Active Pharmaceutical Ingredient

Bisoprolol API Manufacturer & Supplier in India

Also known as: Zebeta, Concor (brand)

CAS: 66722-44-9 Beta Blocker USP / BP / IP Bulk Supply Available
Bisoprolol API Manufacturer India | Mediocon Inc
Bisoprolol — Pharmaceutical Grade API

Product Overview

CAS No: 66722-44-9  |  MF: C₁₈H₃₁NO₄  |  MW: 325.44 g/mol

Bisoprolol is a highly cardioselective beta-1 adrenergic receptor blocker used in the treatment of hypertension, angina pectoris, and heart failure. It reduces heart rate and blood pressure by selectively blocking beta-1 adrenergic receptors. Mediocon Inc supplies pharmaceutical-grade Bisoprolol meeting IP/BP/EP/USP standards.

Key Features

  • Highly selective beta-1 blocker
  • IP/BP/EP/USP compliant quality
  • Hypertension and heart failure treatment
  • Suitable for oral tablet formulations

Applications

  • Oral tablets for hypertension
  • Heart failure management
  • Angina pectoris treatment
  • Cardiovascular drug 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 NameBisoprolol
Also Known AsZebeta, Concor (brand)
CAS Number66722-44-9
Molecular FormulaC₁₈H₃₁NO₄
Molecular Weight325.44 g/mol
CategoryCardiovascular / Beta-1 Blocker
AppearanceWhite to Off-White Crystalline Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay98.0% – 102.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
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 Bisoprolol (CAS 66722-44-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Bisoprolol 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 — Bisoprolol API

What is the minimum order quantity for Bisoprolol API?
Mediocon Inc supplies Bisoprolol 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 Bisoprolol does Mediocon supply?
We supply Bisoprolol 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 Bisoprolol API?
Every shipment of Bisoprolol 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 Bisoprolol bulk orders?
Standard lead time for Bisoprolol 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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