Composition: Each film-coated tablet contains Nevirapine IP 200 mg.
Dosage form: Film-coated tablet
Usage: HIV-1 treatment in combination with other antiretroviral medicines; not stand-alone HIV prevention.
Category: HIV Anti Viral Drugs
Therapeutic category: Antiretroviral / Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)
SKU: Nevirapine Tablets
Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations
Nevirapine Tablets IP is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.
For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.
Manufacturer: Healthy Life Pharma Pvt. Ltd. (WHO-GMP status requires verification)
Exporter: Healthy Inc (Star Export House status requires verification)
Nevirapine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) used in combination antiretroviral therapy for HIV-1 infection. It suppresses viral replication but does not cure HIV. Its use depends on current treatment guidelines, viral resistance, individual safety risks and local regulatory approval.
The supplied formulation confirms Nevirapine IP 200 mg in each film-coated tablet. The product should not be described as an uncoated tablet. Nevirapine has historically been used in programs to prevent mother-to-child transmission, but older single-dose protocols are not equivalent to recommended contemporary maternal HIV treatment.
| Product name | Nevirapine Tablets |
|---|---|
| Composition | Nevirapine IP 200 mg per tablet |
| Confirmed strength | 200 mg |
| Dosage form | Film-coated tablet |
| Pharmacopoeial standard | IP (as supplied); USP/BP compliance not established |
| CAS number | 129618-40-2 (nevirapine) |
| Therapeutic class | Antiretroviral / NNRTI |
| SKU | Nevirapine Tablets |
| Shelf life and packaging | Confirm against approved stability studies and registered label |
Critical manufacturing considerations include raw-material identity, blend uniformity, coating quality, dissolution performance and stability. Claims regarding micronized API, particular granulation methods, tropical-zone stability, bottle sealing or desiccants must be supported by actual validated manufacturing and packaging records.
Testing should follow the applicable approved IP monograph and registered specification, including identity, assay, uniformity of dosage units, dissolution, related substances and stability where relevant. Numeric acceptance limits and a 36-month shelf life cannot be confirmed from the supplied formula alone.
Nevirapine binds to HIV-1 reverse transcriptase and inhibits conversion of viral RNA into DNA, reducing viral replication. It is used with other antiretrovirals in appropriately selected HIV-1 treatment regimens. It is not a vaccine, HIV cure, or stand-alone pre-exposure prophylaxis (PrEP). Regimens for pregnancy and prevention of vertical transmission must follow current specialist guidelines; historical single-dose regimens should not be promoted as standard care.
Confirm current marketing authorization, registered indications, prescribing restrictions and local treatment guidelines before export or promotion. CTD/ACTD dossiers, COA, FSC, COPP, WHO-GMP certification and Star Export House recognition should be advertised only when current supporting documentation is available.
Q: What is the confirmed tablet strength?
A: Nevirapine IP 200 mg in a film-coated tablet.
Q: Does it prevent someone from acquiring HIV?
A: No. This tablet is intended for selected HIV-1 combination treatment regimens, not stand-alone HIV prevention.
Q: Why is a lead-in phase sometimes used?
A: Immediate-release nevirapine treatment commonly uses a clinician-supervised lead-in to lower rash risk. Never begin or change treatment without specialist direction.
Q: What safety issues need monitoring?
A: Serious skin reactions and potentially life-threatening liver injury, particularly early in treatment.
Prescription use only, as part of an appropriate combination antiretroviral regimen. Immediate-release nevirapine regimens commonly involve an initial lead-in period, but the exact schedule, suitability and any dose escalation must be determined by an HIV clinician. Do not increase the dose if rash develops without clinical assessment. Restarting after interruption may require reassessment. The tablet may be taken with or without food according to the approved label. Do not discontinue or alter HIV therapy independently.
Serious skin reactions: Nevirapine may cause severe rash, Stevens–Johnson syndrome and toxic epidermal necrolysis. Rash with fever, blistering, mouth sores, facial swelling or systemic symptoms needs urgent medical attention.
Liver injury: Severe hepatitis and liver failure can occur, especially during the first 18 weeks; clinical assessment and liver-function monitoring are essential. Symptoms including jaundice, dark urine, nausea, abdominal pain or marked fatigue require prompt evaluation. Risk can be higher at treatment initiation in certain patients with higher CD4 counts, including women above 250 cells/mm³ and men above 400 cells/mm³; prescribing must consider the full clinical context.
Other concerns include drug interactions, immune reconstitution effects and treatment resistance if doses are missed. Review pregnancy, hepatitis coinfection and all concurrent medicines with a specialist.
Store in original packaging, protected from excessive moisture and heat, away from children. Follow the approved product label for the exact temperature range; do not assume a particular shelf life or bottle specification without validated documentation.