Active Pharmaceutical Ingredient

Ketorolac Tromethamine API Manufacturer and Supplier in India

CAS: 74103-07-4 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Ketorolac Tromethamine API Manufacturer and Supplier in India — Mediocon Inc
Ketorolac Tromethamine API Manufacturer and Supplier in India

Product Overview

CAS No: 74103-07-4 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

MEDIOCON INC – Ketorolac Tromethamine is the tromethamine salt of Ketorolac, a non-steroidal anti-inflammatory drug (NSAID) with potent analgesic activity. It is used in pharmaceutical formulations for the short-term management of moderately severe acute pain and, in ophthalmic preparations, for relief of ocular pain and inflammation. Ketorolac Tromethamine has the molecular formula C₁₉H₂₄N₂O₆ and molecular weight approximately 376.41 g/mol.

Ketorolac Tromethamine API

Ketorolac Tromethamine is a salt form of Ketorolac developed to provide the active drug in a suitable pharmaceutical form. Ketorolac belongs to the pyrrolo-pyrrole class of NSAIDs and exerts analgesic and anti-inflammatory effects primarily through inhibition of prostaglandin synthesis.

Ketorolac Tromethamine is identified by CAS Number 74103-07-4.

Chemical Information

Product Name: Ketorolac Tromethamine
CAS Number: 74103-07-4
Molecular Formula: C₁₉H₂₄N₂O₆
Molecular Weight: 376.41 g/mol
Chemical Class: Pyrrolo-pyrrole NSAID
Therapeutic Class: Non-Steroidal Anti-Inflammatory Drug / Analgesic
Salt Form: Tromethamine salt of Ketorolac
Parent Compound: Ketorolac
Parent CAS Number: 74103-06-3
IUPAC Name: 5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol
Synonyms: Ketorolac Tromethamine, Ketorolac Tromethamine Salt, Ketorolac Trometamol
PubChem CID: 53821

Mechanism of Action

Ketorolac Tromethamine exerts its pharmacological activity through the Ketorolac moiety, which inhibits cyclooxygenase (COX) enzymes involved in prostaglandin synthesis.

Reduced prostaglandin production contributes to decreased pain and inflammation. Ketorolac is primarily recognized for its analgesic activity rather than as a long-term anti-inflammatory treatment.

Manufacturing and Quality

MEDIOCON INC focuses on supplying pharmaceutical and specialty chemical ingredients with emphasis on quality, consistency, technical documentation and reliable supply.

Ketorolac Tromethamine quality evaluation may include:

  • Identification
  • Assay by HPLC
  • Related substances
  • Residual solvents
  • Loss on drying
  • Residue on ignition
  • Heavy metals
  • Water content
  • pH
  • Specific optical rotation
  • Other product-specific analytical parameters

The exact analytical acceptance criteria should be confirmed against the current approved specification and batch-specific Certificate of Analysis.

Applications

Ketorolac Tromethamine may be used in:

  • Pharmaceutical analgesic formulations
  • Injectable formulations
  • Oral dosage forms
  • Ophthalmic formulations
  • Short-term management of acute pain
  • Ophthalmic pain and inflammatory conditions

The exact dosage form, indication and permitted duration of use depend on the applicable regulatory approval and product labeling.

Product Characteristics

Ketorolac Tromethamine is generally described as a white to off-white crystalline powder.

Appearance: White to off-white crystalline powder

The exact appearance specification should be confirmed against the applicable pharmacopoeial monograph or current MEDIOCON INC batch specification.

Packaging and Documentation

Product availability, packaging configuration, Certificate of Analysis (COA), Safety Data Sheet (SDS/MSDS), technical specifications and other documentation should be confirmed with MEDIOCON INC according to the intended application and customer requirements.

Product Specifications

Product NameKetorolac Tromethamine API Manufacturer and Supplier in India
CAS Number74103-07-4
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to off-white crystalline powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to off-white crystalline powder

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 Ketorolac Tromethamine API Manufacturer and Supplier in India (CAS 74103-07-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Ketorolac Tromethamine API Manufacturer and Supplier in India 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 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
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Ketorolac Tromethamine API Manufacturer and Supplier in India

What is Ketorolac Tromethamine?
Ketorolac Tromethamine is the tromethamine salt of Ketorolac, an NSAID with potent analgesic activity.
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