Lamivudine + Zidovudine

BluepillExpress is a globally recognized name in third-party pharmaceutical manufacturing, offering high-quality formulations backed by robust research, advanced manufacturing infrastructure, and global regulatory compliance. Among our wide range of antiretroviral products, the fixed-dose combination of Lamivudine + Zidovudine holds a significant place, catering to the needs of patients managing HIV infection.

This combination is classified as a nucleoside reverse transcriptase inhibitor (NRTI), commonly prescribed as part of highly active antiretroviral therapy (HAART). BluepillExpress brings excellence to every stage of production, from procurement of quality raw materials to final product packaging, ensuring our partners benefit from end-to-end manufacturing services for Lamivudine + Zidovudine tablets or capsules.

Product Overview: Lamivudine + Zidovudine

Generic Name: Lamivudine + Zidovudine
Therapeutic Class: Antiretroviral (NRTI combination)
Dosage Forms Available: Tablets, Capsules
Strengths Offered:

• Lamivudine 150 mg + Zidovudine 300 mg
  Indications:
• Treatment of HIV-1 infection in combination with other antiretroviral agents.

Therapeutic Significance

Lamivudine and Zidovudine are both synthetic nucleoside analogs. They act by inhibiting the reverse transcriptase enzyme, thereby preventing the conversion of viral RNA into DNA, a critical step in the viral replication process.

Lamivudine

• Inhibits HIV-1 and HBV replication
• Excellent oral bioavailability
• Well-tolerated with minimal side effects

Zidovudine

• The first FDA-approved antiretroviral drug
• Reduces viral load and improves CD4 cell counts
• Prevents perinatal transmission of HIV

Together, they offer a synergistic effect in suppressing viral replication, improving patient compliance and reducing the pill burden.

BluepillExpress Manufacturing Excellence

At BluepillExpress, our third-party manufacturing services for Lamivudine + Zidovudine focus on quality, efficiency, and regulatory compliance. We provide turnkey pharmaceutical contract manufacturing solutions tailored to your brand’s needs.

1. WHO-GMP and ISO-Certified Facilities

Our state-of-the-art production facilities comply with WHO-GMP, ISO 9001:2015, and other international standards. These certifications reflect our commitment to maintaining the highest manufacturing standards for quality, hygiene, and consistency.

2. Stringent Quality Control

Our multi-layered quality control systems begin with raw material sourcing and extend through formulation, in-process checks, packaging, and stability testing. Each batch of Lamivudine + Zidovudine undergoes analytical testing based on pharmacopeial standards (USP, BP, IP) to ensure safety and efficacy.

3. Research & Development Support

We offer extensive R&D services to support customized formulation development, bioequivalence studies, and regulatory documentation. Whether you require a standard formulation or need assistance in developing a new product variation, BluepillExpress delivers flexible solutions.

4. Scalable Production

From pilot batches to large-scale commercial quantities, our modular production capabilities ensure scalability without compromising product integrity. Our advanced machinery facilitates efficient mixing, granulation, compression, and coating processes specific to Lamivudine + Zidovudine formulations.

Formulation and Composition

Each Tablet Contains:

• Lamivudine 150 mg
• Zidovudine 300 mg

Excipients:

• Microcrystalline Cellulose
• Magnesium Stearate
• Sodium Starch Glycolate
• Povidone
• Colloidal Silicon Dioxide
• Film-coating materials (if applicable)

All excipients used are pharmaceutically approved and compatible with antiretroviral APIs, ensuring bioavailability and shelf-life consistency.

Packaging Capabilities

BluepillExpress offers flexible and customized packaging options suited to domestic and international markets. Packaging is designed for product safety, ease of use, and regulatory compliance.

Available Packaging Options:

• Alu-Alu Blister Packs
• Strip Packs
• HDPE Bottles
• Carton Boxes with inserts (customized branding)

Labeling Compliance

We design and print labels in accordance with:

• CDSCO (India)
• US FDA
• EMA
• TGA (Australia)
• SAHPRA (South Africa)
• and other regional regulations, including multilingual support.

Regulatory and Documentation Support

We understand that successful market entry depends on solid documentation. BluepillExpress provides a comprehensive set of documents to facilitate domestic licensing and international registrations.

Documents Offered:

• Certificate of Analysis (CoA)
• Batch Manufacturing Records (BMR)
• Stability Data
• Product Dossiers (CTD/ACTD formats)
• Free Sale Certificates
• WHO-GMP Certificates
• MSDS (Material Safety Data Sheet)
• COPP (Certificate of Pharmaceutical Product)

Our regulatory affairs team assists clients in dossier compilation, variation filing, and product registration across global markets.

Global Reach and Export Expertise

BluepillExpress is a trusted export partner for pharmaceutical companies in over 40 countries, including regions like Africa, South-East Asia, Latin America, CIS nations, and the Middle East.

Export Highlights:

• Pre-shipment testing and third-party analysis
• Assistance with shipping documentation
• Country-specific labeling
• Regulatory guidance for import permits and product registration
• End-to-end logistics and cold chain (if required)

Our global compliance standards enable smooth transactions and facilitate quick market access for Lamivudine + Zidovudine combination products.

Customization Services

We believe in offering tailored solutions. Our Lamivudine + Zidovudine third-party manufacturing services can be customized to meet your brand’s unique requirements.

Customizable Parameters:

• Tablet shape and color
• Blister size and count
• Branding and logo imprint
• Custom inserts and cartons
• Alternative dosages or fixed-dose combinations (subject to feasibility)

We welcome custom development projects for fixed-dose combinations or co-packaged ART kits based on treatment guidelines and your market needs.

Why Choose BluepillExpress for Lamivudine + Zidovudine Manufacturing?

Feature	Advantage
Global Certifications	WHO-GMP, ISO, GLP-compliant
Robust Supply Chain	Timely availability of quality APIs
Affordable Pricing	Competitive contract manufacturing rates
End-to-End Support	From formulation to documentation and export
Confidentiality	Strict IP protection for all partners
Flexible MOQs	Support for startups and growing brands

We cater to businesses of all sizes—whether you are an established pharmaceutical company looking to outsource production or a startup planning to enter the antiretroviral therapy market.

Sustainability and Compliance

As part of our commitment to environmental responsibility, all manufacturing activities are carried out in accordance with environmental protection laws and Good Environmental Practices (GEP). Effluent treatment plants and waste disposal protocols ensure minimal ecological impact.

In addition, our ethical manufacturing practices include:

• No use of child labor
• Gender equality and inclusive hiring
• Adherence to ICH and pharmacovigilance norms

Partner with BluepillExpress

If you are looking for a reliable, quality-focused, and cost-efficient third-party manufacturing partner for Lamivudine + Zidovudine, BluepillExpress is your strategic ally. Our technical know-how, compliance readiness, and customer-first approach make us a preferred choice among global pharmaceutical brands.

Contact us today to explore how we can manufacture, package, and support your Lamivudine + Zidovudine product line with speed, precision, and integrity.