At your WHO-GMP facility in Mumbai, you likely manufacture this as a fixed-dose combination (FDC) tablet containing 150 mg Lamivudine and 300 mg Zidovudine.

Primary Clinical Indications

• HIV-1 Treatment: Used in combination with at least one other antiretroviral agent to slow the progression of HIV, reduce viral load, and increase CD4 cell counts.

• Post-Exposure Prophylaxis (PEP): It can be used as part of a regimen to prevent HIV infection after potential exposure (e.g., a needle-stick injury or unprotected contact), ideally started within 72 hours.

Mechanism: Dual Reverse Transcriptase Inhibition

Both drugs are Nucleoside Reverse Transcriptase Inhibitors (NRTIs).

Phosphorylation: Once inside human cells, both drugs are converted by host enzymes into their active triphosphate forms.

Competitive Inhibition: They compete with natural nucleotides to bind to the HIV reverse transcriptase enzyme.

DNA Chain Termination: Once incorporated into the growing viral DNA chain, they lack the necessary chemical group (3′-OH) to allow further links. This acts as a “stop sign,” terminating the DNA chain and preventing the virus from replicating.

The Pharmacist’s “Technical Warning”

As you promote your firm on digital platforms, providing these technical nuances is essential for professional authority:

• Hematologic Toxicity: Zidovudine is specifically associated with anemia (low red blood cells) and neutropenia (low white blood cells). Frequent blood counts are recommended for patients with advanced disease.

• Lactic Acidosis: Both drugs carry a rare but serious risk of lactic acid buildup in the blood and severe liver enlargement (hepatomegaly), especially in patients who are female or obese.

• Hepatitis B Co-infection: If a patient has both HIV and HBV, stopping the medication can cause a severe “flare-up” of hepatitis because lamivudine also treats HBV.

• Myopathy: Prolonged use of zidovudine has been linked to muscle weakness and pain (myopathy).

The Manufacturer’s Perspective: Technical & Export

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

• The “FDC” Strategy: On your marketplace, highlight that this Fixed-Dose Combination reduces “pill burden,” which is the single most important factor for long-term patient compliance in HIV care.

• Stability & Packaging: Both molecules are sensitive to high humidity and light. Utilizing Alu-Alu blister packaging ensures a 36-month shelf life, vital for export to Zone IVb tropical regions in Africa and SE Asia.

• Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international health tenders and for bidding on PEPFAR or WHO pre-qualification programs.