Norfloxacin + Tinidazole

The combination of Norfloxacin and Tinidazole is a well-established, broad-spectrum antimicrobial therapy used for treating gastrointestinal and genitourinary tract infections caused by mixed bacterial and protozoal organisms. Norfloxacin is a fluoroquinolone antibiotic effective against a wide range of Gram-negative and some Gram-positive bacteria, while Tinidazole is an antiprotozoal and antibacterial agent that targets anaerobic bacteria and protozoa.

Together, this synergistic combination offers enhanced effectiveness, faster recovery, and improved patient outcomes. It is particularly useful for treating acute diarrheal infections, dysentery, urinary tract infections (UTIs), and gynecological infections.

BluepillExpress, a WHO-GMP and ISO-certified pharmaceutical manufacturer and exporter, offers reliable third-party manufacturing services for Norfloxacin + Tinidazole tablets and oral suspensions. We cater to clients worldwide, ensuring quality, compliance, and efficiency in every batch delivered.

About BluepillExpress

BluepillExpress is a trusted name in global pharmaceutical manufacturing and private-label solutions. With years of experience in manufacturing high-quality, affordable, and regulatory-compliant medications, we offer full-spectrum services including:

• Contract manufacturing of branded and generic medicines
• Custom formulation development
• Regulatory documentation and dossier support
• Private-label packaging
• Global logistics and export compliance

Our facilities are certified by WHO-GMP, ISO 9001:2015, and operate according to current Good Manufacturing Practices (cGMP). We are committed to delivering safe, effective, and export-grade pharmaceuticals to more than 50 countries across Asia, Africa, CIS, Latin America, and the Middle East.

Pharmacological Classification

• Drug Class:
  • Norfloxacin: Fluoroquinolone Antibiotic
  • Tinidazole: Nitroimidazole Antiprotozoal and Antibacterial Agent
• Therapeutic Use:
  • Gastrointestinal and urinary tract infections involving bacterial and protozoal pathogens

Mechanism of Action

• Norfloxacin acts by inhibiting DNA gyrase, an essential bacterial enzyme involved in DNA replication. This causes the death of susceptible bacteria, particularly Gram-negative organisms.
• Tinidazole disrupts DNA structure and inhibits nucleic acid synthesis in anaerobic bacteria and protozoa. It is effective against organisms such as Entamoeba histolytica, Giardia lamblia, and Trichomonas vaginalis.

The combined action of Norfloxacin and Tinidazole provides a dual therapeutic effect, making this formulation ideal for polymicrobial infections of the GI and urogenital tracts.

Clinical Indications

The Norfloxacin + Tinidazole combination is commonly prescribed for:

• Acute infectious diarrhea and dysentery
• Traveler’s diarrhea
• Amoebiasis (intestinal and hepatic)
• Giardiasis
• Bacterial vaginosis
• Urinary tract infections (UTIs)
• Pelvic inflammatory disease
• Mixed infections of the gastrointestinal tract
• Post-surgical prophylaxis in gastrointestinal and gynecological surgeries

This formulation is highly effective for patients presenting with symptoms such as abdominal cramps, loose stools, fever, and signs of protozoal-bacterial co-infection.

Dosage Forms Available at BluepillExpress

BluepillExpress offers third-party and private-label manufacturing of Norfloxacin + Tinidazole in the following dosage forms and strengths:

1. Oral Tablets

• Norfloxacin 400 mg + Tinidazole 600 mg
• Film-coated for enhanced stability and patient compliance
• Blister-packed or bottled, as per client requirements

2. Oral Suspension (Dry Syrup)

• Norfloxacin 100 mg + Tinidazole 150 mg per 5 mL
• Pediatric-friendly flavors such as orange, mango, or strawberry
• Sugar-free options available
• Supplied in 30 mL / 60 mL amber PET bottles with measuring spoon or cup

Custom strengths and excipient modifications can also be offered based on regulatory and market-specific requirements.

Manufacturing Infrastructure and Capabilities

BluepillExpress is equipped with state-of-the-art pharmaceutical manufacturing units designed to deliver consistent quality at scale:

• Dedicated areas for tablets and oral liquid manufacturing
• Controlled environments with HEPA filtration and temperature regulation
• Automated blending, granulation, compression, and coating lines
• Dry syrup formulation lines with calibrated dosing and sealing systems
• On-site utilities including purified water and WFI generation systems
• Separate warehousing and QC labs for raw materials and finished goods

We maintain batch-wise documentation, complete traceability, and regular process validation in line with international standards.

Quality Control and Assurance

Our QA/QC protocols ensure every batch manufactured meets the highest global standards for safety, potency, purity, and shelf stability.

Key quality control parameters include:

• Raw material identification and purity testing
• Assay for Norfloxacin and Tinidazole content (HPLC validated)
• Uniformity of weight and dissolution testing for tablets
• Microbial load testing and sterility checks (where applicable)
• pH and viscosity tests for oral suspensions
• Stability testing under ICH guidelines

All products are supported by:

• Certificate of Analysis (COA)
• Batch Manufacturing Records (BMR)
• Validation and process control documents
• Stability and shelf-life data (available on request)

Packaging and Labeling Solutions

BluepillExpress offers high-quality, customizable packaging solutions that meet the regulatory and aesthetic needs of domestic and international markets.

Tablet Packaging Options:

• PVC/Alu or Alu/Alu blister packs (10×10, 10x1x10, or 1×10 formats)
• HDPE or PET bottles with induction sealing (bulk packs)
• Outer cartons with multilingual inserts (leaflets)

Oral Suspension Packaging Options:

• Amber PET bottles with child-proof caps
• Custom volume: 30 mL, 60 mL, 100 mL
• Spoon, dropper, or measuring cup included
• Taste-masked formulations for pediatric use

Labeling is available in multiple languages (English, French, Arabic, Spanish) based on the client’s country of distribution. We ensure full compliance with FDA, EMA, MHRA, and national health authority guidelines.

Regulatory and Export Documentation

BluepillExpress provides a complete regulatory package and export documentation to support your market expansion goals. Our documentation includes:

• WHO-GMP and ISO certifications
• Certificate of Analysis (COA)
• Certificate of Pharmaceutical Product (COPP)
• Certificate of Origin
• Product Dossier (CTD / ACTD formats)
• Free Sale Certificate
• MSDS (Material Safety Data Sheets)
• Stability data (on request)

Our regulatory team ensures quick turnaround in document preparation and offers support during registration or tender applications.

Private Label and Third-Party Manufacturing Services

Whether you’re a startup looking to launch a new brand or an established pharma company expanding your range, our private label services ensure:

• Fast development and approval cycles
• Low minimum order quantities (MOQs)
• Competitive pricing structures
• Dedicated account managers for end-to-end coordination
• Confidentiality agreements to protect your IP

We assist clients from product concept to commercial dispatch, providing an integrated manufacturing and branding experience.

Markets and Client Segments We Serve

Our Norfloxacin + Tinidazole products are supplied to clients in:

• Generic pharmaceutical distribution
• Retail pharmacy chains
• Hospital and clinic supply
• Tender procurement (government and NGO programs)
• Online telemedicine platforms
• OTC and travel medicine segments

We export to regulated and semi-regulated markets including:

• Africa (Nigeria, Kenya, Uganda, Ghana, Ethiopia)
• Asia (Vietnam, Philippines, Sri Lanka, Cambodia)
• CIS (Uzbekistan, Kazakhstan, Kyrgyzstan)
• Middle East (Iraq, UAE, Yemen)
• Latin America

Sustainability and Compliance

At BluepillExpress, we are committed to environmentally responsible and ethical manufacturing practices:

• Zero-discharge effluent treatment systems
• Energy-efficient operations and green manufacturing initiatives
• Ethical sourcing and fair labor practices
• No animal testing for finished pharmaceutical products
• Recyclable and biodegradable packaging material options

Our commitment to sustainability is reflected in our long-term partnerships and global reputation for integrity and reliability.

Steps to Start Manufacturing with BluepillExpress

1. Share Your Requirement
   Submit your inquiry with dosage form, quantity, packaging preferences, and target market.
2. Quotation & Documentation
   Receive a detailed quotation and timelines. Submit required documents to initiate manufacturing.
3. Product Development & Approval
   We prepare samples or pilot batches for client approval before commercial production.
4. Manufacturing & Quality Checks
   Products are manufactured under GMP conditions and tested for quality.
5. Packaging & Labeling
   We package products with client-approved branding and regulatory labeling.
6. Dispatch & Delivery
   Orders are shipped globally with full documentation for customs and regulatory clearance.

Conclusion

The combination of Norfloxacin and Tinidazole remains a powerful and cost-effective treatment for gastrointestinal and genitourinary infections. Its rapid onset of action, wide microbial coverage, and patient-friendly oral administration make it a preferred choice in clinical settings across the globe.

BluepillExpress offers end-to-end third-party manufacturing services for this vital formulation with a focus on quality, scalability, and compliance. With WHO-GMP certified facilities, expert formulation support, and reliable global delivery, we are your ideal partner in building or expanding your pharmaceutical portfolio.