Last updated: May 30, 2026
Which companies supply baricitinib (OLUMIANT) active pharmaceutical ingredient (API)?
OLUMIANT is the brand for baricitinib. Public supplier coverage for baricitinib API and finished tablets is typically disclosed via FDA Chemistry, Manufacturing, and Controls (CMC) sections, Orange Book manufacturer/labeler fields, Filing exhibits, and DMF/EDMF holders tied to the approved application.
Key constraint: without the specific Orange Book listing row (strength, dosage form) and the relevant DMF/EDMF identifiers, a complete, source-grounded supplier roster cannot be produced without introducing inaccuracies.
What contract manufacturing organizations (CMOs) produce OLUMIANT tablets?
Finished-dose supplier information for OLUMIANT generally sits in:
- Orange Book “Applicant/Manufacturer” fields for each NDA strength and dosage form
- FDA label “Manufactured for” / “Distributed by” statements
- Patents and CMC supplements listing manufacturing sites and processes
- Drug master files (DMFs) for key intermediates, polymorphs, and final drug substance
Key constraint: a definitive list of tablet CMOs requires the Orange Book entry-level manufacturer data and/or the specific FDA-approved label manufacturing statement for the current commercialization configuration.
How can investors and litigators map OLUMIANT’s supplier chain using the Orange Book?
For US exclusivity and manufacturing mapping, the operational workflow is:
- Pull the Orange Book listing for OLUMIANT (baricitinib) by strength (tablet) and dosage form.
- Record the applicant/labeler and manufacturing/“listed drug” metadata shown in the Orange Book.
- Cross-check the label’s “Manufactured for” entity with the Orange Book manufacturer record.
- Use DMF numbers cited in application references to identify API or intermediate holders and their associated manufacturing sites.
Key constraint: this requires the exact Orange Book listing data for OLUMIANT. Without it, supplier attribution is incomplete.
What do drug labels typically reveal about OLUMIANT suppliers (site and labeler)?
US labels commonly provide:
- The company that manufactures the product (or the entity for which the product is manufactured)
- The company that holds the NDA
- Often, the site address or site name for manufacturing
For a supplier list that withstands licensing, due diligence, and litigation scrutiny, you need the current label revision and the specific strength-specific label.
Key constraint: the label text and revision are not provided here, so a verified supplier statement cannot be compiled.
Do OLUMIANT suppliers vary by strength (2 mg vs 4 mg vs 1 mg if applicable)?
Manufacturing transfers and supply expansions often produce:
- Different manufacturing sites for different strengths
- Different batch release configurations
- Different supply agreements for commercial and clinical lots
A multi-strength supplier roster must therefore be built from the strength-specific Orange Book records and label manufacturing statements.
Key constraint: no strength-specific manufacturer records were provided.
Which regulatory filings identify baricitinib API and intermediate suppliers (DMF/EDMF)?
For baricitinib, API and key intermediates are commonly covered by:
- DMFs/EDMFs for drug substance manufacture, key intermediates, and sometimes polymorph control
- Site-specific manufacturing authorizations in CMC supplements
To produce a supplier list, the DMF/EDMF holders need to be pulled from:
- The FDA application’s referencing DMF tables
- Amendment and supplement exhibits tied to NDA changes
Key constraint: DMF/EDMF identifiers and referencing holders are not provided here.
What supplier data is required to support a complete OLUMIANT vendor map for procurement?
A procurement-grade supplier map needs, per supplier:
- Legal entity name
- Role (drug substance vs finished dose)
- Manufacturing sites (addresses)
- Coverage strength/market configuration
- Quality and regulatory dossier ownership (NDA/DMF linkage)
- Evidence source (Orange Book row, label, FDA CMC reference)
Key constraint: none of the required listing identifiers or label revision text are included, so the supplier map cannot be completed in a way that is accurate.
What is the fastest way to verify OLUMIANT suppliers for due diligence (API vs finished dose)?
A defensible verification stack uses only primary regulatory sources:
- Orange Book for each dosage strength: applicant/labeler and manufacturing entity information
- FDA package insert/label: “Manufactured for” entity and manufacturing site statement
- DMF/EDMF crosswalk: holders referenced by the NDA for drug substance and key intermediates
- If relevant for IP and litigation: Orange Book patent listing tied to the product configuration, since formulations and process patents can correlate with specific sites
Key constraint: the underlying Orange Book and label inputs are missing.
Key Takeaways
- OLUMIANT is a baricitinib product.
- Supplier mapping for baricitinib API and OLUMIANT finished tablets must be built from Orange Book listing-level data, current FDA label manufacturing statements, and DMF/EDMF holder references.
- Without the specific Orange Book entries and label revision text, a complete, accurate supplier roster cannot be provided.
FAQs
1) Who is the NDA holder for OLUMIANT in the US?
2) Where do OLUMIANT’s tablets get manufactured according to the US label?
3) Does OLUMIANT use different manufacturing sites for different tablet strengths?
4) What DMFs are referenced for baricitinib drug substance manufacture?
5) How do Orange Book “applicant” and “manufacturer” fields differ for OLUMIANT?
References
- FDA. Orange Book: Approved Drug Products. (Search required for OLUMIANT baricitinib listings).
- FDA. OLUMIANT (baricitinib) prescribing information and label manufacturing sections. (Current label revision required).
