Suppliers and packagers for imuran

imuran

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Legacy Pharma	IMURAN	azathioprine	TABLET;ORAL	016324	NDA	Sebela Pharmaceuticals Inc.	54766-590-10	100 TABLET in 1 BOTTLE (54766-590-10)	2017-12-01

Suppliers and packagers for imuran

Last updated: June 1, 2026

IMURAN (azathioprine): Who supplies the active ingredient, finished product, and key excipients?

IMURAN is a brand of azathioprine (oral tablets). The “supplier” landscape depends on whether the question is API source, finished-dose manufacturing/labeler, or excipients. Public records typically identify labelers and generic manufacturers, while API producers and excipient vendors are often not fully disclosed in FDA-facing documents.

Who manufactures IMURAN and supplies the finished drug product?

IMURAN labeler/manufacturer information is usually visible in FDA’s Orange Book (for NDA-listed products) and in FDA product listings. Those records identify the company holding the NDA/labeler and the firm listed as manufacturer for marketed strengths and dosage forms.

What is IMURAN’s dosage form and strength coverage?

IMURAN is marketed as azathioprine oral tablets. The Orange Book listing (and FDA label for that NDA) specifies the strengths and the product-specific listing (e.g., tablet strength, dosage form, and approval history).

How do supply-chain risks show up for branded azathioprine?

For branded products like IMURAN, supply continuity is driven by:

• NDA/labeler quality agreements with contract manufacturers
• Single-source or limited-source API supply
• Ability to qualify alternate manufacturing sites
• Regulatory reporting history for manufacturing changes

Which companies supply azathioprine API used to make IMURAN?

Azathioprine is a mature immunosuppressant with multiple global API suppliers. However, API source identification for IMURAN specifically is usually not deterministically stated in public FDA databases. The typical publicly observable approach is:

• identify generic azathioprine NDA/ANDA manufacturers (finished product), then map likely API sources via commercial intelligence and supplier disclosures, and
• use corporate filings, DMFs, and procurement documentation (often non-public) to confirm the exact API producer behind a particular branded label.

What API suppliers dominate the global azathioprine market?

Publicly visible DMF holders and specialty chemical producers commonly supply azathioprine intermediates and API batches to multiple finished-dose firms. In the azathioprine supply chain, the key commercial pattern is:

• API and intermediate production is distributed across India, China, and Europe, with some additional manufacturing in other regions
• finished-dose manufacturers then place long-term contracts for API supply tied to stability and impurity controls

What patents or regulatory filings affect who can supply azathioprine for IMURAN?

IMURAN is off-patent in most jurisdictions for its original small-molecule brand protection, so supply constraints are usually manufacturing and regulatory, not exclusivity. The relevant patent landscape for azathioprine generally matters most for:

• specific formulations (if any later-protected)
• manufacturing processes
• method-of-use claims
• data exclusivity (limited applicability for long-established molecules)

Do Paragraph IV challenges apply to IMURAN?

Paragraph IV certifications are relevant for ANDA filers targeting listed Orange Book patents. For IMURAN, Paragraph IV activity typically tracks whether any Orange Book-listed patents remain in force. For azathioprine, the brand’s Orange Book relevance is usually limited compared with newer drug approvals.

What does the Orange Book say about IMURAN suppliers and manufacturing firms?

The Orange Book listing provides:

• NDA number and labeler
• listed drug product(s) and route/dosage form
• patent numbers and expiration dates tied to the listed drug
• whether there are active listed patents

How to interpret Orange Book “manufacturer” versus “labeler”

• Labeler is the company named on the NDA application.
• Manufacturer on FDA listings can be the firm that physically manufactures the drug product or a firm responsible for product release.
• Neither field reliably identifies the underlying API plant.

How many suppliers can make azathioprine tablets that compete with IMURAN?

Because azathioprine is a mature generic drug, the market typically has:

• multiple generic finished-dose manufacturers
• recurring production by a set of established CDMOs
• API procurement from a small number of capable API producers that can meet impurity and stability requirements

That competitive structure makes “supplier availability” less about legal access and more about:

• regulatory standing (site history, cGMP track record)
• impurity profiles and batch-to-batch consistency
• ability to supply consistent tablet potency and dissolution specs

Which excipient suppliers support IMURAN tablets?

Finished-dose manufacturers typically select from a qualified pool of excipient vendors for:

• tablet binders and disintegrants
• compression aids
• coating systems (if applicable)

Public records rarely name the specific excipient supplier for a branded product. Instead, excipient supply is managed by the finished-dose manufacturer’s quality system and approved supplier list. As a result, excipient supply is usually inferred through:

• generic manufacturer formulations disclosed via labeling
• excipient specifications and supplier qualification documentation (usually not public at the product level)

Commercial landscape: Who supplies azathioprine tablets in the US versus IMURAN?

The most reliable public “supplier” mapping for azathioprine is:

• US generic drug firms with Orange Book ANDA listings for azathioprine tablets
• labelers/manufacturers for each strength

This yields the competitive and capacity picture even when the API plant is not disclosed.

Key Takeaways

• IMURAN is an azathioprine oral tablet brand; “suppliers” can mean labeler/manufacturer of the finished product or API producers, which are not always the same entities.
• Public FDA datasets reliably support identification of finished product labeler and manufacturing firm, but usually not the exact azathioprine API plant behind IMURAN.
• Supplier constraints for azathioprine are typically cGMP and manufacturing qualification rather than patent exclusivity.
• A practical diligence approach is to map US ANDA/generic manufacturers listed for azathioprine tablets and then trace API sources via DMF holders and commercial supplier disclosures.

FAQs

1. Where can I see who manufactures IMURAN tablets in the US?
   Use FDA’s Orange Book and FDA product listings for the IMURAN NDA to identify the labeler and listed manufacturer.

2. Are there multiple suppliers for azathioprine tablets that can replace IMURAN?
   Yes, azathioprine is typically supplied by multiple generic tablet manufacturers in the US market.

3. What determines whether an API supplier can support azathioprine tablet launches?
   Batch impurity profile, stability, DMF coverage, and ability to meet tablet potency and dissolution specifications under cGMP.

4. Do IMURAN Orange Book patents limit generic azathioprine competition?
   Only if Orange Book patents are listed as active for the specific IMURAN drug product. For mature drugs like azathioprine, legal barriers are usually limited.

5. Can excipient supplier identity be verified from public records for IMURAN?
   Usually not at the product level; excipient sourcing is generally managed through qualified supplier systems and is not consistently disclosed in FDA-facing documents.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drug Product Database (Drugs@FDA / SPL). U.S. Food and Drug Administration.