Composition: Lopinavir 200 mg + Ritonavir 50 mg per film-coated tablet
Dosage form: Film-coated tablet
Usage: HIV-1 treatment with other antiretroviral agents
Category: Antiretroviral / Anti-HIV medicines
Therapeutic category: Boosted HIV protease inhibitor
SKU: Lopinavir & Ritonavir Tablets
Categories: Contract Manufacturer, Formulations Exporter India, Manufacturing Pharmaceutical Company India, Pharmaceutical Exporter India, Pharmaceutical Formulations India, Tablets Manufacturer, WHO GMP Certified Formulations
Lopinavir and Ritonavir 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 (as supplied): Healthy Life Pharma Pvt. Ltd. Exporter (as supplied): Healthy Inc
Lopinavir and Ritonavir Tablets IP 200 mg/50 mg are a fixed-dose combination antiretroviral medicine used as part of combination therapy for HIV-1 infection. Lopinavir inhibits HIV protease; ritonavir increases lopinavir exposure by inhibiting its metabolism.
Healthy Life Pharma Pvt. Ltd. is identified in the supplied material as the manufacturer, with Healthy Inc as exporter. GMP certification, manufacturing-site details, market authorizations and export availability require independent documentary confirmation. Treatment selection depends on current local HIV guidelines, resistance history, patient factors and availability of preferred regimens.
| Product name | Lopinavir and Ritonavir Tablets IP |
|---|---|
| Active ingredients | Lopinavir 200 mg + Ritonavir 50 mg per tablet |
| Dosage form | Film-coated tablet |
| Standard stated in supplied composition | IP (Indian Pharmacopoeia) |
| Therapeutic class | Antiretroviral; boosted HIV protease inhibitor |
| Indication | HIV-1 treatment in combination with other antiretroviral medicines |
| CAS numbers | Lopinavir: 192725-17-0; Ritonavir: 155213-67-5 |
| Packaging and shelf life | To be confirmed against approved product specifications and stability data |
| SKU | Lopinavir & Ritonavir Tablets |
Lopinavir and ritonavir have formulation challenges related to solubility and consistent drug exposure. Heat-stable tablet technologies, including solid-dispersion approaches, are used in some approved products. The specific use of hot-melt extrusion, coating materials, polymorph controls, desiccants and packaging for this manufacturer must be verified from batch records and registered product documentation.
Manufacturing controls should address blend uniformity, dissolution, impurities, packaging integrity and validated stability. A claim that the product needs no refrigeration must be supported by its approved labeling.
Appropriate quality tests include identification and assay of both active ingredients, content uniformity, dissolution, related substances, microbiological quality where applicable, packaging integrity and stability under the registered conditions. Acceptance limits must follow the applicable approved monograph and registered specifications.
Bioequivalence, WHO-GMP status, release specifications and shelf-life claims should not be presented as established without supporting certificates and studies.
Mechanism: Lopinavir inhibits HIV-1 protease, interfering with viral polyprotein processing and formation of infectious virions. Ritonavir inhibits CYP3A-mediated metabolism, boosting lopinavir concentrations.
Clinical use: HIV-1 infection, always in combination with other antiretroviral agents. Lopinavir/ritonavir is not a cure for HIV. It is not a routine preferred first-line regimen in many current treatment guidelines, and it should not be advertised as standard post-exposure prophylaxis (PEP).
B2B supply and registration may require a CTD/ACTD dossier, manufacturing license, certificate of analysis, stability data, labeling, GMP evidence and import approvals. COPP, FSC, bioequivalence reports and other regulatory documents are available only if actually issued for the relevant product and market.
Importation and use depend on the destination country’s HIV-treatment guidance, procurement requirements and marketing authorization.
Q: What is the strength per tablet?
A: Each film-coated tablet contains lopinavir 200 mg and ritonavir 50 mg.
Q: Can it be used alone to treat HIV?
A: No. It is prescribed with other antiretroviral medicines as part of a complete HIV regimen.
Q: Is it equivalent to Kaletra?
A: Kaletra is a reference brand for this active-ingredient combination. Pharmaceutical or therapeutic equivalence of a specific generic product must be established through applicable regulatory approvals and evidence; it cannot be assumed from composition alone.
Q: Does it need refrigeration?
A: Some approved film-coated tablet formulations are stored at controlled room temperature; follow the exact approved product label rather than assuming identical storage requirements for all products.
For certain adult treatment regimens, a labeled dose is lopinavir 400 mg/ritonavir 100 mg twice daily (two 200 mg/50 mg tablets per dose). Other dosing schedules may apply depending on age, previous treatment, resistance, pregnancy, co-medications and local labeling. Some drug combinations require different dosing or should not be used together.
Film-coated tablets should be swallowed whole, not chewed, broken or crushed. They may be taken with or without food when permitted by the product label. Pediatric dosing is weight- or body-surface-area-based and requires specialist guidance. Never change antiretroviral therapy without the HIV care team.
Common effects: Diarrhea, nausea, vomiting and changes in blood lipids. Important risks: hepatotoxicity, pancreatitis, QT/PR interval changes, hyperglycemia, lipid abnormalities and clinically significant drug interactions.
Ritonavir is a strong CYP3A inhibitor; interactions with certain antiarrhythmics, sedatives, statins, anticonvulsants, anticoagulants and other medicines can be serious or contraindicated. Review a complete medication list, including herbal products, with a clinician or pharmacist. Monitoring may include liver tests, lipid profile, glucose and treatment response.
Store in the original packaging according to the approved product label, protected from excessive heat and moisture, and keep the container tightly closed. A temperature limit such as below 30°C should be used only if verified for the actual marketed formulation. Keep out of reach of children.