Active Pharmaceutical Ingredient

Dilevalol Hydrochloride Manufacturer & Supplier in India

Also known as: R,R-Labetalol Hydrochloride

CAS: 75659-07-3 Beta-Adrenergic Blocking Agent (Antihypertensive) IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Dilevalol Hydrochloride API — Mediocon Inc
Dilevalol Hydrochloride — Pharmaceutical Grade API

Product Overview

CAS No: 75659-07-3  |  MF: C19H25ClN2O3  |  MW: 364.87

Dilevalol Hydrochloride is a pharmaceutical-grade active ingredient classified as Beta-Adrenergic Blocking Agent (Antihypertensive). Mediocon Inc supplies high-purity Dilevalol Hydrochloride API conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Dilevalol Hydrochloride is the hydrochloride salt of dilevalol, acting as a combined alpha-1 and beta-adrenergic receptor blocker that lowers blood pressure with sustained antihypertensive activity. It is used as a critical raw material in finished dosage form manufacturing for global pharmaceutical markets.

Key Features

  • High-purity pharmaceutical grade API
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Hypertension management
  • Oral antihypertensive formulations
  • Cardiovascular pharmaceutical research
  • Beta-blocker tablet/capsule manufacturing

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameDilevalol Hydrochloride
CAS Number75659-07-3
Molecular FormulaC19H25ClN2O3
Molecular Weight364.87
CategoryBeta-Adrenergic Blocking Agent (Antihypertensive)
AppearanceWhite to off-white crystalline powder
GradeIP / BP / EP / USP
Batch NoMDCDIL2503871
Mfg DateMAR 2025
Exp DateFEB 2030
Quantity25.00 Kg
Gross Weight26.00 Kg

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Dilevalol Hydrochloride (pharmaceutical grade) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Dilevalol Hydrochloride is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances, residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Stability data available (ICH Q1A guidelines) for regulatory submissions
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Dilevalol Hydrochloride API

What is the minimum order quantity for Dilevalol Hydrochloride API?
Mediocon Inc supplies Dilevalol Hydrochloride with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Dilevalol Hydrochloride does Mediocon supply?
We supply Dilevalol Hydrochloride conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Dilevalol Hydrochloride API?
Every shipment of Dilevalol Hydrochloride comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Dilevalol Hydrochloride bulk orders?
Standard lead time for Dilevalol Hydrochloride is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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