Description

Zidovudine Capsules

Healthy Inc is a specialized global supplier and exporter of life-saving infectious disease and antiretroviral (ARV) therapeutics. We provide high-purity Zidovudine Capsules (100 mg / 250 mg), manufactured in WHO–GMP certified oral solid dosage facilities. This historical “Nucleoside Reverse Transcriptase Inhibitor (NRTI)” is a critical, high-volume export to infectious disease hospitals, HIV/AIDS treatment centers, maternal health clinics, and government health ministries in Africa, LATAM, and Southeast Asia, serving as a vital backbone in combination antiretroviral therapy (cART) and the prevention of maternal-fetal HIV transmission.

Product Overview

This formulation contains Zidovudine (also known as AZT or azidothymidine), a synthetic thymidine analogue.

The “Reverse Transcriptase” Specialist:

• Mechanism (DNA Chain Termination): Once inside the host cell, Zidovudine is phosphorylated by cellular kinases into its active metabolite, zidovudine triphosphate. This active molecule competitively inhibits the HIV-1 reverse transcriptase enzyme. Because it lacks a 3′-hydroxyl group, once the reverse transcriptase enzyme incorporates it into the growing viral DNA strand, no further nucleotides can be attached. This causes immediate viral DNA chain termination, halting the replication of the HIV virus.
• The PMTCT Cornerstone: Zidovudine possesses excellent placental transfer capabilities. It is globally recognized and mandated by WHO guidelines for the Prevention of Mother-to-Child Transmission (PMTCT) of HIV-1, administered to the mother during pregnancy and labor, and subsequently to the newborn infant.
• CNS Penetration: Unlike many other ARVs, Zidovudine has excellent penetration across the blood-brain barrier, making it highly valuable in managing HIV-associated dementia and central nervous system viral reservoirs.

Product Composition & Strength

We supply this product as a Hard Gelatin Capsule, packed in specialized high-density polyethylene (HDPE) bottles or moisture-resistant blister strips.

*Pack Sizes: 100-Capsule HDPE Bottles with Child-Resistant Closures (standard for extended ARV dispensing) or 10×10 Alu-PVC Blisters.

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers and ARV Tender Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• API Purity & Toxicity Mitigation: Because Zidovudine carries significant baseline bone marrow toxicity, our manufacturing ensures the highest chromatographic purity of the API, eliminating any uncharacterized synthetic impurities that could exacerbate hematological side effects in immunocompromised patients.
• Dissolution Precision: Formulated with premium superdisintegrants to ensure rapid gastric dissolution, allowing the drug to quickly achieve the peak plasma concentrations required to suppress rapid viral replication.

Therapeutic Indications (Human Use)

Indicated for the treatment and prevention of HIV-1 infection:

• HIV-1 Infection: Used strictly in combination with other antiretroviral agents (e.g., Lamivudine, Efavirenz) for the treatment of HIV-1 infection in adults and pediatric patients.
• Prevention of Maternal-Fetal Transmission (PMTCT): Indicated for HIV-1 infected pregnant women (>14 weeks of pregnancy) and for their newborn infants to prevent maternal-fetal transmission.

Dosage & Administration

Recommended Dosage (Strictly as per Infectious Disease Specialist):

• Administration: Taken orally, usually twice daily, with or without food.
• Standard Adult Dose: Typically 300 mg twice a day (administered as combination tablets or individual capsules depending on the regimen).
• Maternal Dosing (PMTCT): Highly specific weight-based and gestational-age protocols apply; typically initiated between 14 and 34 weeks of gestation and continued until the onset of labor.

Safety Warnings (CRITICAL):

• BLACK BOX WARNING (Hematologic Toxicity): Zidovudine is heavily associated with severe, dose-dependent bone marrow suppression resulting in profound anemia and neutropenia. Frequent blood counts are mandatory, particularly in patients with advanced HIV disease.
• BLACK BOX WARNING (Myopathy): Prolonged use has been associated with symptomatic myopathy and severe muscle wasting (due to mitochondrial toxicity).
• BLACK BOX WARNING (Lactic Acidosis & Hepatomegaly): Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues alone or in combination.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Bulk Drug Distributors. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Antiretroviral (ARV) Medicines, allowing brands to launch high-quality generic medicines under their own label. Whether you are looking for a reliable NGO Tender Supplier for global health procurement in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely delivery. We actively support Pharmaceutical Drop Shipping models and bulk indenting, ensuring that every Generic Medicine Wholesaler receives WHO-GMP certified products at competitive rates.