sell for research or industrial use; GMP API manufacturing must be confirmed through explicit quality documentation.

  2. What documentation should be standard for estradiol acetate purchases?
    At minimum: CoA per lot, specification sheet, SDS, and lot/batch traceability.

  3. Do suppliers differ on impurity profiles for estradiol acetate?
    Yes. Steroid-related substances and process-byproducts vary by manufacturing route and solvent system.

  4. Who typically delivers the fastest lead times for estradiol acetate?
    Catalog chemical suppliers generally offer faster lead times than qualified GMP API supply chains.

  5. What factors most affect successful formulation of estradiol acetate?
    Assay/impurities, particle properties, and solid-state form, plus residual solvent control.


References

[1] MedChemExpress. Estradiol acetate product page.
[2] TCI Chemicals. Estradiol acetate product page.
[3] Cayman Chemical. Estradiol acetate product page.
[4] Toronto Research Chemicals (TRC). Estradiol acetate product page.
[5] Global Calcium Laboratories. Estradiol acetate product listing.

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