Suppliers and packagers for VALACYCLOVIR HYDROCHLORIDE

VALACYCLOVIR HYDROCHLORIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aurobindo Pharma	VALACYCLOVIR HYDROCHLORIDE	valacyclovir hydrochloride	TABLET;ORAL	090682	ANDA	Major Pharmaceuticals	0904-6565-07	30 BLISTER PACK in 1 CARTON (0904-6565-07) / 1 TABLET, FILM COATED in 1 BLISTER PACK	2010-05-24
Aurobindo Pharma	VALACYCLOVIR HYDROCHLORIDE	valacyclovir hydrochloride	TABLET;ORAL	090682	ANDA	Major Pharmaceuticals	0904-6565-61	100 BLISTER PACK in 1 CARTON (0904-6565-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK	2010-05-24
Aurobindo Pharma	VALACYCLOVIR HYDROCHLORIDE	valacyclovir hydrochloride	TABLET;ORAL	090682	ANDA	NorthStar Rx LLC	16714-697-03	90 TABLET, FILM COATED in 1 BOTTLE (16714-697-03)	2010-05-24

Suppliers and packagers for VALACYCLOVIR HYDROCHLORIDE

Last updated: May 25, 2026

Valacyclovir Hydrochloride Suppliers: Who Manufactures the Drug Substance (API) and Finished Dosage Products

Valacyclovir hydrochloride is manufactured by a limited set of producers for the active pharmaceutical ingredient (API) and by a broader set for branded and generic tablets under FDA-approved ANDA pathways. Supplier selection for US market supply typically hinges on (1) whether a company supplies API for US formulators, (2) ANDA ownership or contract manufacturing capacity for tablets, and (3) whether production can support the same polymorph/impurity profile required by FDA and commercial specifications.

Which companies supply valacyclovir hydrochloride API (drug substance) in 2026?

Featured search intent: identify upstream API suppliers used for US generic and branded valacyclovir hydrochloride.

API supplier landscape (high-probability upstream suppliers) The most reliable way to map valacyclovir API “suppliers” for finished-dose manufacturers is via:

1. ANDA manufacturer identity (tablet) plus known API sourcing relationships disclosed in regulatory filings, and
2. typical API producer participation patterns in US oral small-molecule generics.

For valacyclovir, the supplier set is concentrated in established small-molecule API manufacturers with capability for antiviral nucleoside analog chemistry and salt formation.

Common API manufacturing regions

• India (many US ANDA suppliers use Indian API supply)
• China (API supply for generics)
• EU/US-based API for internal supply in some cases

What companies sell valacyclovir hydrochloride tablets in the US market?

Featured search intent: map the supplier to the marketed drug product, not just API.

In the US, valacyclovir hydrochloride is marketed as:

• Valtrex (brand; historically GlaxoSmithKline)
• Generic valacyclovir hydrochloride tablets (multiple ANDA holders and multiple labelers)

For procurement or risk screening, the commercial supplier list should be built around:

• ANDA holders listed for each NDC/strength
• Manufacturing sites listed in FDA submissions (for both drug product and sometimes drug substance)
• Current marketing status of each NDC

What is the Orange Book status for valacyclovir hydrochloride and how does it affect supplier choice?

Featured search intent: identify product-linked FDA status that controls which companies can legally sell.

Valacyclovir hydrochloride’s Orange Book listing determines:

• Which applicants have approved ANDAs
• Which patent expiration and exclusivity events still constrain certain formulations
• Whether any product is under active litigation risk (driving supply continuity risk)

Supplier selection should prioritize ANDA products that are:

• Actively marketed (not discontinued)
• Backed by manufacturing sites with stable recent FDA compliance history

How do you identify valacyclovir hydrochloride contract manufacturing organizations (CMOs) for tablets?

Featured search intent: identify CMO/contract manufacturer roles.

For oral solids like valacyclovir tablets, “supplier” can mean:

• API supplier
• Finished-dose contract manufacturer
• Labeler/ANDA holder

How CMOs are typically surfaced

• FDA ANDA “Manufactured for” and “Manufactured by” entries
• Site-level listings for drug product manufacturing
• Labeling and NDC data for strength and dosage form

Practical procurement filters

• Site capacity for small-molecule antivirals
• Ability to meet dissolution specs for tablets
• Robust quality systems and change-control maturity (salt form control and impurity control)

Which dosage strengths and formulations drive the supplier network for valacyclovir hydrochloride?

Featured search intent: understand whether suppliers differ by tablet strength.

Valacyclovir hydrochloride is used as oral tablets, typically supplied at:

• 500 mg
• 1 g (commonly as 1000 mg)

Supplier risk can vary by strength because:

• Some manufacturers have site-specific validation for one strength but not another
• Supply continuity can differ by lot production runs
• Distribution contracts can lock certain strengths to particular labelers

When do valacyclovir hydrochloride exclusivity and patent expirations change supplier options?

Featured search intent: timing.

Why this matters commercially

• Patent and exclusivity status affects whether additional ANDA approvals can be marketed
• Litigation posture affects whether ANDA products are pulled or delayed

For supplier planning, the main value is avoiding labelers whose approvals are constrained by:

• Remaining blocking patents
• Ongoing Paragraph IV disputes
• Active FDA holds for specific sites or product codes

Are there Paragraph IV challenges or patent litigation affecting valacyclovir suppliers?

Featured search intent: litigation affects product supply availability.

Paragraph IV challenges can:

• delay launches for specific ANDA applicants
• cause market disruption if settlements require delayed entry
• affect which labelers have reliable near-term supply

A procurement team typically scores suppliers on:

• likelihood of uninterrupted commercialization through the next 12 to 24 months
• history of stable manufacturing releases and recalls

How does valacyclovir hydrochloride compare with acyclovir supply, and how does that change supplier risk?

Featured search intent: substitution and supply-chain robustness.

Valacyclovir is the valine ester prodrug of acyclovir. In supply terms:

• If valacyclovir is constrained, acyclovir remains a different market with different manufacturing chains.
• Direct substitution depends on therapeutic interchangeability and formulary rules, not on patent status alone.

Procurement risk hedging often uses:

• dual-source for valacyclovir
• or a parallel plan with acyclovir where clinical policies allow

Key Takeaways

• Valacyclovir hydrochloride supply is split between upstream API producers and downstream tablet ANDA manufacturers/labelers.
• US market “supplier” decisions should be anchored to Orange Book/ANDA-identified manufacturers and their current marketing NDCs.
• Strength-specific supply continuity (500 mg vs 1 g) can differ by site and validated process capability.
• Patent and litigation status influences which labelers can reliably scale releases; it directly affects near-term market availability.
• For contracting, the most actionable path is site-level qualification tied to FDA listing and commercial batch release history.

FAQs

1) How can I quickly find the ANDA holders for valacyclovir hydrochloride tablets by strength?
Use the FDA Orange Book entries for each NDC and strength, then filter to active ANDA holders.

2) Do valacyclovir hydrochloride tablet manufacturing sites matter more than API source?
For compliance and release predictability, manufacturing site matters most, but API source impacts impurity profile and spec adherence.

3) What documents should be required from a valacyclovir hydrochloride supplier for supplier qualification?
CoA, DMF references (if applicable), validation summary for dissolution, impurity profile controls, and change-control history.

4) Can I dual-source valacyclovir hydrochloride tablets across different labelers without changing bioequivalence requirements?
If both products are FDA-approved ANDAs for the same strength/dosage form, interchangeability is typically supported at the product level.

5) What supply-chain risks are most common for oral small-molecule antivirals like valacyclovir?
API availability constraints, site compliance events, and strength-specific capacity limitations.

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References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration.
2. FDA Approved Drug Products: ANDA approvals and labeling/manufacturer information. US Food and Drug Administration.