Export: +91 9820402906   Domestic: +91 7710003340 | HR: +91 9137757219
Lamivudine Tablets product packshot

Lamivudine Tablets

Composition: Lamivudine IP 100 mg or 150 mg; Cirolam 150 contains Lamivudine USP 150 mg.

Additional combination products: Lamuzy (Lamivudine 150 mg + Zidovudine 300 mg); Lamivudine 150 mg + Zidovudine 300 mg + Nevirapine 200 mg.

Usage: HIV-1 combination therapy; chronic hepatitis B in appropriate approved formulations.

Category: HIV antiviral drugs

Therapeutic category: Antiviral / NRTI / Hepatitis B therapy

SKU: Lamivudine Tablets

Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations

Product Information

Lamivudine Tablets 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.

Description

Lamivudine Tablets — Product and Clinical Information

Manufacturer (as supplied): Healthy Life Pharma Pvt. Ltd.   Exporter (as supplied): Healthy Inc

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is presented as the manufacturer of Lamivudine tablets, with Healthy Inc as exporter. Lamivudine (3TC) is a nucleoside reverse transcriptase inhibitor (NRTI) used in combination antiretroviral therapy for HIV-1 infection and, in appropriate 100 mg formulations, in chronic hepatitis B management.

Different strengths and fixed-dose combinations must be prescribed, labelled, and registered separately. The 100 mg HBV formulation is not interchangeable with HIV-strength products without clinical assessment. Company certifications and product registrations should be verified against current documentation.

2. Product Specifications

Generic: Lamivudine   |   CAS: 134678-17-4   |   Dosage form: Film-coated tablets   |   Class: Antiviral / NRTI

ProductComposition per tabletFormNotes
Lamivudine Tablets IP100 mgFilm-coatedSingle-ingredient; HBV formulation, subject to approved label
Lamivudine Tablets IP150 mgFilm-coatedSingle-ingredient; HIV combination therapy
Cirolam 150 Tablets (USP)150 mgFilm-coatedSingle-ingredient branded formulation
Lamuzy Tablets (IP)Lamivudine 150 mg + Zidovudine 300 mgFilm-coatedSeparate fixed-dose combination for HIV
Lamivudine / Zidovudine / Nevirapine (IP)150 mg + 300 mg + 200 mgFilm-coatedSeparate triple-drug HIV combination

Note: 300 mg Lamivudine single-ingredient tablets appear in the submitted narrative but not in the supplied product compositions; availability requires confirmation. Shelf life, packaging and pharmacopoeial compliance must follow each approved specification.

3. Manufacturing Technology

Manufacturing controls for antiretroviral tablets may include validated blending, compression, film coating, segregation, cleaning validation and suitable moisture-protective packaging. Specific claims of dedicated suites, direct compression, production capacity or three-year stability require supporting facility and product records.

Contract manufacturing and export options are subject to the destination country’s authorization, tender requirements and confirmed production capabilities.

4. Quality Assurance

Relevant tests include identity, assay, uniformity of dosage units, dissolution, related substances, microbial quality where applicable, and stability testing. Acceptance limits are defined by the applicable validated methods and approved pharmacopoeial or product specifications; a universal 90–110% assay limit should not be assumed.

Bioequivalence is a separate regulatory requirement where applicable and cannot be inferred from dissolution testing alone.

5. Pharmacology and Clinical Use

Lamivudine is phosphorylated intracellularly to its active triphosphate metabolite, which inhibits viral reverse transcriptase and causes termination of viral DNA synthesis. It is used as part of a combination regimen for HIV-1 infection. Lamivudine 100 mg may be used for chronic hepatitis B in appropriate patients and jurisdictions, although resistance considerations and modern treatment guidelines influence drug selection.

Important: Lamivudine must not be used as the sole drug for HIV treatment. Patients with HIV/HBV co-infection need a regimen active against both viruses under specialist guidance.

6. Export and Regulatory Support

Potential export documentation includes a certificate of analysis, applicable GMP evidence, product registration dossiers, stability data and certificates issued by the relevant authorities where available. CTD/ACTD files, COPP, free-sale certificates and bioequivalence reports must be confirmed product by product before promising them to buyers.

For wholesale or contract manufacturing enquiries, contact Healthy Life Pharma / Healthy Inc through the enquiry form.

7. Frequently Asked Questions

Q: Are 100 mg and 150 mg Lamivudine tablets interchangeable?
A: No. They may have different approved indications and dosing instructions; use the specific prescribed product.

Q: Is Lamuzy the same as plain Lamivudine?
A: No. Lamuzy contains both Lamivudine 150 mg and Zidovudine 300 mg.

Q: Is the triple combination a plain Lamivudine tablet?
A: No. It additionally contains Zidovudine and Nevirapine, with distinct risks and clinical requirements.

Q: Can Lamivudine alone treat HIV?
A: No. HIV requires an effective combination antiretroviral regimen.

8. Dosage and Administration

For HIV-1, adult Lamivudine regimens commonly use a total of 300 mg daily, as prescribed with other antiretrovirals. For hepatitis B, certain adult formulations use 100 mg once daily, but choice and dosing depend on the approved indication, co-infections and kidney function. These regimens are not interchangeable.

Renal impairment may require dose adjustment; fixed-dose combination tablets may be unsuitable when individual dose adjustment is needed. Follow the approved local label and specialist advice. Do not stop or change therapy without medical supervision.

9. Side Effects and Precautions

Reported adverse effects include nausea, headache and fatigue. Important warnings include lactic acidosis, severe hepatomegaly with steatosis, pancreatitis in some patients and severe hepatitis B exacerbation after stopping Lamivudine in HBV-infected patients. Kidney function, liver disease and HIV/HBV co-infection should be assessed before treatment.

Combination products have additional risks: Zidovudine may cause anemia and neutropenia, while Nevirapine may cause serious liver toxicity and severe skin reactions. Product-specific prescribing information is essential.

10. Storage Instructions

Store in the original, tightly closed packaging according to the approved product label; protect from excessive moisture and heat. The precise temperature limit and shelf life must be confirmed for each registered product. Keep out of reach of children.

Medical and regulatory disclaimer: This page is general product information, not a prescription or proof of regulatory approval, WHO-GMP status, product bioequivalence, or market authorization. Treatment must follow the current approved label and qualified clinician's advice. Verify all manufacturing and export claims before publication.