Suppliers and packagers for CRESTOR

CRESTOR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366	NDA	AstraZeneca Pharmaceuticals LP	0310-7560-90	90 TABLET, FILM COATED in 1 BOTTLE (0310-7560-90)	2022-05-09
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366	NDA	AstraZeneca Pharmaceuticals LP	0310-7570-90	90 TABLET, FILM COATED in 1 BOTTLE (0310-7570-90)	2022-05-09
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366	NDA	AstraZeneca Pharmaceuticals LP	0310-7580-90	90 TABLET, FILM COATED in 1 BOTTLE (0310-7580-90)	2022-01-24
Astrazeneca	CRESTOR	rosuvastatin calcium	TABLET;ORAL	021366	NDA	AstraZeneca Pharmaceuticals LP	0310-7590-30	30 TABLET, FILM COATED in 1 BOTTLE (0310-7590-30)	2022-01-24

Crestor (rosuvastatin): Who supplies what in the value chain?

Last updated: April 24, 2026

What does “supplier” mean for Crestor in practice?

For a branded small-molecule like Crestor (rosuvastatin), “suppliers” typically break into three buckets: (1) active pharmaceutical ingredient (API) manufacturers, (2) drug-product (finished-dose) contract manufacturers (CMOs), and (3) key raw-material and intermediate suppliers used to make rosuvastatin and its salt forms (principally rosuvastatin calcium).

Crestor is manufactured and distributed globally through a mix of affiliates and contract infrastructure. Public disclosure of every upstream intermediate supplier is incomplete, but the API and finished-dose manufacturing footprint can be mapped using regulatory and commercial listings.

Who supplies Crestor’s API (rosuvastatin) in the supply chain?

The most decision-grade view for sourcing is the API manufacturer list on regulatory filings (for example, FDA Orange Book entries and corresponding global approval dossiers). For Crestor, the API is rosuvastatin (commonly supplied as rosuvastatin calcium for commercial tablet manufacture).

Common API supply archetypes seen for rosuvastatin across markets	Supply tier	What it supplies	Where it shows up	Typical supplier type
API	Rosuvastatin (or rosuvastatin calcium)	Marketing authorization dossiers, bioequivalence dossiers for generics, and Orange Book references for branded and therapeutic alternatives	API manufacturer / specialty pharma intermediates
Salt/Crystalline form	Rosuvastatin calcium salt and polymorph control	Chemistry/manufacturing sections of dossiers	API-specialty chemical companies
Intermediates	Key rosuvastatin synthesis intermediates	DMFs/CEP dossiers, dossier exhibits	Intermediate manufacturers
Finished tablets	5/10/20/40 mg film-coated tablets	National product authorizations	Drug-product CMO or affiliate manufacturing plants

Primary API supply signal for rosuvastatin products

• Public Orange Book and regulatory systems generally identify listed drug applicants/holders and, for many submissions, manufacturing site information at the finished-dose level. API site granularity varies by jurisdiction and filing strategy.
• For investment-grade mapping, the most reliable “supplier” facts are the documented manufacturing sites tied to the marketed drug product in each market.

Who supplies the finished Crestor tablets (CMO / manufacturing sites)?

For branded rosuvastatin, finished-dose manufacturing is usually performed by AstraZeneca-affiliated plants and/or contracted manufacturers using AstraZeneca-approved processes and packaging specs. Finished-dose manufacturing sites are recorded through:

• Regulatory product authorizations (EU and national databases)
• FDA approval package and labeling cross-references (where available)
• Packaging/labeling and lot-release information

Because the question is “suppliers for Crestor,” the highest-confidence answer is the set of manufacturing sites documented for marketed rosuvastatin drug products rather than unverified upstream chemistry suppliers.

A practical supplier map to use in sourcing diligence	Workstream	What you need from suppliers	Deliverable artifacts
Tablet manufacture	Powder blending, compression, film coating, tablet QC release	Site DMF/CPPs, batch records, COAs, specs
Packaging	Blistering/bottling, labeling, child-resistant and tamper-evident controls	Packaging validation, artwork specs, serialization readiness
Quality system	GMP compliance and quality agreements	Quality agreement, audit reports, change control rules
Regulatory support	CMC updates for manufacturing changes	Variation pathways and technical justifications

Which regulatory sources list supplier manufacturing sites for Crestor-related rosuvastatin products?

Use these regulatory databases to extract the documented manufacturer of record and site-level manufacturing details:

1) FDA Orange Book (United States): lists “Active ingredient(s)” and the “Dosage form,” plus references used by FDA for listed drugs and some manufacturing labeling data depending on application type.
Source: FDA Orange Book for drug product listings. [1]

2) EMA European Public Assessment Reports (EPAR) and assessment documentation (Europe): often includes manufacturing information, though API supplier disclosure varies.
Source: EMA EPAR product pages and assessment documents. [2]

3) National Competent Authority databases (EU member states): sometimes list manufacturer and release site more explicitly for marketing authorizations.

What suppliers matter most for cost, risk, and scale?

For a statin like rosuvastatin, supplier risk is dominated by:

• API supply continuity (single-source API risk)
• salt/crystal control (rosuvastatin calcium form control and batch consistency)
• tablet manufacturing capacity (blend-to-compression performance, film coating, dissolution profile controls)
• regulatory change complexity (CMC variation approval timelines)

For diligence, the supplier you care about is often the one who can deliver:

• consistent API quality over time
• validated crystal form and particle size distribution ranges
• documented GMP track record for rosuvastatin drug substance and tablets
• ability to support batch release documentation and quality agreements

What is known about AstraZeneca’s supply role for Crestor?

Crestor’s commercialization is tied to AstraZeneca’s global product responsibilities. AstraZeneca typically controls:

• API and drug product process approval
• specs for rosuvastatin content, impurities, and dissolution
• packaging and labeling
• change control and regulatory submissions

Third-party suppliers can operate manufacturing plants under AstraZeneca’s quality system, but the contract structure is product- and region-specific.

Business implication: supplier selection for Crestor is less about “who invented the molecule” and more about who runs approved sites and who can maintain AstraZeneca-aligned CMC controls under contract.

How to interpret “suppliers” when comparing branded vs generic rosuvastatin?

Branded Crestor and generic rosuvastatin share the same active ingredient, but:

• generics often use multiple API suppliers across submissions
• branded products often rely on fewer, controlled supply routes tied to AstraZeneca manufacturing strategy

Buyer-level takeaway

• If you need a supplier for API, the generics market can be a lead list for candidate manufacturers, then filter down to those that can support polymorph and impurity spec alignment.
• If you need a supplier for finished tablets, you focus on tablet CMOs with prior experience in high-quality film-coated tablet production and proven dissolution performance for rosuvastatin.

Key takeaways

• For Crestor, the most actionable “supplier” set is the documented API and finished-dose manufacturing sites listed in regulatory systems like the FDA Orange Book and EMA EPAR documentation. [1,2]
• Finished-dose manufacturing (CMO or affiliate sites) and packaging release are typically the most operationally relevant supplier categories for supply continuity and quality compliance.
• Upstream intermediate and salt-form suppliers are critical to quality and cost, but they are less consistently disclosed publicly; site-level manufacturing records are the cleanest basis for sourcing due diligence.

FAQs

1) Is Crestor’s active ingredient supplied by multiple API manufacturers?
In the broader rosuvastatin market, yes, but Crestor-specific API sourcing depends on AstraZeneca’s approved supply chain and documented manufacturing references in regulatory submissions. [1,2]

2) What supplier documents should be requested for rosuvastatin tablets?
GMP batch records, COAs against release specs, dissolution validation reports, and a quality agreement covering change control and deviations.

3) Does rosuvastatin supplier selection hinge on salt form?
Yes. Commercial rosuvastatin is commonly supplied as rosuvastatin calcium, and control of form and impurity profile affects regulatory and quality acceptance.

4) Can FDA Orange Book be used to identify API suppliers for Crestor?
Orange Book is a starting point for identifying the listed drug and active ingredient references. Site-level details for every upstream supplier may not be fully disclosed, so it is best paired with product approval documentation. [1]

5) Where do I find finished-dose manufacturing site data for Crestor in Europe?
EMA EPAR pages and assessment documents for the relevant marketing authorizations are the primary starting point for manufacturing and quality documentation. [2]

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References (APA)

[1] U.S. Food and Drug Administration. (n.d.). FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] European Medicines Agency. (n.d.). European public assessment reports (EPAR) and product information. https://www.ema.europa.eu/en/medicines