At your WHO-GMP facility in Mumbai, this combination is likely a high-priority product for your antiviral range, as it simplifies dosing schedules and improves patient compliance in chronic care.

Primary Clinical Indications

• HIV-1 Infection: It is indicated for use in combination with other antiretroviral agents (such as a Protease Inhibitor or a Non-Nucleoside Reverse Transcriptase Inhibitor) to reduce viral load and increase CD4 cell counts.

• Prevention of Mother-to-Child Transmission: Occasionally used in specific protocols to reduce the risk of neonatal HIV transmission.

• Post-Exposure Prophylaxis (PEP): Used as part of a regimen for individuals who have been potentially exposed to HIV.

Mechanism: The Double Chain Terminator

This FDC utilizes two different “false building blocks” to stop the virus from replicating:

Lamivudine (3TC): A synthetic nucleoside analogue of cytidine. Once inside the cell, it is phosphorylated into its active form, which competes with natural dCTP for incorporation into viral DNA.

Zidovudine (AZT): A thymidine analogue. It similarly competes with natural dTTP.

Reverse Transcriptase Inhibition: Both drugs act as “chain terminators.” When the HIV enzyme (Reverse Transcriptase) tries to build a DNA copy of its RNA, it accidentally picks up these drugs instead of natural building blocks. Because these drugs lack the necessary “hook” (3′-hydroxyl group) to attach the next piece, the DNA chain breaks, and the virus cannot replicate.

The Pharmacist’s “Technical Warning”

• Hematologic Toxicity: Zidovudine is notoriously associated with anemia (low red blood cells) and neutropenia (low white blood cells). Patients must have regular blood counts monitored.

• Lactic Acidosis: Both drugs carry a boxed warning for lactic acidosis and severe hepatomegaly with steatosis (fatty liver), which can be life-threatening.

• Hepatitis B Co-infection: If a patient has both HIV and HBV, stopping this medication abruptly can cause a severe “flare-up” of Hepatitis B, as Lamivudine also has activity against HBV.

The Manufacturer’s Perspective: Technical & Export

From a production and B2B standpoint at your facility in Mumbai:

• The “FDC” Strategy: On your multivendor marketplace, position this as a “Backbone Therapy.” Highlight that this FDC replaces two separate pills, which is a major selling point for international health NGOs and government procurement programs in Africa and SE Asia.

• Bioequivalence: To attract high-quality B2B buyers, emphasize your product’s bioequivalence to the innovator brand (Combivir).

• Stability & Packaging: Both molecules are sensitive to moisture. We utilize Alu-Alu blister packaging or HDPE bottles with induction sealing and desiccants to ensure a 36-month shelf life in Zone IVb tropical regions.

• Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international tenders and for bidding on Global Fund or PEPFAR-related projects.