IndiaMart
FIEO
BluepillExpress is a globally trusted name in the third-party pharmaceutical manufacturing sector, delivering high-quality and compliant pharmaceutical products to clients around the world. Our manufacturing services for fixed-dose combinations such as Tenofovir Disoproxil Fumarate + Lamivudine highlight our commitment to clinical excellence, regulatory adherence, and patient-centric therapeutic solutions. With state-of-the-art facilities, stringent quality controls, and a highly experienced technical workforce, we ensure the efficient production of antiretroviral drugs that meet global healthcare demands.
Product Overview: Tenofovir Disoproxil Fumarate + Lamivudine
Tenofovir Disoproxil Fumarate + Lamivudine is a widely prescribed antiretroviral combination therapy used in the management of HIV-1 infection. This fixed-dose regimen simplifies treatment by combining two nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) into one convenient dosage form. It is also used in the treatment of chronic Hepatitis B virus (HBV) in certain patient populations.
Key Active Ingredients
- Tenofovir Disoproxil Fumarate (TDF)
- A nucleotide reverse transcriptase inhibitor (NtRTI)
- Inhibits the HIV reverse transcriptase enzyme, essential for viral replication
- Also exhibits activity against Hepatitis B virus
- Lamivudine (3TC)
- A nucleoside reverse transcriptase inhibitor (NRTI)
- Blocks the HIV replication process
- Also effective in managing chronic HBV infection
Together, these agents form a powerful antiretroviral backbone that can be used as part of combination therapy in the fight against HIV and HBV.
Therapeutic Applications
- HIV-1 Infection: First-line therapy as part of antiretroviral combination regimens.
- Chronic Hepatitis B: Effective in patients co-infected with HIV and HBV.
BluepillExpress Manufacturing Capabilities
1. State-of-the-Art Manufacturing Infrastructure
At BluepillExpress, our WHO-GMP, ISO, and cGMP-certified facilities are designed for the precise and sterile manufacturing of complex formulations. We utilize high-throughput production lines, dedicated HVAC systems, dust-free environments, and cleanroom technology to ensure the purity and integrity of each batch of Tenofovir Disoproxil Fumarate + Lamivudine.
2. Dosage Forms and Customization
We manufacture the Tenofovir Disoproxil Fumarate + Lamivudine combination in the following standard dosage forms:
- Tablets: 300 mg Tenofovir Disoproxil Fumarate + 300 mg Lamivudine
Clients can request customized strengths, coatings (film or enteric), and packaging configurations to meet local regulatory and market needs. We also offer blister packs, bottle packaging, and unit dose packs, all compliant with international labeling requirements.
3. Quality Assurance and Regulatory Compliance
Every step of our manufacturing process adheres to stringent quality assurance protocols. Our QA/QC departments perform:
- Raw material validation and certification (with DMF support)
- In-process quality checks
- Finished product testing (assay, dissolution, uniformity, and microbial testing)
- Stability studies as per ICH guidelines
- Documentation per USFDA, EMA, TGA, and other global standards
We ensure all documentation, including Batch Manufacturing Records (BMR), Certificates of Analysis (CoA), and stability data, are available for review and export documentation.
4. Supply Chain and Logistics Support
Our integrated logistics systems allow us to ensure timely procurement, production, and dispatch. With strong relationships with API suppliers and shipping companies, we deliver finished Tenofovir Disoproxil Fumarate + Lamivudine products to over 50 countries, including regions across Africa, Southeast Asia, Latin America, and the CIS zone.
We also assist clients with:
- Product registration dossiers (CTD, ACTD formats)
- WHO prequalification dossier support
- Bioequivalence study coordination
- Artwork development and compliance
- Cold chain handling (if needed)
Why Choose BluepillExpress?
1. Proven Therapeutic Expertise
BluepillExpress specializes in antiretroviral therapy (ART) product manufacturing, giving us a significant edge in the production of Tenofovir Disoproxil Fumarate + Lamivudine. We understand the technical and clinical aspects of these drugs, enabling us to deliver consistent therapeutic efficacy batch after batch.
2. Global Regulatory Familiarity
We have a thorough understanding of the regulatory frameworks of different countries, including:
- WHO PQ standards
- US FDA and UK MHRA expectations
- ANVISA (Brazil), SAHPRA (South Africa), and NDA (Uganda) compliance
Our experienced regulatory team supports our partners in filing and approval processes, making market access faster and more efficient.
3. High Volume, Competitive Pricing
Thanks to our economies of scale and efficient processes, BluepillExpress offers highly cost-effective third-party manufacturing solutions without compromising on quality. This helps our clients remain competitive in price-sensitive markets while ensuring patient access to essential medication.
4. Transparency and Confidentiality
We value your intellectual property and market strategy. All third-party manufacturing contracts are executed under strict non-disclosure agreements (NDAs), and we uphold the confidentiality of formulations, branding, and supply arrangements.
5. End-to-End Support
From API sourcing to final product delivery, we manage the entire production lifecycle. Whether you are a new pharmaceutical company looking to launch your HIV portfolio or an established brand expanding into new geographies, BluepillExpress is your dependable manufacturing partner.
Packaging & Labeling
We offer international standard packaging options:
- Alu-Alu and blister packs
- HDPE bottles with induction sealing
- Tamper-proof secondary packaging
- Multilingual labeling options
- Serialization and barcoding as per client requirement
Customized branding and packaging development services are also available to help clients launch or revamp their product lines in various markets.
Documentation Support
Our comprehensive documentation support includes:
- Drug Master Files (DMFs)
- Certificates of Analysis (CoA)
- Certificates of Pharmaceutical Product (CoPP)
- Stability Data (Zone I-IV)
- Product Development Reports
- Validation Protocols and Reports
- Site Master File
- Batch Manufacturing Records (BMRs)
We ensure full transparency and traceability throughout the manufacturing and supply chain.
Environmental and Safety Compliance
We prioritize sustainability and employee safety:
- Adherence to Environmental Health & Safety (EHS) standards
- Waste minimization and treatment systems
- Periodic safety training and audits
- Compliance with local and international labor and safety laws
Markets We Serve
BluepillExpress serves pharmaceutical companies, NGOs, government health departments, importers, and distributors across:
- Africa (Nigeria, Kenya, Ghana, South Africa, Uganda)
- Asia (India, Philippines, Myanmar, Vietnam, Bangladesh)
- Latin America (Peru, Ecuador, Bolivia, Colombia)
- Middle East (Iraq, Yemen, UAE, Saudi Arabia)
- Europe (Eastern bloc nations and Balkans)
