Carvedilol API Manufacturers and Suppliers in India

Carvedilol

Carvedilol API (CAS 72956-09-3) is a non-selective beta-blocker with additional alpha-1 blocking activity, supplied as a white or almost white crystalline powder for oral solid dosage forms used in heart failure, hypertension and left ventricular dysfunction after myocardial infarction. Bio-Synth manufactures Carvedilol at its Balanagar, Hyderabad site in IP, BP and USP grades, with a Certificate of Analysis issued against the chosen monograph for every batch.

Check Price

Product Description

Product Description

Product name: Carvedilol IP / BP / USP

Chemical name: (2RS)-1-(9H-carbazol-4-yloxy)-3-[[2-(2-methoxyphenoxy)ethyl]amino]propan-2-ol

CAS number: 72956-09-3

Molecular formula: C24H26N2O4

Molecular weight: 406.47 g/mol

Category: Beta-adrenergic blocker with alpha-1 blocking activity

Therapeutic use: Heart failure, hypertension, left ventricular dysfunction following myocardial infarction

Physical form: White or almost white crystalline powder

Storage: USP grade: preserve in a tight container at controlled room temperature. IP grade: store protected from light, at a temperature not exceeding 30 deg C

Packing: As per customer requirement

Synonyms: Carvedilolum

One thing to check when comparing quotes: this page covers Carvedilol base, the racemate described in the IP, BP and USP monographs. Carvedilol phosphate (CAS 610309-89-2) is a different substance with a different molecular weight and its own specification, and quotes for the two are not interchangeable.

Carvedilol API Specification

Each batch is tested against the monograph the customer nominates and released with a Certificate of Analysis. The tests that appear on a Carvedilol CoA are appearance, solubility, identification by IR and HPLC, loss on drying, sulphated ash, assay, related substances (specified, unspecified and total impurities) and residual solvents.

Test

USP grade

IP grade

BP grade

Assay

98.0% – 102.0% w/w on dried substance, by HPLC

99.0% – 101.0% on dried substance, by potentiometry

99.0% – 101.0% on dried substance, by potentiometry

Total impurities

Not more than 0.5%

Not more than 0.5%

Not more than 0.5%

Any other impurity

Not more than 0.1%

Not more than 0.2%

Not more than 0.1%

Two points matter for formulators. Carvedilol is practically insoluble in water, so dissolution of the finished tablet depends on the particle size distribution of the API – ask for the particle size data along with the CoA.

Carvedilol API Manufacturers in India

Bio-Synth, legally Biochemical and Synthetic Products Private Limited, has manufactured APIs and intermediates since 1943. The plant sits at Plot No. 11/6/2029, Phase-2, SVCIE, Balanagar, Hyderabad, and operates under Telangana manufacturing licence 118/HD/AP/96/B/R. The company history is on the our story page.

The published route to Carvedilol couples a carbazole-derived epoxide with 2-(2-methoxyphenoxy)ethylamine, then purifies and crystallises the product. The specified impurities in the pharmacopoeial monographs come from that chemistry: the bis-alkylated impurity formed when a second epoxide reacts with the amine, and carbazole-derived intermediates carried through. Controlling them is a matter of stoichiometry, reaction temperature and the crystallisation solvent. Under ICH Q7 those parameters sit in the batch manufacturing record and change only through formal change control, which is what a buyer’s audit checks.

The current page states that Bio-Synth makes the Carvedilol intermediates in-house. Where an intermediate is made in-house, the benefit to a buyer is simple: the starting material specification is under Bio-Synth’s own control, and a supplier change upstream does not surprise the customer’s regulatory file. The reaction types run at the site are listed on the reaction capabilities page.

Carvedilol Intermediates Manufacturers and Suppliers in India

Bio-Synth supplies pharmaceutical intermediates alongside its APIs. For Carvedilol, Bio-Synth manufactures:

☐ 4-Hydroxy carbazole
CAS Number: 52602-39-8

☐ 4-(2,3-Epoxypropoxy) Carbazole
CAS Number: 51997-51-4

☐ 2-(2-Methoxyphenoxy) ethylamine
CAS Number: 1836-62-0

The wider intermediate product range is on the pharmaceutical intermediates page.

Carvedilol API Suppliers in India

Carvedilol ships as a dry powder in packing configured to the order. Each pack carries a label with the product name, grade, batch number, manufacturing and retest dates and storage condition, matching the CoA that travels with the consignment.

The document set for a first order is a CoA for the batch supplied, the Safety Data Sheet, the specification sheet for the grade ordered, and on request a method of analysis and a stability summary. Open part DMF is available and can be shared under NDA and MOQ.

A first order usually runs in this sequence: enquiry with grade and quantity, specification and sample, sample approval by the buyer’s QC, commercial terms, then the production batch.

Carvedilol API Price in India

Carvedilol API is quoted per order, not listed at a fixed price. Four things move the number: the grade and any customer-specific limits tighter than the monograph, the order volume, the packing, and the lead time requested. A buyer who can accept a standard pack and a planned production slot will see a better price than one who needs a small quantity at short notice.

For orientation only: at the time of writing, an Indian trader listing on Google shows Carvedilol at around INR 13,500 per unit of unspecified size, and marketplace listings vary widely by grade and quantity. Those are third-party figures, not Bio-Synth’s. Send the grade, quantity and destination through the enquiry form and a written quotation follows.

Applications of Carvedilol API

Carvedilol oral tablets are used to treat high blood pressure. It can also improve how well your heart works if you’ve had a heart attack or if you have heart failure.

This drug is approved to treat:

  1. Heart failure
  2. Left ventricular dysfunction (a heart function problem) after a heart attack
  3. High blood pressure

Quality and Compliance

Bio-Synth’s quality management system is certified to ISO 9001:2015 by DNV Business Assurance UK Limited under UKAS accreditation, certificate 156792-2014-AQ-IND-UKAS, first certified on 20 August 2002. The certified scope reads: “Development, manufacture and sale of active pharmaceutical ingredients (APIs), drug intermediates, biological products & liver injectable.”

The Balanagar site holds a WHO-GMP certificate issued by the Drugs Control Administration, Government of Telangana (L.Dis.No. 150458/TS/2024, dated 6 June 2024, valid to 5 June 2027).

Carvedilol is manufactured in line with ICH Q7 principles for API good manufacturing practice, which Bio-Synth states in its own GMP declaration. ICH Q7 requires, among other things, validated cleaning between product campaigns, a qualified quality unit independent of production, and full batch traceability from raw material to release. Related substances are controlled against the monograph and the ICH Q3A framework, and residual solvents against ICH Q3C. More detail on the site’s systems is on the quality page.

How Carvedilol Works and Where It Is Used

Carvedilol blocks beta-1 and beta-2 adrenergic receptors, which slows the heart and reduces myocardial oxygen demand, and blocks alpha-1 receptors in vascular smooth muscle, which lowers peripheral resistance. That combination is why it lowers blood pressure without the reflex tachycardia seen with pure vasodilators.

In formulation it appears in immediate-release tablets, typically 3.125 mg to 25 mg, and in extended-release capsules where the phosphate salt is more common. Approved uses are mild to severe chronic heart failure, hypertension, and left ventricular dysfunction after a myocardial infarction in clinically stable patients.

Carvedilol API FAQs

We are listening.​

We believe that the heart of dialogue is listening.
Please write in your queries and we will get back to you.


    The CAS number of Carvedilol is 72956-09-3. Its molecular formula is C24H26N2O4 and its molecular weight is 406.47 g/mol. Carvedilol phosphate has a different CAS number, 610309-89-2.
    Bio-Synth supplies Carvedilol in IP, BP and USP grades. Each batch is released with a Certificate of Analysis against the monograph specified on the order.
    Carvedilol is used in tablets and capsules for chronic heart failure, hypertension, and left ventricular dysfunction following a myocardial infarction. It is a non-selective beta-blocker that also blocks alpha-1 receptors.
    Carvedilol is the free base described in the IP, BP and USP monographs and used in immediate-release tablets. Carvedilol phosphate is a salt with a higher molecular weight, more often used in extended-release capsules. This page covers Carvedilol base.

    The Balanagar site is ISO 9001:2015 certified and holds a WHO-GMP certificate for the products named in its inspection schedule. Carvedilol is manufactured in line with ICH Q7 principles.
    Yes. Send the grade and intended use through the enquiry form and a sample with its CoA will be arranged.
    Price is quoted per order and depends on grade, quantity, packing and lead time. Bio-Synth does not publish a list price; send the requirement for a written quotation.

    Request a Quotation

    Send the grade (IP, BP or USP), the quantity, the destination country and any customer-specific limits. A specification sheet, a sample CoA and a written quotation come back from the sales team. Use the contact page to reach them.

    Carvedilol is one of the cardiovascular and CNS products in the Bio-Synth range. The full list of APIs manufactured by Bio-Synth is on the products page.