Nevirapine

BluepillExpress is a globally recognized pharmaceutical manufacturer and exporter, offering exceptional third-party manufacturing services for a wide range of generic and branded medicines, including antiretroviral drugs like Nevirapine. With a commitment to quality, regulatory compliance, and innovative pharmaceutical solutions, we are the trusted partner for businesses seeking reliable third-party manufacturing of Nevirapine for HIV treatment.

Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used extensively in combination therapy for HIV-1 infection. Its demand is sustained globally due to its proven efficacy and affordability. At BluepillExpress, we specialize in the scalable production of Nevirapine tablets and oral suspensions, designed to meet both domestic and international standards.

About Nevirapine

Pharmacological Class

• Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)

Mechanism of Action

Nevirapine binds directly to reverse transcriptase, blocking the RNA-dependent and DNA-dependent DNA polymerase activities. This inhibition prevents the replication of HIV-1, thus reducing the viral load in patients.

Therapeutic Use

• Treatment of HIV-1 infection in combination with other antiretroviral agents.
• Prevention of mother-to-child transmission of HIV during childbirth and breastfeeding in resource-limited settings.

Available Forms

• Nevirapine Tablets: 200 mg
• Nevirapine Oral Suspension: 50 mg/5 mL

Why Choose BluepillExpress for Nevirapine Manufacturing?

1. WHO-GMP Certified Manufacturing Facilities

Our manufacturing units are certified by WHO-GMP and comply with stringent international standards. We maintain dedicated cleanrooms, advanced HVAC systems, and automated quality monitoring to ensure contamination-free production of Nevirapine.

2. Regulatory Compliance

BluepillExpress complies with all major global regulatory requirements including:

• WHO prequalification
• US FDA guidelines (where applicable)
• EU-GMP
• TGA (Australia)
• ANVISA (Brazil)
• CDSCO (India)

Our team of regulatory experts supports dossier preparation, DMF submissions, and ensures compliance with international health authorities for successful registration and marketing of Nevirapine products.

3. State-of-the-Art Manufacturing Infrastructure

We utilize cutting-edge technology for granulation, tablet compression, suspension blending, and coating processes to ensure precise formulation and bioavailability of Nevirapine. Our automated packaging lines guarantee consistent fill weights and secure sealing, extending product shelf life.

4. Scalability & Customization

Whether your requirement is for bulk exports or small batches for clinical trials, BluepillExpress offers flexible production volumes. We provide:

• Customized formulation options
• Bulk packaging or final-pack solutions
• Private labeling
• Custom branding and artwork development

Our Manufacturing Capabilities for Nevirapine

Formulation Development

• Custom formulation based on client specifications or generic reference product.
• Stability studies as per ICH guidelines.
• Bioequivalence-ready formulation development.

Production Capacities

• Tablets: Up to 10 million units per month
• Oral Suspension: Up to 500,000 bottles per month

Packaging Options

• Blister packs (PVC/Alu or Alu/Alu)
• Bottles for tablets and suspensions
• Customized secondary packaging (mono cartons, inserts, etc.)
• Barcoding, serialization, and tamper-evident seals available

Quality Assurance and Quality Control

At BluepillExpress, quality is the cornerstone of our third-party manufacturing services. We implement:

• In-process quality checks
• Batch-wise analytical testing
• Microbiological assessments
• Dissolution and content uniformity tests
• Stability testing under various climatic zones

Our fully equipped quality control laboratory is staffed by experienced analysts who ensure that every batch of Nevirapine meets pharmacopeial standards (USP, BP, IP, EP).

Supply Chain and Logistics Support

We provide end-to-end support for supply chain management:

• API sourcing from certified suppliers
• On-time production scheduling
• Cold-chain and ambient logistics management
• Export documentation and customs clearance

Our strong distribution network enables timely delivery of Nevirapine consignments across Africa, Latin America, Asia, the CIS region, and the Middle East.

Advantages of Partnering with BluepillExpress

1. Extensive Therapeutic Portfolio

Beyond Nevirapine, BluepillExpress offers a robust antiretroviral portfolio including Lamivudine, Zidovudine, Efavirenz, Tenofovir, and fixed-dose combinations like Nevirapine + Lamivudine + Zidovudine.

2. Transparent Business Ethics

We believe in transparent pricing, detailed documentation, and open communication throughout the manufacturing and supply process.

3. Dedicated Project Management

Our expert project managers provide personalized support from initial inquiry to final product dispatch. We ensure proactive updates on production schedules, QA approvals, and shipment status.

4. Competitive Pricing

With efficient manufacturing processes and economies of scale, BluepillExpress offers highly competitive rates for Nevirapine manufacturing without compromising on quality.

Documentation Support

We provide comprehensive technical and regulatory documentation to our partners, including:

• Certificate of Analysis (CoA)
• Batch Manufacturing Record (BMR)
• Certificate of Pharmaceutical Product (COPP)
• Stability data
• Product Development Report
• Free Sale Certificate
• Labeling and packaging compliance as per country-specific norms

Contract Manufacturing Process with BluepillExpress

1. Product Inquiry
   • Share your requirement (strength, dosage form, quantity).
   • NDA signed for confidentiality (optional).
2. Quotation and Proposal
   • We provide a commercial quote with lead times and deliverables.
   • Scope of work including packaging and regulatory support outlined.
3. Formulation and Development
   • Pilot batches produced (if needed).
   • Documentation shared for review and approval.
4. Commercial Manufacturing
   • Production scheduled post-approval and PO issuance.
   • In-process quality checks performed at all stages.
5. Packaging and Dispatch
   • Packaging finalized as per client’s artwork.
   • Products dispatched with complete documentation.
6. Post-Supply Support
   • Continued assistance for regulatory queries, market authorization, and re-orders.

Target Markets and Export Focus

We cater to pharmaceutical marketing companies, NGOs, public health organizations, and government tenders across:

• Africa: Nigeria, Kenya, Uganda, Ghana, South Africa, Zambia, Ethiopia
• Latin America: Peru, Bolivia, Guatemala, Haiti
• Southeast Asia: Myanmar, Philippines, Cambodia
• CIS Countries: Ukraine, Kazakhstan, Uzbekistan
• Middle East: Yemen, Iraq, Jordan