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Stavudine

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BluepillExpress is a globally recognized name in pharmaceutical manufacturing, specializing in high-quality third-party and contract manufacturing services. Among the many therapeutic categories we serve, antiretroviral drugs hold a prominent place in our portfolio. One of the key products we offer under our third-party manufacturing services is Stavudine, a vital antiretroviral medication used in the treatment of HIV/AIDS. With our robust infrastructure, stringent quality control systems, and commitment to global regulatory compliance, BluepillExpress delivers unmatched reliability, efficacy, and affordability in Stavudine manufacturing.

About Stavudine

Stavudine, also known by its abbreviation d4T, is a nucleoside reverse transcriptase inhibitor (NRTI). It interferes with the replication process of HIV, the virus responsible for AIDS, by inhibiting the reverse transcriptase enzyme. Stavudine is usually administered in combination with other antiretroviral drugs as part of Highly Active Antiretroviral Therapy (HAART).

Pharmacological Profile:

  • Class: Antiretroviral (NRTI)
  • Molecular Formula: C10H12N2O4
  • Molecular Weight: 224.21 g/mol
  • Available Strengths: 15 mg, 20 mg, 30 mg, 40 mg
  • Dosage Form: Oral capsule, oral solution

Therapeutic Indications

Stavudine is indicated for:

  • The treatment of HIV-1 infection, in combination with other antiretroviral agents.
  • Management of AIDS and its related complications.
  • Use as part of post-exposure prophylaxis (PEP) regimens under specific protocols.

BluepillExpress Manufacturing Excellence

State-of-the-Art Infrastructure

Our WHO-GMP, ISO, and cGMP-certified facilities are equipped with:

  • Automated production lines
  • HEPA-filtered clean rooms
  • High-speed capsule filling, drying, and packing units
  • In-house analytical labs and R&D centers

Our facilities are designed to handle the production of active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs) while maintaining the highest standards of hygiene and cross-contamination prevention.

Formulation Expertise

At BluepillExpress, our pharmaceutical scientists and formulation experts ensure the development of stable and bioequivalent formulations of Stavudine. Our formulation process includes:

  • Pre-formulation and compatibility studies
  • Stability testing as per ICH guidelines
  • Bioequivalence assessments (if required)
  • Customized dosage strength development for pediatric, adult, and geriatric populations

Regulatory Compliance

We strictly adhere to international regulatory guidelines and offer complete documentation support for:

  • WHO PQ
  • US FDA
  • UK MHRA
  • EU EMA
  • TGA Australia
  • GCC and African health authorities

Every batch of Stavudine produced at BluepillExpress is accompanied by:

  • Certificate of Analysis (CoA)
  • Batch Manufacturing Record (BMR)
  • Material Safety Data Sheet (MSDS)
  • Stability Data
  • Packaging & Labeling Compliance Reports

Quality Assurance and Quality Control (QA/QC)

We implement a rigorous multi-tier quality management system, covering:

  • Raw Material Testing: All incoming APIs and excipients undergo identity, purity, and microbial testing.
  • In-process Quality Checks: Ensuring blend uniformity, capsule weight variation, and content uniformity.
  • Finished Product Testing: Evaluation of dissolution, assay, microbial load, and stability parameters.
  • Environmental Monitoring: To maintain aseptic conditions, especially for oral solutions.

All processes are documented in real-time using 21 CFR Part 11-compliant systems, ensuring full traceability and audit readiness.

Packaging and Labeling Solutions

BluepillExpress offers complete packaging and private labeling services tailored to our partners’ branding requirements. Packaging options for Stavudine include:

  • Blister packs
  • HDPE bottles
  • Amber glass bottles for oral liquids
  • Child-resistant and tamper-evident closures

Our packaging meets global standards in terms of protection against light, moisture, and contamination. We also ensure multi-language labeling as per local market requirements.

Contract Manufacturing and Customization Options

Whether you’re a startup, a mid-sized pharmaceutical distributor, or a government procurement agency, BluepillExpress offers:

  • Flexible batch sizes
  • Custom formulation and dosing
  • Fast-track production for urgent orders
  • Private-label manufacturing
  • White-label ready-to-ship formulations

We offer Stavudine in both bulk and retail-ready packaging options.

Stavudine Manufacturing Process

1. Pre-formulation Studies

  • API characterization
  • Solubility and stability profiling
  • Compatibility with excipients

2. Granulation

  • Wet or dry granulation depending on formulation type
  • Use of pharmacopeial-grade excipients

3. Blending

  • Uniform mixing in ribbon or cone blenders
  • In-process checks to maintain consistency

4. Encapsulation

  • Encapsulation using high-precision capsule fillers
  • Weight variation and content uniformity checks

5. Drying and Polishing

  • Optimized drying parameters to prevent degradation
  • Polishing for a clean, professional appearance

6. Quality Control

  • Sampling and testing at each critical stage
  • Microbial, chemical, and physical parameter testing

7. Packaging

  • Automated labeling, coding, and batch tracking
  • Cartoning and boxing with anti-counterfeit features

Why Choose BluepillExpress for Stavudine Manufacturing?

1. End-to-End Solutions

From API procurement to final packaging, we provide a complete turnkey solution to our clients.

2. Global Supply Chain

Our logistics team ensures timely, compliant shipping to over 50 countries, including Latin America, Southeast Asia, Africa, and the Middle East.

3. Competitive Pricing

Thanks to in-house production efficiencies and bulk procurement, we offer cost-effective rates without compromising quality.

4. Regulatory Support

We assist with product registration, dossier preparation (CTD/ACTD formats), and provide validation and stability data for market entry.

5. Dedicated Project Management

Each client is assigned a dedicated project manager to oversee timelines, technical transfers, and documentation.

6. Rapid Turnaround Time

Our agile manufacturing process ensures delivery from order to dispatch within 4–6 weeks, depending on customization.

Documentation and Dossier Support

We offer comprehensive technical and regulatory documentation packages including:

  • Full CTD/ACTD dossiers
  • Product master files
  • Site master files
  • Validation protocols and reports
  • Impurity profiles
  • Bioequivalence data (if available)

These documents help streamline regulatory approvals and product registration processes in global markets.

Environmental and Ethical Manufacturing

BluepillExpress maintains sustainable manufacturing practices through:

  • Waste minimization and recycling systems
  • Effluent Treatment Plants (ETPs)
  • Low-carbon manufacturing processes
  • Ethical sourcing of raw materials

We are also committed to ethical labor practices and operate in compliance with global standards for occupational safety.

Clientele and Market Segments

We serve a broad range of clients including:

  • Government health departments and NGOs
  • Hospital supply chains and procurement agencies
  • Branded pharmaceutical companies
  • Generic medicine distributors
  • International tender participants

Conclusion

At BluepillExpress, we combine science, innovation, and compliance to offer reliable and scalable third-party manufacturing solutions for Stavudine. With our advanced facilities, skilled workforce, and deep regulatory expertise, we empower pharmaceutical companies to extend their market reach with confidence and speed.

Whether you’re looking to launch a new antiretroviral product line, meet demand for tenders, or expand your branded portfolio, BluepillExpress is your trusted partner for the highest quality Stavudine formulations.

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