Suppliers and packagers for VALCYTE

VALCYTE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cheplapharm	VALCYTE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	022257	NDA	H2-Pharma, LLC	61269-485-10	1 BOTTLE, GLASS in 1 CARTON (61269-485-10) / 100 mL in 1 BOTTLE, GLASS	2009-08-28
Cheplapharm	VALCYTE	valganciclovir hydrochloride	TABLET;ORAL	021304	NDA	H2-Pharma, LLC	61269-480-60	1 BOTTLE, PLASTIC in 1 CARTON (61269-480-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2001-03-29

Valcyte suppliers: API, manufacturing sites, and distribution network mapping

Last updated: May 24, 2026

Valcyte (valganciclovir) is supplied through a vertically integrated supply chain split across (1) API manufacture, (2) drug product manufacture, and (3) US distribution via authorized wholesalers. The specific supplier roster varies by dosage form and lot, and it is reflected in FDA drug listing data (and, for US-relevant planning, in the Orange Book listing tied to the NDA-holder plus subsequent manufacturing site notifications).

Who supplies Valcyte (valganciclovir) in the US market?

Valcyte is marketed in the US by Roche/Genentech (NDA holder). The supply chain for the US market typically involves:

• API supply: active ingredient (valganciclovir) manufactured by specialized API sites under cGMP.
• Drug product manufacturing: tablet manufacture at one or more cGMP finished-dose plants.
• Quality-release and distribution: release testing and distribution through licensed wholesalers and hospital/pharmacy channels.

What companies make valganciclovir API used for Valcyte?

API suppliers are generally disclosed through:

• FDA drug establishment registration (site-level) covering API and/or finished-dose manufacture
• FDA drug listing and NDC labeling/labeler attribution
• Inspection history and manufacturing site identifiers (Establishment IDs)

For Valcyte specifically, API manufacturing is carried out by one or more registered active ingredient manufacturing establishments supporting the NDA. The publicly accessible supplier answer is site-based (establishment IDs) rather than a single universal vendor name, because API sourcing can shift by lot and contract term.

Which manufacturers produce Valcyte tablets and where are they made?

Finished-dose manufacturing is typically registered under:

• FDA establishments for “drug product” (tablet manufacturing)
• site-specific cGMP listings tied to the NDA

Valcyte is supplied as film-coated tablets (tablet strength: commonly referenced as 450 mg in the US market). Finished-dose production occurs at one or more FDA-registered plants. Those plants appear in FDA establishment registration and can be matched to product labeling through NDC attribution.

What does FDA labeling say about who makes Valcyte (labeler, NDA holder, distributor)?

The fastest way to map “supplier” in practice is to treat “supplier” as the chain of responsibility embedded in FDA labeling:

• NDA holder: the entity responsible for regulatory compliance and commercial supply
• labeler: appears on the National Drug Code (NDC) labeler field for each dosage/pack size
• manufacturer/distributor: appears as labeler/manufacturer entities tied to NDC packaging

If the goal is to identify the actual plants and release entities, the FDA establishment registration database is the primary public linkage. That approach is lot- and packaging-driven, not brand-wide.

Which Valcyte NDCs and labelers indicate the current supplier chain?

Valcyte NDCs differ by:

• strength
• pack size
• packaging configuration
• labeler/manufacturer attribution

Supplier mapping by NDC is the operationally correct method because different NDCs can be associated with different manufacturing sites under the same NDA. Any “single supplier” claim is not reliably true across all NDCs.

Does Valcyte have generic or biosimilar competition that changes supplier risk?

Valcyte’s key competitive risk is generic valganciclovir under Abbreviated New Drug Application pathways and, in practice, contract-driven supply substitution. When generics enter, payer and procurement programs may shift volumes, pulling demand away from branded sources and increasing bargaining leverage for alternative distributors.

From a supplier standpoint, the risk is not “who makes Valcyte everywhere,” but:

• whether branded supply becomes constrained
• whether generic entrants are validated and consistently available
• whether procurement switches NDCs across labelers and plants

What patent estate affects supplier sourcing and generic entry?

Supplier selection and procurement stability for branded Valcyte can be influenced by:

• brand exclusivities and listed patents in the Orange Book (method-of-use and formulations)
• the presence or absence of Paragraph IV challenges
• any settlement agreements that delay generic launch

Patent-driven entry affects the number of competing supply channels over time, which feeds back into supplier bargaining power and contract terms. (Patent estate mapping requires Orange Book-specific listing data tied to the exact Valcyte NDA.)

How do FDA manufacturing sites and inspections impact Valcyte supplier continuity?

In continuity planning, suppliers are evaluated by:

• whether manufacturing sites remain in active status and hold valid compliance history
• inspection outcomes that can force remediation and slow release
• change control activity (site transfers, line moves, scale-up approvals)

For Valcyte, the operational implication is that even if the NDA holder stays constant, API and drug product supplier plants can change, leading to variations in lead times and lot availability.

What are the commercial supplier channels for Valcyte (wholesalers, GPOs, specialty distribution)?

Valcyte is typically accessed through:

• specialty pharmacy distribution networks for transplant and immunocompromised indications
• wholesaler channels for hospital dispensing
• pharmacy benefit manager (PBM) formularies and GPO contracts that route supply to preferred NDCs and labelers

These channels can alter which labeler/manufacturer is preferred at the point of sale even when the same active ingredient is used.

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Key Takeaways

• Valcyte “suppliers” in practice are best mapped as NDA-holder + NDC labeler + FDA-registered manufacturing sites, not a single global vendor name.
• API and finished-dose manufacturing occur at multiple registered sites and can shift by NDC and lot.
• Supplier continuity risk is driven by plant compliance, site transfer timing, and generic substitution, which can be routed through procurement and specialty distribution.

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FAQs

1) How can I identify who manufactured Valcyte for a specific lot?

Use the lot-specific labeling and NDC mapping to identify the labeler/manufacturer, then crosswalk the labeler to FDA establishment registrations for the finished-dose plant and, where possible, the supporting API sites.

2) Are Valcyte tablets made at different plants for different NDCs?

Yes. Different pack sizes and NDCs can map to different labelers and manufacturing establishments even under the same brand NDA.

3) Does valganciclovir API sourcing affect Valcyte availability during shortages?

Yes. API supply constraints or cGMP disruptions at API plants or finished-dose plants can impact batch release timing and availability.

4) Can generic valganciclovir shift procurement away from Valcyte branded supply?

Yes. Once generics gain market acceptance and formulary coverage, procurement can switch volumes, reducing branded reliance and altering supplier dynamics.

5) What FDA data sources best support a Valcyte supplier audit?

FDA establishment registration and drug listing data are the primary public sources for site and labeler mapping; Orange Book listings support the regulatory timing context for entry risk.

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-05-24).
2. FDA. Drugs@FDA: Valcyte (valganciclovir) NDA and labeling. (Accessed 2026-05-24).
3. FDA. NDC Directory: Valcyte (labeler/NDC mapping). (Accessed 2026-05-24).
4. FDA. Drugs and Medical Devices: Drug Establishments. (Accessed 2026-05-24).