Itopride Hydrochloride API Manufacturer & Exporter
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Itopride Hydrochloride is a gastroprokinetic agent that enhances gastrointestinal motility. Produced under WHO-GMP facilities, our Itopride is compliant with international quality standards and backed by regulatory filings.
It is widely used in formulations for functional dyspepsia and related gastrointestinal disorders, with a strong presence in Asian and global markets.
Itopride HCL Specifications | CAS 122898-67-3
| Attribute | Details |
|---|---|
| Pharmacopoeia Standard | JP / EP |
| CAS Number | 122898-67-3 |
| Molecular Formula | C₂₀H₂₄N₂O₄·HCl |
| Molecular Weight | 394.88 g/mol |
| Therapeutic Application | Prokinetic Agent (GI motility enhancer) |
| DMF / EDMF Status | Available |
| Manufacturing Standard | WHO-GMP Certified |
| Appearance | White crystalline powder |
| Purity | ≥ 99% |
Itopride Hydrochloride API Manufacturing Facility in India
As a WHO-GMP certified manufacturer, We are equipped for high-purity pharmaceutical intermediate production. Our Itopride Hydrochloride API manufacturing line is purpose-built for controlled synthesis, ensuring batch-to-batch consistency and compliance with international pharmacopoeial standards.
WHO-GMP Certified Infrastructure
DK Pharmachem operates a dedicated WHO-GMP certified manufacturing facility in India, equipped for high-purity pharmaceutical intermediate production.
Facility highlights to list as bullet points below this paragraph:
- Dedicated synthesis and processing units
- In-house HPLC and analytical quality control laboratory
- ISO-compliant raw material storage and handling
- ETP (Effluent Treatment Plant) for safe waste management
- Validated cleaning and production procedures
Production Capacity & Bulk Supply Capabilities
As a bulk Itopride Hydrochloride API supplier in India, DK Pharmachem maintains scalable production capacity to meet both regular and high-volume procurement requirements. Our supply chain is designed to support uninterrupted manufacturing operations for our clients.
Supply capabilities to list as bullet points:
- Consistent monthly output to meet bulk order requirements
- Flexible packaging: HDPE drums, fiber drums, bulk options
- Shelf-stable formulation with documented storage guidelines
- Batch traceability from raw material to finished product
- COA, MSDS, and EDMF documentation provided with every shipment
Certifications & Regulatory Compliance
Every batch of Itopride Hydrochloride API manufactured at our India facility is backed by:
- WHO-GMP Certification
- European Pharmacopoeia (EP) compliance
- British Pharmacopoeia (BP) compliance
- EDMF (European Drug Master File) registration
- Certificate of Analysis (COA) per batch
- Material Safety Data Sheet (MSDS) available on request
As one of the established Itopride Hydrochloride API manufacturers in India, we ensure uninterrupted supply chains and strict adherence to global quality standards.
Itopride Hydrochlorides Therapeutic Applications in Pharmaceutical Formulations
Itopride Hydrochloride is a dopamine D2 antagonist and acetylcholinesterase inhibitor used primarily in the treatment of functional dyspepsia and gastroparesis. It is commonly formulated as 50 mg oral tablets and is a widely prescribed prokinetic agent in regulated and semi-regulated pharmaceutical markets. DK Pharmachem supplies Itopride HCl API to formulators developing both branded and generic gastrointestinal drug products.
Functional Dyspepsia
Prokinetic Tablet Formulations (50 mg)
Gastroparesis
Gastric Motility Enhancement Therapies
Generic API Manufacturing
Gastrointestinal Drug Portfolios
Combination Therapies
Multi-Drug GI Formulation Development
We supply bulk Itopride Hydrochloride API from India
DK Pharmachem serves clients across pharmaceuticals, agrochemicals, water treatment, and contract manufacturing sectors. We maintain consistent stock availability to support both spot orders and long-term supply agreements.
As an established Itopride Hydrochloride API exporter, we ship to regulated markets including Europe, North America, Southeast Asia, and the Middle East. All export shipments are accompanied by full documentation - COA, MSDS, EDMF, and country-specific regulatory filings where required.
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Partner with DK Pharmachem for consistent pharmaceutical-grade quality, reliable bulk supply, and comprehensive regulatory documentation. Get in touch with our team today to discuss your requirements, timelines, and pricing.
Packaging, Handling & Storage Guidelines
Itopride Hydrochloride is packed carefully to maintain stability and ensure safe handling throughout the supply chain.
Packaging Options
- HDPE drums
- Fiber drums with inner liners
- Bulk packaging options available
Handling & Storage
- Store in a cool, dry, and well-ventilated area
- Protect from moisture and direct sunlight
- Keep containers tightly closed
- Follow standard safety precautions during handling
Proper storage preserves product quality and performance.
Why Choose DK Pharmachem for Itopride Hydrochloride sourcing?
Choosing the right sourcing partner for Itopride Hydrochloride API means evaluating quality, regulatory standing, supply reliability, and long-term partnership capability. DK Pharmachem has been a trusted name in pharmaceutical APIs for over four decades, built on a foundation of manufacturing excellence and customer trust.
Direct Manufacturer, Not a Trader
WHO-GMP Certified Manufacturing
EDMF Registration Support
EP/BP Compliant Product Quality
Comprehensive Technical & Export Documentation
Bulk Supply & Long-Term Contract Support
D.K. Pharmachem is trusted by pharmaceutical companies for consistent quality and dependable supply of APIs
Frequently Asked Questions
Find answers to common questions about Itopride Hydrochloride API
Is DK Pharmachem a direct bulk Itopride Hydrochloride supplier?
Yes, we are a direct manufacturer and supplier in India, producing Itopride HCl in-house at our WHO-GMP certified facility in Badlapur, Maharashtra.
What is the minimum order quantity for bulk Itopride Hydrochloride?
Our standard minimum order quantity is 25 kg (one drum), though smaller sample quantities may be available.
Does your Itopride Hydrochloride comply with IP and BP standards?
Yes, our API conforms to Indian Pharmacopoeia (IP) and British Pharmacopoeia (BP) specifications, with a Certificate of Analysis (COA) provided for every batch.
Can we request a sample before placing a bulk order?
Yes, samples are available upon request along with COA and MSDS documentation.
Which countries does DK Pharmachem export Itopride Hydrochloride to?
We export to pharmaceutical companies in Southeast Asia, Africa, the Middle East, and other international markets, complete with necessary regulatory documentation.
What is the CAS number for Itopride Hydrochloride?
The CAS number is 122892-31-3 (Molecular Formula: C₂₀H₂₆N₂O₄ · HCl; Molecular Weight: 422.90 g/mol).