D.K. Pharmachem Pvt. Ltd.

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Dopamine Hydrochloride API - Trusted Manufacturer & Supplier in India

WHO-GMP Certified | Purity ≥99% | Injectable-Grade | DMF/EDMF Support | Global Supply

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D.K. Pharmachem regulatory documentation support for Dopamine Hydrochloride API - DMF, CoA, MSDS
D.K. Pharmachem is an established Dopamine Hydrochloride API manufacturer based in India, supplying pharmaceutical-grade Dopamine HCl to injectable drug makers, hospitals, and formulation companies worldwide. Produced under WHO-GMP certified conditions, our Dopamine Hydrochloride API meets the stringent purity and stability requirements of USP, BP, and IP pharmacopoeias. With reliable supply, full regulatory documentation, and decades of experience in critical-care API manufacturing, we are the trusted partner for your Dopamine HCl sourcing needs.

Dopamine Hydrochloride API
Technical Specifications & Quality Standards

Attribute Details
Pharmacopoeia Standard USP / EP
CAS Number 62-31-7
Molecular Formula C₈H₁₁NO₂·HCl
Chemical Name 3,4-Dihydroxyphenethylamine Hydrochloride
Molecular Weight 189.64 g/mol
Therapeutic Application Cardiac Support & Neurotransmitter Precursor
DMF / EDMF Status Available
Manufacturing Standard WHO-GMP Certified
Appearance White to light yellow crystalline powder
Purity ≥ 99% (HPLC)
Storage Conditions Store below 25°C in a tightly closed, light-protected container
Available Pack Sizes 1 kg | 5 kg | 25 kg | Custom bulk quantities
Regulatory Support US DMF | EDMF | CoA | MSDS available on request

Our Dopamine Hydrochloride API Manufacturing Process

Our Dopamine Hydrochloride API manufacturing process is carried out in a dedicated, WHO-GMP compliant facility in India. Every batch of Dopamine HCl API undergoes stringent in-process controls and final quality testing to ensure a minimum purity of ≥99%. The manufacturing process is validated, documented, and designed to support regulatory submissions including US DMF, EDMF, and other global dossier requirements. As a vertically integrated Dopamine Hydrochloride API manufacturer, D.K. Pharmachem provides consistent batch-to-batch quality and the supply reliability that critical-care drug manufacturers demand.

GMP-Compliant Manufacturing Facility

Synthesis & Purification Process Overview

In-Process Quality Control & Batch Testing

Packaging & Cold-Chain Compliance

Our manufacturing strength supports consistent quality and reliable long-term supply.

Packaging, Handling & Storage Guidelines

Dopamine HCl API is packaged to maintain chemical integrity during storage and transportation.

Packaging Options
  • Pharmaceutical-grade sealed containers
  • Custom pack sizes available on request
Handling & Storage
  • Store in a cool, dry, and controlled environment
  • Protect from light and moisture
  • Keep containers tightly closed
  • Handle as per injectable API safety guidelines
Proper storage is critical to maintain stability and shelf life.
Buclizine hydrochloride API manufacturing facility with cleanroom production and industrial processing systems

Global Supply of Dopamine Hydrochloride API

D.K. Pharmachem exports Dopamine Hydrochloride API to pharmaceutical manufacturers across North America, Europe, the Middle East, Southeast Asia, and Africa. Our logistics infrastructure and documentation capabilities support seamless import across all major regulated and semi-regulated markets.We support both spot orders and long-term supply agreements with volume pricing, dedicated account management, and guaranteed batch-to-batch consistency.

For Pharmaceutical Manufacturers & Research Labs

Partner with a WHO-GMP certified supplier for consistent quality, regulatory compliance, and reliable supply of Dopamine Hydrochloride for your critical applications.

Request a Quote for Dopamine HCl API

Regulatory Support & Documentation for Dopamine HCl API

D.K. Pharmachem provides comprehensive regulatory support for all global markets. Our Dopamine Hydrochloride API is backed by a full documentation package designed to streamline your regulatory submissions and accelerate time to market.

Drug Master File (DMF)

US DMF available for FDA submissions. Supports ANDA and NDA filings for injectable dopamine formulations.

European Drug Master File (EDMF)

EDMF support for EMA regulatory submissions across EU member states.

Certificate of Analysis (CoA)

Full batch-specific CoA provided with every shipment, including HPLC assay, appearance, and residual solvent results.

Material Safety Data Sheet (MSDS)

Comprehensive MSDS available on request for all regulatory and safety purposes.

Pharmacopoeial Compliance

Complies with USP (United States Pharmacopoeia), BP (British Pharmacopoeia), and IP (Indian Pharmacopoeia).

Stability Data

Stability study data available to support shelf-life claims in regulatory dossiers.

Why Choose D.K. Pharmachem as Your Dopamine Hydrochloride API Supplier?

Pharmaceutical companies and formulation manufacturers across North America, Europe, and Asia trust D.K. Pharmachem for consistent, compliant, and competitively priced Dopamine Hydrochloride API.

WHO-GMP Certified Manufacturing

Regulatory Support (DMF/EDMF)

Consistent Purity ≥99%

Reliable Global Supply

USP / BP / IP Compliance

Decades of API Expertise

D.K. Pharmachem is a dependable partner for injectable and ICU-focused pharmaceutical manufacturers.
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Frequently Asked Questions

Find answers to common questions about Dopamine Hydrochloride API products and services

What is Dopamine Hydrochloride API used for?

Dopamine Hydrochloride API is a critical care active pharmaceutical ingredient used in injectable formulations to treat haemodynamic instability, cardiogenic shock, septic shock, and acute heart failure in ICU settings.
D.K. Pharmachem is a leading Dopamine Hydrochloride API manufacturer in India. We operate a WHO-GMP certified facility and supply injectable-grade Dopamine HCl to pharmaceutical companies worldwide.
Our Dopamine Hydrochloride API manufacturing facility is WHO-GMP certified. We comply with USP, BP, and IP pharmacopoeial standards and provide full regulatory support including US DMF, EDMF, CoA, and MSDS.
Yes. D.K. Pharmachem provides US Drug Master File (DMF) support for FDA submissions and European Drug Master File (EDMF) support for EMA submissions. Contact us for details on available filings.
We support both small-scale and large bulk orders of Dopamine Hydrochloride API. Contact our sales team at dkc@dkpharmachem.com to discuss your quantity requirements and receive a quote.
Yes. A full Certificate of Analysis (CoA) is provided with every batch of Dopamine Hydrochloride API. MSDS and stability data are also available on request.
Our Dopamine Hydrochloride API meets the specifications of the United States Pharmacopoeia (USP), British Pharmacopoeia (BP), and Indian Pharmacopoeia (IP).
Yes. D.K. Pharmachem exports Dopamine HCl API to regulated and semi-regulated markets globally, including the USA, Europe, Middle East, Southeast Asia, and Africa.