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Zidovudine + Lamivudine + Nevirapine

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In the evolving landscape of global healthcare, antiretroviral therapy (ART) stands at the forefront of life-saving treatment regimens, particularly for the management of HIV/AIDS. One of the most effective combinations in ART is Zidovudine + Lamivudine + Nevirapine, a fixed-dose combination that offers a potent, convenient, and WHO-recommended first-line treatment option. As a trusted name in pharmaceutical third-party manufacturing, BluepillExpress is proud to offer comprehensive contract manufacturing services for this combination, adhering to stringent international standards and certifications.

With state-of-the-art infrastructure, expert formulation teams, and a deep commitment to quality and regulatory compliance, BluepillExpress empowers brands and healthcare distributors worldwide by delivering high-quality antiretroviral combinations under their private label.

About the Formulation

Composition (Typical Strength)

  • Zidovudine – 300 mg
  • Lamivudine – 150 mg
  • Nevirapine – 200 mg

Dosage Form

  • Oral Tablet (Film-coated)
  • Also available in customized formulations as per client specifications

Therapeutic Class

  • Antiretroviral (ARV) Therapy
  • Belongs to NRTIs (Zidovudine, Lamivudine) and NNRTI (Nevirapine) classes

Indications

This fixed-dose combination is used in the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection. It works by reducing the viral load in the blood, enhancing immune function, and improving patient quality of life.

Why Choose BluepillExpress for Zidovudine + Lamivudine + Nevirapine Manufacturing?

1. WHO-GMP and International Certifications

At BluepillExpress, we operate WHO-GMP, ISO, and EU-GMP compliant manufacturing units, ensuring the highest pharmaceutical manufacturing standards. Our quality systems are aligned with stringent regulatory requirements including US FDA, TGA (Australia), and MHRA (UK) standards for regulated and semi-regulated markets.

2. State-of-the-Art Manufacturing Facilities

Our advanced manufacturing units feature:

  • Automated production lines
  • Cleanroom environments with HEPA filtration
  • In-house quality testing laboratories
  • Advanced blister and strip packaging systems
    These facilities ensure contamination-free production and consistent batch quality.

3. Customized Contract Manufacturing

Whether you’re a pharmaceutical brand, distributor, NGO supplier, or government healthcare partner, BluepillExpress provides tailor-made manufacturing solutions. This includes:

  • Custom labeling and packaging
  • Bulk or small batch production
  • Regulatory dossier preparation (CTD/ACTD format)
  • API sourcing and logistics support

4. Robust Quality Assurance

We ensure:

  • In-process quality control
  • Finished product testing
  • Stability studies under ICH guidelines
  • Microbiological testing
    Every batch of Zidovudine + Lamivudine + Nevirapine manufactured is supported with a Certificate of Analysis (CoA) and complies with pharmacopeial standards (USP/BP/Ph. Eur.).

BluepillExpress Manufacturing Process Overview

1. Sourcing & Procurement

We source high-purity, DMF-grade APIs from audited vendors with full traceability. The materials are inspected and quarantined until cleared for production.

2. Formulation & Blending

Using validated formulation protocols, APIs are blended with excipients to ensure uniformity and optimal bioavailability. Process parameters are optimized for maximum therapeutic efficacy.

3. Granulation & Compression

Depending on the formulation needs, either dry or wet granulation is performed. Tablets are compressed using high-speed rotary tablet machines with strict in-process control.

4. Coating & Finishing

The tablets undergo film coating to enhance stability, taste masking, and patient compliance. Coated tablets are visually inspected and passed through metal detectors for safety.

5. Primary & Secondary Packaging

We offer:

  • Blister packaging (Alu-Alu, PVC)
  • Strip packaging
  • Bottle packaging with desiccants
    Custom packaging solutions are available for NGOs, hospitals, or retail exports.

Regulatory Documentation Support

BluepillExpress provides full regulatory support to accelerate product registrations globally:

  • Product Master File (PMF)
  • Certificate of Pharmaceutical Product (CoPP)
  • Batch Manufacturing Records (BMR)
  • Stability Data (Real-time & Accelerated)
  • Product Specification Sheet
  • MSDS (Material Safety Data Sheet)

Our regulatory team assists clients in filing dossiers for various health authorities across Africa, Asia, CIS countries, and Latin America.

Global Reach and Export Capabilities

BluepillExpress has a wide export network with successful deliveries across:

  • Africa: Nigeria, Kenya, South Africa, Uganda, Ghana
  • Asia: India, Philippines, Vietnam, Bangladesh
  • Latin America: Brazil, Peru, Dominican Republic
  • Middle East: UAE, Iraq, Yemen
  • CIS and Eastern Europe: Ukraine, Uzbekistan, Georgia

We provide sea and air shipment support, multilingual labeling, and country-specific documentation (e.g., legalized invoices, packing lists, COO, fumigation certificates, etc.).

Private Label & Branding Opportunities

BluepillExpress enables your brand to stand out in competitive HIV therapeutic markets with:

  • Custom brand name registration support
  • Full packaging design services (blister foil, cartons, leaflets)
  • Multilingual labeling per market
  • Choice of packaging type, tablet color, shape, and imprint

Whether you’re launching a new product line or expanding an existing one, our end-to-end solutions help you go to market faster and more efficiently.

Clinical Significance of Zidovudine + Lamivudine + Nevirapine

  • Zidovudine: A thymidine analog that inhibits reverse transcriptase, slowing the replication of HIV.
  • Lamivudine: A cytidine analog with potent activity against HIV-1 and HIV-2, synergistic with Zidovudine.
  • Nevirapine: A non-nucleoside reverse transcriptase inhibitor that directly binds to reverse transcriptase, blocking its function.

The combination has been proven to:

  • Reduce viral load significantly
  • Improve CD4 cell counts
  • Delay disease progression
  • Lower the risk of opportunistic infections

It is recommended by WHO as a first-line therapy in resource-limited settings, offering a powerful, accessible, and convenient treatment regimen.

Packaging and Shelf Life

  • Standard Pack Sizes: 30s, 60s, 90s tablets per bottle or blister
  • Labeling: Customizable with multilingual print support
  • Shelf Life: 24–36 months under recommended storage conditions
  • Storage: Store below 30°C in a dry place, protect from light and moisture

Partner with BluepillExpress – A Trusted Name in Antiretroviral Manufacturing

As the global burden of HIV/AIDS remains significant, the demand for safe, effective, and affordable antiretroviral drugs continues to grow. At BluepillExpress, we are proud to contribute to this critical healthcare mission by offering trusted third-party manufacturing of Zidovudine + Lamivudine + Nevirapine and other essential medicines.

Our commitment to quality, compliance, confidentiality, and client success ensures a lasting partnership built on trust and transparency. Whether you’re seeking a long-term contract manufacturing partner or a specialized short-run production, we are here to support your business and patient care goals.

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