Ofloxacin

Ofloxacin is a synthetic broad-spectrum fluoroquinolone antibiotic that exhibits potent activity against a wide range of gram-positive and gram-negative bacteria. With its proven efficacy, favorable pharmacokinetics, and excellent tissue penetration, Ofloxacin has earned a significant place in global antimicrobial therapy across various healthcare settings. It is especially useful for treating infections of the respiratory tract, genitourinary tract, gastrointestinal tract, and skin.

At BluepillExpress, we are proud to offer third-party manufacturing services for high-quality Ofloxacin formulations in multiple dosage forms. With WHO-GMP certified facilities, ISO 9001:2015 compliance, and a strong commitment to regulatory excellence, BluepillExpress ensures your brand is backed by superior-quality Ofloxacin products suitable for both domestic and international markets.

We partner with pharmaceutical companies, marketing firms, institutional buyers, and healthcare distributors to deliver customized manufacturing solutions that align with therapeutic needs, regulatory norms, and commercial objectives.

About Ofloxacin

Ofloxacin belongs to the fluoroquinolone class of antibiotics. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes critical for DNA replication, transcription, and repair. This bactericidal mechanism makes it highly effective against various pathogens, including those resistant to other classes of antibiotics.

Ofloxacin is known for its:

• Broad-spectrum antimicrobial activity
• Excellent oral and IV bioavailability
• High penetration into tissues and fluids
• Rapid onset of action
• Favorable safety and tolerability profile

It is prescribed for:

• Lower respiratory tract infections such as bronchitis and pneumonia
• Urinary tract infections, including cystitis and pyelonephritis
• Skin and soft tissue infections
• Prostatitis and other genitourinary infections
• Gastrointestinal infections, including traveler’s diarrhea
• Eye and ear infections (in ophthalmic and otic formulations)

Due to its wide applicability and cost-effectiveness, Ofloxacin remains a frontline therapy in both outpatient and hospital-based care.

BluepillExpress: Comprehensive Third-Party Manufacturing Solutions

BluepillExpress provides end-to-end third-party manufacturing services for Ofloxacin in various oral and parenteral forms. With a well-established presence in India’s pharmaceutical hub and a wide global footprint, we offer clients unmatched flexibility, scalability, and regulatory support in producing and marketing Ofloxacin formulations.

We manufacture Ofloxacin in the following formats:

• Ofloxacin Tablets (200 mg, 400 mg)
• Ofloxacin Infusion (200 mg/100 ml)
• Ofloxacin Oral Suspension (50 mg/5 ml, 100 mg/5 ml)
• Ofloxacin Eye/Ear Drops (0.3% w/v)
• Ofloxacin Dispersible Tablets (200 mg DT)
• Fixed Dose Combinations (FDCs) such as Ofloxacin + Ornidazole, Ofloxacin + Metronidazole, and more

Whether you’re seeking private label, white label, or bulk manufacturing, BluepillExpress supports your Ofloxacin product line with quality, efficiency, and regulatory clarity.

Manufacturing Capabilities

Our production units are equipped with advanced systems to ensure the accurate formulation, blending, filling, and packaging of Ofloxacin in accordance with GMP protocols and international pharmacopeial standards.

Key manufacturing highlights include:

• Separate beta-lactam and non-beta-lactam zones
• Fully automated tablet compression and blister packaging lines
• Sterile manufacturing zones for infusions and drops
• Homogenization and emulsification systems for suspensions
• Quality-controlled water systems (RO + EDI + WFI)
• HEPA-filtered cleanrooms with class 100/1000 environment
• Stability chambers and analytical labs for validation and testing

We maintain strict environmental controls and quality audits, ensuring every batch of Ofloxacin meets regulatory expectations and product label claims.

Ofloxacin Dosage Forms and Specifications

1. Ofloxacin Tablets:

• Strengths: 200 mg, 400 mg
• Packaging: Blister packs, alu-alu, strip packs
• Dosage: Twice or once daily depending on severity
• Coating: Film-coated for stability and ease of swallowing
• Shelf Life: 24–36 months depending on formulation and packaging

2. Ofloxacin Infusion:

• Strength: 200 mg in 100 ml
• Packaging: Glass bottle or FFS (Form-Fill-Seal) bags
• Base: Normal saline or dextrose
• Indication: Hospital-based IV therapy for severe infections
• Shelf Life: 24 months

3. Ofloxacin Suspension:

• Strengths: 50 mg/5 ml, 100 mg/5 ml
• Format: Dry powder for reconstitution or ready-to-use syrup
• Flavor options: Orange, mango, strawberry (customizable)
• Volume: 30 ml, 60 ml, 100 ml
• Packaging: Amber PET bottles with caps, spoons, and cartons

4. Ofloxacin Eye/Ear Drops:

• Strength: 0.3% w/v
• Packaging: 5 ml, 10 ml LDPE bottles with droppers
• Use: For bacterial conjunctivitis, otitis externa
• Sterility: Aseptic manufacturing with microbial quality checks

5. Dispersible Tablets (DT):

• Strength: 200 mg
• Advantages: Ideal for pediatric or elderly patients
• Flavoring and color: Optional for patient compliance
• Disintegration: Within 30 seconds in water or mouth

We provide formulation flexibility and tailor-made options for client-specific requirements, regional regulatory compliance, and consumer preferences.

Quality Control and Assurance

At BluepillExpress, we prioritize comprehensive quality assurance across every stage of production. All raw materials are sourced from approved GMP-compliant vendors, and every finished product batch undergoes stringent testing.

Our quality assurance steps include:

• API identity, assay, and purity checks
• In-process control during blending, granulation, compression, and filling
• Finished product testing for dissolution, disintegration, sterility (for IV and drops)
• Microbial testing (TAMC, TYMC, E. coli, Salmonella)
• Stability studies (accelerated and real-time)
• Batch traceability and recall protocol

Each batch is released only after meeting all specifications and is accompanied by:

• Certificate of Analysis (COA)
• Stability data (6–12 months)
• Material Safety Data Sheet (MSDS)
• Batch Manufacturing Record (BMR)
• Test reports and third-party validation (upon request)

Packaging and Customization

BluepillExpress offers flexible and customizable packaging for all Ofloxacin dosage forms to suit brand identity, regulatory needs, and market-specific expectations.

Packaging options include:

• Blister and alu-alu strips for tablets
• Bottles and jars for suspensions and liquids
• Glass bottles or FFS pouches for infusions
• Dropper bottles for eye/ear drops
• Customized carton designs with company logo, brand color, and barcode
• Multi-language labeling for export markets
• Tamper-evident, child-resistant, and senior-friendly designs

We also assist clients in packaging artwork creation and regulatory label compliance for regions including Africa, Middle East, CIS, Southeast Asia, and Latin America.

Regulatory Documentation Support

BluepillExpress provides a comprehensive set of documents and regulatory support for Ofloxacin manufacturing:

• WHO-GMP Certification
• Free Sale Certificate (FSC)
• Certificate of Pharmaceutical Product (CoPP)
• Certificate of Origin (COO)
• Stability Reports
• Technical Data Sheet (TDS)
• Product Dossier (CTD/eCTD format available)
• Third-party reports if required

We also assist in registration support with agencies such as NAFDAC (Nigeria), PPB (Kenya), MOH (Vietnam), TGA (Australia), and DRAP (Pakistan), among others.

Private Label and White Label Services

Looking to build your brand around Ofloxacin? BluepillExpress offers tailored private label manufacturing solutions for startups, marketers, and established distributors.

Our private label solutions include:

• Custom formulation development
• Logo and packaging design
• Product sampling and pilot batch preparation
• Branding and artwork customization
• Intellectual property protection via NDA
• Logistics and shipping assistance

We also offer white-label ready products for quick launch with your brand name and packaging.

Export and Logistics Support

BluepillExpress is a globally trusted pharmaceutical exporter with supply networks spanning:

• Africa: Ghana, Kenya, Nigeria, Uganda
• Middle East: UAE, Iraq, Jordan, Saudi Arabia
• Southeast Asia: Vietnam, Cambodia, Philippines
• CIS: Uzbekistan, Armenia, Georgia
• Latin America: Bolivia, Guatemala, Peru

We manage end-to-end export logistics, including:

• Custom clearance and freight forwarding
• Air or sea shipment coordination
• Incoterms (EXW, FOB, CIF, DDP)
• Temperature-controlled shipping (if required)

Minimum Order Quantities (MOQ)

We offer flexible MOQ structures to suit different client needs:

• Small batch trial runs for startups or market testing
• Bulk production for institutional and tender supply
• Regular monthly supply for branded product marketing
• White-label programs with quick turnaround

Our competitive pricing and high-volume capacity ensure profitability and timely delivery for all order sizes.

Why Choose BluepillExpress?

• WHO-GMP, ISO 9001:2015 certified infrastructure
• Full-spectrum Ofloxacin manufacturing across oral and injectable forms
• In-house R&D, quality control, and formulation development
• Complete regulatory and export documentation
• Global export experience with reliable logistics partners
• Private label and brand-building support
• Transparent communication, confidentiality, and business ethics

At BluepillExpress, we go beyond manufacturing. We help you build your brand, scale your business, and earn trust in competitive pharmaceutical markets.

Client Testimonials

“Their quality of Ofloxacin tablets and syrups is consistent across batches. Regulatory support was also thorough and well-documented.”
— Distributor, Kenya

“We developed our own pediatric suspension line with BluepillExpress. The taste masking and flavoring were excellent.”
— Pediatric Brand Owner, Vietnam

“Excellent service from product sampling to shipment. The eye drops we ordered met all local compliance requirements.”
— Pharmacy Chain, Middle East

Conclusion

As the demand for reliable, affordable, and globally accepted antibiotics continues to rise, Ofloxacin remains a cornerstone therapy for a wide range of infections. Its broad spectrum, strong safety profile, and multi-format availability make it ideal for multiple therapeutic and commercial applications.

BluepillExpress is your ideal partner for third-party manufacturing of Ofloxacin. We offer world-class quality, flexible packaging, full regulatory documentation, and trusted export support to bring your product to market efficiently.