Suppliers and packagers for ASTAGRAF XL

ASTAGRAF XL

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096	NDA	Astellas Pharma US, Inc.	0469-0647-73	1 BOTTLE in 1 CARTON (0469-0647-73) / 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE	2013-07-19
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096	NDA	Astellas Pharma US, Inc.	0469-0677-73	1 BOTTLE in 1 CARTON (0469-0677-73) / 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE	2013-07-19
Astellas	ASTAGRAF XL	tacrolimus	CAPSULE, EXTENDED RELEASE;ORAL	204096	NDA	Astellas Pharma US, Inc.	0469-0687-73	1 BOTTLE in 1 CARTON (0469-0687-73) / 30 CAPSULE, COATED, EXTENDED RELEASE in 1 BOTTLE	2013-07-19

Suppliers and packagers for ASTAGRAF XL

Last updated: June 11, 2026

ASTAGRAF XL Suppliers: Who Manufactures and Supplies Astagraf XL (Tacrolimus Extended-Release) Globally?

ASTAGRAF XL (tacrolimus extended-release) is supplied in the US by Astellas Pharma US, Inc. The drug’s manufacturing and secondary-supply footprint is controlled through Astellas’ global supply chain for tacrolimus ER and the contracted sites listed in regulatory filings and product packaging.

Who manufactures ASTAGRAF XL (tacrolimus extended-release) and supplies the US market?

US marketer/sponsor: Astellas Pharma US, Inc.
ASTAGRAF XL is marketed in the US under the Astellas brand via its US entity.

Key supply chain pattern: In the US, the manufacturing and distribution network is tied to (1) the NDA holder’s internal manufacturing program and (2) contract manufacturing and packaging sites named in US product labeling and FDA submissions. For ASTAGRAF XL, those site-specific details should be pulled from the current label’s “Manufactured for/Distributed by” and FDA CMC submissions supporting the NDA.

What entities appear on ASTAGRAF XL labels as “manufacturer,” “manufactured for,” or “distributed by”?

In practice for brand tacrolimus ER products, the label typically lists:

• a company name as the “manufacturer” and/or “manufactured for” (NDA holder or contract manufacturer)
• a distribution company (often the NDA holder’s US sales entity)

For ASTAGRAF XL, the consistent publicly listed supplier-facing entity in the US is Astellas Pharma US, Inc. (label-facing supply entity).

What is the FDA regulatory status of ASTAGRAF XL and how does it define supplier obligations?

ASTAGRAF XL is regulated as an approved prescription drug with an NDA marketing authorization. The NDA holder bears responsibility for:

• CMC compliance and manufacturing controls
• product labeling content
• ongoing pharmaceutical quality system obligations
• US supply continuity (with licensed manufacturing/packaging sites)

Does ASTAGRAF XL have an Orange Book listing that identifies supplier-relevant details?

Orange Book listings identify the approved NDA and can include:

• dosage forms
• active ingredient
• patent listings
• reference to regulatory documentation that anchors CMC and labeling

Supplier identification at the site level is usually not fully enumerated in Orange Book; it is typically handled via:

• the package insert/label “Manufactured for/Distributed by”
• FDA facility listings (for drugs) tied to the NDA

Which contract manufacturers or packaging suppliers support ASTAGRAF XL (tacrolimus ER) production?

Contract manufacturing and packaging suppliers are typically disclosed through:

• the commercial label (manufacturing/packaging sites sometimes appear with company names)
• FDA facility registration and drug establishment data tied to the NDA and dosage form
• procurement and supply agreements governed by Astellas’ quality system

For ASTAGRAF XL specifically, the supplier list that matters for operations and compliance is the combination of:

1. Astellas Pharma US, Inc. as the US marketer/sponsor entity
2. the manufacturing site(s) named on the label and/or in FDA CMC documents
3. packaging/repackaging and distribution nodes used for US commercial supply

How many manufacturing sites supply ASTAGRAF XL and what dosage forms are covered?

ASTAGRAF XL is an oral extended-release capsule product line. Supply coverage usually includes:

• capsule strength variants (multiple strengths)
• one or more filled-capsule manufacturing streams
• packaging lines for commercial lot release in the US

The number of manufacturing sites is determined by Astellas’ commercial strategy and the approved CMC manufacturing description for the NDA. Site count must be reconciled against:

• the current label “Manufactured for” entity and address
• FDA registered establishment records tied to the dosage form

What competing tacrolimus ER suppliers matter for ASTAGRAF XL sourcing risk?

ASTAGRAF XL’s competitive supplier set includes other tacrolimus extended-release brands and their NDA holders, which can create procurement leverage and continuity risk comparisons for wholesalers and transplant centers.

If sourcing risk analysis is required, decision-makers compare:

• brand NDA holder quality and continuity records
• manufacturing site footprint size and geographic distribution
• shortage history and FDA shortages database patterns (if any)

What is the likely supply chain model for ASTAGRAF XL (global procurement to US distribution)?

Astellas’ supply model for a complex oral ER product generally follows:

• bulk drug substance and formulated dosage production under NDA CMC control
• capsule filling and ER formulation release under validated manufacturing processes
• packaging into US-labeled cartons/blisters/bottles through approved packaging lines
• lot release and distribution through US commercial logistics managed by Astellas’ US organization

From a supplier lens, the critical procurement questions are:

• which manufacturing establishments are approved in the NDA
• which establishments handle secondary packaging for US distribution
• which distribution entities hold US warehousing and fulfillment roles

Key supplier entities for ASTAGRAF XL (actionable list)

US supplier-facing entity (brand sponsor/marketer):

• Astellas Pharma US, Inc.

Supplier identification at the site level (manufacturing/packaging):

• Determined by the current ASTAGRAF XL label “Manufactured for” / “Distributed by” statements and the NDA CMC manufacturing description registered with FDA.

Key Takeaways

• ASTAGRAF XL (tacrolimus extended-release) is supplied in the US under Astellas Pharma US, Inc. as the marketer/sponsor entity.
• Site-level manufacturer and packaging suppliers are embedded in the current product label and the NDA CMC/FDA registered establishment records.
• For procurement, shortage, and compliance risk decisions, the actionable supplier map is: Astellas US sponsor entity + NDA-approved manufacturing/packaging establishments tied to the dosage form.

FAQs

1) Who distributes ASTAGRAF XL in the US?

Astellas Pharma US, Inc. is the US distribution/marketing entity associated with ASTAGRAF XL.

2) Are ASTAGRAF XL manufacturing sites listed on the package insert?

Yes. The label typically includes “manufactured for” and/or “distributed by” statements that identify the responsible company and may include address details tied to manufacturing and distribution.

3) How can I verify ASTAGRAF XL manufacturing establishments used for US lots?

Cross-reference the current label with FDA drug establishment registrations tied to the NDA and dosage form.

4) Do Orange Book listings name ASTAGRAF XL suppliers?

Orange Book generally lists NDA and patent/regulatory details, not a complete site-by-site manufacturing supplier roster; supplier identification is more reliably obtained from labeling and FDA facility records.

5) What supplier risks matter most for tacrolimus ER products like ASTAGRAF XL?

Manufacturing lot continuity across approved sites, ER formulation consistency, and packaging line capacity for US-labeled finished product.

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References (APA)

1. Astellas Pharma US, Inc. ASTAGRAF XL (tacrolimus extended-release) prescribing information and product labeling. FDA labeling database.
2. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
3. U.S. Food and Drug Administration. Drug Establishments Current Registration Site data (facility registration and listings).