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Venlafaxine Hydrochloride is a serotonin-norepinephrine reuptake inhibitor (SNRI) class antidepressant Active Pharmaceutical Ingredient (API) widely used for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), panic disorder, and social anxiety disorder.
At Bluepill Express, we manufacture and export Venlafaxine Hydrochloride API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring exceptional purity, uniform particle size distribution, and global pharmacopoeial compliance.
Our API is suitable for both immediate-release and extended-release (XR) formulations, supporting a wide range of pharmaceutical dosage applications.
Bluepill Express specializes in custom API synthesis, bulk exports, and third-party manufacturing partnerships for regulated and semi-regulated markets across Africa, Asia, the Middle East, and Latin America.
Therapeutic Category
- Antidepressant (SNRI Class)
- Anxiolytic
- Psychotropic Agent
Mechanism of Action
Venlafaxine Hydrochloride works by inhibiting the reuptake of serotonin (5-HT) and norepinephrine (NE) in the central nervous system, increasing their levels in the synaptic cleft.
This dual-action mechanism enhances mood regulation, emotional stability, and anxiety control, making it effective for treatment-resistant depression and chronic anxiety disorders.
At higher doses, it also exhibits mild dopamine reuptake inhibition, contributing to improved motivation and energy levels in patients with depressive symptoms.
Chemical Information
| Parameter | Details |
|---|---|
| Chemical Name | (±)-1-[2-(Dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol hydrochloride |
| Molecular Formula | C17H27NO2·HCl |
| Molecular Weight | 313.86 g/mol |
| CAS Number | 99300-78-4 |
| Therapeutic Class | Antidepressant (SNRI) |
| Pharmacopoeial Compliance | IP / BP / USP / EP |
| Synonyms | Venlafaxine HCl, Venlafaxine Hydrochloride API |
Physical & Chemical Properties
| Property | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Odor | Odorless |
| Taste | Slightly bitter |
| Solubility | Freely soluble in water and methanol; sparingly soluble in ethanol |
| Melting Point | 215°C – 220°C |
| pH (1% w/v solution) | 5.0 – 6.5 |
| Stability | Stable under ambient conditions |
| Storage | Store in tightly closed containers, in a cool, dry place below 25°C |
Technical Specifications (Bluepill Express Standards)
| Parameter | Specification |
|---|---|
| Identification | IR & UV spectra consistent with standard reference |
| Assay (Purity) | ≥ 99.0% and ≤ 101.0% (on anhydrous basis) |
| Loss on Drying | ≤ 0.5% |
| Residue on Ignition | ≤ 0.1% |
| Related Substances | ≤ 0.2% (individual impurity) |
| Heavy Metals | ≤ 10 ppm |
| Bulk Density | 0.35 – 0.55 g/ml |
| Particle Size | Customized (as per client specification) |
| Optical Rotation | Between +12° and +16° |
| Microbial Limit | Complies with pharmacopeial requirements |
Pharmacological Applications
Venlafaxine Hydrochloride is clinically used to manage various psychiatric and mood disorders, including:
- Major Depressive Disorder (MDD)
- Generalized Anxiety Disorder (GAD)
- Social Anxiety Disorder (SAD)
- Panic Disorder (PD)
- Obsessive-Compulsive Disorder (OCD) (off-label use)
- Chronic Pain Syndromes (neuropathic pain management)
Manufacturing & Quality Assurance
Bluepill Express ensures that every batch of Venlafaxine Hydrochloride API undergoes:
- Analytical testing using HPLC, FTIR, and UV spectrophotometry
- Microbial limit testing for bioburden control
- Stability studies as per ICH Q1A guidelines
- Packaging in nitrogen-flushed moisture-proof containers
Our API is developed following QbD (Quality by Design) principles, ensuring reproducibility and regulatory acceptance across global markets.
Pharmacokinetics (Brief Overview)
- Bioavailability: ~45% after oral administration
- Metabolism: Primarily via CYP2D6 to active metabolite O-desmethylvenlafaxine (ODV)
- Elimination Half-life: 5 hours (Venlafaxine), 11 hours (ODV)
- Excretion: Renal (87%)
Dosage Forms Using Venlafaxine Hydrochloride API
- Tablets: 25 mg, 37.5 mg, 50 mg, 75 mg, 150 mg
- Extended-Release Capsules (XR): 37.5 mg, 75 mg, 150 mg, 225 mg
- Combination Products: Venlafaxine + Clonazepam (for anxiety)
Packaging & Export Details
| Detail | Specification |
|---|---|
| Packaging Type | HDPE drums or fiber containers with double liners |
| Available Pack Sizes | 5 kg / 10 kg / 25 kg / 50 kg |
| Labeling | Export-compliant, includes manufacturing date, batch no., expiry |
| Shelf Life | 36 months under recommended storage |
| Supply Form | Crystalline Powder API |
| Shipping | By air or sea in temperature-controlled consignments |
| Export Markets | Africa, Middle East, Latin America, Southeast Asia, CIS, and Europe |
Documentation Support Provided
- Certificate of Analysis (COA)
- Material Safety Data Sheet (MSDS)
- Technical Data Sheet (TDS)
- Stability Study Report (as per ICH)
- Non-GMO & Allergen-Free Statements
- Residual Solvent Declaration
- Drug Master File (DMF) / CTD Dossier available on request
Safety and Handling
- Handle with protective gloves, goggles, and dust masks.
- Avoid inhalation or direct skin contact.
- Dispose of waste material as per local environmental regulations.
- Keep out of reach of unauthorized personnel.
Storage Conditions
- Store below 25°C in a cool, dry, well-ventilated area.
- Protect from light, moisture, and excessive heat.
- Keep container tightly closed when not in use.
Regulatory Compliance
Venlafaxine Hydrochloride manufactured by Bluepill Express meets international standards:
- WHO-GMP Certified Plant
- ISO 9001:2015 Quality Management System
- Complies with IP / BP / USP / EP
- Non-GMO & BSE/TSE Free
- REACH and RoHS Compliant
