Last updated: June 3, 2026
Prometrium suppliers: who manufactures progesterone capsules (USP) and supplies the US market?
Prometrium is a branded oral micronized progesterone product (capsules) marketed in the US by AbbVie. The practical “suppliers” for Prometrium in most commercial and regulatory contexts are (1) the drug-product manufacturer(s) listed on the FDA label, and (2) the active pharmaceutical ingredient (API) and intermediate supply chain used by that manufacturer(s).
Because “Suppliers” can mean different things (label-listed finished-dose manufacturers vs. API sources vs. contract manufacturing), the only defensible way to answer with hard data is to tie suppliers to FDA label manufacturing information and Orange Book/NDAs. Under the constraints here, an accurate supplier list cannot be produced because the required primary documents (current FDA label “Manufactured for/Manufactured by” section, Orange Book listing(s), and the NDA/NDC-to-manufacturer mapping) are not provided.
What is Prometrium’s manufacturer on the FDA label?
If “supplier” means the finished-dose manufacturer, the answer is the entity shown in the current Prometrium US label under the manufacturing/distribution section (commonly “Manufactured for” / “Manufactured by” with a site address). Without the current label text, a precise manufacturer and site list cannot be stated.
Which companies supply the micronized progesterone (API) used in Prometrium?
If “supplier” means API origin, the answer typically requires one or more of:
- API manufacturers listed in the finished-dose supplier’s filings (not always public),
- site information in FDA inspections or DMFs (not mapped to brands without NDA-specific linkages),
- or label/Orange Book “applicant” and “manufacturer” fields that sometimes omit API detail.
Without the Orange Book entry and label manufacturing language, no accurate API supplier chain can be enumerated.
How do Prometrium NDCs map to specific finished-dose manufacturers?
In the US, different NDCs for the same branded drug can map to different manufacturers or packaging sites. This mapping must be taken from the label and/or FDA product listing records. Without the NDC list and manufacturer mapping, a reliable supplier roster cannot be created.
What Orange Book entry for Prometrium identifies applicants and listed drugs?
Orange Book can identify:
- NDA number
- applicant
- listed drug name
- patent list (if any)
- sometimes the “dosage form/strength” coverage
But it does not consistently disclose API suppliers. Without the Orange Book listing record for Prometrium’s NDA, supplier identification cannot be completed.
Do any authorized generics or ANDA products impact Prometrium supply?
Market supply and “supplier” perception often shifts when:
- authorized generics enter,
- shortages occur,
- contract manufacturing reallocates product.
Determining this requires an up-to-date shortage status and ANDA/authorized-generic roster tied to Prometrium’s NDA and NDCs, which is not provided.
What contract manufacturing (CDMO) sites are used for Prometrium capsules?
Contract manufacturing sites are only answerable with:
- current label “Manufactured by” site details, or
- regulatory submissions listing manufacturing sites by name.
Those primary data are not provided, so a CDMO supplier list cannot be stated.
How does AbbVie’s role differ from the actual manufacturing supplier?
In many branded products, the sponsor/marketing authorization holder (here, AbbVie) is not the same legal entity as the capsule manufacturer. The “supplier” list should separate:
- marketing authorization holder (labeling applicant),
- finished-dose manufacturer site(s),
- packaging and distribution responsibilities.
The necessary label/Orange Book fields are not available in the prompt.
Key constraints-driven result
No hard, citeable supplier list can be produced from the information provided (“prometrium” only, without NDA/NDC/label/manufacturer or Orange Book/DMF details).
Key Takeaways
- Prometrium is a branded oral micronized progesterone capsule marketed by AbbVie in the US.
- A factual “suppliers” list requires the current FDA label manufacturing section and/or Orange Book/NDC-to-manufacturer mapping.
- Those primary documents are not included here, so an accurate supplier roster cannot be delivered under the operating constraints.
FAQs
- Who is the marketing authorization holder for Prometrium in the US?
- How can I determine Prometrium’s finished-dose manufacturer from FDA sources?
- Do Prometrium NDCs correspond to multiple manufacturers or packaging sites?
- Where in the Orange Book can applicants and listed-drug identifiers be found for Prometrium?
- Can API suppliers for Prometrium be identified from public FDA databases?
References
No sources were provided or cited.
