Suppliers and packagers for ESTRACE

ESTRACE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	ESTRACE	estradiol	CREAM;VAGINAL	086069	ANDA	Teva Pharmaceuticals USA, Inc.	0093-3541-43	1 TUBE, WITH APPLICATOR in 1 CARTON (0093-3541-43) / 42.5 g in 1 TUBE, WITH APPLICATOR	2018-01-02
Abbvie	ESTRACE	estradiol	CREAM;VAGINAL	086069	ANDA	Allergan, Inc.	0430-3754-14	36 CARTON in 1 CASE (0430-3754-14) / 1 TUBE, WITH APPLICATOR in 1 CARTON / 42.5 g in 1 TUBE, WITH APPLICATOR	2001-07-01
Abbvie	ESTRACE	estradiol	CREAM;VAGINAL	086069	ANDA	A-S Medication Solutions	50090-2321-0	1 TUBE in 1 CARTON (50090-2321-0) / 42.5 g in 1 TUBE	2001-07-01
Abbvie	ESTRACE	estradiol	CREAM;VAGINAL	086069	ANDA	A-S Medication Solutions	50090-3327-0	1 TUBE, WITH APPLICATOR in 1 CARTON (50090-3327-0) / 42.5 g in 1 TUBE, WITH APPLICATOR	2018-01-02

Estrace (estradiol) Suppliers: Who Manufactures Estrace Brands, Generics, and Key Finished-Dose Inputs

Last updated: May 28, 2026

Estrace is an estradiol product line marketed in the U.S. in tablet form (oral) and in vaginal cream form. Supply is split between the branded finished-dose manufacturer (label holder and NDA/ANDA manufacturing chain) and the broader generic supply base for estradiol tablets and estradiol vaginal creams.

Which companies supply Estrace (estradiol) finished dose products in the U.S.?

Answer: Estrace supplies in the U.S. depend on the specific dosage form (oral tablets vs vaginal cream). The branded product is sourced from the company listed as the NDA holder/manufacturer on the FDA label and related FDA submissions; generic supply is distributed across ANDA holders and contract manufacturers listed in ANDA labeling and FDA databases.

Key supply chain nodes to identify for Estrace:

• NDA holder and labeler for the branded drug (controls branded product release).
• Finished-dose manufacturer(s) for each dosage form on the label.
• NDA/ANDA supplement changes that shift manufacturing sites.
• Contract manufacturing organizations (CMOs) producing estradiol finished dose and packaging.

How can you map Estrace suppliers using FDA label and Orange Book data?

Answer: The fastest way to map suppliers is to extract (1) the NDA holder and (2) the manufacturing site listed on the current U.S. prescribing information, then validate the legal status and related product entries in the Orange Book.

What does the Orange Book show for estradiol products like Estrace?

• Product-level identification (active ingredient, dosage form, strength)
• NDA number
• Applicant/holder
• Patent and exclusivity records tied to the product listing

What does the prescribing information show?

• Drug label holder and contact
• Manufacturing site(s) for each dosage form
• Packaging and storage conditions

What manufacturers supply estradiol vaginal cream (Estrace cream) vs estradiol tablets?

Answer: Estradiol cream and estradiol tablets usually come from different finished-dose manufacturing lines and often different release sites, even when the same labeler markets both.

Estrace vaginal cream supply profile (practical checklist)

• Identify the labeler and finished-dose plant in the cream section of the prescribing information.
• Track any “manufactured for” statements and “manufacturing site” lines.
• Compare to generic cream ANDA label manufacturing statements to see alternate supply chains.

Estrace tablets supply profile (practical checklist)

• Identify the labeler and finished-dose plant for tablets in the tablet section.
• Confirm if tablets and cream share manufacturing sites or are produced separately.

Which companies supply generic estradiol tablets and estradiol vaginal creams?

Answer: Generic estradiol supply is broad, with multiple ANDA applicants competing across strengths and dosage forms. The specific list of suppliers is determined by the ANDA applicants and the manufacturing site named in each ANDA label.

Generic entry risk factors that shape supplier availability

• ANDA manufacturing site capacity (estradiol is potency-sensitive)
• Sterile vs non-sterile handling constraints (cream is generally non-sterile, but manufacturing control is still tightly regulated)
• Changes in excipients and scale-up batches tied to site transfers

What matters most when choosing a generic supplier

• Facility compliance history for hormonal APIs and finished-dose controls
• Ability to meet label specs (assay, uniformity, release)
• Packaging and distribution footprint for healthcare systems

What raw-material suppliers matter for estradiol-based finished doses?

Answer: Estradiol product supply depends on API availability plus finished-dose excipients and packaging components. The API supplier base includes estradiol producers and upstream intermediates producers used to make estradiol.

API and upstream inputs that constrain supply

• Estradiol API (potency and impurity spec control)
• Solvents used in API crystallization and wet granulation where relevant
• Excipients specific to vaginal creams (base/viscosity system) and tablet cores (binders, disintegrants, lubricants)
• Primary packaging (tube/closure systems for cream, blister/bottles for tablets)

Which excipient and packaging suppliers dominate Estrace cream vs Estrace tablets?

Answer: For creams, the limiting factors are typically excipient system control (viscosity and release properties) and tube/closure compatibility. For tablets, the limiting factors are direct compression and coating/handling inputs and blister or bottle packaging compliance.

Packaging constraints by dosage form

• Vaginal cream: tube materials, seals, and closure systems that maintain stability and dosing accuracy
• Tablets: blister lidding and foil integrity or bottle closure controls to prevent moisture uptake

How does FDA regulatory status affect supplier eligibility for estradiol products?

Answer: Estradiol products are generic-eligible through ANDAs and may be eligible for 505(b)(2) depending on labeling and formulation changes. Supplier eligibility is driven by current good manufacturing practice (cGMP) compliance and ANDA/NDA approval status for each dosage form and strength.

What to check in FDA listings

• ANDA applicant vs manufacturing site
• CMC supplements that move production
• If a supplier operates multiple strengths on one platform or has dedicated lines

What patent estate or exclusivity affects who can supply Estrace?

Answer: Patent and exclusivity status affects generic entry timing for each specific Estrace dosage form and strength. Estradiol products often have matured patent estates, so availability usually hinges on ANDA approval and manufacturing readiness rather than active barrier exclusivity.

How to interpret Orange Book timelines for estradiol

• Look for listed patents by dosage form/strength
• Check whether exclusivity has been logged for the relevant NDA

What Paragraph IV challenges or settlements impact estradiol supplier landscape?

Answer: Where present, Paragraph IV filings and settlements can delay generic supply for the specific NDA-listed patents. For older estradiol products, the supplier landscape is usually driven more by ANDA approvals and manufacturing transfers than fresh Paragraph IV actions, but the exact impact requires dosage-form-specific Orange Book and litigation checks.

Are biosimilars relevant to Estrace supply?

Answer: No. Estrace is a small-molecule estradiol product, not a biologic, so biosimilar pathways do not apply.

What generic launch scenarios exist for estradiol once approvals are in place?

Answer: Once an ANDA is approved for a given strength and dosage form, the supplier can launch subject to market readiness and supply chain capacity. Launch timing then depends on:

• Availability of inventory
• Distribution agreements with wholesalers
• Batch release timing after manufacturing runs

What are the commercial supply implications for procurement?

Answer: Procurement leverage in estradiol products comes from:

• Number of ANDA suppliers for the specific dosage form and strength
• Manufacturer qualification and ability to sustain supply
• Packaging compatibility with formulary requirements and purchasing contracts

Key takeaways

• Estrace supply splits by dosage form: tablet and vaginal cream have distinct finished-dose manufacturers and supply chains.
• The most actionable supplier map comes from the current FDA label manufacturing statements plus Orange Book product listing identifiers by strength/dosage form.
• Generic estradiol availability is typically broad; the limiting factor is usually qualified manufacturing capacity and label- and formulation-specific ANDA approval status, not biosimilars.
• Procurement and licensing decisions should anchor on the finished-dose manufacturing site(s) stated for each product, not only the applicant/labeler name.

FAQs

1. Which FDA databases identify the NDA holder and manufacturing site for Estrace?
2. Do estradiol vaginal cream and estradiol tablets share the same manufacturing plant?
3. How many ANDA applicants typically supply generic estradiol vaginal cream by strength?
4. What packaging components most affect stability for estradiol cream tubes and tablet blister packs?
5. How do cGMP manufacturing site transfers change estradiol supply continuity?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. U.S. Food and Drug Administration. Drugs@FDA. FDA.
3. U.S. Food and Drug Administration. Prescribing Information (label) for Estrace (estradiol). FDA access via label repository.