Suppliers and packagers for prograf

prograf

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	PROGRAF	tacrolimus	CAPSULE;ORAL	050708	NDA	Astellas Pharma US, Inc.	0469-0607-73	1 BOTTLE in 1 CARTON (0469-0607-73) / 100 CAPSULE, GELATIN COATED in 1 BOTTLE	1998-08-24
Astellas	PROGRAF	tacrolimus	CAPSULE;ORAL	050708	NDA	Astellas Pharma US, Inc.	0469-0617-73	1 BOTTLE in 1 CARTON (0469-0617-73) / 100 CAPSULE, GELATIN COATED in 1 BOTTLE	1994-04-08
Astellas	PROGRAF	tacrolimus	CAPSULE;ORAL	050708	NDA	Astellas Pharma US, Inc.	0469-0657-73	1 BOTTLE in 1 CARTON (0469-0657-73) / 100 CAPSULE, GELATIN COATED in 1 BOTTLE	1994-04-08

PROGRAF suppliers: drug substance, branded product manufacturers, and contract manufacturing footprint

Last updated: May 25, 2026

PROGRAF (tacrolimus) is manufactured by multiple branded and contract suppliers depending on market and dosage form. The supplier landscape is anchored by (1) the Orange Book-listed drug product manufacturer(s) and (2) contract manufacturing organizations (CMOs) that support scale-up and fill-finish. A complete supplier map requires Orange Book “Applicant/Holder” and NDA label “Manufactured for” (and, where applicable, distributor) identification for each dosage form strength and market.

Which companies are listed as PROGRAF suppliers in the Orange Book?

Orange Book listings identify the NDA holder and the labeled drug product “applicant/holder” for PROGRAF strengths and dosage forms. These are the highest-signal supplier entities for regulatory and licensing decisions because Paragraph IV certifications and patent listings attach to the Orange Book structure.

What to pull from the PROGRAF Orange Book listing

For each dosage form (immediate-release capsules; extended-release formulations only if separately listed), capture:

• NDA number and applicant/holder name
• dosage form and strength
• manufacturing/labeler entities appearing on the drug label (“manufactured for”)
• associated Orange Book patent numbers and exclusivity indicators (to determine which supplier’s product is tied to which regulatory submission)

Why the Orange Book “applicant/holder” matters

• It is the party that controls NDA regulatory responsibilities.
• It is the most defensible party for licensing and patent enforcement.
• It is the party that certifies exclusivity timelines and governs application substitutions.

Who manufactures PROGRAF capsules and who fills them?

For PROGRAF, the supply chain commonly splits into:

1. drug substance manufacturer (tacrolimus API)
2. drug product manufacturer (capsule bulk)
3. fill-finish and packaging entities (bottling and blistering)

API suppliers vs. finished-dose suppliers

• API suppliers are rarely visible in US Orange Book entries.
• FDA labels and commercial packaging often provide “manufactured for” and/or “distributed by” entities that indicate the finished-dose manufacturer and packager.

How to map capsule manufacturing responsibilities

For each PROGRAF strength:

• read the US prescribing information label section for “Manufactured for” and “Distributed by”
• align that label entity with the Orange Book “applicant/holder”
• identify whether the label explicitly states a CMO name or only the brand owner

What contract manufacturing organizations supply PROGRAF fill-finish?

CMO participation in PROGRAF is determined by:

• label site-of-manufacture statements
• inspection histories tied to labeled manufacturing sites
• drug master file (DMF) relationships when disclosed in supplier documentation

How to identify fill-finish suppliers from labels

Search the PROGRAF container and label for:

• site name and address
• whether the packaging is performed by a different entity than capsule filling
• whether “manufactured for” points to a brand owner or a CMO

What investors and litigators treat as “supplier”

In diligence and dispute contexts, “supplier” is usually interpreted as:

• the finished-dose manufacturer labeled on the product
• the NDA holder
• the site-of-manufacture responsible for current production These entities drive product availability and regulatory risk allocation.

What raw-material and component suppliers matter for PROGRAF?

PROGRAF supply dependencies extend beyond tacrolimus API to excipients, capsule shell components, and packaging materials.

High-risk inputs in tacrolimus capsule manufacturing

• capsule shells (gelatin or alternative capsule materials depending on formulation)
• film coatings and printing inks
• desiccants and bottle closure systems
• blister components (if blister-packaged in the applicable market)
• analytical reference standards for assay and impurity profiling

Supply risk controls that affect supplier selection

• validated alternative sources for excipients and packaging
• tight control of water activity and moisture-sensitive processing steps
• stability-indicating analytical methods and reference standard qualification

Do PROGRAF suppliers differ by country or dosage form?

Yes. Supplier identity is typically market- and label-dependent:

• US and EU labels can name different “manufactured for” entities.
• Some markets use local packagers and distributors even when the drug product is produced elsewhere.
• If dosage forms differ (for example, immediate-release capsules vs. any separately regulated extended-release variant), supplier footprints change.

How to compare supplier footprints across markets

Build a crosswalk by:

• label “manufactured for” entity per market
• NDA or MAH (marketing authorization holder) per region
• manufacturing site addresses
• packager/distributor per region

Which PROGRAF suppliers are relevant for generic and biosimilar entry risk?

For small-molecule generics (tacrolimus), “supplier” impacts practical launch timing through:

• capacity availability at labeled sites
• ability to meet bioequivalence specifications
• quality system readiness and stability data generation

What matters in Para IV and ANDA timing

In a generic challenge environment, the supplier profile affects:

• whether the brand’s listed manufacturing sites can sustain launch-date inventory
• whether the NDA holder changes manufacturing sites during the exclusivity or litigation window (site-change can require CMC supplements)
• how quickly authorized generics or launch partners can replicate label packaging and analytical release testing

What is the competitive manufacturing landscape for tacrolimus capsules?

Tacrolimus generics compete based on:

• dissolution and bioequivalence performance
• impurity profiles (including process-related impurities)
• production robustness and batch-to-batch consistency

Supplier differentiation points

• ability to scale tacrolimus API purification
• encapsulation process control (fill weight uniformity and moisture management)
• packaging configuration matching the reference product

How do you build a complete PROGRAF supplier list for diligence?

A diligence-grade supplier list should be structured as a table by:

• dosage form and strength
• NDA label manufacturer (“manufactured for”)
• Orange Book “applicant/holder”
• site-of-manufacture address
• any explicitly named CMO
• packaging/distribution entity

Supplier map template (populate from labels and Orange Book)

Dosage form	Strength	Orange Book applicant/holder	Labeled “manufactured for”	Site-of-manufacture	Packaging/distribution	Notes (CMO/brand)
PROGRAF capsules	—	—	—	—	—	Immediate-release tacrolimus
PROGRAF capsules	—	—	—	—	—	Immediate-release tacrolimus

Key takeaways

• PROGRAF supplier identification is driven by Orange Book applicant/holder plus the label’s “manufactured for” and site-of-manufacture statements by dosage form and strength.
• Finished-dose manufacturers and CMOs are often label-dependent; API suppliers are usually not visible in Orange Book but can be inferred from label site disclosures and supplier DMF relationships when available.
• Supplier footprints vary by country due to local packaging/distribution and differences in manufacturing sites.

FAQs

1. How do I identify the finished-dose manufacturer for PROGRAF in the US label? Look for the “Manufactured for” and site-of-manufacture address on the prescribing information/label and correlate that with the Orange Book applicant/holder.
2. Are PROGRAF API suppliers the same as capsule manufacturers? Often not. Tacrolimus API suppliers and finished-dose capsule manufacturers are frequently different entities.
3. Which supplier entities matter most for ANDA quality and bioequivalence execution? The finished-dose manufacturing site(s), the batch release controls, and the packaging configuration that supports bioequivalence study conditions.
4. Can PROGRAF manufacturing sites change during exclusivity or litigation? Yes, and such changes typically require CMC supplements; the labeled “site-of-manufacture” and NDA submission history determine the controlling supplier at any time.
5. Do PROGRAF suppliers differ between blister and bottle packaging? They can. Packaging and blister-fill suppliers may differ even when the capsule manufacturing site remains the same.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (PROGRAF, tacrolimus). FDA.
2. FDA. Approved drug label information for PROGRAF (tacrolimus) (sections for “Manufactured for” and labeling/manufacturer details). FDA.