IndiaMart
FIEO
BluepillExpress is a globally recognized pharmaceutical company that specializes in third-party manufacturing of high-quality, WHO-GMP-compliant antiretroviral formulations. Among our most in-demand combination therapies is Nevirapine + Tenofovir Disoproxil Fumarate + Lamivudine, an essential fixed-dose regimen for the effective treatment of HIV-1 infection. BluepillExpress delivers this vital formulation with a commitment to quality, global regulatory compliance, and customized manufacturing solutions.
This fixed-dose combination offers a triple antiretroviral mechanism of action, helping to reduce viral replication and delay disease progression. It is widely recommended by national and international HIV treatment guidelines, including those of the WHO.
Product Overview
Product Name: Nevirapine + Tenofovir Disoproxil Fumarate + Lamivudine
Dosage Form: Film-coated tablets
Dosage Strengths: Customizable – Common strength:
- Nevirapine 200 mg
- Tenofovir Disoproxil Fumarate 300 mg
- Lamivudine 300 mg
Therapeutic Category: Antiretroviral (ARV)
Pharmacological Class: - Nevirapine – Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)
- Tenofovir Disoproxil Fumarate – Nucleotide Reverse Transcriptase Inhibitor (NtRTI)
- Lamivudine – Nucleoside Reverse Transcriptase Inhibitor (NRTI)
Therapeutic Indication
This combination is indicated for the treatment of HIV-1 infection in adults and adolescents as part of a comprehensive antiretroviral treatment (ART) program. It is used both in first-line and second-line therapies depending on individual patient needs and national treatment protocols.
Composition and Mechanism of Action
Nevirapine
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that binds directly to reverse transcriptase and blocks RNA-dependent and DNA-dependent DNA polymerase activities. It thereby inhibits viral replication by preventing the conversion of viral RNA into DNA.
Tenofovir Disoproxil Fumarate (TDF)
TDF is a nucleotide reverse transcriptase inhibitor (NtRTI). It inhibits reverse transcriptase by acting as a chain terminator during the process of viral DNA synthesis. Its oral prodrug form enhances bioavailability and facilitates once-daily dosing.
Lamivudine
Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) that competes with the natural substrate deoxycytidine triphosphate and gets incorporated into the viral DNA, causing chain termination and inhibition of reverse transcriptase.
Synergistic Effect
The combination offers a synergistic inhibition of HIV replication by targeting reverse transcriptase at different sites, reducing the risk of drug resistance, improving adherence through simplified therapy, and enhancing patient outcomes.
Manufacturing Capabilities at BluepillExpress
At BluepillExpress, we offer end-to-end third-party manufacturing solutions for Nevirapine + Tenofovir Disoproxil Fumarate + Lamivudine, meeting the exacting standards of both domestic and international regulatory agencies.
Facility Accreditations
- WHO-GMP certified
- ISO 9001:2015
- cGMP compliance under Schedule M (India)
- EU-GMP (for selective units)
- PIC/S, ANVISA, and other country-specific certifications as needed
Key Manufacturing Highlights
- Dedicated cleanroom environments for ARV production
- Automated granulation, compression, and coating lines
- In-house analytical laboratory for QC and QA
- Scalable batch sizes, from pilot to commercial production
- Custom packaging and labeling as per partner requirements
- DMF and CTD dossier support for global registrations
Formulation & Packaging Support
BluepillExpress offers custom formulation development, including modified release profiles and combination adjustments. Packaging options are available in:
- HDPE bottles
- Blister strips (Alu-Alu, PVC)
- Sachets or secondary cartons with multilingual inserts
Quality Assurance and Regulatory Support
We prioritize zero-defect quality and ensure every batch undergoes:
- Raw material identity, assay, and purity testing
- In-process checks during granulation, blending, and compression
- Finished product testing for potency, dissolution, disintegration, and stability
- Microbial limits testing and uniformity checks
BluepillExpress also provides:
- Regulatory documentation support for international markets (Asia, Africa, CIS, Latin America, and MENA)
- Dossier preparation and validation protocols (BE/BA studies, COAs, MSDS)
- Batch release under stringent QC norms
Research & Development
Our dedicated R&D division continuously innovates formulation techniques to enhance the pharmacokinetics and patient compliance of triple-combination therapies. BluepillExpress is actively engaged in:
- Bioequivalence studies
- Compatibility and stability profiling
- Developing pediatric-friendly formulations
- Exploring once-daily fixed-dose combinations
Customization Options for Clients
As a trusted third-party manufacturer, BluepillExpress offers complete customization flexibility, including:
- Private labeling with your brand name
- Customized dosage strengths or excipient profiles
- Alternate APIs or salt forms based on market availability or cost-efficiency
- Co-marketing or licensing options for regional partners
- Differentiated packaging per client market (including Braille embossing or child-resistant packs)
Supply Chain & Logistics
We ensure robust and timely global deliveries of ARV formulations using:
- GDP-compliant transport and cold chain (if required)
- Temperature-monitored shipping containers
- Multi-modal logistics including air, sea, and land routes
- Strategic warehousing hubs for fast order fulfillment
BluepillExpress provides bulk exports, consignment manufacturing, and contract-based deliveries for hospital tenders, public health programs, and NGO supplies under PEPFAR, Global Fund, and other international initiatives.
Competitive Advantages of Partnering with BluepillExpress
- Global reach with local expertise
- 100+ satisfied B2B partners across 35+ countries
- Scalable manufacturing suited for both small-scale startups and large government tenders
- On-time delivery record with 99.8% batch release punctuality
- Regulatory transparency and complete IP protection
- Dedicated client relationship managers for technical and commercial support
Stability and Shelf Life
- Shelf Life: Typically 24 to 36 months under recommended storage
- Storage Conditions: Store in a cool, dry place below 30°C. Protect from moisture and sunlight.
Market Demand and Applications
This triple therapy is in high demand in regions with significant HIV burdens, including:
- Sub-Saharan Africa
- South and Southeast Asia
- Central America and the Caribbean
- Eastern Europe and CIS countries
BluepillExpress supplies these markets in partnership with national health programs, private distributors, and international aid organizations.
Compliance & Ethical Standards
At BluepillExpress, all manufacturing and sourcing practices adhere to:
- WHO prequalification guidelines
- TRIPS-compliant IP regulations
- Pharmacovigilance and recall systems
- Environmental safety protocols
- CSR initiatives in public health awareness
Documentation and Dossier Support
We offer comprehensive regulatory documentation, including:
- Certificate of Analysis (COA)
- Certificate of Pharmaceutical Product (CPP)
- GMP Certificate
- Stability Data
- DMF availability for key APIs
- Bioequivalence data (on request)
Conclusion
As a trusted partner in the global fight against HIV/AIDS, BluepillExpress stands at the forefront of high-quality, affordable, and accessible ARV manufacturing. The Nevirapine + Tenofovir Disoproxil Fumarate + Lamivudine fixed-dose combination represents our commitment to therapeutic innovation, quality manufacturing, and scalable partnerships.
Whether you’re a pharmaceutical company seeking to expand your product line, a public health tendering authority, or a healthcare nonprofit aiming to reach underserved populations—BluepillExpress is your ideal third-party manufacturing partner for this life-saving combination therapy.
