Nalidixic Acid

In the ongoing fight against bacterial infections, especially those affecting the urinary tract, Nalidixic Acid remains a time-tested antibacterial agent. As one of the earliest quinolone antibiotics developed for clinical use, Nalidixic Acid is known for its targeted action against Gram-negative uropathogens, particularly Escherichia coli. Despite the emergence of newer antibiotics, Nalidixic Acid continues to be widely prescribed in various parts of the world, especially for uncomplicated urinary tract infections (UTIs), due to its proven efficacy, safety, and cost-effectiveness.

At BluepillExpress, we offer robust third-party manufacturing services for Nalidixic Acid formulations, supported by WHO-GMP certified facilities, advanced manufacturing equipment, and complete regulatory documentation. Our flexible, end-to-end solutions empower pharmaceutical companies, marketing partners, and healthcare distributors to bring high-quality, affordable antibiotics to the global market with confidence.

About BluepillExpress

BluepillExpress is a globally recognized pharmaceutical manufacturer and exporter offering comprehensive third-party and contract manufacturing services. With a focus on quality, compliance, and innovation, we manufacture a wide portfolio of pharmaceutical formulations—including antibiotics, antimalarials, supplements, and pediatric medicines—for clients in Asia, Africa, the Middle East, Latin America, and CIS countries.

We operate under strict quality management systems and adhere to international regulatory standards including WHO-GMP, ISO 9001:2015, FSSAI, and Pharmacopeial norms (IP, BP, USP). With dedicated production zones for antibiotics, we are fully equipped to manufacture Nalidixic Acid in multiple dosage forms and packaging formats, ensuring global distribution readiness.

Product Overview: Nalidixic Acid

Nalidixic Acid is a synthetic antibacterial agent belonging to the quinolone class of antibiotics. It is effective primarily against Gram-negative bacteria that cause urinary tract infections. Its mechanism of action involves inhibition of bacterial DNA gyrase, an enzyme essential for DNA replication and cell division, ultimately leading to bacterial cell death.

Pharmacological Class: First-generation Quinolone Antibiotic
Mechanism of Action: Inhibits DNA gyrase and topoisomerase II, preventing bacterial DNA replication

Commonly Used Brand Names: Available as standalone and combination products across various geographies

Formulations Offered by BluepillExpress

We offer a range of Nalidixic Acid formulations suitable for adults and pediatric use, including:

• Nalidixic Acid Tablets 500 mg
• Nalidixic Acid Suspension 300 mg/5 ml (Pediatric use)
• Nalidixic Acid + Other Antibiotic Combinations (on request)
• Custom Strengths or Blends based on client requirements

Therapeutic Indications

Nalidixic Acid is primarily indicated for the treatment of:

• Uncomplicated urinary tract infections (UTIs) caused by susceptible Gram-negative organisms such as E. coli, Klebsiella, Proteus, and Enterobacter species
• Cystitis and pyelonephritis in both adults and children
• Prophylaxis for urinary tract instrumentation procedures
• Recurrent or chronic UTIs in pediatric populations

Although now used selectively due to the advent of newer fluoroquinolones, Nalidixic Acid remains an essential medicine in many low-to-middle income countries due to its affordability and targeted action.

Advantages of Nalidixic Acid

• Selective Gram-negative activity suitable for UTIs
• Time-tested safety profile in adult and pediatric use
• Cost-effective treatment alternative
• Low resistance in certain geographical areas
• Available in both tablet and liquid suspension forms
• Minimal drug interactions compared to later fluoroquinolones

Manufacturing Expertise at BluepillExpress

Our antibiotic production line operates under cGMP-compliant, dedicated manufacturing areas, designed to ensure product purity, batch-to-batch consistency, and minimal risk of cross-contamination:

• Granulation and Tablet Compression Units: For uniform dosage and content accuracy
• Liquid Formulation Area: For syrup/suspension production with accurate dosing and stability
• Quality-Controlled Blending and Coating Systems: To enhance bioavailability and shelf life
• Automatic Filling and Packaging Lines: Ensuring efficient production output with strict sterility standards
• In-House QC Laboratories: Equipped with HPLC, UV spectrophotometers, dissolution testers, and microbial testing facilities

We strictly comply with environmental, health, and safety (EHS) guidelines throughout the production process.

Packaging and Presentation Options

Our Nalidixic Acid formulations are available in a wide variety of packaging formats to suit diverse market needs:

For Tablets:

• Blister Packs: Alu-Alu / Alu-PVC
• Strip Packs: 10×10, 10×6, 10×15 formats
• HDPE Bottles for bulk packaging

For Oral Suspension:

• Amber/White HDPE Bottles: 30 ml, 60 ml, 100 ml
• Child-resistant caps and calibrated measuring spoons included
• Multilingual outer carton with dosage instructions

All labels and leaflets are designed in accordance with regulatory requirements and customized with the client’s brand identity under private label agreements.

Quality Control and Assurance

At BluepillExpress, quality is integrated into every stage of manufacturing, from procurement to dispatch. Our quality assurance (QA) and quality control (QC) systems include:

• Raw Material Testing: Verification for identity, purity, assay, and microbial limits
• In-Process Checks: Uniformity, weight variation, friability, pH, and viscosity (for liquids)
• Finished Product Testing: Assay (active content), dissolution, microbial contamination, shelf-life stability, packaging integrity
• Stability Testing: Performed under ICH guidelines for real-time and accelerated conditions

Every product batch is released with Certificate of Analysis (CoA), MSDS, and Batch Manufacturing Records (BMR) for traceability and compliance.

Shelf Life and Storage

• Tablet Formulations: Typically stable for 24 to 36 months under ambient storage
• Suspension (Dry Powder for Reconstitution): Shelf life of 24 months (before reconstitution); stable for 7–14 days post-reconstitution (as per label)
• Storage Conditions: Store in a cool, dry place, away from direct sunlight

Regulatory and Export Documentation

BluepillExpress provides comprehensive regulatory and documentation support to facilitate product registration and import approvals in global markets:

• Certificate of Pharmaceutical Product (COPP)
• Certificate of Analysis (CoA)
• GMP Certificate
• Free Sale Certificate
• CTD/ACTD-format dossiers
• Product Stability Data and Validation Reports
• Material Safety Data Sheet (MSDS)
• Label and artwork design compliant with MOH standards

Private Label Manufacturing Services

We provide fully customized private labeling solutions for pharmaceutical marketers and distributors:

• Branded packaging with client’s logo and design
• Customizable leaflet content
• Batch-specific QR codes, holograms, and serialization
• Low Minimum Order Quantities (MOQ) for market entry
• Confidentiality Agreements to protect proprietary formulations and designs

Global Distribution and Logistics Support

As a trusted global exporter, BluepillExpress ensures reliable and efficient product delivery with comprehensive logistics services:

• Export-ready packaging for sea and air freight
• Cold-chain or temperature-controlled logistics (if required)
• Collaboration with reputed freight forwarders
• Country-specific labeling and documentation support
• Multiple incoterms (FOB, CIF, DDP) available upon request

Target Clients and Markets

• Generic pharmaceutical companies
• Pediatric antibiotic distributors
• Hospital and clinic supply chains
• Government tenders and NGOs
• Private label marketers
• OTC pharmaceutical wholesalers

Why Choose BluepillExpress for Nalidixic Acid Manufacturing?

• WHO-GMP and ISO-certified manufacturing facilities
• Regulatory expertise across 30+ countries
• Flexible production volumes from pilot batches to bulk orders
• Competitive pricing and consistent product quality
• End-to-end solutions from R&D to global dispatch
• Full support for private label and custom packaging
• Excellent post-manufacturing service and technical support

Conclusion

Nalidixic Acid continues to serve as a reliable and cost-effective treatment for uncomplicated urinary tract infections, especially in developing healthcare systems where access to affordable antibiotics is essential. As a trusted third-party manufacturing partner, BluepillExpress offers global pharmaceutical companies the opportunity to deliver high-quality Nalidixic Acid formulations backed by international certifications, stringent quality standards, and unmatched customer service.

From formulation development to regulatory documentation, packaging, and international shipping, BluepillExpress provides a complete manufacturing ecosystem designed for reliability, scalability, and long-term growth.