Last Updated: June 30, 2026

Suppliers and packagers for JAYPIRCA


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JAYPIRCA

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Loxo Oncol JAYPIRCA pirtobrutinib TABLET;ORAL 216059 NDA Eli Lilly and Company 0002-6902-30 30 TABLET, COATED in 1 BOTTLE (0002-6902-30) 2023-01-27
Loxo Oncol JAYPIRCA pirtobrutinib TABLET;ORAL 216059 NDA Eli Lilly and Company 0002-7026-60 60 TABLET, COATED in 1 BOTTLE (0002-7026-60) 2023-01-27
Loxo Oncol JAYPIRCA pirtobrutinib TABLET;ORAL 216059 NDA Eli Lilly and Company 0002-7026-99 30 TABLET, COATED in 1 BOTTLE (0002-7026-99) 2023-01-27
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for JAYPIRCA

Last updated: May 28, 2026

Jaypirca (pirtobrutinib) suppliers: active ingredient, contract manufacturing, and packaging sources

Jaypirca is the brand name of pirtobrutinib. Supplier coverage is constrained by the fact that Jaypirca distribution and manufacturing responsibility are not fully captured in publicly available, consistently structured records in the way an Orange Book patent list is. As a result, only specific, directly citable supplier roles can be stated as “suppliers” without fabricating names.

Who manufactures Jaypirca (pirtobrutinib) tablets and supplies the drug to the US market?

Answer (publicly stated manufacturers only): No complete, verifiable “tablet manufacturer list” can be produced from the available public record provided here.

Is Jaypirca manufactured by a named contract manufacturing organization (CMO) in FDA or label records?

Answer: Not enough label-linked manufacturing detail is available in the provided information to name specific CMOs for drug substance or drug product.

What does the US prescribing information disclose about drug product manufacturing and packaging?

Answer: Not enough prescribing-information manufacturing/packaging detail is available in the provided information to name specific suppliers.

What suppliers provide pirtobrutinib drug substance (API) for Jaypirca?

Answer: No verifiable API supplier roster can be produced from the provided information without naming entities that cannot be substantiated.

Which plants or API makers are used for pirtobrutinib bulk drug substance?

Answer: Not available in the provided information.

Which companies are the likely Jaypirca supply partners (licensee, developer, distributor) by corporate role?

Answer: Based on the drug’s market role, the commercial and regulatory sponsor is the primary supplier pathway, but corporate “supplier” naming is not the same as manufacturing or packaging sourcing. From the provided information, specific manufacturing and packaging partners cannot be listed.

What is the sponsor/holder of the Jaypirca application in FDA records?

Answer: Not provided in the available input.

How do Jaypirca supply chains differ for US vs ex-US markets?

Answer: Not enough market-specific regulatory or label documentation is available in the provided information to compare geographic sourcing.

Do ex-US versions of Jaypirca name different CMOs for tablets or different packagers?

Answer: Not available in the provided information.

What is the Orange Book or FDA inspection signal for Jaypirca manufacturing supply risk?

Answer: Not enough FDA manufacturing inspection and Orange Book-linked manufacturing-role data is available in the provided information to assess supply-chain risk.

Does Jaypirca have multiple listed manufacturing sites for drug product?

Answer: Not provided.

Where can Jaypirca purchasers verify suppliers today (regulatory and labeling sources)?

Answer: Jaypirca supplier verification requires pulling the prescribing information manufacturing and the FDA application’s listed manufacturing sites. That source extraction is not possible from the provided information.

What are the most reliable supplier verification artifacts for pirtobrutinib products?

Answer: Prescribing information manufacturing/packaging statements, FDA application manufacturing site listings, and establishment inspection records.

Key Takeaways

  • Jaypirca is pirtobrutinib, but the set of named “suppliers” for manufacturing and packaging cannot be stated from the provided information without risking inaccuracies.
  • Supplier verification for Jaypirca requires direct extraction from Jaypirca label manufacturing/packaging text and FDA listing records tied to the application and manufacturing establishments.

FAQs

  1. What does the Jaypirca label say about who manufactures the tablets?
  2. Who supplies pirtobrutinib API (drug substance) for Jaypirca?
  3. Are there multiple manufacturing sites for Jaypirca tablets in the FDA record?
  4. Which packaging suppliers are listed on the Jaypirca prescribing information?
  5. How can procurement teams confirm Jaypirca supply-chain continuity using FDA records?

References (APA)

  1. (No citable sources provided in the prompt.)

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