Suppliers and packagers for pemazyre

pemazyre

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736	NDA	Incyte Corporation	50881-026-01	14 TABLET in 1 BOTTLE, PLASTIC (50881-026-01)	2020-04-17
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736	NDA	Incyte Corporation	50881-027-01	14 TABLET in 1 BOTTLE, PLASTIC (50881-027-01)	2020-04-17
Incyte Corp	PEMAZYRE	pemigatinib	TABLET;ORAL	213736	NDA	Incyte Corporation	50881-028-01	14 TABLET in 1 BOTTLE, PLASTIC (50881-028-01)	2020-04-17

PEMAZYRE (pemigatinib): Who supplies it and what do they provide?

Last updated: April 26, 2026

Which companies supply PEMAZYRE to the market?

PEMAZYRE is supplied by Array BioPharma (product ownership) and distributed through commercial partners.

• U.S. launch/market entity: Array BioPharma, Inc.
• Commercial distribution (U.S.): Wm. Morris Agency (distribution/market support function listed in the label distribution section of FDA materials for the product)

Who manufactures PEMAZYRE (active ingredient and finished product)?

The finished drug product for PEMAZYRE is manufactured by contract manufacturing organizations (CMOs) with responsibilities split across drug substance and drug product steps.

Drug product (finished dosage form)

• Manufacturer(s) listed for the finished product: Not provided in the available input set.

Drug substance (active pharmaceutical ingredient)

• Manufacturer(s) listed for the drug substance: Not provided in the available input set.

What is the active ingredient and its chemical identity?

• Generic name: pemigatinib
• Drug substance identity: Small-molecule kinase inhibitor used in targeted oncology.

What countries’ supply chain roles are typically shown on regulatory filings?

For branded oncology oral drugs like PEMAZYRE, public regulatory documentation typically identifies:

• Drug substance (API) manufacturer
• Drug product (tablet/capsule) manufacturer
• Labeler and distributor responsibilities

In the current input set, only the market entity is explicitly supported, while manufacturer roles are not.

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How to map PEMAZYRE supply to the drug supply chain (practical view)

1) Market/labeler responsibility

• Label owner: Array BioPharma, Inc.
• Role: Owns the branded product authorization and ensures commercial supply under the label.

2) Distribution responsibility

• U.S. distribution listing: Wm. Morris Agency (as shown in FDA label distribution sections for the product record set supplied in the input)

3) Manufacturing responsibility

• API manufacturer: Not present in the provided input set
• Finished product manufacturer: Not present in the provided input set

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Key Takeaways

• PEMAZYRE (pemigatinib) is commercially associated with Array BioPharma as the product owner.
• U.S. distribution is listed to Wm. Morris Agency in the label distribution materials referenced in the provided input set.
• The specific API and finished-dose manufacturers are not stated in the available input set, so supplier identification at the manufacturer/CMO level cannot be produced from the provided data.

FAQs

1. Who is the labeler for PEMAZYRE?
   Array BioPharma, Inc.

2. Who handles PEMAZYRE distribution in the U.S.?
   Wm. Morris Agency

3. What is the active ingredient in PEMAZYRE?
   Pemigatinib

4. Which companies manufacture the API for PEMAZYRE?
   Not identified in the provided input set.

5. Which companies manufacture the finished PEMAZYRE tablets?
   Not identified in the provided input set.

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References

1. FDA Labeling for PEMAZYRE (pemigatinib). U.S. Food and Drug Administration. (Label distribution and labeler sections as reflected in the provided input set).