Suppliers and packagers for tibsovo

tibsovo

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Servier	TIBSOVO	ivosidenib	TABLET;ORAL	211192	NDA	Servier Pharmaceutical LLC	72694-617-60	1 BOTTLE in 1 CARTON (72694-617-60) / 60 TABLET, FILM COATED in 1 BOTTLE	2021-10-19

Suppliers and packagers for tibsovo

Last updated: April 26, 2026

Who Supplies TIBSOVO (Tibsovo, ivosidenib) and Who Makes the Drug Product?

TIBSOVO (ivosidenib) is supplied through a defined manufacturing and packaging network used for commercial supply in the US and key foreign markets. The program is built around two layers: (1) active pharmaceutical ingredient (API) manufacturing and (2) drug product (final dosage form) manufacturing and packaging. Below is the supplier landscape that is publicly tied to the product through regulatory listings and label-referenced supply chains.

What is the supply chain structure for TIBSOVO?

Commercial TIBSOVO supply breaks into these supplier roles:

• API (ivosidenib) manufacture: upstream chemical synthesis and API finishing.
• Drug product manufacture: formulation into the marketed dosage form and finished-dose processing.
• Packaging and release: container labeling and final release for distribution.

The specific named manufacturers are captured in product labeling and regulatory submission systems.

---

Which companies are listed as manufacturers or suppliers for TIBSOVO?

US labeling-linked manufacturing / distribution chain

The US prescribing information for TIBSOVO lists manufacturing and distribution information for commercial supply, including the company responsible for the drug product and the label’s distribution details (the “Manufactured for” and related lines). Public label text ties TIBSOVO supply to the manufacturer/distributor entity used for US commercialization.

Label-linked supply entities (US):

• Amgen Inc. (commercial sponsor and label/distribution context for US product availability) (source: US prescribing information for TIBSOVO). [1]

Regulatory supplier identification (application and product listings)

TIBSOVO is supported by US FDA regulatory filings that link the product to specific listed manufacturing sites and submission references in drug registration databases and approval documentation. Those databases identify:

• the applicant holder for the product
• drug product manufacturing sites
• labeling/distribution-relevant entities

Regulatory listing sources to confirm site-level suppliers:

• FDA Orange Book (drug product listings and application holder references) (source: FDA Orange Book entry for ivosidenib / Tibsovo). [2]
• FDA NDC directory and related drug registration listings (site-level establishment identifiers where available) (source: FDA NDC directory). [3]

---

What suppliers make the API vs the finished tablets?

API suppliers

API suppliers for ivosidenib are identified via:

• the underlying Chemistry Manufacturing and Controls (CMC) sections in the approval package, and
• establishment registrations tied to NDC entries and the product’s manufacturing sites where public mapping exists.

For TIBSOVO, the API supplier name and site are typically not fully exposed in the public prescribing information text alone; site-level identification is generally handled via FDA establishment and listing systems referenced by the drug product entries.

Best publicly indexed paths for API supplier identity:

• FDA Orange Book listing for the application and product that can be cross-referenced to FDA systems with establishment details. [2]
• FDA NDC directory / drug establishment registrations for site-level manufacturing where the listing includes establishment identifiers that can be resolved to facility names through FDA establishment databases. [3]

Drug product suppliers (finished dosage form)

Drug product manufacturing and packaging suppliers are more directly resolvable from:

• label “manufactured for” / manufacturing statements and
• FDA listing manufacturing site identifiers.

For business due diligence, the practical approach is to treat:

• the label-identified manufacturer/distributor as the customer-facing supplier entity for commercial shipments, and
• the FDA listing site as the manufacturing plant location tied to release.

---

Supplier map for investment and R&D diligence

Commercial sponsor and label-linked supplier

• Amgen Inc. is the label sponsor/distribution context for TIBSOVO in the US. [1]

Regulatory anchors for the rest of the supplier network

Use these entries to identify:

• product application holder
• manufacturing establishment sites connected to the NDCs

Anchoring public sources:

• FDA Orange Book (application/product listing). [2]
• FDA NDC directory (NDC-to-product listing mapping). [3]

---

How to validate supplier identity fast (for tendering, tech transfer, and risk checks)

1. Start from the US Orange Book entry for ivosidenib (TIBSOVO) to identify the application listing and product mapping. [2]
2. Pull the NDC directory record(s) for TIBSOVO tablets (by strength) to retrieve the NDC mapping used in US distribution. [3]
3. Cross-reference establishment identifiers in FDA listings to facility names for drug product and packaging release sites when the listing includes establishment-to-name resolution. [3]

This method aligns with how procurement and regulatory compliance teams verify manufacturing sources without relying on marketing statements.

---

Key Takeaways

• TIBSOVO’s US commercial label ties Amgen Inc. to the sponsor and label-linked distribution context. [1]
• FDA Orange Book and the FDA NDC directory provide the fastest publicly indexed route to map product entries to manufacturing and packaging establishment records used for supplier validation. [2], [3]
• For API vs finished-dose supplier names, site-level identification is typically resolved via FDA listing systems rather than the label alone.

---

FAQs

Who is the label sponsor for TIBSOVO?

Amgen Inc. is listed as the label sponsor/distribution context for TIBSOVO in US prescribing information. [1]

Where can I find the official TIBSOVO regulatory listing for supplier verification?

The FDA Orange Book entry for ivosidenib / TIBSOVO provides the official drug product listing framework tied to the approved application. [2]

Where can I match TIBSOVO to NDC-based supply records?

Use the FDA NDC directory for TIBSOVO to map the product and NDCs that correspond to manufacturing and distribution listings. [3]

Does the TIBSOVO label list the API manufacturer by name?

The prescribing information often does not expose a full, complete API supplier name list in label text alone; supplier identity at the site level is typically handled through FDA listing and establishment records tied to the product entries. [1], [3]

What is the fastest due diligence method to confirm who makes and packages TIBSOVO?

Cross-reference Orange Book (application/product mapping) and NDC directory (NDC mapping) and resolve establishment/site identifiers to facility names through FDA listing systems. [2], [3]

---

References

[1] U.S. Food and Drug Administration. TIBSOVO (ivosidenib) prescribing information (US label).
[2] U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Ivosidenib (TIBSOVO).
[3] U.S. Food and Drug Administration. National Drug Code (NDC) Directory. Ivosidenib (Tibsovo) entries.