Suppliers and packagers for ARIMIDEX

ARIMIDEX

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ani Pharms	ARIMIDEX	anastrozole	TABLET;ORAL	020541	NDA	ANI Pharmaceuticals, Inc.	62559-670-30	30 TABLET in 1 BOTTLE (62559-670-30)	2018-06-26

ARIMIDEX (anastrozole) suppliers: who makes the drug substance and finished tablets, plus key upstream contractors

Last updated: June 1, 2026

Executive summary

• Active ingredient (API): anastrozole is sourced from multiple global chemical suppliers that produce the API to pharmaceutical grade and supply generic and branded tablet manufacturers. The commercially relevant “supplier” landscape is typically defined by ANDA/DMF API holders and CDMOs rather than a single upstream source.
• Finished product supply: ARIMIDEX tablets are produced through contract manufacturing networks that include tablet formulators, granulation/compression lines, packaging vendors, and QA release sites. In the US, the FDA’s CDER Orange Book and labeling do not name all upstream suppliers; the practical supplier set is identified via DMF/CEP holders, inspection records, and approved ANDA supply chains.
• Business implication: For licensing, litigation, and supply-risk workstreams, the defensible approach is to map (1) anastrozole API DMF/ASR holders and (2) tablet manufacturing sites tied to approved labels/ANDA submissions, then stress-test availability by geography and inspection history.

Who supplies anastrozole API for ARIMIDEX tablets?

ARIMIDEX’s active ingredient is anastrozole, a nonsteroidal aromatase inhibitor used in estrogen receptor–positive breast cancer (adjuvant and advanced settings). API sourcing for anastrozole is widely distributed across chemical manufacturers supporting both branded and generic tablet supply.

Common supplier categories upstream of ARIMIDEX

1. Anastrozole API manufacturers (DMF/ASR holders)
   • Companies that file an FDA Drug Master File (DMF) for anastrozole API, covering synthesis route, specifications, stability, and manufacturing sites.
2. Intermediates producers
   • Firms that supply late-stage intermediates used to synthesize anastrozole, often operating under contractual procurement by the API manufacturer.
3. CDMOs for conversion
   • Contract organizations that convert API into bulk drug product (blend, granulate where applicable, milling, compression support) under cGMP and site QA release.

What makes “API suppliers” hard to pin to one name

• The FDA’s Orange Book listing for ARIMIDEX (NDA) identifies the application holder and dosage form, but not the full upstream supply chain.
• Upstream supplier identity is usually discoverable by triangulating DMF holders, site inspectors’ observations, and ANDA source-of-manufacture references rather than from labeling alone.

Which companies manufacture ARIMIDEX finished tablets and who are the contract manufacturers?

ARIMIDEX is marketed as oral tablets (commonly 1 mg strength in most markets). Finished-product manufacturing is typically performed at one or more tablet manufacturing sites, with packaging at primary and secondary packagers.

Finished product supply chain components

• Tablet manufacturing site (bulk compression, labeling line)
• QA release unit
• Packaging vendors (bottles/blisters, carton pack)
• Distribution centers (sometimes integrated with the packager)

Practical way to identify finished-product manufacturers

• Track labeler/manufacturer names on packaging inserts and GPI (generic product indicator) mappings across markets.
• Use FDA facility registration and inspection databases to connect the tablet NDA/ANDA chain to specific manufacturing sites.
• Compare with generic anastrozole ANDA manufacturing relationships, which usually reference the same API supplier families and common CDMOs.

What Orange Book data reveals about ARIMIDEX manufacturing and supplier footprints?

The Orange Book is the starting point for regulatory status and formulation identity, not a supplier directory.

Orange Book elements that can be used for supplier mapping

• NDA holder and dosage form listing
• Active ingredient and strength
• Patent and exclusivity status (not “who makes it”)
• Hatch-Waxman coded data for listed patents and exclusivity, which affects what generics can enter and how supply chains compete

Key supplier-risk insight

• Once generics enter, the supplier set shifts to those that support lowest-cost, high-volume ANDA production at regulated sites with acceptable inspection outcomes. For anastrozole, this often means multiple API sources and multiple finished-product packager/manufacturer combinations.

How do generic anastrozole ANDA supply chains map back to ARIMIDEX suppliers?

When generics have ANDAs approved for anastrozole tablets, those approvals typically reference:

• API source (often via DMF or cross-reference statements)
• Finished-product manufacturing site
• Bioequivalence and dissolution performance

Mapping approach used in competitive intelligence

• Compile the largest-market share generic manufacturers for anastrozole tablets.
• Pull the manufacturing site list for their ANDAs.
• Cross-check those sites against common API DMF holders.
• The resulting set often approximates the supplier network that can also supply branded products or compete for market share.

What supplier bottlenecks exist for anastrozole (API and tablet manufacturing)?

Supplier risk is rarely a single-company failure. The key bottlenecks are:

• API crystallization/polymorph control
• impurity profile management (process-related impurities)
• site capacity for high-volume compression
• packaging lead times for bottles and blisters
• regulatory inspection outcomes that limit usable manufacturing lots

Common technical constraints that affect supply

• API process control for anastrozole synthesis and purification
• Stability of API and tablet blend
• Dissolution performance consistency across granulation/compression lines

Which contract manufacturing organizations (CMOs/CDMOs) typically support anastrozole tablets?

For anastrozole tablets, CMOs/CDMOs generally fall into two groups:

• Tablet compression specialists with high-volume facilities
• Full-service solid oral dose providers that handle granulation, blending, compression, coating (if applicable), and packaging

How to identify the most relevant CDMOs for ARIMIDEX

• Use ANDA manufacturing site lists and compare overlaps across multiple ANDAs.
• Prioritize sites that show repeated approvals for solid oral dosage forms and stable inspection histories.

Does ARIMIDEX use multiple suppliers by geography (US/EU/Asia)?

Most brands that have long market lifetimes maintain multi-site manufacturing strategies:

• Primary manufacturing site for the NDA
• Secondary/backup sites in case of capacity or compliance events
• Region-specific packaging and distribution networks

For ARIMIDEX specifically, the supply chain is shaped by long-standing generic competition, which drives stronger reliance on CDMO networks and alternative packaging vendors.

What patent and litigation factors affect ARIMIDEX supplier access?

Supplier access is indirectly affected by:

• Patent estate strength (composition, method-of-use, formulations)
• Exclusivity windows (where applicable to specific listings)
• ANDA settlement agreements that can restrict generic entry timing
• Paragraph IV litigation outcomes that determine when alternative suppliers can legally sell

Commercial impact

• When patents are fully expired or invalidated, the supplier set expands quickly, driven by ANDA approvals and CDMO capacity.

Key Takeaways

• ARIMIDEX supplier identification is best treated as a network problem: anastrozole API DMF/ASR holders plus tablet manufacturing and packaging sites tied to approved labels and ANDAs.
• Orange Book does not enumerate upstream suppliers; high-intent supplier work uses DMF-based API mapping and ANDA manufacturing site overlaps.
• The supplier bottlenecks for anastrozole are typically API quality control and high-volume tablet compression capacity, not a single proprietary input.

FAQs

1) How can I find who makes the anastrozole API used in branded and generic tablets?
Use FDA DMF/ASR holder identification and reconcile with ANDA source-of-manufacture references and inspection histories.

2) Which data fields best identify finished-product manufacturing sites for anastrozole tablets?
ANDA manufacturing site listings and associated facility inspection records, cross-referenced to solid oral dose production.

3) What happens to anastrozole tablet supply after patent exclusivity ends?
Supplier count typically increases via additional ANDA manufacturers and CDMOs, reducing lead-time risk but increasing sourcing variance.

4) Are there formulation-specific supplier constraints for anastrozole tablets?
Yes, performance depends on blend/process control for dissolution and stability, so sites need proven compression and QA release capability.

5) How do settlement agreements affect supplier availability for anastrozole?
They can delay lawful generic launches, concentrating volume with incumbent manufacturers until the restraint is lifted.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. FDA. Drug Master Files (DMF).
3. FDA. ANDA approvals and labeling for anastrozole oral tablets (solid oral dosage form).