Suppliers and packagers for MYFEMBREE

MYFEMBREE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sumitomo Pharma Am	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846	NDA	Sumitomo Pharma America, Inc	72974-415-01	28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-01)	2021-05-26
Sumitomo Pharma Am	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846	NDA	Sumitomo Pharma America, Inc	72974-415-99	7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-99)	2021-05-26

MYFEMBREE (norethindrone acetate 1 mg/relugolix 40 mg/estradiol 1 mg) suppliers: who makes the active ingredients and finished drug?

Last updated: May 26, 2026

Who supplies the APIs for MYFEMBREE (relugolix, estradiol, norethindrone acetate)?

Answer (from publicly available drugmaster/registration and FDA listing records): MYFEMBREE’s supply chain is anchored by licensing/manufacturing commitments from Myovant’s US commercial operations and its manufacturing partners for final dosage form, while the APIs are sourced through qualified global suppliers tied to the product’s chemistry, manufacturing and controls (CMC) package and FDA-approved site listings. Public FDA labeling typically does not disclose named API vendors at the level needed to identify specific “API supplier” companies for relugolix, estradiol, or norethindrone acetate.

What is reliably identifiable from FDA product record artifacts (high-intent takeaway):

• Finished-dose suppliers: identified by FDA label “Manufactured for” and/or “Manufactured by” and the drug product manufacturing site listings tied to the NDA.
• API suppliers: usually not listed by vendor name in FDA public-facing labeling; vendor details generally sit in DMFs and CMC submissions and are not consistently exposed in the public record.
• Distribution logistics: US distribution is commonly handled by the NDA holder’s commercial network, with wholesalers and specialty distributors supporting fulfillment.

Actionable path used in licensing and procurement workstreams: treat API vendor identification as a DMF/CMC site-by-site exercise tied to the NDA’s listed manufacturing sites and any DMF cross-references in the eCTD. That is how procurement teams determine qualified supplier lists for relugolix-containing combination products.

Who manufactures MYFEMBREE in the US and what are the labeled manufacturing sites?

Answer: The NDA holder’s label is the controlling public reference for finished-goods manufacturing. For MYFEMBREE, the manufacturing site(s) shown on the FDA-approved US prescribing information identify the party responsible for producing the marketed tablet/film strength combination and packaging.

What to extract for supplier due diligence (procurement checklist):

• Label line “Manufactured for” (commercial brand owner).
• Label line “Manufactured by” (finished-dose site operator).
• Any listed packager site if different from the manufacturer.
• Strength-specific manufacturing notes if the product has multiple SKU configurations (typical for combination hormonal regimens).

What does the FDA label list for manufacturers, and how is that used to map suppliers?

Answer: FDA labeling is used to map two layers:

1. Drug product manufacturer(s): the site operator name and address on the label.
2. NDA holder and contact: the company responsible for regulatory compliance and post-approval changes.

Commercial implication: if you are qualifying a second-source manufacturer for supply continuity, you validate:

• the site approval status (inspection history and process capability),
• whether that site is already used in the NDA lifecycle for scale-up batches,
• and whether the commercial label’s manufacturing sites include alternates or only one primary line.

Is MYFEMBREE supplied as a single API combination or separate inputs at manufacturing?

Answer: MYFEMBREE is a fixed-dose combination (relugolix with estradiol and norethindrone acetate), made through a combination drug product manufacturing process. In procurement terms:

• the manufacturer receives qualified APIs (relugolix, estradiol, norethindrone acetate),
• then performs formulation, blending, granulation/pressing or tableting, coating where applicable, and packaging under GMP at the approved site(s).

Supply-risk implication: capacity constraints for combination hormonal products often track the bottleneck API and the tablet process at the drug product site, not the packaging step.

Which companies are associated with MYFEMBREE (NDA holder) and finished product supply?

Answer: MYFEMBREE’s commercial/regulatory sponsor is Myovant Sciences. The finished product is supplied through GMP drug product manufacturers and packagers shown on labeling and in FDA establishment listings. Public sources may show the NDA holder, but they do not consistently name each API vendor for the three actives.

How do manufacturers qualify for MYFEMBREE supply under GMP and NDA controls?

Answer: The manufacturer must be:

• approved for the drug product manufacturing steps in the NDA,
• able to meet validated process parameters and control strategy for the combination regimen,
• and compliant with post-approval changes (CMC supplements, annual reports, and comparability studies where relevant).

Operational detail that matters to buyers: for a combination hormonal product, comparability expectations are typically strict on:

• dissolution and content uniformity,
• segregation control for multi-component blends,
• and stability under the registered storage conditions.

What supplier risks exist for MYFEMBREE (relugolix-based combination) from a procurement and continuity standpoint?

Answer: The most material risks for relugolix-containing products are:

• API sourcing concentration (relugolix supply can be less globally commoditized than estradiol/norethindrone acetate),
• tablet manufacturing line availability for fixed-dose multi-active products,
• and regulatory change burden if an alternate site is added (CMC comparability package, stability lots, and supplement timing).

Continuity best practice: qualify alternates at the finished-dose site first, then validate API supply continuity through long-term quality agreements and incoming testing.

What is the competitive landscape for MYFEMBREE suppliers and how does it affect availability?

Answer: Competitively, the supplier landscape is driven by:

• whether the NDA uses one primary manufacturing site or multiple,
• whether there are established alternates for commercial scale,
• and whether API production for relugolix is available across multiple qualified suppliers.

If the product is made on a limited set of drug product lines, availability shocks tend to originate in that constraint.

What supplier information is available through FDA databases (Orange Book, label, and establishment listings) for MYFEMBREE?

Answer: For supplier identification, the practical publicly accessible dataset sequence is:

1. FDA label (Prescribing Information): manufacturer and packager names.
2. FDA drug establishment registration and listing: identifies registered sites for drug products.
3. NDA administrative and product details: confirms the sponsor and manufacturing relationships that sit behind the label.
4. Orange Book: generally focuses on patents/exclusivity, not supplier lists. (It is relevant for timing, not procurement.)

How does supplier mapping connect to generic or biosimilar risk for MYFEMBREE?

Answer: MYFEMBREE is a small-molecule fixed-dose oral combination. Supplier mapping affects generic risk in two ways:

• The CMC burden for generics depends on the feasibility of sourcing relugolix and matching the formulation performance.
• If relugolix is sourced from a limited number of qualified upstream vendors, the earliest generic entrants can face supply qualification delays even with a submission in hand.

Key Takeaways

• NDA holder: MYFEMBREE is sponsored by Myovant Sciences.
• Finished drug manufacturers: the FDA label identifies the finished-dose manufacturers/packagers; this is the primary reliable public route to name the supply parties.
• API vendor names: the public FDA-facing record does not consistently identify specific API suppliers for relugolix, estradiol, and norethindrone acetate.
• Procurement risk: combination hormonal products can be constrained by relugolix upstream concentration and tablet manufacturing line availability, not by packaging alone.
• Due diligence approach: map supplier sites from label + FDA establishment listings, then confirm API sources via DMF/CMC cross-references tied to the NDA.

FAQs

1) Does the MYFEMBREE label name the contract manufacturer and packager?
Yes, the FDA-approved label typically lists “manufactured by” and/or “packaged by” parties; those are the most reliable public supplier names.

2) Are relugolix API suppliers publicly listed for MYFEMBREE?
Not consistently in public FDA labeling. API vendor identification usually requires DMF/CMC linkage analysis rather than label review.

3) How can I identify alternate manufacturing sites for MYFEMBREE?
Use FDA establishment listings and corroborate against the label’s manufacturer/packager statements and any NDA supplements that change manufacturing.

4) What parts of MYFEMBREE’s supply chain most affect availability?
API upstream for relugolix and capacity at the approved finished-dose tablet site are usually the main constraints.

5) How does supplier readiness affect generic entry timing for MYFEMBREE?
Even when regulatory pathways are pursued, generic timelines can slip if API supply qualification and formulation performance demonstrations lag.

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References (APA)

1. U.S. Food and Drug Administration. Prescribing Information for MYFEMBREE (relugolix combination hormonal regimen). FDA label document.
2. U.S. Food and Drug Administration. Drug Establishment Registration and Listing (DERL) for MYFEMBREE drug product manufacturing/packaging sites.