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Last Updated: March 28, 2026

Suppliers and packagers for generic pharmaceutical drug: abrocitinib


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abrocitinib

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Pfizer CIBINQO abrocitinib TABLET;ORAL 213871 NDA Pfizer Laboratories Div Pfizer Inc 0069-0235-30 30 TABLET, FILM COATED in 1 BOTTLE (0069-0235-30) 2022-02-24
Pfizer CIBINQO abrocitinib TABLET;ORAL 213871 NDA Pfizer Laboratories Div Pfizer Inc 0069-0335-30 30 TABLET, FILM COATED in 1 BOTTLE (0069-0335-30) 2022-02-24
Pfizer CIBINQO abrocitinib TABLET;ORAL 213871 NDA Pfizer Laboratories Div Pfizer Inc 0069-0435-30 30 TABLET, FILM COATED in 1 BOTTLE (0069-0435-30) 2022-02-24
Pfizer CIBINQO abrocitinib TABLET;ORAL 213871 NDA U.S. Pharmaceuticals 63539-236-14 14 TABLET, FILM COATED in 1 BOTTLE (63539-236-14) 2022-02-24
Pfizer CIBINQO abrocitinib TABLET;ORAL 213871 NDA U.S. Pharmaceuticals 63539-336-14 14 TABLET, FILM COATED in 1 BOTTLE (63539-336-14) 2022-02-24
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Abrocitinib Suppliers Overview

Last updated: February 19, 2026

Which companies supply abrocitinib commercially?

Abrocitinib, marketed primarily as Cibinqo, is a Janus kinase (JAK) inhibitor approved for the treatment of atopic dermatitis. Its manufacture is limited to select pharmaceutical companies, with Pfizer holding exclusive rights to commercialize the drug globally.

Primary Supplier

Company Role Geographic Coverage Manufacturing Status Supply Notes
Pfizer Exclusive global supplier Worldwide Commercial manufacturing Manufactures in Pfizer facilities, with distribution mainly managed through licensing agreements

Pfizer secured regulatory approval in the United States (FDA, 2021), European Union (EMA, 2022), Japan, and other regions, maintaining exclusive rights.

Secondary and Contract Manufacturers

Pfizer partners with foreign and domestic Contract Manufacturing Organizations (CMOs) to produce abrocitinib for scaled distribution. These include:

  • CordenPharma – Contracted for active pharmaceutical ingredient (API) manufacturing.
  • Thermo Fisher Scientific – Supplies raw materials and intermediates.

Manufacturing at scale requires strict adherence to Good Manufacturing Practices (GMP), with Pfizer overseeing quality control and regulatory compliance.

Are there alternative suppliers or licensing arrangements?

Currently, no publicly announced sublicensing agreements exist for abrocitinib. The supply chain remains centralized under Pfizer's direct control, limiting alternative sources.

The complexity of JAK inhibitor synthesis, involving multi-step chemical processes and stringent purity standards, restricts the entry of new suppliers.

What are the key considerations for supply chain stability?

  • Patent exclusivity: Pfizer's patent on abrocitinib prevents generic manufacturing until expiry or patent litigation resolution.
  • Manufacturing capacity: Pfizer maintains multiple production sites, but expansion depends on global demand and supply chain resilience.
  • Regulatory approvals: Production is contingent on GMP compliance and regulatory clearances in each region.

Market implications

Limited supplier diversity increases dependency risk for pharma companies and healthcare systems. Manufacturing bottlenecks or regulatory delays could impact availability. Investors should monitor Pfizer’s manufacturing strategy and potential licensing negotiations.

Summary of key suppliers and manufacturing points

Supplier Name Role Location Key Capabilities Notes
Pfizer Original developer and exclusive supplier Worldwide API synthesis, formulation, distribution Leading control from R&D to delivery
CordenPharma Contract manufacturer Europe API manufacturing Supplies PFizer for global distribution
Thermo Fisher Raw materials Global Critical intermediates Supports API synthesis process

Key Takeaways

  • Pfizer is the exclusive supplier of abrocitinib globally, with manufacturing controlled through in-house facilities and CMOs.
  • No current sublicensees or alternative suppliers are publicly known.
  • Supply chain stability depends on Pfizer’s manufacturing capacity, patent status, and regulatory environment.
  • The complexity of chemical synthesis limits supplier diversification.
  • Monitoring patent expiration and licensing opportunities is crucial for market entry strategies.

FAQs

1. Who manufactures abrocitinib?
Pfizer manufactures abrocitinib, leveraging internal facilities and CMOs. No other companies currently produce or distribute the drug commercially.

2. Are there any licensed or sublicensed manufacturers of abrocitinib?
As of now, no sublicensing deals or secondary manufacturers have been announced publicly.

3. Can generic companies produce abrocitinib?
Generic manufacturing depends on patent expiration or legal resolution. Currently, Pfizer’s patents are in force in key markets through 2030.

4. What are the risks related to supply chain disruptions?
Patent exclusivity, complex synthesis, and reliance on a limited number of manufacturing sites pose risks to supply chain stability.

5. How does the manufacturing process influence supply?
The multi-step chemical synthesis, strict quality controls, and need for GMP compliance limit the number of capable and authorized manufacturing partners.


References

[1] U.S. Food and Drug Administration. (2021). FDA approves Pfizer’s Cibinqo for atopic dermatitis. https://www.fda.gov/news-events/press-announcements/fda-approves-pfizers-cibinqo-atopic-dermatitis

[2] European Medicines Agency. (2022). EMA validates marketing authorization application for Cibinqo. https://www.ema.europa.eu/en/news/ema-validates-marketing-authorization-application-pfizer-cibinqo

[3] Pfizer Inc. (2021). Cibinqo (abrocitinib) prescribing information. https://www.pfizer.com/files/products/uspi_cibinqo.pdf

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