Last updated: April 25, 2026
Who supplies anastrozole active pharmaceutical ingredient (API)?
Anastrozole is manufactured as an API and sold to branded and generic finished-dose producers. The supplier market is concentrated around a small set of API producers and specialty generics firms that supply high-volume tablets.
Common supplier archetypes
- API manufacturers: produce anastrozole API and sell to formulation plants under DMF/CEP-supported supply chains.
- Finished-dose generic manufacturers: buy API from contract sources and sell tablets in individual markets under local MA/ANDA pathways.
Representative supplier set (API and related supply-chain roles)
The following entities are repeatedly associated with anastrozole API supply, submissions, and/or finished-dose manufacturing for global markets:
- Hetero Labs (Hetero Drugs) (API and/or formulation supply for generics markets; India)
- Sun Pharmaceutical Industries (generic supply; India)
- Sandoz (generic distribution; global stewardship)
- Teva Pharmaceuticals (generic supply; global stewardship)
- Accord Healthcare (generic supply; multiple markets)
- Mylan / Viatris (generic supply; multiple markets)
- Cipla (generic supply; multiple markets)
- Dr. Reddy’s Laboratories (generic supply; multiple markets)
Who supplies anastrozole finished-dose tablets (global generic market)?
Finished-dose anastrozole is typically sold as 1 mg tablets under many brands and generic labels. The finished-dose supplier list changes by country, but the companies below are consistently active across EU, UK, US, and other regulated markets.
Representative finished-dose suppliers
- Teva
- Sandoz
- Accord Healthcare
- Mylan / Viatris
- Cipla
- Dr. Reddy’s
- Hetero Labs
- Sun Pharma
Dose and formulation
- Strength: 1 mg tablets (standard market form for anastrozole)
- Drug class: aromatase inhibitor used in hormone receptor-positive breast cancer in postmenopausal patients
What regulatory documentation typically governs anastrozole supply?
For regulated supply chains, manufacturers rely on:
- DMF/ASMF filings (US/EU-style documentation where applicable) for API technical disclosure and control strategy
- CEP where used in EU distribution networks
- GMP manufacturing approvals tied to specific sites
Practical impact for sourcing
- Qualified buyers require site-specific GMP status and alignment of specifications (assay, impurities, residual solvents, polymorph/solid-state where relevant) with internal quality agreements.
- Procurement decisions usually depend more on regulatory readiness and batch release reliability than on price alone, given anastrozole’s long-term generic footprint and strict specification adherence.
How do API sourcing and finished-dose manufacturing split in practice?
Most commercial supply is structured like this:
- API production at one or more qualified manufacturing sites
- Formulation and packaging at a separate tablet-manufacturing facility
- Market authorization tied to the finished dose and labeling for each jurisdiction
Typical division of labor
- API producers focus on anastrozole API quality, impurity profile control, and batch consistency.
- Finished-dose manufacturers focus on formulation performance, dissolution/biowaiver strategy where accepted, and local labeling requirements.
What should buyers validate in anastrozole vendor qualification?
Even without changing the buyer’s compliance framework, anastrozole sourcing generally concentrates vendor qualification on:
Quality and consistency
- Assay and impurity profile consistent with pharmacopoeial and internal specs
- Residual solvent controls within permitted limits
- Stability program results aligned to projected shelf life
- Change control history at both API and tablet sites (process, analytical, packaging)
Supply continuity
- Evidence of scale and capacity for sustained demand (anastrozole has stable long-term generic volumes)
- Batch-release timelines and standard lead times by plant and geography
- Backup sourcing arrangements for API and excipients
Vendor short list for procurement planning
A procurement “short list” for anastrozole should include suppliers that are repeatedly present in global generics supply chains across multiple jurisdictions, typically with strong regulatory documentation.
Short-list candidates (representative, global active players)
- Hetero Labs
- Sun Pharmaceutical Industries
- Teva
- Sandoz
- Accord Healthcare
- Viatris / Mylan
- Cipla
- Dr. Reddy’s Laboratories
Key Takeaways
- Anastrozole supply is dominated by a core set of global generic manufacturers and specialty API/formulation suppliers.
- Finished-dose market activity centers on 1 mg tablets, with procurement typically split between API producers and tablet formulators.
- Vendor qualification for anastrozole focuses on impurity control, GMP status, stability, and supply continuity under site-specific regulatory documentation.
FAQs
-
Is anastrozole mainly sourced as API or as finished tablets?
Both structures exist. Many procurement models source API for in-house or contract formulation, while others buy finished tablets directly from authorized generic manufacturers.
-
What is the standard commercial strength of anastrozole tablets?
The standard generic market strength is 1 mg tablets.
-
Which categories of suppliers matter most for sourcing?
API producers for the technical supply chain and finished-dose manufacturers for product release and market authorization.
-
How do regulatory filings affect anastrozole supply?
API supply is typically tied to DMF/ASMF or CEP-style documentation and site GMP approval, which governs qualification and change acceptance.
-
What tends to be the biggest procurement risk in anastrozole?
The most material risks are tied to site-specific GMP gaps, impurity-spec drift, and supply continuity rather than molecule science.
References (APA)
[1] U.S. Food and Drug Administration. (n.d.). Drug databases and approvals (including generic drug product information for anastrozole). FDA. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approvals-and-databases
[2] European Medicines Agency. (n.d.). European public assessment reports and medicines information (anastrozole products). EMA. https://www.ema.europa.eu/
[3] World Health Organization. (n.d.). International Nonproprietary Names (INN) for pharmaceutical substances (anastrozole). WHO. https://www.who.int/teams/health-product-and-policy-standards/standards-and-specifications/naming-of-pharmaceutical-substances
