Suppliers and packagers for EFFIENT

EFFIENT

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307	NDA	Cosette Pharmaceuticals, Inc.	0713-0881-30	30 TABLET, COATED in 1 BOTTLE (0713-0881-30)	2022-09-01
Cosette	EFFIENT	prasugrel hydrochloride	TABLET;ORAL	022307	NDA	Cosette Pharmaceuticals, Inc.	0713-0882-30	30 TABLET, COATED in 1 BOTTLE (0713-0882-30)	2022-09-01

Suppliers and packagers for EFFIENT

Last updated: June 2, 2026

Effient (prasugrel) suppliers: who manufactures Effient tablets and API, and who supplies the market?

Effient is marketed in the US as prasugrel hydrochloride tablets (Effient). Commercial supply is supported by branded-drug manufacturing and upstream API procurement tied to the authorized product and labeled strengths. Publicly available, regulator-linked supplier visibility is primarily through FDA labeling (manufacturing sites) and Orange Book / drug listing records, with additional visibility via NDA/ANDA supplements and inspection histories.

Who are the authorized manufacturers and label-listed suppliers for Effient (prasugrel) tablets?

Answer (US market): Effient’s tablet supply is handled through the branded product’s authorized NDA manufacturing network identified in the approved FDA label “Manufactured for/Manufactured by” sections and associated supplement filings. Effient is not a “distributor brand” where multiple unrelated suppliers are equally interchangeable; instead, the active labeled product is made at specific FDA-registered sites for the NDA holder and its contract manufacturers.

What does the Effient label typically disclose about manufacturing

• Tablet manufacturer identity (site-level “Manufactured for” or “Manufactured by” language)
• Packager/labeler where applicable
• Strengths: commonly marketed as 5 mg and 10 mg tablets in the US labeling (per product labeling)

How to map “supplier” to the supply chain

In practical procurement terms, “supplier” for Effient can mean:

1. Finished-dose manufacturer (contract manufacturer producing tablets)
2. Labeler / NDA holder (responsible for market authorization)
3. API source (prasugrel hydrochloride made by an upstream API manufacturer, often not named on the US label)
4. Packaging and distribution (packager/shipper listed in label components)

Which companies supply the prasugrel (Effient) API, and who makes the raw material?

Answer: API supplier names are rarely comprehensive in public-facing labels. API procurement is usually determined by:

• NDA chemistry, manufacturing, and controls (CMC) filings that list manufacturing sites
• DMFs that may list API manufacturers (name redaction can occur in publicly viewable documents)
• FDA facility registrations and inspection assignments linked to API production

In the Effient supply chain, upstream prasugrel hydrochloride API and any intermediate steps are typically sourced from specialized chemical manufacturing plants supporting the NDA and CMC batch genealogy. Finished-dose “supplier” and API supplier may be different entities.

What FDA records identify Effient suppliers: Orange Book, drug listing, and label “Manufactured for” text?

Answer: The most operationally useful supplier mapping comes from:

• FDA Orange Book: confirms the application and identifies the product for which patent and exclusivity attach (useful for tying manufacturing networks to the authorized product)
• FDA drug listing / SPL: ties the drug product to the label and application, often exposing manufacturer/labeler fields
• US prescribing information: lists the finished-dose manufacturer and sometimes packager

Orange Book: how it helps supplier identification

Orange Book listings do not routinely provide full upstream supplier lists, but they do:

• Tie the labeled product to the NDA holder and application
• Help confirm which product configuration is authorized (strength, dosage form)
• Provide the anchor for locating manufacturing-related CMC supplements

Are there contract manufacturing suppliers for Effient tablets, or does the sponsor manufacture in-house?

Answer: Effient is commonly supported through contract manufacturing and site-specific production within a branded NDA network. Sponsors often retain control of formulation and specifications, while production can be outsourced to manufacturing partners that hold the necessary FDA approvals and can run the NDA product under current good manufacturing practices.

What procurement teams look for in supplier diligence

• NDA-linked manufacturing site registration
• Batch release testing ownership and QMS linkage
• Sterility is not the issue (tablet), but particulate/assay and tablet integrity are
• Change control history for formulation and process changes (affects supplier qualification)

How many supply sources exist for Effient, and what are the typical redundancy and risk points?

Answer: Branded tablet products usually have a limited number of validated commercial sites rather than a broad open supplier market. The practical supplier count depends on:

• Whether the NDA has one primary manufacturing site or multiple
• Whether manufacturing has shifted via supplements (site transfers, capacity expansions)
• Whether packaging is separated from bulk tablet compression/coating

Key supply continuity constraints for prasugrel tablets

• Solid oral dose line qualification for the specific tablet design
• Coating and compression process reproducibility
• API quality consistency (polymorph/particle size controls, if specified)
• API supply lead times and traceability requirements

How do Effient biosimilar or generic supply scenarios affect supplier choices?

Answer: Effient is a small-molecule drug, so the “biosimilar” concept does not apply. Generic entry changes supplier landscape by introducing additional finished-dose manufacturers, but those are enabled only after:

• Brand patent and regulatory exclusivity windows
• Patent challenges and any settlement that dictates launch timing

For supplier procurement, generic entry reduces dependence on the branded sponsor’s validated supply chain once generics are launched and approved at additional sites.

What patent and exclusivity status governs supplier turnover for Effient?

Answer: Supplier churn for branded vs generic is driven by:

• Patent term for prasugrel (including formulation and method-of-use claims, where applicable)
• Orphan exclusivity is not the typical driver for antiplatelets like prasugrel
• Regulatory exclusivity periods attached to the NDA (if any)
• Paragraph IV litigation outcomes that may delay generic approval/launch

Orange Book and FDA litigation records determine whether alternative sources enter while the brand remains protected.

Key takeaways

• Effient “supplier” in the US is anchored to the NDA’s authorized finished-dose manufacturers and label-identified production sites.
• API supplier identification for prasugrel is typically derived from CMC/DMF-linked records, facility registrations, and manufacturing chain documentation, not from Orange Book alone.
• The supply chain is usually a small set of validated commercial sites, which limits supplier redundancy unless the sponsor has filed and approved additional manufacturing locations.
• Any generic supply expansion depends on Orange Book patent and exclusivity status plus Paragraph IV and litigation/settlement outcomes.

FAQs

1. Where on the Effient prescribing information does it name the tablet manufacturer and labeler?
2. Does Orange Book list the prasugrel API manufacturer, or only the NDA product and patent/exclusivity details?
3. What types of changes trigger FDA supplements for Effient manufacturing sites and process changes?
4. How does a Paragraph IV challenge affect when new suppliers can launch generic prasugrel tablets?
5. What due diligence steps do procurement teams use to qualify a new Effient tablet manufacturer or generic supplier?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. U.S. Food and Drug Administration. Drug Labeling (Effient prescribing information).