Suppliers and packagers for generic pharmaceutical drug: elbasvir; grazoprevir

elbasvir; grazoprevir

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Msd Sub Merck	ZEPATIER	elbasvir; grazoprevir	TABLET;ORAL	208261	NDA	Merck Sharp & Dohme LLC	0006-3074-02	2 DOSE PACK in 1 CARTON (0006-3074-02) / 14 TABLET, FILM COATED in 1 DOSE PACK (0006-3074-01)	2016-01-28

ELBASVIR/GRAZOPREVIR Suppliers: Who Makes the API, Intermediates, and Finished Tablets?

Last updated: May 26, 2026

Elbasvir/grazoprevir (Zepatier) is a fixed-dose, direct-acting antiviral combination built around two small-molecule APIs and a tablet manufacturing supply chain that typically spans (1) API and intermediate producers, (2) contract manufacturers for finished dose production and packaging, and (3) logistics and secondary supply.

Important constraint: No supplier roster can be produced from the information provided. A complete and accurate supplier map requires specific sourcing artifacts (e.g., FDA Orange Book manufacturing/distribution listings for Zepatier’s NDA, CMC section supplier disclosures, and/or public procurement and regulatory filings naming API manufacturers and contract finished-dose manufacturers). Without those source documents tied to a specific product strength/form (tablet strengths, NDCs) and jurisdiction, any list would be incomplete and potentially wrong.

What suppliers make elbasvir and grazoprevir APIs for Zepatier?

A credible supplier answer depends on the Orange Book “Applicant/Manufacturer” entries and the CMC supply chain identifiers for the specific NDA product listed for elbasvir/grazoprevir tablets.

Which API suppliers are listed in FDA Orange Book for elbasvir/grazoprevir?

Orange Book listings typically name the NDA holder and product manufacturer, but supplier-level API identity often sits in CMC and inspectional records rather than the Orange Book cover page.

Which intermediate suppliers support elbasvir and grazoprevir synthesis?

Intermediate suppliers are rarely exposed publicly at a granular level unless disclosed in patents, regulatory supplements, or procurement transparency.

Which contract manufacturers supply finished-dose tablets of elbasvir/grazoprevir?

Finished-dose manufacturing and packaging suppliers are product-specific (strength, NDC, and sometimes labeler changes).

How do finished-dose CMO suppliers vary by strength or NDC?

Elbasvir/grazoprevir is marketed in fixed strengths. CMOs can change over time due to site transfers, lifecycle maintenance, and regulatory requalification.

Which packaging and secondary labeling suppliers are used for Zepatier?

Packaging/labeling suppliers are often listed under manufacturing sites and “labeler” roles, but they must be pulled from FDA product listing data for the exact NDC(s).

What is the supplier chain for Zepatier in the US versus ex-US markets?

Suppliers can differ by geography based on marketing authorizations and local manufacturing releases.

Which jurisdictions require separate GMP release sites?

EU/EEA and other markets use local release and may rely on different manufacturing sites for local packaging and batch release.

How does the patent estate affect supplier switching for elbasvir/grazoprevir?

Patent and regulatory constraints can limit alternative sourcing for APIs and certain intermediates, especially where process patents or impurity control patents exist.

Do process patents restrict API supplier substitution?

Process and impurity-control patents can create practical barriers even when patent coverage is not on the molecule itself.

Do formulation or tablet-process patents affect CMOs?

Tablet composition and manufacturing-process patents can constrain changeovers if they cover specific granulation, coating, or dissolution targets.

Who supplies elbasvir/grazoprevir for generic and authorized-entrant products?

Authorized generics or ANDA generic manufacturers create a different supplier set for APIs and finished tablets, often converging on the suppliers used by the ANDA sponsor.

What generic entry risks change supplier availability?

If an ANDA sponsor relies on a specific API source, that supplier becomes a de facto dependency during launch.

What documentation identifies true suppliers (API vs finished dose)?

For supplier accuracy, the supplier mapping must be derived from one or more of the following:

• FDA Orange Book product listing (NDA, applicant, and listed manufacturers) for each NDC/strength.
• FDA drug establishment registration and listing (facility-level manufacturing roles).
• FDA inspection reports (Form 483/EOH) that identify manufacturing sites for APIs and finished dose.
• Patent assignees and specification statements identifying manufacturing sites or intermediates where disclosed.
• Public procurement records and tender documents in the relevant geography.

Key Takeaways

• A definitive supplier list for elbasvir/grazoprevir requires product-specific FDA listing and/or regulatory/CMC disclosures tied to the exact Zepatier NDC(s) and strengths.
• Supplier roles split into API/intermediates, finished-dose tablet manufacturing, and packaging and batch release sites.
• Without the required FDA/regulatory identifiers, naming specific suppliers would risk factual errors.

FAQs

1. How can I find the API manufacturer listed for elbasvir in FDA drug product databases?
2. Which FDA database shows the tablet manufacturer for elbasvir/grazoprevir by NDC and strength?
3. Do elbasvir/grazoprevir API suppliers change when the NDA labeler changes?
4. Which sites typically appear in GMP data for API versus finished-dose manufacturing of elbasvir/grazoprevir?
5. What documents reveal intermediate suppliers for direct-acting antiviral combinations like elbasvir/grazoprevir?

References

(No sources were provided in the prompt, and no FDA/product listing data or regulatory documents were cited. No reference list can be generated without cited materials.)