Suppliers and packagers for FEMARA

FEMARA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Novartis Pharms	FEMARA	letrozole	TABLET;ORAL	020726	NDA	Novartis Pharmaceuticals Corporation	0078-0249-15	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0078-0249-15)	1997-07-31

Suppliers for Femara (letrozole): API Manufacturers, Contract Manufacturing, and Key Upstream Sources

Last updated: May 26, 2026

Femara is letrozole (aromatase inhibitor) used in breast cancer. Upstream “suppliers” for letrozole typically break into three supply nodes: (1) letrozole API producers, (2) finished-dose manufacturers (tablets), and (3) excipient and packaging suppliers tied to specific global sites. Public detail on site-level sourcing is limited in the way patent and Orange Book records are detailed, so the actionable way to map suppliers is through regulatory listings (FDA Orange Book for finished products), ANDA/505(b)(2) submissions, and procurement footprints disclosed in regulatory databases and labels.

What regulatory records show about Femara suppliers?

Orange Book status, listing, and NDA holder are the most reliable public starting points for identifying which companies market specific Femara dosage forms in the US and, indirectly, which manufacturing sites are used for labeled products.

What companies supply Femara (letrozole) tablets in the US?

Featured snippet answer: Femara is marketed in the US under NDA status by the branded holder; generic letrozole tablets are marketed by multiple ANDA sponsors. The FDA Orange Book identifies the NDA/ANDA sponsor(s) and the specific product strengths and dosage forms available.

Who is the branded manufacturer/labeler for Femara?

• Femara (letrozole) is the branded product associated with Novartis for the US market. (Femara is a Novartis product line; the label and Orange Book entries identify the US applicant/holder.)
• The supplier of the dosage form for the branded product is the labeler/manufacturer designated on the FDA listing.

Which ANDA sponsors supply generic letrozole tablets (US)?

Generic letrozole is widely available. In the US, ANDA sponsors and their listed manufacturers appear in the FDA Orange Book “Applicant” and “Manufacturer” fields for each strength.

Practical supplier list (supply-side mapping):

• Use Orange Book “Drug Product” and “Applicant” to pull sponsor names by strength (2.5 mg is the standard tablet strength).
• Use Orange Book “Manufacturer” to identify listed manufacturing sites for each sponsor’s product.

What patents govern Femara supply chains and do they point to supplier networks?

Femara’s patent landscape is most relevant to competition timing and generic entry risk. It does not, by itself, disclose API or tablet manufacturing source contracts. Still, patent assignee records can correlate with specific corporate groups active in development and manufacturing.

How does letrozole patent estate affect supplier entry?

• If branded composition of matter patents have expired, generic API and finished-dose suppliers can enter without patent licensing, assuming regulatory and manufacturing compliance.
• If method-of-use or formulation patents remain, suppliers must avoid infringing claims or secure licenses (rare for classic letrozole, where the market has long matured).

Who supplies letrozole API (active pharmaceutical ingredient)?

Featured snippet answer: Multiple global API producers supply letrozole to downstream finished-dose manufacturers. API sourcing is not typically disclosed in US labels, and supplier lists require triangulation from ANDA chemistry/manufacturing information, DMFs, and inspection histories.

Typical upstream footprint for letrozole API

Letrozole API manufacturers commonly appear in:

• DMF holders listed in FDA databases (where publicly accessible through references in filings)
• ANDA application “API manufacturer” fields in submission references
• Importer of record and lot sourcing signals from recalls or inspection lists

What to use to build a defensible API supplier map

• Cross-reference: Orange Book ANDA applicant → corresponding ANDA → API DMF references
• Cross-check: branded and generic product manufacturing sites and their API supplier disclosures in non-confidential parts of filings

Which finished-dose manufacturers make Femara tablets?

Featured snippet answer: The branded finished product and each generic product strength have “manufacturer” entries in the Orange Book. Those manufacturer entries point to specific tablet manufacturing sites for US distribution.

Dosage form specifics

• Femara tablet: typically 2.5 mg, film-coated tablets (US standard).
• Finished-dose manufacturing is site-specific; companies often outsource manufacturing to contract development and manufacturing organizations (CDMOs) even when they are the labeled holder.

What contract manufacturing suppliers produce letrozole for branded and generic markets?

Featured snippet answer: The CDMO landscape for oral solid dose (OSD) includes firms that manufacture tablets for multiple ANDA sponsors, so supplier identification requires mapping each company’s Orange Book “manufacturer” site and then linking that site to known CDMO capabilities and inspection records.

How supplier mapping works in practice for OSD

• A generic sponsor may contract with a tablet manufacturer that is listed as the “manufacturer” in Orange Book.
• That site may buy API from one of several API producers under GMP supply agreements.

When do Femara exclusivity and generic entry timelines drive supplier availability?

Femara has long passed primary US composition-of-matter exclusivity for standard letrozole tablets, so supply availability is mostly determined by ongoing regulatory approvals and whether any remaining formulation or method-of-use patents affect specific product variants.

What does “loses exclusivity” mean for supplier diversification?

• Once regulatory exclusivity and patent barriers expire (or are cleared), more ANDA sponsors file and more manufacturing sites become eligible.
• Supplier diversity increases at the tablet level first (new ANDA sites), then at the API level (additional API suppliers qualify).

What Paragraph IV challenges affect letrozole tablet suppliers?

Paragraph IV litigation affects which generic entrant gets first-to-market incentives. That changes market share among generic suppliers but usually does not remove the ability of other suppliers to sell after successful clearance or settlement.

How to identify Paragraph IV-driven supplier shifts

• Pull court filings for letrozole ANDA challenges (from USPTO/RECAP and PACER-linked dockets)
• Tie the ANDA sponsor to the marketed generic labeler and manufacturing site in Orange Book

What is the Orange Book status of Femara?

Featured snippet answer: The Orange Book listing for Femara identifies the NDA and patent/ exclusivity status by listed patents and exclusivity codes. For supply planning, the actionable part is which patents (if any) remain listed and their expiration dates.

What to look for on the Femara Orange Book listing

• NDA number
• Dosage form and strength
• Listed patents (with expiration dates)
• Exclusivity codes (if present)
• Applicant/holder and manufacturer

How do biosimilar risks apply to Femara suppliers?

Letrozole is a small molecule. Biosimilar frameworks apply to biologics, not to Femara’s chemistry-based oral solid drug product.

Does Femara have biosimilar competition?

• No. The competition framework is ANDA generics and authorized generics, not biosimilars.

Which jurisdictions have the biggest letrozole supplier footprint?

Featured snippet answer: Generic letrozole is globally commoditized. The largest supplier footprint typically sits across:

• India
• China
• EU-based manufacturers
• US-labeled generic sponsors

Supply chain compliance and inspection outcomes determine which sites qualify in regulated markets.

Where procurement usually concentrates

• India and China for API and tablet intermediate supply
• EU and US for marketing, packaging, and distribution under local regulatory requirements

What generic entry risks exist for new letrozole tablet suppliers?

For a mature molecule, the main risks are regulatory and manufacturing execution:

• Batch failure risk for OSD
• Stability/impurity profile non-conformity
• Binding patent claims for specific product variants (less common for plain 2.5 mg tablets)

How to reduce procurement and litigation exposure

• Select an ANDA-manufacturer site with an established inspection record
• Ensure API is sourced from qualified suppliers with compliant DMFs/references

Key Takeaways

• Femara is letrozole, a mature small-molecule breast cancer therapy. The branded labeler is associated with Novartis, while US market supply also includes many ANDA generic sponsors.
• Defensible supplier identification for Femara and letrozole tablets is done via FDA Orange Book listings (applicant and manufacturer fields) and then linked to ANDA/DMF references for API suppliers.
• Paragraph IV and patent listings mostly influence market share and first-generic timing rather than eliminating supply, given the long-established nature of letrozole.
• Biosimilar risk does not apply to Femara; competition is generic/ANDA-based.

FAQs

1) Which companies list as the manufacturer for generic letrozole tablets in the FDA Orange Book?
Orange Book “Drug Product” entries for letrozole 2.5 mg list the labeled manufacturer sites by ANDA sponsor.

2) Are there different letrozole tablet strengths that change supplier mapping?
Yes. Supplier mapping can differ by strength and dosage form, so Orange Book must be pulled by strength and form.

3) How can I identify letrozole API suppliers used in ANDAs?
By mapping an ANDA sponsor to referenced DMFs and the CMC sections that identify API manufacturing sources.

4) What filings reveal contract manufacturing sites for oral solid dose letrozole?
Orange Book “Manufacturer” fields and ANDA manufacturing site references are the primary public indicators.

5) Do patent listings for Femara still constrain generic manufacturers?
Check the Orange Book for any still-listed patents for the relevant NDA/dosage form and compare expiration dates to the generic’s filing and launch status.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Femara/letrozole listings). U.S. Food and Drug Administration.
2. FDA. Drug Approval Reports and related regulatory records for letrozole-containing products. U.S. Food and Drug Administration.