Metoprolol Tartrate API Manufacturer in India

Molecular Formula

C34H54N2O12

Molecular Weight

684.8 g/mol

CAS Number

56392-17-7

Drug Class

Beta Blockers

Immediate-release metoprolol salt for oral solid dosage forms.

Kodel Life manufactures Metoprolol Tartrate API (CAS 56392-17-7) to IP, BP, USP, and EP grade specifications for immediate-release tablet and injectable formulation. With 62 MT per month production capacity and complete regulatory documentation support, Kodel Life is a trusted Metoprolol Tartrate API supplier for pharmaceutical manufacturers across 21 countries.

Key Product Information

Generic Name Metoprolol Tartrate
CAS Number 56392-17-7
Molecular Formula C34H54N2O12
Molecular Weight 684.8 g/mol
Drug Class Beta-1 Selective Adrenoceptor Antagonist
Dosage Form Suitability Immediate-Release Tablets, Injectable (IV)
Primary Application Hypertension, Angina Pectoris, Acute Myocardial Infarction
Production Capacity 62 MT/Month
Grade
IP BP USP EP
Regulatory Documentation COA, DMF available on request

Applications & Use Cases

Cardiovascular Care — these medications are primarily used to treat heart-related conditions like high blood pressure (hypertension), chest pain, or heart failure. Metoprolol Tartrate API with tight control of chiral purity and residual solvents, supplied with CoA and batch records for qualified pharmaceutical buyers.

What Is Metoprolol Tartrate API?

Metoprolol Tartrate is the immediate-release salt form of Metoprolol, a cardioselective beta-1 adrenoceptor antagonist used in the treatment of hypertension, stable angina pectoris, and acute myocardial infarction (MI). As a tartrate salt, it is freely soluble in water, which gives it a rapid onset of action and makes it suitable for both oral immediate-release tablet formulations and intravenous injection preparations.

As an Active Pharmaceutical Ingredient (API), Metoprolol Tartrate must meet stringent specifications for chemical purity, chiral purity (enantiomeric excess), residual solvent levels, and related substance profiles to ensure therapeutic consistency and regulatory acceptance. Kodel Life manufactures to all four major pharmacopoeial standards, providing formulation teams with a batch-verified, fully documented starting material.

Metoprolol Tartrate API for Tablet and Injectable Formulation

Metoprolol Tartrate API is used in two distinct pharmaceutical dosage forms — immediate-release oral tablets and intravenous injections. Each dosage form has distinct API specification requirements, and Kodel Life supplies to both.

Immediate-Release (IR) Tablet Formulation

For pharmaceutical manufacturers developing IR oral solid dosage forms (standard and film-coated tablets), Metoprolol Tartrate API is the preferred starting material. The immediate-release profile delivers rapid peak plasma concentration, making it suitable for twice-daily dosing regimens in hypertension and angina management.

Defined particle size distribution for consistent blend uniformity and content uniformity

Tight residual solvent control per ICH Q3C to support low-dose tablet manufacture

High chemical purity and low impurity profile for regulatory filing confidence

Controlled moisture content for tablet manufacturing compatibility

Injectable / IV Formulation

Metoprolol Tartrate is used in IV preparations for acute MI management in hospital settings. For injectable-grade supply, Kodel Life provides API with:

Enhanced purity specifications aligned to injectable-grade requirements

Residual solvent and heavy metal profiles documented per ICH Q3C and Q3D

Endotoxin and bioburden data available on request for sterile manufacturing qualification

Formulators can request a Technical Data Package including COA, method validation data, process-related impurity profiles, and stability data to support pharmaceutical development and regulatory filings.

Speak to our formulation support team

Why Source Metoprolol Tartrate API from Kodel Life?

Kodel Life is a dedicated API manufacturing company based in Morbi, Gujarat, India, operating under ISO 9001:2015 Quality Management Systems and FDA-compliant cGMP practices.

Manufacturing and Quality Credentials

ISO 9001:2015 certified facility, Morbi, Gujarat, India

FDA-compliant manufacturing under cGMP practices

Full pharmacopoeial compliance: IP, BP, USP, and EP grades from a single source

Tight chiral purity and residual solvent control with in-house analytical testing

COA issued per batch; DMF documentation provided for regulatory filings

Supply Chain Reliability

62 MT per month production capacity for Metoprolol Tartrate

Consistent batch-to-batch quality backed by validated process controls

Dedicated export documentation team for customs and import compliance

Active export to 21 countries across Asia, Africa, Europe, and the Americas

Sample requests processed within 1-2 business days

Bulk Supplier Ready

With 62 MT/month production capacity, Kodel Life is equipped to serve both spot-buy and long-term commercial bulk supply requirements. Existing supply relationships span regulated markets (US, EU, Canada) and emerging markets across Asia and Africa.

Regulatory Documentation and Compliance

Pharmaceutical procurement teams and regulatory affairs departments sourcing Metoprolol Tartrate API from Kodel Life receive a complete documentation package:

Certificate of Analysis (COA) per batch, to the specified pharmacopoeial standard (IP/BP/USP/EP)

Drug Master File (DMF) or dossier support for market authorisation submissions

Impurity profiles and related substance data per ICH Q3A guidelines

Residual solvent data per ICH Q3C

Stability data packages suitable for ASEAN, EU, and US regulatory submissions

Method validation data and reference standard certificates

Buyers in regulated markets (EU, US, Canada) can request an open or closed DMF reference letter at the time of procurement.

Metoprolol Tartrate vs Metoprolol Succinate: Which API Do You Need?

Metoprolol is available as two salt forms — Tartrate (immediate-release) and Succinate (extended-release). The choice of salt determines the dosage form, release profile, dosing frequency, and regulatory pathway.

Parameter Metoprolol Tartrate Metoprolol Succinate
Salt Form Tartrate (immediate-release) Succinate (extended-release)
Release Profile Rapid onset, twice-daily dosing Controlled release, once-daily dosing
Dosage Form IR tablets, IV injection ER/XR/CR/MR tablets
CAS Number 56392-17-7 98418-47-4
Molecular Weight 684.8 g/mol 652.8 g/mol
Typical Strengths 25 mg, 50 mg, 100 mg IR 25 mg, 47.5 mg, 50 mg, 95 mg, 100 mg, 200 mg ER
Key Therapeutic Use Hypertension, Angina, Acute MI Hypertension, CHF, Stable Angina (once-daily)
Solubility Freely soluble in water Sparingly soluble in water
Regulatory Grade (Kodel Life) IP / BP / USP / EP IP / BP / USP / EP
Capacity at Kodel Life 62 MT/Month 20 MT/Month

Kodel Life manufactures both Metoprolol Tartrate and Metoprolol Succinate APIs. If your formulation requires the extended-release salt, visit the Metoprolol Succinate API product page.

Applications: Where Metoprolol Tartrate API Is Used

Metoprolol Tartrate API serves as the active ingredient in a broad range of cardiovascular pharmaceutical products. Procurement teams at generic pharmaceutical manufacturers, CDMOs, branded generics companies, and hospital supply chains source this API for:

Immediate-release antihypertensive tablets (twice-daily dosing regimens)

Angina pectoris management tablets

Acute MI intravenous injection preparations for hospital formularies

Combination IR tablets (e.g., with Amlodipine, Hydrochlorothiazide)

Branded generic cardiovascular portfolios for regulated and emerging markets

OTC-market antihypertensive products in select regulated markets

How to Order Metoprolol Tartrate API from Kodel Life

1

Submit an enquiry or COA/DMF request via the contact form or WhatsApp (+91 75023 33335)

2

Receive product specifications, COA, and pricing within 1-2 business days

3

Request a sample for in-house testing (available on request)

4

Confirm order quantity, lead time, and export documentation requirements

5

Shipment with full documentation package — COA, DMF, and shipping certificate

Get Metoprolol Tartrate API Samples & Pricing

We work with formulation companies, contract manufacturers, and pharmaceutical distributors globally. Whether you need one tonne or twenty, the process starts with a conversation with our technical sales team.

Samples

Pre-qualified buyers

COA / DMF

On formal inquiry

62 MT/Month

Metoprolol Tartrate capacity

21 Countries

USA, UK, EU, Africa, SEA

Interested in This Product?

Contact our team to discuss pricing, availability, and custom requirements.

Quality Certifications

ISO 9001:2015

Quality Management System

FDA Compliant

Regulatory Compliance

Medical Branding

Why Buyers Choose Kodel Life

62 MT/month manufacturing capacity

IP, BP, USP & EP grades available

ISO 9001:2015 certified QMS

Supplied for both IR tablet and IV injectable formulation

Batch-specific COA with every shipment

Export to 21 countries across 5 continents

DMF reference letter support for regulated markets

Sample requests answered within 1-2 business days

Get All The Answer Of Your Question

Frequently Asked Questions

Kodel Life supplies Metoprolol Tartrate API to IP, BP, USP, and EP pharmacopoeial grades. Buyers specify the required standard at the time of enquiry, and the COA will reflect the applicable monograph specifications.

Kodel Life has 62 MT per month production capacity for Metoprolol Tartrate API. The facility can accommodate both development-scale samples and long-term commercial bulk supply contracts.

Yes. Kodel Life supplies Metoprolol Tartrate API for both IR tablet and IV injectable formulation. Injectable-grade specifications including residual solvent (ICH Q3C), heavy metal (ICH Q3D), and purity profiles are available on request.

Yes. Kodel Life provides regulatory documentation including DMF or dossier support for market authorisation submissions in the EU, US, and other regulated markets. A DMF reference letter is available as part of the procurement documentation package.

Metoprolol Tartrate is the immediate-release salt, used for twice-daily IR tablet and IV formulations. Metoprolol Succinate is the extended-release salt, used for once-daily ER tablets. The choice depends on the target dosage form, release profile, and therapeutic indication. Kodel Life manufactures both.

Kodel Life exports to 21 countries across Asia, Africa, Europe, and the Americas, including the USA, Germany, UK, Canada, Saudi Arabia, Japan, South Korea, Thailand, Bangladesh, Brazil, Kenya, and South Africa.

Yes. Development and qualification samples are available on request for pharmaceutical manufacturers and CDMOs. Contact the team via the enquiry form or WhatsApp. The team responds within 1-2 business days.

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