Suppliers and packagers for generic pharmaceutical drug: VENLAFAXINE BESYLATE

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VENLAFAXINE BESYLATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Almatica	VENLAFAXINE BESYLATE	venlafaxine besylate	TABLET, EXTENDED RELEASE;ORAL	215429	NDA	Almatica Pharma LLC	52427-632-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (52427-632-30)	2022-06-30

Suppliers and packagers for generic pharmaceutical drug: VENLAFAXINE BESYLATE

Last updated: June 29, 2026

Venlafaxine Besylate Suppliers: Who Makes API, Intermediates, and Finished Dosage Forms?

Venlafaxine besylate supply is typically split between (1) API manufacturers, (2) intermediate/side-chain suppliers used to build the venlafaxine scaffold, and (3) finished-dose producers that sell tablets through distributors or through generic-license supply chains. Public procurement data and market intelligence for “venlafaxine besylate” varies widely because many suppliers market the base API as venlafaxine (free base or HCl) and convert to the besylate salt for specific customers, registrations, or label requirements.

Supplier mapping by supply tier

• API / Salt conversion
  • Companies that can supply venlafaxine API and perform salt formation to venlafaxine besylate for finished-dose or contract manufacturing customers.
• Key intermediates
  • Suppliers of phenoxyethylamine building blocks and alkylation/side-chain intermediates used in venlafaxine manufacture.
• Finished dosage manufacturers (tablets/capsules)
  • Generic and authorized generic manufacturers that file Abbreviated New Drug Applications (ANDAs) and source API from approved vendor lists and DMFs.

Which companies supply venlafaxine besylate API and salt conversion?

Venlafaxine besylate supply is rarely exclusive to one vendor because finished-dose manufacturers require multiple qualified sources for continuity and cost control. In practice, customers screen suppliers through regulatory dossiers (DMFs) tied to ANDA formulations and through quality agreements (audit status, batch release testing, residual solvent and polymorph control for the salt form).

API supply chain reality

• Many manufacturers can produce venlafaxine base and then convert to the besylate salt under controlled crystallization and drying conditions, which affects:
  • particle size distribution
  • polymorphic form
  • water content (Karl Fischer)
  • specific surface area and compressibility for tablet direct compression
• Finished-dose manufacturers often specify salt form and solid-state specs in the drug product development package, which drives demand for direct venlafaxine besylate supply.

What jurisdictions are most common for venlafaxine besylate API supply?

• India and China dominate cost-competitive small-molecule API supply for older CNS products.
• EU/US specialty manufacturers may supply higher-spec or DMF-ready lots, usually at higher cost or with tighter pharma QA constraints.

Who provides venlafaxine synthesis intermediates used to make the API?

Venlafaxine API production typically relies on intermediates in two linked domains:

1. A substituted phenoxyethylamine core
2. A substituted side-chain construction that leads to venlafaxine after purification and salt formation

Intermediate sourcing patterns

• Some suppliers sell only isolated intermediates (route-specific fragments).
• Others supply “API-ready” intermediates (substances close to the final API) to reduce customer cycle time.
• Customers prefer intermediates that already have established analytical methods and residuals profiles to simplify regulatory documentation.

Which manufacturers produce venlafaxine besylate tablets for US and international markets?

Finished-dose supply is organized through ANDA manufacturers and distributor networks. Many products listed as “venlafaxine besylate tablets” use the same active ingredient but differ by:

• strength (eg, 37.5 mg, 50 mg depending on product)
• release profile (immediate release vs extended release is a separate issue)
• excipient system (compression, film coating, and dissolution design)

Market structure

• US supply typically includes multiple generics competing on acquisition price and availability.
• International markets may have additional license holders and local generic manufacturers, depending on patent and regulatory clearances.

How do you identify the real venlafaxine besylate suppliers for your dossier (DMF/ANDA approach)?

The most reliable way to identify suppliers for venlafaxine besylate used in a specific product is to trace:

• DMF holder(s) for the API (often includes multiple manufacturing sites)
• ANDA applicant and listed manufacturing sites in FDA submissions
• current-good-manufacturing-practice (cGMP) status for each site

Practical mapping method

• Identify the ANDA product(s) you want to emulate or source against.
• Pull the API DMF number(s) and read the manufacturing site(s) and solvent/salt preparation details where publicly available.
• Cross-check supplier quality history via inspection outcomes and audit confirmations.

What procurement and qualification barriers affect venlafaxine besylate supply?

Key constraints that typically limit alternative suppliers:

• Salt quality and solid-state control
  • reproducible crystallization conditions for the besylate form
• Analytical method availability
  • HPLC assay method transfers, besylate-specific characterization, and residual solvent testing
• Regulatory documentation readiness
  • DMF completeness and alignment with the specific drug product formulation
• Capacity and lead times
  • API lines for CNS actives often prioritize high-volume molecules; continuity depends on contracted slots

How strong is supplier competition for venlafaxine besylate vs branded venlafaxine salts?

Venlafaxine is a mature CNS molecule with broad generic adoption, so supplier competition is generally higher than for newer entrants. The competitive edge shifts based on:

• price-per-kilogram for API and salt-form conversion services
• ability to meet USP/EP specs for related substances and water content
• speed of DMF updates and site change notifications

Key takeaways

• Venlafaxine besylate supply is typically sourced from a small set of API producers with the ability to convert venlafaxine base to the besylate salt, plus multiple finished-dose manufacturers that qualify those API sources via DMFs.
• The fastest way to identify “your” suppliers is to map from target ANDA filings to the linked API DMFs and manufacturing sites rather than relying on reseller labeling.
• Supply continuity is driven by salt-form solid-state control, analytical method transfer readiness, and DMF documentation completeness.

FAQs

1. How do I find the API DMF holders for venlafaxine besylate used in US generic products?
2. Do suppliers commonly make venlafaxine besylate directly, or do they convert from venlafaxine base/HCl?
3. What solid-state parameters most affect tablet performance for venlafaxine besylate?
4. Are there common inspection or batch-release issues specific to besylate salt forms of APIs?
5. Which finished-dose manufacturers typically source venlafaxine besylate from multiple API vendors?

References

1. FDA. “Drug Master Files (DMF).” FDA, accessed 2026-06-29. (General regulatory background for DMF use; no product-specific supplier list cited.)