Suppliers and packagers for generic pharmaceutical drug: DEURUXOLITINIB PHOSPHATE

DEURUXOLITINIB PHOSPHATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sun Pharm Inds Inc	LEQSELVI	deuruxolitinib phosphate	TABLET;ORAL	217900	NDA	Sun Pharmaceutical Industries, Inc.	47335-108-86	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (47335-108-86)	2025-06-25

Deuruxolitinib Phosphate Suppliers: Who Manufactures the API, Intermediate, and Finished Dosage and What to Verify in Due Diligence

Last updated: May 28, 2026

No complete, verifiable public supplier roster exists for “deuruxolitinib phosphate” as a named drug substance in FDA/Orange Book-linked sources, major global chemical registries, or validated patent-assigned manufacturing disclosures that can be cited precisely for API, intermediates, or drug product.

Who supplies deuruxolitinib phosphate API?

Answer: No citable, source-backed list of commercial API suppliers for deuruxolitinib phosphate is available in public records that can be used for a reliable procurement or IP diligence decision.

What to check instead of supplier names

Because “deuruxolitinib phosphate” supplier attribution is not consistently published under that exact string, due diligence should anchor to:

• Drug substance naming control: confirm whether suppliers market under a different capitalization, salt form labeling, or a parent compound name (free base vs phosphate).
• Regulatory anchor: require API COA match to the exact API identity used in the NDA/ANDA (or IND manufacturing description) rather than relying on web listings.
• Site qualification: verify that the supplier’s manufacturing site is active and capable of the specific salt form (phosphate) with current quality agreements.
• DMF or CEP linkage: request proof of regulatory filings that cover the exact API and salt (DMF type, listed APIs, and site address), or CEP scope if used.

Which companies manufacture deuruxolitinib (free base) and sell the phosphate salt?

Answer: A definitive manufacturer mapping from deuruxolitinib to the phosphate salt supplier set cannot be produced from publicly citable sources with sufficient specificity.

Typical mapping logic procurement teams use

Even when a salt form is sold commercially, public disclosures often track:

• the core scaffold manufacturer for the free base
• a separate salt-former or salt-conversion step supplier (phosphating)
• a different set of companies supplying key intermediates used to build the core

Without source-backed evidence, assigning suppliers to any step for deuruxolitinib phosphate would not meet diligence-grade accuracy.

Are there DMF-linked suppliers for deuruxolitinib phosphate?

Answer: No defensible DMF-linked supplier list for deuruxolitinib phosphate can be compiled here using citable public records.

What matters in DMF diligence

A DMF-based supplier list must include:

• the DMF number(s) that explicitly cover the phosphate salt (not only the free base)
• the Applicant/DMF holder and manufacturing site address
• the API specifications tied to salt form, polymorph, and impurity profiles

What finished-dose suppliers produce deuruxolitinib phosphate tablets or capsules?

Answer: No citable, source-backed finished dosage manufacturer list is available for deuruxolitinib phosphate at the drug product level.

What to request from contract manufacturers (CMOs)

For commercial readiness and quality alignment, contracts should cover:

• finished dosage form and packaging configuration
• scale-up capability for the phosphate salt form
• analytical method ownership and transfer status
• current GMP certificate tied to the exact site and product category
• stability protocol aligned to the phosphate salt

What contract manufacturing organizations (CMOs) make phosphate salts for JAK inhibitors like deuruxolitinib?

Answer: A generic “phosphate salt CMO” list is not equivalent to a supplier list for deuruxolitinib phosphate specifically.

Why generic salt expertise is insufficient

Salt-form conversion and control require:

• impurity fate mapping from the upstream intermediate
• phosphate stoichiometry control, water content control, and process validation
• polymorph management and specification locking to the clinical/regulatory dataset

Without a source-backed link to deuruxolitinib phosphate production, a generic CMO shortlist would not be procurement-grade.

Key Takeaways

• A citable supplier roster for deuruxolitinib phosphate cannot be produced from publicly verifiable records with enough specificity to support procurement, licensing, or IP diligence.
• Due diligence should be anchored to exact regulatory substance naming, DMF/CEP scope, and site-level GMP evidence that explicitly covers the phosphate salt and its specifications.
• Supplier claims from web sources must be validated against regulatory filings and COA identity testing aligned to the phosphate form used in development or marketing.

FAQs

1. Can I treat “deuruxolitinib” suppliers as substitutes for “deuruxolitinib phosphate” suppliers?
   No, phosphate salt production capability and specification control must be explicitly covered for the exact salt form used in the drug product.

2. How do I confirm an API supplier truly manufactures the phosphate salt (not only the free base)?
   Demand regulatory scope proof (DMF/CEP listing), phosphate-specific specifications, and COA identity that matches the salt form used in the development dossier.

3. What documentation should I require to qualify an intermediate supplier for phosphate salt drugs?
   Intermediate specs tied to impurities relevant to the final salt form, change-control history, and evidence of impurity carryover control.

4. Are there polymorph or hydrate risks specific to phosphate salts in deuruxolitinib phosphate?
   Salt form and solid-state behavior must be controlled to the clinical/regulatory dataset, including water content and solid-state form as defined in specifications.

5. What is the best way to build a defensible supplier map for an under-documented API?
   Build the map from regulatory filing entities and manufacturing site addresses, then validate by COA, GMP scope, and batch release records tied to the exact salt form.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. (Accessed 2026-05-28).
2. U.S. Food and Drug Administration. Drugs@FDA. FDA. (Accessed 2026-05-28).