Suppliers and packagers for xermelo

xermelo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Tersera	XERMELO	telotristat etiprate	TABLET;ORAL	208794	NDA	TerSera Therapeutics LLC	70720-125-85	4 BOX in 1 CASE (70720-125-85) / 1 BLISTER PACK in 1 BOX (70720-125-22) / 21 TABLET in 1 BLISTER PACK	2020-10-05

XERMELO Suppliers: Who Manufactures and Supplies Xermelo (Telotristat Ethyl) APIs, Finished Dosage Forms, and Key Inputs

Last updated: May 26, 2026

Xermelo (telotristat ethyl) supply is concentrated around the original manufacturing and packaging network for the marketed product, with active ingredient manufacture sitting upstream in the supply chain. Publicly available disclosures tied to the U.S. FDA drug product listing and Orange Book identify the marketed product’s manufacturing/label-contact structure, but they do not provide a complete, global map of all raw-material and API suppliers worldwide.

Which companies supply Xermelo (telotristat ethyl) in the US market?

Answer: The U.S. supply chain for Xermelo is anchored by the holder and listed manufacturer(s) shown on FDA drug and Orange Book listings for the marketed NDA product. Those listings are the controlling reference for who is authorized to manufacture and market the finished drug in the U.S.

What does the FDA’s Orange Book list for Xermelo manufacturing responsibility?

The Orange Book ties Xermelo’s NDA to:

• Drug product/manufacturer listings for the marketed dosage form(s)
• Patent and exclusivity records that constrain generic and NDA-505(b)(2) competition

From a supplier perspective, the critical deliverable in the Orange Book is the set of listed manufacturing establishments for the approved product.

What does the FDA drug listing show for Xermelo?

The FDA’s structured drug listing (Drugs@FDA product listing records tied to the approved NDA) typically shows:

• Applicant/labeler (the entity responsible for marketing)
• Manufacturing sites used for production and packaging operations

These records are the most defensible public sources for identifying the “official” U.S. suppliers for the finished dosage form.

What is the API supplier chain for telotristat ethyl?

Answer: Telotristat ethyl API supply is upstream and usually not exhaustively disclosed in public Orange Book patent records. Publicly available records generally connect API production to the NDA’s manufacturing responsibility framework rather than naming every API vendor globally.

Are telotristat ethyl API suppliers named in public records?

In many NDA cases:

• API vendor names are not always directly enumerated in Orange Book records.
• API supply is instead reflected through the NDA’s listed manufacturing/processing sites and the drug product’s quality system and release chain under the NDA.

Where to look in FDA/Orange Book for upstream manufacturing clues?

For upstream supply-chain identification, the most reliable public approach is to:

1. Extract listed manufacturing establishments for the drug product
2. Identify which sites are described as responsible for manufacture/processing
3. Use those site-level entries as a proxy for the API manufacture integration where manufacturing is bundled

Which Xermelo manufacturers are listed on FDA and Orange Book records?

Answer: The specific manufacturer names and establishment identifiers must come directly from the FDA product listing and Orange Book entries for the approved NDA.

What you should expect to see in the Xermelo listing fields

When you pull the Xermelo NDA product record, the supplier view typically includes:

• NDA applicant/labeler
• Manufacturing and packaging site entries (often as multiple lines)
• Submission history affecting post-approval changes to sites

How do NDA manufacturing changes affect supplier continuity?

When manufacturing sites change:

• The FDA record updates listed manufacturing establishments.
• The Orange Book stays tied to the NDA and its product and patent coverage.
• Supplier continuity may shift without changing the labeled manufacturer if the NDA approves new sites.

How does Xermelo supply risk show up in patent and exclusivity constraints?

Answer: Patent and exclusivity do not directly identify suppliers, but they restrict entry paths for competing manufacturers, which in practice keeps supply concentrated in the reference NDA manufacturing network for longer.

What does Xermelo exclusivity mean for alternative sourcing?

• If exclusivity and patents are in force, generic and biosimilar-style competition (for small molecules: ANDA-based generics) is delayed.
• That delay keeps demand reliant on the NDA’s existing manufacturing footprint.

Does Paragraph IV litigation change suppliers?

Paragraph IV challenges target generic entry timing and IP. They typically do not change the reference product’s manufacturing suppliers, but they can:

• influence settlement-driven timing of generic launches (which affects downstream sourcing mix)

What generic entry risks exist for Xermelo suppliers?

Answer: Generic entry risk is driven by Orange Book-listed patents and exclusivity, not by current supplier announcements. Suppliers for generics (once allowed) come from ANDA filers’ contracted manufacturing networks.

Timing gates that control when new suppliers can appear

Key gating items:

• Patent expiration dates
• Any remaining exclusivity windows (data exclusivity and/or other FDA-granted exclusivity)
• Litigation and settlement status for Paragraph IV cases

How to connect generic launch to supplier diversification

Once a generic is approved and launched:

• The market’s sourcing shifts toward the ANDA filer’s contracted manufacturers.
• New suppliers then enter the distribution chain in addition to the reference product.

What formulation and packaging suppliers are involved for Xermelo?

Answer: The formulation is tied to the approved drug product manufacturing and packaging sites listed for the NDA product. Those sites are the practical “formulation/package suppliers” for the marketed product.

Dosage form handling

For oral small-molecule products like Xermelo:

• packaging operations (bottles/blister, labeling, and repack where applicable) sit downstream
• manufacturing of tablets/capsules and any specialized controls (e.g., moisture protection) sit upstream

The FDA listings for the NDA are the public anchor to identify which sites conduct these operations.

Key Takeaways

• Xermelo supply in the U.S. is anchored by the NDA’s listed applicant and manufacturing establishments on FDA product listings and Orange Book records.
• Public sources generally support identification of listed drug product manufacturing sites, not a complete global “API vendor roster.”
• Patent and exclusivity timelines constrain alternative sourcing by delaying generic entry, keeping supply concentrated in the reference NDA network.

FAQs

1. Where on FDA’s Orange Book can I verify Xermelo manufacturing establishments?
   Look up Xermelo’s NDA in the Orange Book and review the drug product listing that includes manufacturing/labeler fields and associated product entries.

2. Are telotristat ethyl API suppliers publicly named for Xermelo?
   Often they are not fully enumerated in public Orange Book entries; supplier identification is typically inferred via listed manufacturing/processing establishments tied to the NDA.

3. What drives supplier changes for Xermelo after approval?
   FDA approval of manufacturing site supplements and changes to listed establishments.

4. How do Paragraph IV challenges affect Xermelo supply contracts?
   They mainly affect generic entry timing; they do not typically change reference product manufacturing responsibility but do influence future market sourcing mix after generic launches.

5. Which records best identify the current U.S. drug product manufacturer for Xermelo?
   FDA’s Drugs@FDA product listing and the Orange Book drug product listing tied to the approved NDA.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Xermelo/telotristat ethyl NDA listing).
2. U.S. Food and Drug Administration. Drugs@FDA: Drug Details for Xermelo (telotristat ethyl).