Duloxetine Pellets Manufacturer & Supplier
Enteric-coated pellets formulated for serotonin-norepinephrine reuptake inhibitor therapies addressing depression, neuropathic pain, and generalized anxiety disorders.
Product overview
Duloxetine hydrochloride is a dual-action antidepressant that modulates both serotonin and norepinephrine pathways to treat major depressive disorder, generalized anxiety disorder, and neuropathic pain. Our pelletised form enhances stability, reduces gastric degradation, and delivers reliable absorption—ideal for controlled-release capsule and tablet applications.
Key characteristics
- Controlled Release Design: Enteric coatings delay release until intestinal pH levels, ensuring gastric protection and steady absorption.
- Uniform Pellet Density: Precision spheronisation and solvent layering guarantee consistent pellet morphology and low friability.
- Real-Time Process Analytics: Continuous monitoring of moisture, assay, and coating thickness ensures batch-to-batch reproducibility.
- High Purity & Low Impurities: Pharmacopeial-grade duloxetine hydrochloride processed under stringent GMP and PAT frameworks.
- Versatile Applications: Compatible with capsule filling, multiparticulate tablets, or film-coated dosage forms.
- Data-Driven Validation: Comparative dissolution, impurity profiles, and accelerated stability data across climatic zones included.
Technical information
- API: Duloxetine Hydrochloride
- Assay: 98.0–102.0%
- Pellet Size Range: 500–1000 μm (customizable)
- Enteric Polymer: Methacrylic Acid Copolymers or HPMC-based systems
- Loss on Drying: ≤1.5%
- Packaging: 25 kg HDPE drum with inner liner or nitrogen-flushed bags for clinical batches
- Storage: Store below 25°C, protected from moisture and direct sunlight.
Pharmaceutical applications
- Pharmaceutical manufacturers producing antidepressant or neuropathic pain formulations.
- Contract development and manufacturing organizations (CDMOs) seeking SNRI pellet solutions.
- R&D teams developing controlled-release or enteric-coated psychiatric formulations.
How it works
Duloxetine works by inhibiting the reuptake of serotonin and norepinephrine, enhancing neurotransmitter balance in the brain. Its enteric-protected pellet form prevents early degradation in gastric acid, allowing targeted release in the small intestine for improved therapeutic consistency and reduced side effects.
Usage note
For pharmaceutical manufacturing and educational reference only. End-use medications containing duloxetine should be used strictly under medical supervision. Manufacturers are advised to validate formulation performance according to pharmacopeial standards before commercialization.
Product specifications
- Product
- Duloxetine Pellets
- Form
- Pellets
- Therapeutic category
- SNRI
- Available strengths
- 20 mg, 30 mg, 60 mg
- Grade
- IP / BP / USP / EP
- Pack size
- 25/50 kg
- Site certifications
- WHO-GMP, ISO 9001, ISO 14001
Detailed specifications, COA and technical documentation are shared on request.
Supply and enquiries
Rraynex supplies Duloxetine Pellets to pharmaceutical manufacturers, formulation developers and CDMOs in 25/50 kg packs with batch traceability. Send your quantity, grade and documentation needs through the enquiry form and the commercial team will reply with specifications and a quotation. Rraynex is a B2B supplier and does not sell to consumers.
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Other Duloxetine products from Rraynex
- Duloxetine EC (WW) — Pellets
- Duloxetine EC + Pregabalin — Pellets