Suppliers and packagers for VALSARTAN AND HYDROCHLOROTHIAZIDE

VALSARTAN AND HYDROCHLOROTHIAZIDE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Alembic	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	201662	ANDA	Alembic Pharmaceuticals Limited	46708-453-10	100 TABLET, FILM COATED in 1 CARTON (46708-453-10)	2016-05-20
Alembic	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	201662	ANDA	Alembic Pharmaceuticals Limited	46708-453-30	30 TABLET, FILM COATED in 1 BOTTLE (46708-453-30)	2016-05-20
Alembic	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	201662	ANDA	Alembic Pharmaceuticals Limited	46708-453-71	500 TABLET, FILM COATED in 1 BOTTLE (46708-453-71)	2016-05-20
Alembic	VALSARTAN AND HYDROCHLOROTHIAZIDE	hydrochlorothiazide; valsartan	TABLET;ORAL	201662	ANDA	Alembic Pharmaceuticals Limited	46708-453-90	90 TABLET, FILM COATED in 1 BOTTLE (46708-453-90)	2016-05-20

VALSARTAN AND HYDROCHLOROTHIAZIDE Supplier Map: API Producers, Key Intermediates, Contract Manufacturing, and Patent/IP Barriers

Last updated: May 26, 2026

Executive summary:
The valsartan and hydrochlorothiazide supply chain splits into (1) valsartan API manufacturing and (2) hydrochlorothiazide API manufacturing, then merges into combination tablet production (fixed-dose valsartan/HCTZ). Supplier concentration is high on API, with multiple qualified manufacturers supporting combination tablet plants that are, in practice, the bottleneck for market entry. For US availability, the dominant commercial constraint is not only API capacity but also regulatory chemistry manufacturing and controls (CMC) readiness and patent/IP barriers tied to the specific branded and generic reference products.

Because you did not specify country or dosage form strength (e.g., 80/12.5 mg, 160/12.5 mg, 320/12.5 mg, 160/25 mg), a complete “who supplies what strength in which market” roster cannot be produced accurately without risking incorrect supplier-to-strength attribution.

What companies supply valsartan and hydrochlorothiazide APIs for tablets?

Featured snippet: Valsartan supply is dominated by API producers with established DMF and cGMP histories; hydrochlorothiazide supply is more widely distributed due to older history and lower formulation complexity. Combination tablet CMO/CDMOs are selected for bioequivalence execution, line clearance, and packaging readiness for specific strengths.

How is the supply chain structured for valsartan/HCTZ?

1. Valsartan API
   Manufactured via multi-step chemical synthesis (including protected intermediates) and shipped as solvent-relevant API suitable for tablet granulation/compression.
2. Hydrochlorothiazide API
   Manufactured via heterocycle-forming routes with strong focus on impurity profile control (related substances) to meet DMF specifications.
3. Combination drug product (tablet)
   Tablets use blended APIs, excipient systems for compression and dissolution, and stability-controlled packaging. CMO plants typically manage scale-up, cleaning validation, and stability protocols aligned to ANDA submissions.

API vs finished-dose sourcing: what matters for availability

• API qualification and DMF linkage drive whether a tablet manufacturer can file and launch quickly.
• Impurity controls (process impurities, genotoxic impurities where applicable) drive which API lots are usable.
• Particle size and polymorph control can affect blend uniformity and dissolution, impacting bioequivalence success.

Which suppliers produce valsartan API at scale?

Featured snippet: Valsartan is a synthesis-intensive API with fewer large-scale producers than simpler APIs, so tablet manufacturers often dual-source valsartan API to reduce launch risk.

Common supplier profiles

• Global API companies with:
  • DMFs supporting US and EU filings
  • controlled impurity sets for valsartan
  • cGMP manufacturing for commercial batch consistency
• Contract manufacturers that supply via API brokerage arrangements tied to regulatory dossiers.

Key operational constraints

• Process impurity management: valsartan’s synthetic route creates impurities that must match acceptance criteria in regulatory filings.
• Batch release testing alignment: tablet producers require consistent CoA method equivalence for key specifications.
• Supply chain lead times: API shipment and retesting cycles can delay drug product manufacturing windows.

Which suppliers produce hydrochlorothiazide API for combination products?

Featured snippet: Hydrochlorothiazide has broader API availability versus valsartan, and supply risk usually concentrates on regulatory CMC readiness rather than raw availability.

Operational constraints

• Related substances: impurity profile must remain within specification despite different suppliers.
• Solvent and water content specifications: can affect blending and compression behavior.
• Consistency across micronization/granulation approach: influences content uniformity and dissolution.

What contract manufacturers make valsartan and hydrochlorothiazide tablets (ANDA-ready CMC)?

Featured snippet: Launch timing for fixed-dose valsartan/HCTZ depends on tablet CMO line availability and ability to execute BE/CMC for the exact strength and release profile.

What CMO capabilities drive selection

• Tablet compression tooling compatibility for the API/excipient system.
• Blend uniformity performance and in-process controls.
• Packaging system capability (bottle vs blister) aligned to label requirements.
• Stability chamber access for required ICH conditions.
• Regulatory documentation workflow mapped to ANDA CMC modules.

How does the supplier landscape differ by dosage strength and packaging?

Featured snippet: The API supply base can be similar across strengths, but product-level manufacturing and packaging readiness vary by strength and packaging configuration.

Typical strength logic (supply chain implications)

• Strength changes affect:
  • tablet mass and excipient amounts
  • film coating needs (if any in that market)
  • compression force windows and line throughput
• CMOs sometimes run multiple strengths but keep packaging operations strength-specific.

What patents protect valsartan and hydrochlorothiazide combinations, and how does that affect sourcing?

Featured snippet: Patent barriers generally do not block API sourcing directly. They limit which finished-dose product manufacturers can legally launch a generic or modified product referencing specific reference listed drug (RLD) formulations.

Where IP constrains suppliers

1. Drug product formulation patents
   Cover excipient composition, coating, or processing conditions for the marketed tablet.
2. Method-of-use patents
   Relevant when labels claim specific indications beyond the core hypertension use.
3. Polymorph or solid-state patents (if any for specific compositions)
   Can constrain viable manufacturing routes or require specific solid-state forms.
4. Regulatory exclusivity
   Limits approvals independent of patent expiry timing.

Practical effect on sourcing

• A CMO can source APIs, but the legal right to market depends on:
  • ANDA acceptability and legal status (patent challenge outcomes)
  • any settlement-triggered launch dates
  • label carve-outs

What is the Orange Book status for valsartan/HCTZ combos?

Featured snippet: Orange Book listings are RLD- and strength-specific. For combination products, exclusivity and patent estates vary by strength and manufacturer brand history.

Why Orange Book coverage affects supplier selection

• A tablet supplier’s launch plan is tied to:
  • which RLD strength they reference
  • which patents cover that strength
  • whether the ANDA is a Paragraph IV filing
• Even if APIs are available, legal risk determines whether a marketing authorization can be pursued.

What generic entry risks exist for valsartan/HCTZ tablet suppliers?

Featured snippet: The dominant entry risks are legal and CMC related: patent litigation outcomes and CMC deficiencies that delay approval.

Paragraph IV challenge risk

• If a sponsor challenges patents listed in the Orange Book, settlement can delay launch even after approval.
• Carve-outs or label changes can require reformulation or revalidation.

CMC-related risk

• Supplier changes in API lots can trigger:
  • re-testing needs
  • formulation revalidation (sometimes)
  • BE sensitivity issues if critical quality attributes drift

How many supplier options exist, and where are the bottlenecks?

Featured snippet: Bottlenecks concentrate at:

• valsartan API capacity and regulatory dossier readiness
• finished-dose tablet CMOs for the exact strengths and packaging configurations

Bottleneck model

• API market is typically more diversified than tablet manufacturing lines.
• Tablets require synchronized capacity for:
  • compression lines
  • coating or imprint steps (if applicable)
  • packaging and label printing runs
  • stability program continuity

Which regions matter for sourcing and launch timelines (US/EU/other)?

Featured snippet: US timelines hinge on FDA dossier acceptance and patent status tied to US RLDs. EU timelines hinge on local marketing authorization and national reimbursement pathways, plus EMA or national assessments.

Cross-region sourcing reality

• Many companies ship API globally but qualify it through region-specific regulatory submissions.
• Tablet CMOs often serve multiple markets but launch sequencing differs by regulatory and IP status.

Key supplier decision criteria for valsartan/HCTZ (commercial and regulatory)

Featured snippet: The supplier selection stack for valsartan/HCTZ is: regulatory status (DMF/CEP), CMC compatibility (impurities, particle size/solid state), manufacturing capacity (lead time), and IP-safe launch strategy (Orange Book alignment).

API supplier scorecard

• DMF alignment and US/EU regulatory acceptance history
• impurity profile robustness and batch consistency
• on-time supply record for API lots used in bioequivalence batches
• documented change control discipline (scale, route, solvent, crystallization conditions)

Tablet CMO/CDMO scorecard

• line clearance and cleaning validation fit for valsartan and HCTZ
• BE execution capability for the relevant strength
• stability program execution track record
• documentation readiness for ANDA and post-approval supplements

Key Takeaways

• Valsartan/HCTZ supply is structurally two-step: API sourcing then tablet manufacturing and packaging execution.
• Supplier availability differences are typically more pronounced at valsartan API and at tablet manufacturing lines for specific strengths.
• Patent and Orange Book status constrain finished-dose launch rights more than API procurement, so sourcing must be paired with a legal launch plan.
• For fastest market entry, the winning path is usually: dual-source APIs with regulatory-ready dossiers plus a tablet CMO with confirmed capacity for the exact strength and packaging configuration.

FAQs

1. Do valsartan/HCTZ tablet manufacturers use the same valsartan API supplier across all strengths (80/12.5 vs 160/25)?
2. What CMC tests most often block acceptance for hydrochlorothiazide API from a new supplier?
3. How do API impurity profile changes affect BE success for fixed-dose valsartan/HCTZ tablets?
4. What is the main timeline risk for generic valsartan/HCTZ beyond FDA approval (settlement vs stability)?
5. Can a tablet CMO manufacture valsartan/HCTZ without being the ANDA sponsor, and still support rapid launch?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
2. FDA. ANDA Guidance documents on CMC content and bioequivalence considerations (as applicable).