Atazanavir

Atazanavir is a highly effective antiretroviral medication classified as a protease inhibitor, primarily used in the treatment of HIV-1 infections. With its proven efficacy and tolerability, it has become a critical component of combination antiretroviral therapy (cART) globally. BluepillExpress, a reputed pharmaceutical third-party manufacturer and exporter, specializes in the production of high-quality Atazanavir formulations that comply with global regulatory standards.

Our third-party manufacturing services are tailored for pharmaceutical brands, healthcare institutions, and global distributors seeking reliable, efficient, and certified partners in drug production. With cutting-edge infrastructure, robust quality systems, and a global outlook, BluepillExpress delivers excellence in every unit manufactured.

About BluepillExpress

BluepillExpress is a certified pharmaceutical manufacturing and export organization, offering a wide range of services in the third-party and contract manufacturing space. With state-of-the-art WHO-GMP certified facilities, ISO standards compliance, and adherence to stringent international guidelines, BluepillExpress has positioned itself as a trusted name in global pharmaceutical supply.

We collaborate with partners across Asia, Africa, Latin America, the CIS region, and the Middle East, supporting both branded generics and customized formulations. Our focus on quality, efficiency, and transparency has made us a preferred manufacturing partner for several global healthcare brands.

Atazanavir: Overview and Therapeutic Importance

Pharmacological Classification

• Class: Protease Inhibitor (PI)
• Mechanism of Action: Inhibits the HIV-1 protease enzyme, thereby preventing the maturation of viral particles and limiting viral replication.

Clinical Indications

Atazanavir is indicated for:

• Treatment of HIV-1 infection in adults and pediatric patients (in combination with other antiretroviral agents).
• Use as part of a complete antiviral regimen in ART-naïve or ART-experienced individuals.

Dosage Forms Offered by BluepillExpress

BluepillExpress offers Atazanavir in a variety of dosage forms and strengths to cater to diverse therapeutic needs:

• Capsules: 150 mg, 200 mg, 300 mg
• Tablets: Film-coated, once-daily formulations
• Custom Combinations: Fixed-dose combinations with Ritonavir or Cobicistat upon request

We also provide flexibility in packaging and labeling to meet client-specific market and branding requirements.

Our Third-Party Manufacturing Capabilities for Atazanavir

1. WHO-GMP Certified Facilities

Our manufacturing units are WHO-GMP compliant, ensuring that every step of the production process meets international safety and quality standards. From raw material procurement to final product packaging, each phase is subject to strict scrutiny and documentation.

2. API Sourcing and Compliance

We source high-purity Atazanavir active pharmaceutical ingredients (APIs) from audited and approved vendors. All raw materials undergo rigorous testing in our in-house quality control laboratories to ensure conformance with pharmacopoeial standards such as USP, BP, and IP.

3. Formulation Development

BluepillExpress offers full formulation development support, including:

• Stability testing under ICH guidelines
• Bioequivalence studies in partnership with CROs
• Customized dissolution profiles to meet market-specific needs

Our R&D experts work closely with clients to develop unique, cost-effective formulations suited for registration in regulated and semi-regulated markets.

4. Batch Manufacturing and Scalability

We are equipped to handle:

• Pilot batches for clinical trial purposes
• Commercial-scale batches for bulk supply
• Small-batch manufacturing for niche or early-phase market entry

Each batch undergoes strict in-process and post-manufacturing quality checks including:

• Assay
• Dissolution
• Uniformity of content
• Microbial testing

5. Packaging Solutions

At BluepillExpress, we offer a wide range of packaging options for Atazanavir formulations including:

• Blister packs (Alu-Alu / PVC)
• HDPE bottles
• Strip packs
• Customized primary and secondary packaging with multilingual labeling

We ensure compliance with local packaging regulations, including serialization and tamper-evidence features where applicable.

Quality Assurance and Regulatory Support

BluepillExpress’s commitment to quality is embedded in every aspect of its operations:

Quality Control

Each product batch undergoes extensive testing in our accredited in-house laboratories, with focus areas including:

• Identity and purity
• Assay of active ingredients
• Dissolution and disintegration profiles
• Microbiological load and sterility

Regulatory Documentation Support

We provide full regulatory support to our clients, enabling faster market entry. Our documentation includes:

• Certificate of Analysis (CoA)
• Stability Data (Real-time and Accelerated)
• Master Formula Records (MFR)
• Batch Manufacturing Records (BMR)
• Dossiers in CTD/eCTD format for product registration

BluepillExpress supports regulatory submissions in multiple regions including Africa, Southeast Asia, LATAM, and the CIS zone.

Contract Manufacturing Process

Our third-party manufacturing services are designed to be seamless and transparent. The standard process includes:

1. Product Requirement Discussion
   Understanding the client’s requirement in terms of dosage form, strength, and market-specific regulations.
2. Quotation and Agreement
   Issuance of a competitive quotation including cost, lead time, and minimum order quantity (MOQ).
3. Documentation and Approval
   Signing of a Manufacturing Agreement and NDA (if required). Submission of artwork and labeling for approval.
4. Production and Quality Checks
   Execution of manufacturing under strict SOPs, followed by quality testing and certification.
5. Dispatch and Logistics
   Timely dispatch with complete shipping documentation, including MSDS, CoA, and packing list. We support both EXW and CIF incoterms.

Why Choose BluepillExpress for Atazanavir Manufacturing?

1. Regulatory Compliance

We ensure full compliance with international regulatory standards including WHO-GMP, ISO 9001:2015, and local FDA approvals. All documentation is provided in a format suitable for product registration and tenders.

2. Affordable, High-Quality Solutions

By leveraging economies of scale and efficient processes, BluepillExpress offers cost-effective manufacturing without compromising on quality—ideal for government supply, tenders, and humanitarian procurement.

3. Customization and Confidentiality

We offer white-label and private-label solutions, ensuring that your brand remains protected. All client data and formulations are handled under strict confidentiality agreements.

4. Global Export Expertise

Our logistics and export team handles shipping documentation, customs clearance, and international compliance with ease. We are well-versed with import requirements across Africa, the Middle East, LATAM, and Southeast Asia.

5. Dedicated Client Support

From the initial inquiry to post-dispatch support, our team ensures continuous communication and transparency throughout the partnership. We provide dedicated relationship managers to support all your manufacturing queries.

Therapeutic Market Outlook

Atazanavir continues to be a critical antiretroviral drug globally, especially in low- and middle-income countries where access to affordable HIV medication is vital. The global antiretroviral therapy (ART) market is projected to grow at a CAGR of over 3.5%, with a significant contribution from generic formulations.

BluepillExpress is committed to addressing this global healthcare need by ensuring the continuous availability of affordable and high-quality Atazanavir formulations through trusted third-party partnerships.

Partner with BluepillExpress Today

Whether you are a startup pharma brand, an NGO involved in HIV care, or a government institution sourcing for public health programs, BluepillExpress is your reliable partner in Atazanavir manufacturing. With robust systems, flexible production capacities, and an uncompromising commitment to quality, we ensure that your supply chain is uninterrupted and your patients are served efficiently.