Suppliers and packagers for aromasin

aromasin

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Pfizer	AROMASIN	exemestane	TABLET;ORAL	020753	NDA	Pharmacia & Upjohn Company LLC	0009-7663-04	30 TABLET in 1 BOTTLE (0009-7663-04)	1999-10-21
Pfizer	AROMASIN	exemestane	TABLET;ORAL	020753	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	59762-2858-1	30 TABLET, SUGAR COATED in 1 BOTTLE (59762-2858-1)	2011-04-01

AROMASIN (exemestane): Who Supplies It and What Is in the Supply Chain

Last updated: April 26, 2026

Aromasin is an oral aromatase inhibitor where the critical supply chain is organized around (1) the active pharmaceutical ingredient (API) exemestane, (2) finished-dose oral tablet manufacturing, and (3) packaging and distribution. Public sources typically identify the commercial authorization holder and the marketed product strengths; they do not consistently disclose the underlying API and tablet manufacturers at the “supplier-by-supplier” level across all jurisdictions. Where public filings do specify manufacturers, the supplier list is jurisdiction-specific and tied to local marketing-authorizations, distributors, and label packers.

Who are the market-facing suppliers for Aromasin by jurisdiction?

Aromasin marketing is handled by regional product authorizations and commercial organizations. Public label, regulatory, and distributor listings show different “supplier” entities depending on geography and packaging configuration (strength and pack size).

United States (FDA label access via authorized brand channels)

• Marketed product name: Aromasin
• Route/dosage form: Oral tablets
• Key regulator: FDA (US label and listing system)

(Public US-facing label distributors and manufacturers are not consistently exposed in a way that supports a single global “supplier list” for API and tablet across all pack configurations.)

European market (EMA national marketing authorizations)

• Regulatory framework: Member State marketing authorizations under EU rules
• Product supply: Typically involves a local marketing authorization holder and multiple manufacturing sites for API or finished product

(EU public records do not provide a single cross-market supplier roster in a standardized table format for all member states.)

What are the critical inputs suppliers must provide?

For Aromasin tablets, supplier capabilities generally break into three categories.

Supply chain node	What suppliers provide	What is validated
API	Exemestane (active)	Identity, purity, polymorph control (if applicable), residual solvents, assay
Finished dose	Aromasin tablets (excipients + exemestane blend, compression/coating)	Tablet composition, dissolution, stability, impurity profile
Packaging	Blister or bottle packaging, labeling, distribution	Serialization where applicable, label compliance, storage/shipping conditions

Aromasin is a prescription oral product. In practice, procurement teams typically track vendor compliance against GMP, data integrity, and change-control history for both API and finished-dose manufacturing.

What does “supplier” mean for Aromasin in procurement terms?

Procurement for Aromasin normally distinguishes between:

1. API manufacturer (exemestane site)
2. Finished-dose manufacturer (tablet manufacturing site)
3. Label packer and logistics supplier (often different from tablet maker)
4. Commercial distributor (country-dependent)

Public sources commonly provide the commercial/distribution and regulatory authorization layers, while API and tablet manufacturing sites are frequently disclosed in regulatory documents rather than product-market listings.

What APIs and tablet specs drive supplier qualification?

Aromasin’s supplier qualification package typically includes:

• CMC-related release specifications
  • Exemestane identity (and impurity thresholds)
  • Assay and related substances (including degradation impurities under stress)
  • Dissolution profile for each strength
• Stability program
  • Shelf-life support for packaging configuration
  • Temperature and humidity storage data
• Manufacturing controls
  • Blend uniformity and content uniformity strategies
  • Wet granulation/dry granulation and tablet compression controls (process-specific)
  • Coating and curing parameters (process-specific)

Even when two vendors source from the same API grade, finished-dose performance can differ due to excipient selection and process parameters. That is the reason procurement often requires a full bridging package when swapping manufacturing sites.

Supplier landscape: what is visible vs. what is typically hidden

Publicly visible:

• The brand product and strengths marketed under Aromasin
• The regulatory record for the product (and sometimes manufacturing site names in regulatory databases, depending on jurisdiction and access format)
• The commercial distributor/marketing authorization holder on labels

Typically not visible in a single consolidated public list:

• A cross-country mapping of every API supplier for exemestane used in all Aromasin packs
• A cross-country mapping of every finished-dose tablet site producing Aromasin
• Back-up sites for emergency supply

For high-stakes R&D and sourcing decisions, this means supplier selection must be anchored to the specific product dossier and manufacturing sites that correspond to the intended market and packaging.

What should sourcing teams request from Aromasin suppliers?

To qualify an Aromasin supply partner at the level needed for launch continuity, procurement teams typically demand:

• GMP certificates for API and finished-dose sites (current dates and scope)
• DMF/ASMF or regulatory dossier linkage for exemestane grade used
• Batch release CoA history for the exact strength and pack configuration
• Change control commitments for formulation/process and impurity specification drift
• Stability summaries aligned to packaging and label configuration

Key Takeaways

• Aromasin supply chain is structured around API exemestane, finished-dose tablet manufacturing, and local packaging and distribution layers.
• Public sources often show commercial/distribution and regulatory authorization holders by market, but do not consistently provide a single global table of API and tablet suppliers across all jurisdictions.
• Supplier qualification must be anchored to the specific regulatory dossier/manufacturing sites for the target market and pack configuration, with a complete CMC and stability evidence package.

FAQs

1) Who is the API supplier for exemestane used in Aromasin?

The API supplier is the exemestane manufacturing site(s) listed in the relevant regulatory dossier for the specific market. Public visibility varies by jurisdiction and regulatory database structure.

2) Are Aromasin tablets always made by the same manufacturer?

No. Finished-dose tablet manufacturing can vary by market, pack configuration, and supply strategy. The manufacturing site is typically tied to the product’s regulatory approval in that jurisdiction.

3) What documents determine whether a vendor is acceptable for Aromasin supply?

At minimum, sourcing requires GMP scope, regulatory dossier linkage for the API grade, and batch CoAs that match the exact strength and packaging configuration.

4) Can a buyer swap API suppliers without reformulating finished tablets?

Often yes at the API level, but product equivalence must be demonstrated through CMC evidence, because impurity profiles and physical properties can affect tablet dissolution and stability.

5) What drives supplier pricing differences for Aromasin?

Costs shift based on API grade constraints, finished-dose process complexity, stability/bridging requirements, and packaging and compliance needs for the target market.

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References

[1] U.S. Food and Drug Administration. (n.d.). Aromasin (exemestane) Prescribing Information. FDA label repository. https://www.accessdata.fda.gov/
[2] European Medicines Agency. (n.d.). Medicines database: Aromasin. EMA. https://www.ema.europa.eu/
[3] Drugs@FDA. (n.d.). Aromasin drug product information. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/