Suppliers and packagers for generic pharmaceutical drug: toremifene citrate

toremifene citrate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Kyowa Kirin	FARESTON	toremifene citrate	TABLET;ORAL	020497	NDA	Kyowa Kirin, Inc.	42747-327-30	30 TABLET in 1 BOTTLE (42747-327-30)	1997-06-30
Kyowa Kirin	FARESTON	toremifene citrate	TABLET;ORAL	020497	NDA	Kyowa Kirin, Inc.	42747-327-72	7 TABLET in 1 BLISTER PACK (42747-327-72)	1997-06-30
Msn	TOREMIFENE CITRATE	toremifene citrate	TABLET;ORAL	212818	ANDA	Novadoz Pharmaceuticals LLC	72205-050-30	30 TABLET in 1 BOTTLE (72205-050-30)	2020-09-02
Rising	TOREMIFENE CITRATE	toremifene citrate	TABLET;ORAL	208813	ANDA	Rising Pharma Holdings, Inc.	64980-404-03	30 TABLET in 1 BOTTLE, PLASTIC (64980-404-03)	2019-01-18

Suppliers and packagers for generic pharmaceutical drug: toremifene citrate

Last updated: May 27, 2026

Toremifene Citrate Suppliers: What Companies Supply the Active Ingredient, Intermediates, and Finished Dosage Forms?

Toremifene citrate supply chains split into (1) active pharmaceutical ingredient (API) manufacturers and (2) finished-dosage drug product (tablets/capsules) and contract manufacturing. For each, the practical supplier set is constrained by regulatory filings (FDA drug submissions and listed DMFs), audited manufacturing capacity (GMP), and IP status for branded and generic presentations.

Who supplies toremifene citrate API (active pharmaceutical ingredient)?

The API supplier landscape for toremifene citrate is defined by companies that hold Drug Master Files (DMFs) and/or support FDA ANDA filings, plus specialty manufacturers supplying to branded and generic producers. In practice, most market supply comes from a small number of firms that maintain consistent control of polymorph and impurity profiles and can support regulatory submissions.

What are the common supplier categories for toremifene citrate?

1. API manufacturers with DMFs: Companies supplying drug substance used in FDA-marketed products and ANDA submissions.
2. Intermediate manufacturers: Firms producing key chemical intermediates under GMP that are then converted to API by API specialists.
3. CDMO/API packagers: Manufacturers that mill, blend, dry, or package API into supplier-ready configurations.
4. Finished-dose manufacturers: Contract manufacturers producing tablets or capsules under cGMP using supplied API.

How do API suppliers typically differentiate?

• Impurity control strategy (regulatory relevant impurities).
• Salt form and crystallization process consistency (toremifene citrate is the marketed salt form).
• Analytical method packages supporting DMF updates (stability and impurity method validation).

Supplier qualification signals buyers track

• Whether the API is supported by an FDA-listed DMF.
• History of regulatory approvals with the same supplier.
• Ability to provide CoA, impurity profile, residual solvents, and stability data consistent with the intended ANDA/505(b)(2) pathway.

Which companies supply toremifene citrate tablets or finished dosage forms?

Finished-dose suppliers are identified by the NDA/ANDA holder’s manufacturing footprint and contract manufacturing relationships for tablet/capsule production, packaging, and labeling. Finished-dose manufacturing typically sits with one or more domestic (US-market) packagers or international CDMOs.

What inputs determine finished-dose supplier selection?

• Tablet strength and dosage form specification (for toremifene, marketed strengths depend on the specific product label).
• Brand or generic submission requirements (bioequivalence expectations, dissolution profile).
• Packaging configurations (bottles/blisters) and label-control systems.

What is the procurement reality for drug product buyers?

Most commercial drug product supply comes through:

• The NDA/ANDA sponsor’s listed facilities and contractors; or
• Contract manufacturers that already support ANDA or 505(b)(2) dossiers for the same formulation strength.

How do FDA filings identify toremifene citrate suppliers (DMF and label manufacturers)?

For high-confidence supplier mapping, procurement teams align three regulatory layers:

1. API layer (DMF references): DMFs list the manufacturer of the drug substance process.
2. Drug product layer (NDA/ANDA site listings): Application submissions list the manufacturing and packaging sites for drug product.
3. Orange Book and application linkage: Confirms which product strengths are marketed and which applications underpin them.

What to extract from FDA records

• DMF holder name(s) and DMF numbers tied to the API manufacturer(s).
• ANDA sponsor and listed manufacturing/packaging facilities.
• Strength, dosage form, and (where applicable) supplier-specific changes or supplements.

What generic toremifene citrate products exist, and which suppliers typically manufacture them?

Generic entry affects supplier diversity. Where multiple ANDAs exist for the same dosage strength, it usually increases the number of API manufacturers used across ANDA sponsors. Procurement leverage increases when:

• Multiple ANDA sponsors source from different DMF-holding API suppliers, and
• Drug product manufacturing is not exclusively tied to a single contract manufacturer.

Procurement implication

If an ANDA sponsor changes API supplier or manufacturing site post-approval, procurement should track:

• Site transfer documentation (prior approval supplements where required).
• Stability commitments after process transfers.
• Update cadence for DMF and regulatory correspondence.

When does toremifene citrate lose exclusivity for suppliers to enter (generic/ANDA timing)?

Exclusivity timing determines whether new suppliers can realistically be qualified into commercial supply for the US market. The operational answer is driven by:

• Patent expiry for branded compositions and method-of-use claims,
• Regulatory exclusivities (where applicable), and
• Whether ANDA approvals have already been granted for the marketed strength(s).

What supplier decisions depend on exclusivity

• Whether buyers will qualify additional API sources during the exclusivity window.
• Whether developers can pursue Paragraph IV strategies or only rely on Paragraph III/IV timing and settlement posture.

What patents protect toremifene citrate products, and how does that affect supplier access?

Patent landscape determines licensing constraints for suppliers through:

• “Use” and formulation patents (composition claims, salt/process claims),
• Method-of-use claims for approved indications, and
• Potential enforcement relating to the generic’s proposed labeling.

Supplier impact channels

• API manufacturers may be constrained if the claimed process or composition is enforced and the supplier’s process cannot be designed around.
• Finished-dose manufacturers may face constraints if the labeling or method-of-use triggers injunction risk.

How strong is the patent estate for toremifene citrate, and which risks block generic supply?

For procurement and licensing, “strength” is not academic. It translates to:

• Likelihood of injunction or non-approval,
• Expected settlement ranges, and
• The probability that ANDA launches proceed on the first possible date.

Risk areas typically seen in toremifene generics

• Method-of-use label restrictions that must be carved out to avoid infringement.
• Formulation or process changes needed to meet safety and quality, while staying non-infringing.

What Paragraph IV challenges exist for toremifene citrate, and which companies are challenging?

Paragraph IV challenges drive launch timing, settlement outcomes, and supplier qualification windows. For a procurement-grade answer, the dataset must include:

• Challenging ANDA applicants,
• Filed strengths and submission dates,
• Litigation docket outcomes,
• Settlement agreements.

Without the full set of FDA/Orange Book entries and court records for toremifene citrate, providing an exact list of Paragraph IV filers and dates would be incomplete.

What does the Orange Book show for toremifene citrate (listing status that maps to suppliers)?

The Orange Book indicates:

• Which patents are listed for which product(s),
• Whether those patents are active and expiring,
• Which application (NDA/ANDA) is tied to marketed supply.

Supplier mapping depends on the Orange Book’s link between:

• Product application holders, and
• Listed patents that define exclusivity and litigation exposure.

Without the specific Orange Book listings for each toremifene citrate strength and applicant, any supplier list would be structurally unreliable.

How does toremifene citrate supplier coverage compare with competing SERMs (e.g., tamoxifen, raloxifene)?

Supplier coverage tends to be broader for older SERMs with multiple established generics and more ANDA launches. For toremifene citrate, supplier diversity depends on:

• Number of generic approvals,
• Whether US-market supply is dominated by one or two sponsors,
• Whether API supply is concentrated among a few DMF-holding manufacturers.

Procurement strategy for toremifene citrate typically mirrors SERM procurement:

• Qualify at least one backup API supplier,
• Keep a formulation and dissolution acceptance plan if switching drug product manufacturers, and
• Ensure impurity profile comparability if switching DMF-backed API sources.

What manufacturing/IP barriers constrain toremifene citrate suppliers?

Barriers that limit supplier entrance:

• Salt form control and crystallization reproducibility.
• Impurity control that must match regulatory specifications.
• Audit readiness: cGMP systems, validation packages, and batch record discipline.
• Patent-driven process design constraints if supplier synthesis overlaps with protected processes.

Contract manufacturing bottlenecks

• Compression capability for tablet strengths.
• Controlled-release or specific excipient systems if used in the marketed formulation.
• Packaging line qualification (labeling controls).

Key Takeaways

• Toremifene citrate supply is constrained by API DMF-backed manufacturing and finished-dose cGMP/packaging capacity.
• Supplier mapping that supports commercial procurement must be tied to FDA DMF holders and NDA/ANDA manufacturing site listings, which in turn track Orange Book patent status and exclusivity.
• Patent and Paragraph IV dynamics affect when additional suppliers can be qualified into commercial supply without launch interruption risk.

FAQs

1. How do I identify the toremifene citrate API DMF holder responsible for US supply?
2. Which drug product manufacturing sites produce toremifene citrate tablets for specific NDA/ANDA applications?
3. What Orange Book patents for toremifene citrate most directly affect generic launch timing?
4. What technical comparability tests (impurities, dissolution, stability) matter when switching toremifene citrate API suppliers?
5. How do Paragraph IV litigation outcomes influence supplier qualification and contract awards for toremifene citrate?

References (APA)

No sources were provided in the prompt, and no FDA/Orange Book or court record identifiers for toremifene citrate were included; therefore, citations cannot be generated without fabricating records.