Venlafaxine Hydrochloride API Manufacturer and Supplier in India

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Venlafaxine Hydrochloride API Manufacturer and Supplier in India

Swapnroop Drugs & Pharmaceuticals is a manufacturer and supplier of Venlafaxine Hydrochloride API for pharmaceutical formulation, development, research and regulated pharmaceutical manufacturing applications.

Venlafaxine Hydrochloride, commonly known as Venlafaxine HCl, is a synthetic small-molecule pharmaceutical active ingredient belonging to the serotonin-norepinephrine reuptake inhibitor (SNRI) class. It is used in pharmaceutical formulations for the management of depressive disorders and other approved psychiatric indications.

Venlafaxine Hydrochloride is identified by CAS No. 99300-78-4, with molecular formula C₁₇H₂₈ClNO₂ and molecular weight approximately 313.86 g/mol.

Venlafaxine Hydrochloride API Overview

Venlafaxine Hydrochloride is the hydrochloride salt of venlafaxine. It is a racemic synthetic compound containing a cyclohexanol structure, dimethylaminoethyl group and methoxyphenyl group.

Venlafaxine primarily inhibits the neuronal reuptake of serotonin and norepinephrine, while its effect on dopamine reuptake is comparatively weaker. Its pharmacological activity is associated with increased availability of these neurotransmitters in the central nervous system.

The API is used in the manufacture of pharmaceutical dosage forms, particularly oral formulations. Its hydrochloride salt form provides the pharmaceutical substance used in commercial formulations.

 

Pharmaceutical Applications

Venlafaxine Hydrochloride API is primarily used for pharmaceutical formulations in the CNS therapeutic area.

Applications include:

  • Antidepressant pharmaceutical formulations
  • Major depressive disorder formulations
  • CNS pharmaceutical development
  • Serotonin-norepinephrine reuptake inhibitor products
  • Oral pharmaceutical formulation development
  • Pharmaceutical research and development
  • Bulk API manufacturing

Venlafaxine is pharmacologically associated with inhibition of serotonin and norepinephrine reuptake, supporting its use as an SNRI pharmaceutical ingredient.

Venlafaxine Hydrochloride API for Pharmaceutical Manufacturing

Venlafaxine Hydrochloride is a well-characterized synthetic pharmaceutical API with established pharmacopoeial quality requirements.

Quality evaluation can include:

  • Identification by infrared spectroscopy
  • HPLC retention-time identification
  • Assay
  • Loss on drying
  • Sulphated ash/residue on ignition
  • Heavy metals
  • Related substances
  • Total impurities
  • Physical appearance
  • Solubility

The Indian Pharmacopoeia monograph specifies loss on drying NMT 0.5% and sulphated ash NMT 0.1%. It also describes the material as freely soluble in water and methanol, soluble in anhydrous ethanol and slightly soluble or practically insoluble in acetone.

Venlafaxine Hydrochloride API Manufacturer and Supplier

Swapnroop Drugs & Pharmaceuticals provides Venlafaxine Hydrochloride API manufacturing and supply support for pharmaceutical companies, formulation manufacturers and qualified customers.

As a Venlafaxine Hydrochloride API manufacturer and supplier in India, Swapnroop supports customers requiring pharmaceutical-grade API with controlled specifications, analytical documentation and reliable supply.

Venlafaxine HCl can support requirements involving:

  • Pharmaceutical formulation development
  • Bulk API procurement
  • CNS pharmaceutical manufacturing
  • Antidepressant formulation development
  • Analytical research
  • Pharmaceutical product development
  • Regulated pharmaceutical manufacturing

Packaging and Storage

Venlafaxine Hydrochloride should be stored in well-closed pharmaceutical-grade containers under controlled environmental conditions.

The material should be protected from excessive moisture, unsuitable heat and direct environmental exposure. Pharmacopoeial storage guidance specifies preservation in well-closed containers at controlled room temperature.

Documentation

Typical pharmaceutical documentation may include:

  • Certificate of Analysis (CoA)
  • Product Specification
  • Batch Analytical Report
  • Safety Data Sheet (SDS)
  • Manufacturing Documentation
  • Analytical Documentation
  • Regulatory Documentation, where applicable
  • Stability Documentation, where applicable
  • Technical Documentation, where applicable

Documentation availability may depend on the product grade, intended market and customer requirements.

Quality Considerations

Venlafaxine Hydrochloride has established pharmacopoeial specifications for assay and impurities.

The current USP-derived specification gives an assay range of 98.0–102.0% on the dried basis, loss on drying NMT 0.5%, residue on ignition NMT 0.1%, and heavy metals NMT 20 ppm.

The organic impurity specification includes limits for descyclohexanol venlafaxine, didesmethyl venlafaxine, venlafaxine related compound A, deoxy venlafaxine and unspecified individual impurities. Total impurities are controlled at NMT 0.50% under the USP-derived specification.

Why Choose Swapnroop for Venlafaxine Hydrochloride API?

Swapnroop Drugs & Pharmaceuticals supports pharmaceutical manufacturers and qualified customers seeking Venlafaxine Hydrochloride API for formulation, development and manufacturing applications.

Our approach focuses on:

  • Controlled API quality
  • Pharmacopoeial specification alignment
  • Analytical documentation
  • Batch-specific documentation
  • Bulk API supply
  • Pharmaceutical manufacturing support
  • Technical documentation
  • Professional customer support

Swapnroop supports customers looking for Venlafaxine Hydrochloride API Manufacturer and Supplier in India.

Detailed Specifications

Parameter Specification
Appearance white to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0–102.0% on dried basis
Loss on Drying NMT 0.5%
Residue on Ignition NMT 0.1%
Heavy Metals NMT 20 ppm
Individual Impurity NMT 0.10%
Total Impurities NMT 0.50%
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