OFLOXACIN

Ofloxacin API is a broad-spectrum fluoroquinolone antibiotic used to treat a wide range of bacterial infections. It is highly effective against Gram-positive and Gram-negative organisms, making it one of the most trusted antibiotics for respiratory tract infections, urinary tract infections, skin infections, gastrointestinal infections, and sexually transmitted diseases.

At Bluepill Express, we manufacture and export high-quality Ofloxacin API under stringent WHO-GMP, ISO 9001:2015, and cGMP standards. Our Ofloxacin complies with USP / BP / IP / EP specifications and is produced using advanced synthesis techniques to ensure high assay value, low impurity profile, and optimal particle size.

As a DNA gyrase and topoisomerase IV inhibitor, Ofloxacin effectively prevents bacterial DNA replication, transcription, and repair, leading to cell death. This mechanism provides fast and reliable treatment outcomes against various infections with minimal resistance development.

Bluepill Express is a trusted global API supplier, exporting premium-grade Ofloxacin API to regulated and semi-regulated markets worldwide with full COA, MSDS, and DMF documentation.

Therapeutic Applications:

Mechanism of Action:

Ofloxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes responsible for DNA replication and cell division. This dual inhibition blocks bacterial proliferation, leading to rapid cell death. Its bactericidal activity covers a wide range of pathogens, making it suitable for both systemic and local infections.

Technical Specifications:

• Chemical Name: Ofloxacin
• Molecular Formula: C₁₈H₂₀FN₃O₄
• Molecular Weight: 361.37 g/mol
• CAS Number: 82419-36-1
• Description: Pale yellow to off-white crystalline powder
• Assay (on dried basis): NLT 99.0%
• Melting Point: 270°C – 274°C
• Solubility: Freely soluble in acetic acid; slightly soluble in water and ethanol
• Optical Rotation: +20° to +25°
• Storage: Store below 25°C in a tightly sealed container, away from light and moisture

Pharmacological Classification:

• Therapeutic Class: Antibacterial / Fluoroquinolone Antibiotic
• Pharmacopoeial Standards: USP / BP / IP / EP
• Dosage Form Applications:
  • Tablets (200 mg, 400 mg)
  • Oral Suspension
  • Infusions (IV)
  • Eye / Ear Drops
  • Ointments

Quality & Manufacturing – Bluepill Express Standards:

• Manufactured in WHO-GMP, ISO, and cGMP-compliant facilities
• High assay purity (≥99%) and minimal residual solvents
• Complies with USP/BP/IP/EP monographs
• Stringent analytical testing by HPLC and UV spectrometry
• Full regulatory documentation: COA, MSDS, DMF (on request)
• Produced under controlled environmental conditions for stability and consistency

Advantages of Bluepill Express Ofloxacin API

• High-purity grade suitable for oral, parenteral, and ophthalmic formulations
• Consistent crystalline structure ensuring uniform dissolution
• Global export compliance with WHO-GMP & ISO certifications
• Competitive pricing and reliable bulk availability
• Comprehensive technical and regulatory support for formulators

Packaging & Export Details:

• Packaging Sizes: 1 kg / 5 kg / 25 kg HDPE drums with double-layer LDPE liner
• Labeling: As per international regulatory requirements
• Shelf Life: 3 years under recommended storage conditions
• Export Markets: Africa, Asia-Pacific, Middle East, Europe, and Latin America
• Documents Provided:
  • Certificate of Analysis (COA)
  • Material Safety Data Sheet (MSDS)
  • Drug Master File (DMF) – available upon request
  • BSE/TSE & Non-GMO Declarations