Last updated: June 1, 2026
GATTEX KIT suppliers: who manufactures and supplies Gattex (teduglutide) and its components?
GATTEX KIT is a branded form of teduglutide (a GLP-2 analog). The supply chain is split into (1) drug substance and drug product manufacturing for teduglutide and (2) kit components used to reconstitute and administer the product (typically including the lyophilized teduglutide drug product and required diluent/consumables, depending on country packaging configuration).
Actionable supplier view (who to map for sourcing, licensing, and regulatory dossiers):
- Brand manufacturer for teduglutide drug product (primary supplier of the kit).
- Kit component suppliers (diluent and packaging/labeling supply chain for the final kit build).
- Contract manufacturing organizations (CMOs) for aseptic filling/lyophilization and kit packaging (often the true operational suppliers behind the labeled holder).
- Active ingredient (drug substance) manufacturer (teduglutide synthesis and purification).
Key point
A complete, accurate “list of suppliers” requires tying the kit to its labeled MAH/NDA holder and then mapping NDC strength/form, packaging configuration, and country-specific manufacturing site(s) from regulatory labels and product databases. Without that mapping, supplier names can be inaccurate across jurisdictions and package configurations.
Which companies supply the GATTEX KIT finished product?
The finished kit is supplied under the brand GATTEX (teduglutide). In practice, the supplier set is anchored by the NDA/MAH and its labeled manufacturing sites, with additional entities supplying kit packaging and diluent.
Who is the labeled “manufacturer” on product labeling?
For GATTEX, the labeled manufacturer on the US prescribing information and cartons determines:
- Drug product release sites (aseptic processing or lyophilization and filling)
- Kit packaging sites (blistering/cartoning, labeling, configuration)
- Whether CMOs are named as manufacturing sites
How to treat “kit component suppliers” in sourcing maps?
Kit component sourcing splits into:
- Diluent / reconstitution solution supply (commonly GMP-manufactured and packaged to match the reconstitution instructions)
- Ancillary consumables included with the kit (needles/syringes/other delivery parts, if packaged)
- Primary packaging for the lyophilized drug product (vials) and secondary packaging (cartons), plus labeling/UDI build
What manufacturing sites and CMOs build GATTEX KIT?
CMO identification depends on the labeled manufacturing location for each marketed NDC/package. In many branded injectables, the kit build is performed by the labeled manufacturer or a designated CMO under quality agreements, with manufacturing stages split:
- Teduglutide synthesis (API)
- Drug substance-to-drug product conversion
- Lyophilization and filling into vials
- Kit build and final packaging
A practical supplier mapping approach
For supply chain due diligence, map each stage to a supplier class:
- API manufacturer (teduglutide drug substance)
- Lyophilization/filling CMO (final drug product vial)
- Kit packaging CMO (kitting, labeling, distribution-ready packs)
Do generic or biosimilar suppliers offer GATTEX KIT components?
No equivalent to “GATTEX KIT” exists in the market in a way that makes generic/“kit compatible” sourcing straightforward at the product level. The most relevant competition risk is:
- Alternative GLP-2 analogs or pipeline teduglutide biosimilar-like products (where applicable by jurisdiction), not “unbranded kits”
- Reconstitution and administration consumables that can often be sourced broadly, but do not replicate the proprietary drug product and its regulatory release
How many suppliers feed the GATTEX KIT supply chain?
A typical branded kit like GATTEX includes at least:
- 1 primary supplier for the teduglutide drug product (through the labeled manufacturer or its CMO)
- 1 supplier for diluent (or a packaging line at the same labeled manufacturer)
- 1 to 2 suppliers for kit packaging (cartoning and labeling often distinct from aseptic/lyophilization)
But the exact supplier count and names vary by:
- Country and NDC/package
- Contract transitions over time
- Regulatory site changes and line swaps
What is the Orange Book status of GATTEX that affects supplier and generic sourcing?
The “supplier list” is indirectly constrained by patent and regulatory status because:
- If no approved generics exist, the labeled manufacturer and its CMOs remain the practical sources
- If there are ANDA approvals or 505(b)(2) products, their approved manufacturing sites can become alternate sources
However, this requires Orange Book listing details for GATTEX (patent numbers, dosage form, and listed approved products) to identify whether any alternatives exist that would change supplier mapping.
Key Takeaways
- GATTEX KIT sourcing is best treated as a two-layer supply chain: teduglutide drug product supplier plus kit component/packaging suppliers.
- The only supplier names that can be asserted with high confidence are those tied to the labeled manufacturer/MAH and its registered manufacturing sites for the relevant NDC and packaging configuration.
- Without NDC/country-specific label and regulatory listing mapping, any “supplier list” risks being incorrect due to site changes and kit configuration differences.
FAQs
- Who is the manufacturer listed on GATTEX KIT cartons in the US?
- Are GATTEX kit diluent and injection consumables sourced from the same supplier as teduglutide vials?
- Do the registered manufacturing sites for GATTEX change over time, and how can that affect supplier due diligence?
- Is there any approved generic teduglutide that would provide alternate GATTEX KIT-like sourcing?
- What manufacturing stage is typically performed by CMOs for lyophilized injectable kits like GATTEX?
References
(No sources provided in the prompt; no citations can be produced without label/regulatory records.)
