Suppliers and packagers for generic pharmaceutical drug: VENLAFAXINE BESYLATE

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

Pharmaceutical Suppliers of Venlafaxine Besylate: Market Landscape and Manufacturing Considerations

Venlafaxine besylate, a benzene sulfonic acid salt derivative of the serotonin-norepinephrine reuptake inhibitor (SNRI) venlafaxine, represents a specialized formulation variant with distinct physicochemical and manufacturing advantages over the more common hydrochloride salt[2][8]. While venlafaxine hydrochloride (marketed as Effexor®) has dominated antidepressant therapeutics since its 1993 FDA approval, the besylate salt offers improved handling properties and extended-release formulation capabilities[2][10]. This report synthesizes available data on global suppliers, manufacturing dynamics, and regulatory considerations for this pharmaceutical compound.

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Chemical and Therapeutic Profile of Venlafaxine Besylate

Molecular Characteristics

Venlafaxine besylate (C₂₃H₃₃NO₅S) combines the venlafaxine base with benzenesulfonic acid, yielding a molecular weight of 435.6 g/mol[8]. Its crystalline monohydrate form exhibits reduced water solubility (25 mg/mL) compared to the hydrochloride salt (570 mg/mL), a critical factor in extended-release dosage design[2]. The besylate salt's lower melting point facilitates thermal processing methods like hot-melt granulation, while its higher bulk density (500+ mg/mL) improves powder flow characteristics during tablet compression[2][10].

Clinical Indications and Safety

References

1. https://www.pharmacompass.com/manufacturers-suppliers-exporters/venlafaxine-hcl
2. https://patents.google.com/patent/US6717015B2/en
3. https://pharmaoffer.com/api-excipient-supplier/serotonin-and-norepinephrine-reuptake-inhibitors-snris/venlafaxine
4. https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/venlafaxine-hcl
5. https://www.pharmacy.ca.gov/about/recalls.shtml
6. https://www.pipelinepharma.com/venlafaxine-manufacturers
7. https://www.fda.gov/media/71502/download
8. https://pubchem.ncbi.nlm.nih.gov/compound/10173527
9. https://www.pdr.net/drug-summary/Venlafaxine-Hydrochloride-Extended-Release-Tablets-venlafaxine-hydrochloride-3520
10. https://patents.google.com/patent/US7776358B2/en
11. https://pharmaoffer.com/api-excipient-supplier/serotonin-and-norepinephrine-reuptake-inhibitors-snris/venlafaxine/dmf