Last updated: June 1, 2026
Amlodipine Besylate, Valsartan, and Hydrochlorothiazide Suppliers: Who Manufactures the API and Combination Products?
Executive summary
Suppliers for amlodipine besylate + valsartan + hydrochlorothiazide (HCTZ) concentrate in two tiers: (1) API manufacturers for each active pharmaceutical ingredient and (2) finished-dose combination tablet contract manufacturing organizations (CMOs) plus brand/generic product holders. The sourcing landscape is fragmented by regulatory footprint (FDA DMFs and inspections), particle/grade control for tablet performance, and combination product formulation know-how (blend uniformity, dissolution, and stability).
A complete, accurate supplier list requires itemized confirmation of each supplier’s FDA Drug Master File (DMF) or Abbreviated NDA/ANDA linkage and whether they supply the APIs or the finished triple-combination tablet. Without that dossier-level dataset, a definitive supplier roster cannot be produced.
Which companies supply amlodipine besylate API for generic tablet manufacturing?
Amlodipine besylate API supply is typically structured around large Indian and Chinese API houses plus specialty manufacturers with consistent particle-size and polymorph control. In practice, generic tablet makers select API suppliers based on:
- DMF coverage (site-specific manufacturing details)
- EDQM/ICH stability history aligned with target shelf-life
- Inspection outcomes for oral solid dosage API plants
- Ability to support combination-tablet blend specifications (dose-level uniformity)
Common supplier archetypes (API):
- API-focused manufacturers with multiple DMFs across dose-relevant grades
- Salt/form control specialists for besylate form
- Firms that supply directly to ANDA filers and to downstream CMOs
What grades and specifications matter for amlodipine besylate API supply?
Key commercial selection criteria include:
- Particle size distribution and flow properties (critical to low-dose blending)
- Polymorph/form consistency of the besylate salt
- Residual solvents and elemental impurities aligned with USP/ICH limits
Which companies supply valsartan API for triple-combination tablet production?
Valsartan API has tighter sourcing constraints because of historically sensitive process impurities and strict regulatory expectations. Downstream buyers typically require:
- DMF support that maps to controlled impurity profiles
- Manufacturing provenance from inspectable sites with consistent batch records
- Ability to match particle size, crystal form, and dissolution needs
What impurity and process controls drive valsartan API sourcing?
Valsartan supply selection is dominated by:
- Ability to maintain specified impurity limits batch to batch
- Demonstrated process capability for solvent removal and purification
- Documented stability under stress conditions for blend compatibility
Which companies supply hydrochlorothiazide API for fixed-dose combinations?
HCTZ API supply is broader than valsartan in many markets, but buyers still prioritize:
- Consistent crystal form and water content
- Low variability in assay and impurities
- DMF and site alignment with the intended ANDA/brand dossier
What controls matter most for HCTZ API in combination tablets?
- Blend uniformity driven by API properties and particle engineering
- Moisture and stability management because combination tablets are hygroscopic-risk depending on excipient system
Who manufactures the finished amlodipine/valsartan/hydrochlorothiazide triple-combination tablets under contract?
Triple-combination oral solid manufacturing is handled by:
- Brand internal manufacturing networks
- Generic product manufacturers with in-house or captive tablet plants
- CMOs producing tablets for multiple ANDA holders under QMS and tech-transfer controls
What CMO capabilities are required for amlodipine-valsartan-HCTZ tablets?
- Tablet formulation control for three-actives stability
- Co-processing and blending that maintains uniform distribution of low- and high-dose components
- Packaging configuration and stability support for target markets
What is the Orange Book status of amlodipine besylate/valsartan/HCTZ combination products?
A reliable Orange Book status requires the specific FDA product name, strength(s), and NDA/ANDA holder, because patent and exclusivity listings vary by formulation and strength. A generic “triple-combination” label is not enough to map a single Orange Book record.
When does exclusivity expire for triple-combination amlodipine/valsartan/HCTZ products?
Exclusivity timing depends on:
- Whether the product is an NDA new chemical entity, a 505(b)(2) product, or an ANDA
- Whether there are new formulation or method-of-use patents
- Whether the product claims 3-year/5-year exclusivity or other exclusivity triggers
Without the exact FDA application identifiers and product strengths, expiry cannot be stated accurately.
What patent estates protect amlodipine/valsartan/HCTZ and how does that affect sourcing?
Patent estates affect sourcing primarily through:
- Licensing and settlement status that governs generic/combination launch timing
- Constraints on formulation, ratios, and release/dissolution approaches
- Barriers to using certain excipient systems or manufacturing steps if protected
What generic entry risks exist for triple-combination amlodipine/valsartan/HCTZ?
Generic entry risks typically stem from:
- Orange Book-listed patents tied to the specific marketed strength
- Paragraph IV challenges for competing ANDAs
- Settlement agreements that delay launch
A precise risk map again requires the exact FDA application and strength set.
How does triple-combination sourcing compare with dual-combination options (amlodipine/valsartan, valsartan/HCTZ)?
Triple-combination procurement generally adds:
- Higher formulation development and stability burden
- Tighter tablet performance requirements for three-actives
- Potentially higher regulatory scrutiny for manufacturing controls and impurity interactions
Dual combinations often have more established supply chains and more finished product precedents.
Key takeaways
- Supplier sourcing for amlodipine besylate + valsartan + hydrochlorothiazide spans API suppliers (DMF-backed) and tablet manufacturers/CMOs with tech-transfer and stability capability for triple-actives.
- A definitive supplier list cannot be produced without mapping to specific FDA dossier identifiers (DMFs for APIs and ANDA/NDA/Orange Book entries for finished products), because supplier eligibility is application- and site-specific.
- Selection hinges on regulatory footprint (FDA readiness), impurity controls (especially valsartan), and combination-tablet formulation stability and dissolution performance.
FAQs
- How do DMFs determine which companies are eligible amlodipine besylate API suppliers for ANDA filings?
- What sourcing constraints are typical for valsartan API compared with hydrochlorothiazide API?
- Can a CMO manufacture triple-combination tablets for multiple ANDA holders without owning the formulation IP?
- What manufacturing data do buyers typically require for API and tablet stability in amlodipine/valsartan/HCTZ products?
- How do Paragraph IV filings and settlements change supplier timing for generic triple-combination launches?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA.
- FDA. Drug Master Files (DMF). US FDA.
- FDA. Abbreviated New Drug Application (ANDA) and related regulatory guidance. US FDA.
