Isoniazide

Tuberculosis (TB) remains one of the world’s deadliest infectious diseases, with millions affected annually, especially in low- and middle-income countries. Isoniazid, a frontline antitubercular drug, plays a pivotal role in both active TB treatment and prophylaxis of latent TB infection. Its proven efficacy, affordability, and global recognition as part of the WHO-recommended DOTS strategy make it indispensable in national and international TB control programs.

At BluepillExpress, we provide world-class third-party manufacturing services for Isoniazid, empowering pharmaceutical distributors, government agencies, and private healthcare brands to deliver consistent, high-quality anti-TB medications. With WHO-GMP certified manufacturing facilities, regulatory compliance, and scalable capacity, we support global efforts in the fight against tuberculosis.

BluepillExpress is a leading Indian pharmaceutical manufacturer and exporter offering complete third-party manufacturing services for generic medicines, branded formulations, and public health drugs. With operational reach in over 30+ countries across Asia, Africa, CIS, Latin America, and the Middle East, we specialize in therapeutic categories aligned with public health priorities.

About BluepillExpress

Key Highlights:

• WHO-GMP, ISO 9001:2015 certified facilities
• CTD dossier support and regulatory documentation
• Custom formulation, packaging, and private label services
• Export and logistics support to public and private sector buyers
• Experience in working with international NGOs, MOHs, and institutional buyers

Our Isoniazid products are manufactured under strict quality controls and tailored to meet the diverse needs of global TB control programs.

Product Overview: Isoniazid

Isoniazid (INH) is a synthetic antibacterial agent, specifically active against Mycobacterium tuberculosis. It works by inhibiting the synthesis of mycolic acids, essential components of the mycobacterial cell wall, leading to bacterial death.

Therapeutic Class: Antitubercular
WHO ATC Code: J04AC01
Mechanism of Action: Inhibits mycolic acid synthesis in the mycobacterial cell wall

Available Strengths:

• Isoniazid 100 mg Tablets
• Isoniazid 300 mg Tablets
• Isoniazid 400 mg Tablets (on request)

Other Formulations:

• Fixed-Dose Combinations (e.g., INH + Rifampicin, INH + Pyrazinamide)
• Pediatric dispersible tablets (100 mg)
• Isoniazid Syrup (available upon special request)

Indications and Uses

Isoniazid is used for:

• First-line treatment of active tuberculosis (pulmonary and extrapulmonary)
• Prophylaxis of latent tuberculosis infection (LTBI)
• Combination therapy with other antituberculars such as Rifampicin, Ethambutol, and Pyrazinamide
• TB prevention in HIV-positive individuals and other immunocompromised patients

Isoniazid is included in essential medicine lists by WHO and most national healthcare systems, and is a core component of the DOTS strategy.

Dosage and Administration

Typical Adult Dosage:

• Prophylaxis: Isoniazid 300 mg orally once daily for 6 to 9 months
• Active TB Treatment: 5 mg/kg/day (up to 300 mg) in combination with other TB drugs for 6 months or as per national guidelines

Pediatric Dosage:

• 10–15 mg/kg (maximum 300 mg/day) orally

Note: Co-administration of pyridoxine (Vitamin B6) is recommended to prevent peripheral neuropathy.

Advantages of Isoniazid

• High efficacy in both monotherapy (for LTBI) and multi-drug therapy
• Low cost and easy availability
• Rapid bactericidal activity against M. tuberculosis
• Can be used safely in both adults and children
• Listed as an essential medicine by the WHO

Manufacturing Capabilities at BluepillExpress

BluepillExpress’s manufacturing units are designed to handle bulk production of antituberculars like Isoniazid while maintaining international quality benchmarks.

Key Manufacturing Features:

• Dedicated production zones for high-potency drugs
• Tablet compression, granulation, and coating lines with automated systems
• Fully validated SOPs and batch traceability
• Advanced dust containment and cross-contamination control systems
• Controlled humidity and temperature environments to protect product stability

We are capable of producing Isoniazid tablets in large volumes for tenders, government supply chains, institutional programs, and NGO procurement.

Quality Assurance & Quality Control

Every stage of Isoniazid manufacturing is monitored by a skilled QA/QC team to ensure consistency, safety, and regulatory compliance.

QA/QC Highlights:

• Raw Material Testing: Identity, assay, microbial load, and heavy metal content
• In-process Controls: Weight variation, hardness, thickness, and disintegration
• Finished Product Testing: Uniformity, assay, dissolution, microbial testing
• Stability Studies: Performed under ICH Zone II and Zone IV conditions
• Documentation Provided: CoA, BMR, MSDS, Product Specifications, Validation Reports

Compliance with USP, BP, IP, or client-specified pharmacopoeial standards is maintained as required.

Packaging Solutions

We offer robust and regulatory-compliant packaging solutions for global markets:

Available Packaging Types:

• Blister packs (Alu-Alu or Alu-PVC)
• Strip packs (10×10, 10×15)
• Bulk HDPE bottles (100, 500, or 1000 tablets)
• Institutional and government packaging formats

Labeling Services:

• Custom branding with private labels
• Multilingual inserts and instructions
• Serialization and barcoding for track & trace
• Country-specific packaging designs and regulatory text

All packaging materials are tested for UV protection, moisture resistance, and child safety compliance, where required.

Shelf Life & Storage

• Standard Shelf Life: 24 to 36 months
• Storage Conditions: Store in a cool, dry place below 30°C, protected from light and moisture
• Packaging includes desiccants or barrier layers as necessary for shelf life optimization

Regulatory & Export Documentation

BluepillExpress offers complete regulatory support to simplify market entry and product registration for Isoniazid formulations.

Documentation Support Includes:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (CoPP)
• Free Sale Certificate
• Certificate of Analysis (CoA)
• CTD/ACTD dossiers (Module 1 to 5)
• Bioequivalence data (if applicable)
• Packing List, Commercial Invoice, and Bill of Lading for export compliance

We are experienced in meeting regulatory demands for tenders, institutional procurement, and Ministry of Health registrations.

Private Label & Customization Services

Clients can benefit from our private label manufacturing services, enabling brand differentiation and localized marketing.

Services Include:

• Custom brand name and logo
• Unique tablet shapes or colors (subject to regulatory approval)
• Language-specific labeling
• Dedicated artwork and design team
• Legal support for trademark and copyright compliance

MOQ flexibility is available for both large tenders and boutique brand launches.

Global Supply & Logistics Support

BluepillExpress manages end-to-end export logistics and supply chain solutions, ensuring fast and reliable product delivery:

• Air freight, sea freight, and courier options
• Cold chain or controlled temperature logistics (if needed)
• Hazardous materials handling compliance (for bulk INH)
• Real-time order tracking and inventory coordination
• Export documentation tailored to the importing country’s requirements

We support delivery to government health ministries, international NGOs, pharmacies, hospital systems, and distributors.

Target Clients and End Users

Our Isoniazid third-party manufacturing services are suited for:

• Generic drug importers
• Government and non-governmental health programs
• Public health institutions and national TB programs
• Tender participants and institutional suppliers
• Humanitarian organizations like WHO, UNICEF, and MSF
• Retail and hospital supply chains

Why Choose BluepillExpress for Isoniazid Manufacturing?

• WHO-GMP certified manufacturing with a public health focus
• Decades of experience in antitubercular drug production
• Regulatory dossier availability for rapid registration
• High-volume, low-cost manufacturing for tenders
• Global export and documentation support
• Custom branding and multilingual packaging
• Proven reliability across 30+ countries

Conclusion

As the fight against tuberculosis continues worldwide, Isoniazid remains a cornerstone of both treatment and prevention strategies. At BluepillExpress, we are proud to contribute to this global effort by offering high-quality, compliant, and accessible Isoniazid products through advanced third-party manufacturing solutions.

Our infrastructure, regulatory experience, and customer-first approach make us the ideal partner for governments, NGOs, and pharmaceutical brands seeking to expand their TB treatment portfolio with a reliable manufacturer.