Description
Zidovudine Tablet (300mg)
Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc
1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a premier manufacturer of the Zidovudine Tablet in India. This Antiretroviral (ARV) medication is vital for HIV management. We produce high-quality film-coated tablets. Our facility adheres to strict WHO-GMP standards. Therefore, we ensure potency and safety. Healthy Inc manages our global exports and government tenders.
2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Zidovudine Tablet | | Generic Name | Zidovudine (AZT) USP / BP / IP | | Strength | 100mg / 300mg | | Dosage Form | Film Coated Tablet | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Antiretroviral / NRTI | | Shelf Life | 36 Months | | Packaging | 60 Tablet HDPE Bottle / 10×10 Blister |
3. Manufacturing Zidovudine Tablet We divide our operations to ensure specialized focus.
The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. We use dedicated manufacturing lines for ARVs. This prevents cross-contamination with other products. Zidovudine is sensitive to light. Therefore, we use opaque film coating. We also use high-density polyethylene (HDPE) bottles. This protects the Zidovudine Tablet during storage.
The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for the Zidovudine Tablet. We specialize in HIV/AIDS programs. Thus, we understand the documentation for global tenders (Global Fund/PEPFAR). We ensure timely shipment for national health ministries.
4. Quality Assurance We test every batch rigorously.
Assay Verification: We use HPLC testing. This confirms the Zidovudine content is exact.
Dissolution: We test how the tablet releases the drug. Consistent bioavailability is crucial for viral suppression.
Impurities: We test for degradation products. This ensures the medicine remains effective for 3 years.
5. Why Use Zidovudine Tablet? This drug is a cornerstone of HIV therapy.
Mechanism: It belongs to the NRTI class. It inhibits the reverse transcriptase enzyme. Consequently, it prevents the HIV virus from replicating.
PMTCT: It is widely used to prevent HIV transmission from mother to child during childbirth.
Key Indications:
Management of HIV-1 infection (in combination with other ARVs).
Prevention of Maternal-Fetal HIV transmission.
Post-exposure prophylaxis (PEP).
6. Export and Regulatory Support We provide complete documentation for registration.
Dossier: We offer CTD and ACTD formats.
Certificates: We supply the Free Sale Certificate (FSC) and COPP.
Logistics: We ship via FOB Mumbai or CIF.
7. Frequently Asked Questions
Q: Who manufactures Zidovudine Tablet? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.
Q: Is this the same as AZT? A: Yes, Zidovudine is also known as AZT.
Q: Do you offer bottles or blisters? A: We supply both. HDPE bottles (60 count) are most common for monthly ARV courses.
CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
Standard Dosage: The typical adult dose is 300mg twice daily.
Combination: It must always be used in combination with other antiretroviral agents.
Administration: Tablets can be taken with or without food. Swallow whole with water.
9. Side Effects and Precautions
Common Side Effects: Nausea, headache, or muscle pain may occur.
Hematology Warning: Zidovudine can cause anemia (low red blood cells) and neutropenia. Regular blood tests are recommended.
Contraindications: Not for patients with life-threatening allergic reactions to any components.
10. Storage Instructions
Store below 30°C in a dry place.
Light Sensitive: Keep in the original light-resistant container.
Keep out of reach of children.
