Last updated: June 6, 2026
CREXONT (dexlansoprazole) Suppliers, Manufacturing Partners, and Upstream Component Sources
CREXONT is a branded pharmaceutical with upstream supply controlled through a mix of contract manufacturing, API sourcing, and packaging/labeling vendors. The supplier map is driven by (1) the approved FDA marketing route, (2) the listed manufactures on the FDA label and Orange Book entries, and (3) the current Good Manufacturing Practice supply chain for the finished dosage form and any required components.
Direct supplier identification requires Orange Book/label-level manufacturer listings and FDA database mappings. Without those source-specific listings for CREXONT, a complete and accurate supplier roster cannot be produced.
Who supplies CREXONT finished drug products and who manufactures it?
Answer (required for accuracy): The identities of the CREXONT finished-dose manufacturers are determined by the product’s FDA listing (Orange Book and label “Manufactured for / Distributed by” sections).
What to look for on FDA labels
- “Manufactured for” (marketing authorization holder) and “Manufactured by” (site and company)
- NDC labeler/manufacturer fields
- Any “Packaged by” line when packaging is separated from drug substance manufacturing
Where Orange Book lists the supplier
Orange Book entries typically list:
- Drug substance (active ingredient) and manufacturer
- Drug product (finished dosage form) and manufacturer
- Patent coverage that can constrain substitution and parallel sourcing
Which companies supply the dexlansoprazole API (drug substance) for CREXONT?
Answer (required for accuracy): The API supplier is the company named as the drug substance manufacturer in Orange Book for CREXONT’s active ingredient entry.
API sourcing patterns by PPI brands
For proton pump inhibitors, supply chains often include:
- Contract API manufacturers (multi-plant)
- Salt-form or intermediate vendors depending on synthetic route
- Downstream formulation manufacturers that may be different legal entities
How to map the API to the CREXONT product
The mapping is done by linking:
- Orange Book “Active Ingredient” manufacturer name
- The CREXONT drug product manufacturer/site
- Any linked DMF reference to the API manufacturing site (when publicly cross-indexed)
What excipients and packaging suppliers are used for CREXONT tablets/capsules?
Answer (required for accuracy): Excipients and packaging suppliers are not reliably derivable from public high-level product descriptions. The correct approach is to use:
- Approved labeling (inactive ingredient list identifies excipient types, not supplier identities)
- NDA/ANDA administrative chemistry details and DMF-linked excipient manufacturers (if disclosed in public summaries, which is not consistent)
Packaging and secondary container supply
Finished-goods packaging can include:
- Bottles vs blister packs
- Desiccant induction
- Tamper-evident components
Supplier identities depend on the specific NDC presentation.
What is the CREXONT Orange Book status and what does it imply for supplier access?
Answer (required for accuracy): Orange Book status defines:
- Whether CREXONT is listed as a reference listed drug (RLD)
- Whether there are any listed patents that restrict generic/biosimilar substitution
- The set of listed manufacturers (drug product and drug substance)
How Orange Book ties to manufacturer records
For a given NDC strength, Orange Book typically links:
- RLD status
- Patent numbers
- Market entry dates
- Manufacturer(s) listed for the product
When can generics enter CREXONT, and which suppliers would benefit first?
Answer (required for accuracy): Generic entry timing depends on:
- Patent expiration dates
- Exclusivity periods (if any)
- Whether paragraph IV litigation is filed and settled
- Whether the generic files against CREXONT’s specific patents
What supplier implications follow from entry timing
- Early-to-market generics often use the same contract packaging and formulation vendor ecosystem
- API supply competition increases after patent barriers drop
Does CREXONT have any patent-protected formulations that limit alternative manufacturing?
Answer (required for accuracy): Formulation barriers exist only if Orange Book lists formulation, composition, or method-of-use patents covering CREXONT’s dosage form and route.
Formulation patent types that can affect supply
- Composition-of-matter for formulation excipients or ratios
- Controlled-release or enteric-coating patents
- Method-of-manufacture patents for coating or granulation
What Paragraph IV challenges exist for CREXONT and which generic suppliers are tied to them?
Answer (required for accuracy): Paragraph IV challenges and challenger companies are identified from FDA Orange Book litigation-linked sources and court dockets. These cannot be listed accurately without the CREXONT-specific case set.
How litigation changes the supplier landscape
- If a challenger wins or settles early, the formulation and packaging partners can shift
- API supplier qualification can be accelerated post-settlement
Which contract manufacturers typically produce CREXONT-like proton pump inhibitor products?
Answer (required for accuracy): CREXONT-like supply chains are industry-typical but cannot be translated into company-specific supplier lists without CREXONT’s approved manufacturer and site data.
Why “typical vendor” is not enough
A correct supplier roster must name:
- The specific site(s) manufacturing the CREXONT drug product
- The specific company for the API as listed in Orange Book
- The specific NDC presentation labeling/packaging lines
Key Takeaways
- CREXONT supplier identification requires Orange Book and FDA label-linked manufacturer listings for the specific NDC/strength.
- The supplier map splits into three layers: API supplier (drug substance manufacturer), finished-dose manufacturer (drug product site), and packaging/labeling vendor.
- Patent and exclusivity status, if mapped via Orange Book, can constrain generic supply and change vendor qualification after entry barriers lift.
FAQs
- How do I find the drug product manufacturer for CREXONT for a specific NDC?
- Does Orange Book list the API manufacturer for CREXONT or only the finished dose site?
- What does a change in “manufactured for” versus “manufactured by” mean for CREXONT supply chain?
- How does paragraph IV litigation for CREXONT affect API qualification timelines for generic entrants?
- Can inactive ingredient types on the CREXONT label be mapped to specific excipient suppliers?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
