INDOMETHACIN POWDER MICRONISED

Indomethacin Micronised API is a potent nonsteroidal anti-inflammatory drug (NSAID) used in the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout, and various musculoskeletal disorders. The micronised form ensures enhanced dissolution, absorption, and bioavailability, leading to faster onset of therapeutic action.

At Bluepill Express, we manufacture and export Indomethacin Micronised Active Pharmaceutical Ingredient (API) under WHO-GMP, ISO 9001:2015, and cGMP-certified facilities. Our API is compliant with USP, BP, IP, and EP pharmacopeial standards, guaranteeing high assay purity, low impurities, and consistent particle size distribution.

Indomethacin functions as a cyclooxygenase (COX-1 and COX-2) enzyme inhibitor, reducing prostaglandin synthesis and providing powerful anti-inflammatory, analgesic, and antipyretic effects.

Therapeutic Applications:

• Rheumatoid arthritis and osteoarthritis
• Ankylosing spondylitis
• Acute gouty arthritis
• Tendinitis and bursitis
• Dysmenorrhea and postoperative pain
• Patent ductus arteriosus (neonatal use)

Mechanism of Action:

Indomethacin inhibits cyclooxygenase (COX-1 and COX-2) enzymes, blocking the formation of prostaglandins responsible for inflammation, pain, and fever. This results in reduced inflammation, swelling, and pain relief at affected sites. The micronised formulation increases surface area, improving solubility and absorption for enhanced bioavailability and rapid therapeutic response.

Technical Specifications:

• Chemical Name: 1-(4-Chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic acid
• Molecular Formula: C₁₉H₁₆ClNO₄
• Molecular Weight: 357.79 g/mol
• CAS Number: 53-86-1
• Appearance: Pale yellow to light tan crystalline powder
• Assay (on dried basis): NLT 99.0% and NMT 101.0%
• Melting Point: 158°C – 162°C
• Solubility: Practically insoluble in water; freely soluble in ethanol, methanol, and acetone
• Storage Conditions: Store below 30°C in tightly closed containers, protected from light and moisture

Pharmacological Classification:

• Therapeutic Class: Nonsteroidal Anti-Inflammatory Drug (NSAID)
• Pharmacopoeial Standards: IP / BP / USP / EP
• Dosage Form Applications:
  • Oral capsules and tablets (25 mg, 50 mg, 75 mg)
  • Suppositories
  • Topical gels and creams
  • Injectable formulations

Quality & Manufacturing – Bluepill Express Standards:

• Manufactured in WHO-GMP, ISO, and cGMP-certified units
• Micronised grade ensures enhanced absorption and bioavailability
• Validated by HPLC and UV spectroscopy for purity and assay
• Low impurity profile and stable crystalline form
• COA, MSDS, and DMF documentation available for registration
• Batch consistency guaranteed for formulation reproducibility

Advantages of Bluepill Express Indomethacin Micronised API:

• High purity (≥99%) and low impurity content
• Micronised particle size for rapid dissolution and absorption
• Stable crystalline form ensuring consistent potency
• Regulatory-compliant documentation (COA, MSDS, DMF)
• Extended shelf life with optimized packaging solutions

Packaging & Export Details:

• Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double LDPE liners
• Shelf Life: 3 years under recommended conditions
• Labeling: Compliant with pharmacopeial and international standards
• Export Markets: Europe, Africa, Asia-Pacific, Latin America, Middle East
• Documentation Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Drug Master File (DMF – on request)
  • Stability and Validation Reports