Last updated: June 7, 2026
Envarsus XR suppliers: who manufactures, supplies, and sells extended-release tacrolimus
Envarsus XR (extended-release tacrolimus tablets) is supplied in the U.S. by Hikma Pharmaceuticals (brand commercial and supply arrangement via Hikma Pharmaceuticals USA, Inc.) and manufactured under Astellas Pharma’s tacrolimus XR development and technology lineage, with ercalcitriol not applicable (Envarsus XR is tacrolimus only). Direct supplier mapping is controlled through (1) the FDA Orange Book listing for Envarsus XR (tacrolimus extended-release tablets) and (2) the approved label’s “Manufactured for/Manufactured by” and distribution language.
Who supplies Envarsus XR in the U.S.?
Answer: Hikma Pharmaceuticals USA, Inc. is the U.S. brand-supplier entity listed on Envarsus XR product materials and market supply channels, while manufacturing responsibility sits with the approved NDA supply chain described on the FDA-approved labeling and Orange Book manufacturing information.
What entities appear on the label and FDA product record?
For an Envarsus XR “supplier” audit, the practical supplier list is:
- Marketing/supply holder (U.S.): Hikma Pharmaceuticals USA, Inc.
- Manufacturing site(s): the NDA-approved manufacturing facilities disclosed in the label and Orange Book manufacturing information
- Quality/regulatory responsibilities: tied to the NDA holder and manufacturing sites referenced in the approved application
What is the Orange Book status of Envarsus XR and which manufacturers are listed?
Answer: Envarsus XR is listed in the FDA Orange Book under tacrolimus extended-release tablets with associated NDA number(s) and patent and exclusivity entries. Orange Book listings are the authoritative crosswalk for “supplier” evidence because they identify the approved drug product and manufacturer relationships used for regulatory and substitution.
Orange Book fields that determine “supplier”
When mapping suppliers for Envarsus XR, use these Orange Book fields:
- Dosage form: tacrolimus extended-release tablets
- Applicant/License holder: the entity carrying the approved NDA
- Manufacturer information: manufacturing and packaging site entries tied to the approved product
Which company manufactures Envarsus XR tablets?
Answer: Envarsus XR is manufactured by the NDA-approved manufacturing facilities disclosed in the FDA-approved labeling and Orange Book manufacturing entries, with Astellas as the technology origin for Envarsus XR’s extended-release tacrolimus product lineage and Hikma as the U.S. commercial supplier.
How to validate manufacturing responsibility for diligence
For licensing, litigation, and procurement due diligence, “supplier” validation uses:
- Label block: “Manufactured by” / “Manufactured for” and address
- Orange Book: manufacturer entries linked to the listed dosage strength(s)
What suppliers support Envarsus XR packaging and distribution?
Answer: Packaging and distribution suppliers follow the label’s “packaged by” or “distributed by” statements tied to the approved product record. In practice, brand suppliers use:
- Primary packaging sites referenced in FDA labeling
- Distribution responsibility carried by the U.S. brand supplier (Hikma)
Why packaging suppliers matter
Procurement contracts, temperature/handling controls, and counterfeit-risk controls rely on:
- Identifying the packaging site(s)
- Confirming lot release site(s) referenced in documentation provided to wholesalers and hospitals
Are there multiple Envarsus XR strengths with different suppliers?
Answer: Multiple strengths can share the same NDA and often share manufacturing, but supplier mapping must be strength-verified via:
- Orange Book entries per strength
- Label manufacturing lines per strength (if different packaging or pack sizes exist)
Diligence checklist for strength-level supplier mapping
- Match strength (mg) to Orange Book product listing
- Match that listing to label “manufactured for/manufactured by” lines
What contract manufacturing and supply risks exist for Envarsus XR?
Answer: Supplier risk is primarily driven by:
- Limited number of qualified manufacturing/packaging facilities on the approved NDA
- Change-control requirements and post-approval manufacturing supplements
- Lot release capacity and regulatory compliance at the manufacturing sites
Where risk shows up
- Recalls or supply interruptions tied to manufacturing sites
- Delays tied to CMC supplements affecting manufacturing or packaging
How does Envarsus XR compare with generic tacrolimus XR suppliers?
Answer: Generics compete on manufacturing capability and abbreviated regulatory pathway, but “supplier” for the brand is fixed to the NDA-approved supply chain, while generics can use multiple manufacturers. Envarsus XR’s brand supply is anchored to the approved product record; generic supply is determined by each ANDA filer’s manufacturing sites once approved.
What this means commercially
- Brand sourcing is stable but facility-limited
- Generic sourcing is broader but constrained by ANDA approval timing and patent challenges
What is the strongest way to identify true Envarsus XR suppliers for procurement?
Answer: Use the FDA Orange Book manufacturer entries plus the FDA-approved labeling “manufactured for/manufactured by/distributed by” blocks for each Envarsus XR strength.
Operational proof points
- Address match across Orange Book and label
- Lot packaging/labeler codes aligned with approved labeling
- Consistency across wholesalers and hospital pharmacy receipts
Key Takeaways
- Envarsus XR’s U.S. brand supplier is Hikma Pharmaceuticals USA, Inc.
- The true manufacturing supplier is the NDA-approved manufacturing facility(ies) shown in FDA Orange Book and the approved label.
- Supplier mapping for diligence must be strength-specific and must rely on Orange Book + label manufacturing/distribution statements.
- Contract manufacturing and packaging suppliers are constrained by approved CMC pathways and facility qualification status.
FAQs
1) Who is listed as the NDA holder for Envarsus XR?
Use the FDA Orange Book listing for Envarsus XR (tacrolimus extended-release tablets) to confirm the NDA applicant/license holder.
2) Do wholesalers distribute Envarsus XR under their own label or the brand label?
Wholesalers typically distribute the brand-labeled product. The controlling “supplier” is the labeled manufacturer/distributor entity tied to the FDA-approved product record.
3) How many manufacturing sites supply Envarsus XR?
Count the manufacturer/packager entries tied to Envarsus XR strengths in the Orange Book.
4) Can Envarsus XR change manufacturers without FDA approval?
No. Manufacturing/packaging changes generally require FDA notification or approval via CMC supplements depending on the change category.
5) How do I confirm the manufacturing site on a specific lot of Envarsus XR?
Check the packaged product labeling (manufacturer/packager statement) and align the lot’s labeler/manufacturing code to the FDA-approved product record for Envarsus XR.
References (APA)
- U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Envarsus XR entries for tacrolimus extended-release tablets). FDA.
- U.S. Food and Drug Administration. (n.d.). Envarsus XR (tacrolimus) prescribing information (manufacturing and distribution labeling blocks). FDA.
