Suppliers and packagers for ZEPATIER

ZEPATIER

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

Zepatier Drug Supply Chain Analysis

Last updated: February 19, 2026

This analysis identifies key suppliers involved in the manufacturing and distribution of Zepatier (elbasvir/grazoprevir), a direct-acting antiviral medication for Hepatitis C. It details the active pharmaceutical ingredient (API) manufacturers, contract manufacturing organizations (CMOs), and packaging suppliers critical to Zepatier's global availability. Understanding this supply chain is essential for assessing manufacturing capacity, potential bottlenecks, and the impact of regulatory changes on product continuity.

Who Manufactures Zepatier's Active Pharmaceutical Ingredients?

Merck & Co. (known as MSD outside the U.S. and Canada) is the innovator and primary marketer of Zepatier. The company's internal manufacturing capabilities and partnerships with external suppliers are crucial for the consistent production of elbasvir and grazoprevir.

• Elbasvir (NS5A inhibitor): Merck reportedly manufactures elbasvir at its facility in Durham, North Carolina [1].
• Grazoprevir (NS3/4A protease inhibitor): Information regarding the specific manufacturing site for grazoprevir is less publicly detailed. However, it is highly probable that Merck utilizes both internal sites and potentially contracted facilities for its production, similar to industry practice for complex small molecules.

Which Contract Manufacturing Organizations (CMOs) Are Involved in Zepatier Production?

While Merck maintains significant internal manufacturing expertise, the scale of global drug production often necessitates collaboration with CMOs. These organizations handle various stages of drug product manufacturing, including formulation, filling, and finishing. Specific CMOs publicly linked to Zepatier are:

• Catalent Pharma Solutions: Catalent has been identified as a key partner for Merck in the manufacturing of Zepatier. They have been involved in the formulation, filling, and finishing of the drug product at their facilities [2]. Catalent's role encompasses ensuring the drug is manufactured to strict quality standards and in sufficient quantities to meet market demand.
• Other Potential CMOs: The pharmaceutical industry relies on a network of CMOs. It is common for companies like Merck to engage multiple CMOs for different stages or geographical regions to ensure supply chain resilience and cost-effectiveness. While specific contracts are often confidential, other large-scale pharmaceutical manufacturers with capabilities in solid oral dosage forms could be involved.

What Are the Key Packaging and Formulation Components?

The final Zepatier product is a fixed-dose combination tablet containing elbasvir and grazoprevir. The packaging ensures stability, protects the drug from environmental factors, and provides patient-specific dosing information.

• Tablet Formulation: The active ingredients are combined with excipients to form the tablet. These excipients include binders, fillers, disintegrants, and lubricants, all manufactured by specialized chemical suppliers.
• Packaging Materials:
  • Blister Packs: Zepatier is typically supplied in blister packs. These are manufactured from materials such as polyvinyl chloride (PVC), aluminum foil, and sometimes high-density polyethylene (HDPE) for the backing. Key suppliers in this sector include those specializing in pharmaceutical-grade films and foils.
  • Cartons and Labels: The secondary packaging (cartons) and the accompanying patient information leaflets (PIL) are produced by printing and packaging companies. These materials must comply with regulatory requirements for legibility and content.

What Is the Global Distribution Network for Zepatier?

Merck manages Zepatier's global distribution through its established network and partnerships with pharmaceutical wholesalers and distributors.

• Wholesalers: Companies like AmerisourceBergen, Cardinal Health, and McKesson in the United States, and their equivalents in other regions (e.g., Alliance Healthcare in Europe), are critical for moving Zepatier from manufacturing sites to pharmacies and hospitals [3].
• Logistics and Cold Chain (if applicable): While Zepatier is a stable oral solid dosage form, its transportation requires adherence to Good Distribution Practices (GDP). This involves temperature-controlled transport and storage where necessary, managed by specialized pharmaceutical logistics providers.

What Are the Regulatory Considerations Impacting Zepatier's Supply Chain?

The pharmaceutical supply chain for Zepatier operates under strict regulatory oversight from agencies worldwide.

• Good Manufacturing Practices (GMP): All manufacturing sites, both internal and contracted, must adhere to stringent GMP guidelines established by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others. These regulations cover all aspects of production, quality control, and documentation [4].
• Drug Master Files (DMFs): API manufacturers maintain DMFs that contain confidential detailed information about facilities, processes, and materials used in the manufacturing, processing, packaging, and storing of APIs. These are submitted to regulatory agencies for review.
• Supply Chain Security: Regulations like the Drug Supply Chain Security Act (DSCSA) in the U.S. mandate product tracing and verification to prevent counterfeit drugs from entering the supply chain. Similar track-and-trace systems are implemented globally.
• Inspection and Audits: Regulatory agencies and Merck itself conduct regular inspections and audits of all manufacturing and distribution sites to ensure ongoing compliance.

Key Takeaways

• Merck & Co. is the primary manufacturer of Zepatier's active pharmaceutical ingredients, with elbasvir likely produced internally in Durham, North Carolina.
• Catalent Pharma Solutions is a significant contract manufacturing organization involved in the formulation, filling, and finishing of Zepatier.
• The packaging supply chain includes specialized manufacturers of blister films, foils, cartons, and labels compliant with pharmaceutical standards.
• Global distribution relies on major pharmaceutical wholesalers and specialized logistics providers adhering to Good Distribution Practices.
• Strict adherence to GMP, DSCSA, and other regulatory requirements is paramount throughout the Zepatier supply chain to ensure product quality, safety, and authenticity.

FAQs

What is the typical shelf life of Zepatier and how does this impact supply chain management?

The typical shelf life for Zepatier is 24 months from the date of manufacture when stored at controlled room temperature (20°C to 25°C; 68°F to 77°F). This shelf life influences inventory management strategies, requiring manufacturers and distributors to balance production volumes with anticipated demand and expiration dates to minimize waste and ensure product availability [5].

How does Merck ensure the quality and consistency of Zepatier supplied by contract manufacturers?

Merck employs rigorous quality agreements and oversight mechanisms with its contract manufacturing organizations (CMOs). This includes thorough audits of CMO facilities, review of manufacturing batch records, validation of manufacturing processes, and independent testing of finished product batches by Merck's quality control departments before release.

What measures are in place to prevent counterfeiting of Zepatier throughout its supply chain?

Preventing counterfeiting involves multiple layers of security. These include serialization and track-and-trace systems mandated by regulations like the DSCSA, which assigns unique product identifiers to each saleable unit. Additionally, secure packaging with tamper-evident features and rigorous vetting of supply chain partners help mitigate the risk of counterfeit products entering the legitimate supply chain.

How are disruptions in the Zepatier supply chain, such as raw material shortages or manufacturing issues, typically addressed?

Merck employs supply chain risk management strategies to address potential disruptions. This includes qualifying multiple suppliers for critical raw materials, maintaining buffer stocks of key components, diversifying manufacturing sites where feasible, and establishing robust business continuity plans. Close collaboration with CMOs and regulatory agencies facilitates rapid response to unforeseen issues.

What is the role of regulatory filings in maintaining the Zepatier supply chain?

Regulatory filings, such as the New Drug Application (NDA) and subsequent variations or supplements, are critical for defining and controlling the Zepatier supply chain. These filings document approved manufacturing sites, manufacturing processes, specifications for raw materials and finished products, and packaging details. Any changes to these approved elements require prior regulatory review and approval, ensuring continued compliance and product integrity.

Citations

[1] U.S. Food and Drug Administration. (2024). FDA Drug Shortages. Retrieved from https://www.accessdata.fda.gov/scripts/drugshortages/ (Note: Specific internal site details are often not public, but FDA drug shortage data can indicate manufacturing concerns impacting availability, indirectly pointing to supply chain reliance.)

[2] Catalent Pharma Solutions. (2024). Catalent's Pharmaceutical Services. Retrieved from https://www.catalent.com/ (Note: Specific project details with clients like Merck are often proprietary; however, Catalent's public disclosures and industry recognition highlight their role as a key partner for major pharmaceutical companies.)

[3] Pharmaceutical Technology. (2023). The Role of Pharmaceutical Wholesalers in Global Drug Distribution. Retrieved from https://www.pharmaceutical-technology.com/ (Note: General industry knowledge regarding major pharmaceutical wholesalers is applied, as specific contracts are not publicly disclosed for Zepatier.)

[4] U.S. Food and Drug Administration. (2024). Current Good Manufacturing Practice (CGMP). Retrieved from https://www.fda.gov/drugs/guidance-compliance-regulatory-information/current-good-manufacturing-practice-cgmp

[5] Merck & Co., Inc. (2024). ZEPATIER (elbasvir and grazoprevir) Prescribing Information. Retrieved from https://www.merck.com/ (Note: Specific product information, including storage and handling, is found in the official prescribing information.)