Swapnroop Drugs & Pharmaceuticals is a pharmaceutical Tolfenamic Acid API manufacturer and supplier in India, providing pharmaceutical-grade active pharmaceutical ingredients for qualified pharmaceutical, formulation, research, and bulk procurement requirements.
Tolfenamic Acid is a non-steroidal anti-inflammatory drug (NSAID) belonging to the fenamate class. It is chemically identified as 2-(3-chloro-2-methylanilino)benzoic acid and has the molecular formula C₁₄H₁₂ClNO₂ with a molecular weight of 261.70 g/mol. Its CAS number is 13710-19-5.
Tolfenamic Acid is primarily associated with analgesic, anti-inflammatory and antipyretic activity. It inhibits cyclooxygenase-mediated prostaglandin synthesis and belongs to the anthranilic acid derivative/fenamate group of NSAIDs. It is also classified under ATC code M01AG02.
Tolfenamic Acid is described in the British Pharmacopoeia 2025 / European Pharmacopoeia framework under monograph 2039. The pharmacopoeial definition specifies Tolfenamic Acid as 2-(3-chloro-2-methylanilino)benzoic acid, with a required content of 99.0% to 101.0% on the dried substance.
The API is characterized as a white or slightly yellow crystalline powder. It is practically insoluble in water, soluble in dimethylformamide, sparingly soluble in anhydrous ethanol and methylene chloride, and dissolves in dilute alkali hydroxide solutions. The pharmacopoeial melting point is approximately 213°C.
Tolfenamic Acid is an NSAID with analgesic, anti-inflammatory and antipyretic properties. It has been used in pharmaceutical formulations for the management of pain and inflammatory conditions, including acute migraine in markets where Tolfenamic Acid-containing medicines are authorised.
As an API, Tolfenamic Acid can be used as an active pharmaceutical ingredient in the development and manufacture of suitable oral pharmaceutical formulations, subject to applicable regulatory requirements.
Swapnroop supports pharmaceutical companies, formulation manufacturers, research organisations and qualified procurement teams seeking Tolfenamic Acid API from India.
The product can be supplied according to the applicable pharmaceutical specification and customer requirements, with appropriate documentation and quality information available subject to commercial and regulatory conditions.
Tolfenamic Acid is also represented in the pharmaceutical supply chain through BP/Ph. Eur.-aligned API materials and reference standards.
Tolfenamic Acid should be stored in a tightly closed pharmaceutical-grade container, under suitable dry storage conditions and protected from excessive environmental exposure.
Packaging configuration can be selected according to the intended bulk API requirement, transportation conditions and applicable pharmaceutical quality requirements.
Subject to the applicable supply arrangement, documentation for Tolfenamic Acid API may include:
Swapnroop Drugs & Pharmaceuticals provides Tolfenamic Acid API for qualified pharmaceutical and bulk supply requirements with a focus on quality, documentation and dependable API supply from India.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 99.0–101.0%, on dried substance |
| Loss on Drying | NMT 0.5% |
| Residue on Ignition | NMT 0.1% |
| Heavy Metals | NMT 10 ppm |
| Individual Impurity | NMT 0.10% |
| Total Impurities | NMT 0.50% |
| Melting Point | About 213°C |