MEFENAMIC ACID

Mefenamic Acid is a nonsteroidal anti-inflammatory drug (NSAID) used for the treatment of mild to moderate pain, inflammation, and menstrual cramps (dysmenorrhea). It works by inhibiting prostaglandin synthesis, effectively reducing pain, swelling, and fever.

At Bluepill Express, we manufacture and export high-purity Mefenamic Acid API under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities, ensuring compliance with IP, BP, USP, and EP pharmacopoeial standards.

Our Mefenamic Acid API offers assay purity ≥99%, controlled particle size distribution, and low impurity levels, making it ideal for tablet, capsule, and suspension formulations. Each batch is rigorously tested to ensure high stability, consistency, and reproducibility for pharmaceutical manufacturers worldwide.

Therapeutic Applications:

• Relief of menstrual pain (primary dysmenorrhea)
• Treatment of musculoskeletal pain and inflammation
• Management of toothache, headache, and postoperative pain
• Used in rheumatoid arthritis and osteoarthritis for symptom relief

Mechanism of Action:

Mefenamic Acid inhibits cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing prostaglandin synthesis responsible for pain and inflammation. This dual inhibition provides effective analgesic, anti-inflammatory, and antipyretic action without causing central nervous system sedation.

Technical Specifications:

• Chemical Name: 2-[(2,3-Dimethylphenyl)amino]benzoic acid
• Molecular Formula: C₁₅H₁₅NO₂
• Molecular Weight: 241.29 g/mol
• CAS Number: 61-68-7
• Appearance: White to light yellow crystalline powder
• Assay (on dried basis): NLT 98.0% and NMT 102.0%
• Melting Point: 230°C – 233°C
• Solubility: Practically insoluble in water; soluble in alcohol and chloroform
• Storage Conditions: Store below 25°C, protected from light and moisture

Pharmacological Classification:

• Therapeutic Class: Nonsteroidal Anti-Inflammatory Drug (NSAID)
• Pharmacopoeial Standards: IP / BP / USP / EP
• Dosage Form Applications:
  • Tablets (250 mg, 500 mg)
  • Capsules and oral suspensions
  • Fixed-dose combinations for pain management

Manufacturing & Quality Standards – Bluepill Express:

• Produced under WHO-GMP and cGMP certified plants
• High assay purity and stability for reliable formulation performance
• Analytical validation via HPLC, FTIR, and NMR techniques
• DMF-ready documentation for international registration
• Batch consistency and reproducibility ensured via validated processes
• Fully compliant with ICH Q3A/B impurity standards

Advantages of Bluepill Express Mefenamic Acid API:

• High purity (≥99%) and excellent physicochemical stability
• Optimized particle size for uniform mixing and tablet compression
• Regulatory documentation (COA, MSDS, DMF, stability data) available
• Custom packaging and labeling for global shipment
• Trusted export partner in more than 40 countries

Packaging & Export Details:

• Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double LDPE liners
• Shelf Life: 3 years when stored as recommended
• Labeling: Compliant with pharmacopeial and international export norms
• Export Markets: Asia, Africa, Latin America, Europe, and the Middle East
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Drug Master File (DMF)
  • Stability & Validation Reports