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Lamivudine | CAS No: 134678-17-4 | GMP-certified suppliers
A medication that supports effective management of HIV infection and chronic hepatitis B, offering reliable antiviral coverage for diverse treatment strategies across key global markets.
Therapeutic categories
Agents Causing Muscle ToxicityAnti-HIV AgentsAnti-Infective AgentsAnti-Retroviral AgentsAntiinfectives for Systemic UseAntiviral Agents
Generic name
Lamivudine
Molecule type
small molecule
CAS number
134678-17-4
DrugBank ID
DB00709
Approval status
Approved drug, Investigational drug
ATC code
J05AR27
Primary indications
- For the treatment of HIV infection and chronic hepatitis B (HBV)
Product Snapshot
- Lamivudine is an oral small‑molecule API supplied in multiple tablet and solution presentations
- It is used in antiviral formulations for HIV infection and chronic hepatitis B
- It holds approved status in the US, EU, and Canada, with some investigational listings in certain markets
Clinical Overview
Lamivudine (CAS 134678-17-4) is a synthetic nucleoside analogue classified among 3'-thia pyrimidine nucleosides. It is structurally related to deoxycytidine and incorporates a sulfur atom at the 3' position of the pentose ring. Lamivudine is indicated for the treatment of HIV-1 infection and chronic hepatitis B virus infection. Its clinical use spans adult and pediatric populations and includes combination antiretroviral regimens for HIV and monotherapy or combination therapy for HBV, depending on regional guidance.
Lamivudine exhibits pharmacologic activity as a nucleoside reverse transcriptase inhibitor. After intracellular uptake, it undergoes sequential phosphorylation to its active metabolite, lamivudine triphosphate. This metabolite competes with natural deoxycytidine triphosphate for incorporation into viral DNA by HIV reverse transcriptase and HBV DNA polymerase. Because lamivudine lacks a 3'-hydroxyl group, its incorporation results in chain termination and interruption of viral DNA replication.
Absorption following oral dosing is rapid, with high bioavailability. The compound displays low plasma protein binding and distributes into extracellular fluids. Lamivudine is not extensively metabolized and is eliminated primarily unchanged through renal excretion via glomerular filtration and active tubular secretion, involving transporters such as OAT1 and OCT2. Dose adjustments are required in renal impairment to mitigate drug accumulation.
Lamivudine is generally well tolerated, though mitochondrial toxicity is a class consideration for nucleoside analogues. Reported safety concerns include potential exacerbation of hepatitis after discontinuation in HBV-infected individuals and rare instances of lactic acidosis with hepatic steatosis. Drug interactions are mainly related to transporter-mediated competition rather than extensive metabolic pathways.
Lamivudine is widely incorporated into fixed-dose antiretroviral combinations used globally. For API procurement, quality considerations include controlling stereochemical purity, impurity profiles consistent with ICH guidance, and verification of compliance with pharmacopeial specifications to support reliable formulation performance and regulatory acceptance.
Lamivudine exhibits pharmacologic activity as a nucleoside reverse transcriptase inhibitor. After intracellular uptake, it undergoes sequential phosphorylation to its active metabolite, lamivudine triphosphate. This metabolite competes with natural deoxycytidine triphosphate for incorporation into viral DNA by HIV reverse transcriptase and HBV DNA polymerase. Because lamivudine lacks a 3'-hydroxyl group, its incorporation results in chain termination and interruption of viral DNA replication.
Absorption following oral dosing is rapid, with high bioavailability. The compound displays low plasma protein binding and distributes into extracellular fluids. Lamivudine is not extensively metabolized and is eliminated primarily unchanged through renal excretion via glomerular filtration and active tubular secretion, involving transporters such as OAT1 and OCT2. Dose adjustments are required in renal impairment to mitigate drug accumulation.
Lamivudine is generally well tolerated, though mitochondrial toxicity is a class consideration for nucleoside analogues. Reported safety concerns include potential exacerbation of hepatitis after discontinuation in HBV-infected individuals and rare instances of lactic acidosis with hepatic steatosis. Drug interactions are mainly related to transporter-mediated competition rather than extensive metabolic pathways.
Lamivudine is widely incorporated into fixed-dose antiretroviral combinations used globally. For API procurement, quality considerations include controlling stereochemical purity, impurity profiles consistent with ICH guidance, and verification of compliance with pharmacopeial specifications to support reliable formulation performance and regulatory acceptance.
Identification & chemistry
| Generic name | Lamivudine |
|---|---|
| Molecule type | Small molecule |
| CAS | 134678-17-4 |
| UNII | 2T8Q726O95 |
| DrugBank ID | DB00709 |
Pharmacology
| Summary | Lamivudine is a nucleoside reverse transcriptase inhibitor that targets HIV‑1 reverse transcriptase and HBV polymerase to disrupt viral DNA synthesis. After intracellular phosphorylation to lamivudine triphosphate, it competes with natural nucleosides for incorporation into viral DNA and induces chain termination. Its antiviral activity arises from inhibition of nucleic acid elongation in HIV and HBV. |
|---|---|
| Mechanism of action | Lamivudine is a synthetic nucleoside analogue and is phosphorylated intracellularly to its active 5'-triphosphate metabolite, lamivudine triphosphate (L-TP). This nucleoside analogue is incorporated into viral DNA by HIV reverse transcriptase and HBV polymerase, resulting in DNA chain termination. |
| Pharmacodynamics | Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1) and hepatitis B (HBV) to disrupt viral DNA synthesis. When phosphorylated, lamivudine can form active metabolites that compete for incorporation into viral DNA. Via DNA incorporation, lamivudine metabolites competitively inhibit the activity of the HIV reverse transcriptase enzyme and act as a chain terminator of DNA synthesis. Due to the lack of a 3'-OH group, incorporated nucleoside analogues prevent the formation of a 5' to 3' phosphodiester linkage that is essential for DNA chain elongation. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Reverse transcriptase/RNaseH | Human immunodeficiency virus 1 | inhibitor |
| DNA | Humans | binder |
| Protein P | HBV-F | inhibitor |
ADME / PK
| Absorption | Lamivudine was rapidly absorbed after oral administration in HIV-infected patients. Absolute bioavailability in 12 adult patients was 86% ± 16% (mean ± SD) for the 150-mg tablet and 87% ± 13% for the oral solution. The peak serum lamivudine concentration (Cmax) was 1.5 ± 0.5 mcg/mL when an oral dose of 2 mg/kg twice a day was given to HIV-1 patients. When given with food, absorption is slower, compared to the fasted state. |
|---|---|
| Half-life | 5 to 7 hours (healthy or HBV-infected patients) |
| Protein binding | <36% bound to plasma protein. |
| Metabolism | Metabolism of lamivudine is a minor route of elimination. In man, the only known metabolite of lamivudine is the trans-sulfoxide metabolite. This biotransformation is catalyzed by sulfotransferases. |
| Route of elimination | The majority of lamivudine is eliminated unchanged in urine by active organic cationic secretion. 5.2% ± 1.4% (mean ± SD) of the dose was excreted as the trans-sulfoxide metabolite in the urine. Lamivudine is excreted in human breast milk and into the milk of lactating rats. |
| Volume of distribution | Apparent volume of distribution, IV administration = 1.3 ± 0.4 L/kg. Volume of distribution was independent of dose and did not correlate with body weight. |
| Clearance | * Renal clearance = 199.7 ± 56.9 mL/min [300 mg oral dose, healthy subjects] * Renal clearance = 280.4 ± 75.2 mL/min [single IV dose, HIV-1-infected patients] * Total clearance = 398.5 ± 69.1 mL/min [HIV-1-infected patients] |
Formulation & handling
- Lamivudine is a small‑molecule, highly water‑soluble nucleoside analogue suitable for conventional oral solid and liquid formulations.
- Solution and syrup forms are straightforward to prepare due to good aqueous solubility, with no special pH‑dependent solubility constraints.
- Food has minimal impact on exposure, so formulations do not require food‑specific release or timing considerations.
Regulatory status
| Lifecycle | The API shows a mature market position in Canada and the EU, where key patents have long expired, while U.S. exclusivity extends into 2030 due to a later‑expiring patent. Overall, the product is largely in a post‑exclusivity phase outside the United States, with remaining protection shaping its U.S. lifecycle. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Lamivudine is produced by a small number of originator companies, with ViiV Healthcare and GlaxoSmithKline responsible for primary API and branded product development, while a wide network of repackagers supports downstream distribution in North America. Branded products are established in the US, EU, and Canada, indicating broad global availability. Most core substance patents have expired, and although one later‑expiring U.S. patent remains, the overall landscape supports existing and widespread generic competition. |
|---|
Safety
| Toxicity | The most common reported adverse reactions (incidence ≥15%) in adults were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough. |
|---|
High Level Warnings:
- Occupational exposure may pose risks of CNS and gastrointestinal effects, including headache, nausea, malaise, fatigue, diarrhea, and respiratory irritation
- Bulk‑powder handling should minimize inhalation or dermal contact due to reported nasal signs/symptoms and cough associated with exposure
- Implement appropriate containment and ventilation controls for materials with systemic tolerability profiles involving multiple organ systems
Lamivudine is a type of Anti-HIV
The Anti-HIV category of pharmaceutical APIs comprises a range of active pharmaceutical ingredients (APIs) specifically designed to combat the human immunodeficiency virus (HIV). These APIs play a critical role in the development and production of antiretroviral drugs, which are used to treat HIV infections and prevent the progression to acquired immunodeficiency syndrome (AIDS).
Anti-HIV APIs work by targeting various stages of the HIV life cycle, inhibiting viral replication and reducing the viral load in the body. Some commonly used APIs in this category include nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), and integrase inhibitors (INIs).
NRTIs, such as tenofovir and emtricitabine, act by blocking the reverse transcriptase enzyme, an essential component in the replication of the virus. NNRTIs, such as efavirenz and nevirapine, bind to the reverse transcriptase enzyme, preventing its proper functioning. PIs, like ritonavir and atazanavir, inhibit the protease enzyme, crucial for viral maturation and assembly. INIs, such as raltegravir and dolutegravir, target the integrase enzyme, impeding viral integration into the host's DNA.
These APIs are carefully synthesized and undergo rigorous quality testing to ensure their safety, efficacy, and compliance with regulatory standards. Pharmaceutical companies utilize these APIs as key building blocks to formulate antiretroviral medications, which are then prescribed to individuals living with HIV/AIDS worldwide.
Overall, the Anti-HIV API category plays a vital role in the ongoing battle against HIV/AIDS, offering effective treatment options and improved quality of life for patients affected by this challenging condition.
Lamivudine API manufacturers & distributors
Compare qualified Lamivudine API suppliers worldwide. We currently have 22 companies offering Lamivudine API, with manufacturing taking place in 5 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Anhui Biochem United Phar... | Producer | China | China | CoA, GMP, USDMF, WHO-GMP | 6 products |
| Arch Pharmalabs | Producer | India | Unknown | CEP, CoA, FDA, GMP | 19 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| Cipla | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 164 products |
| Hangzhou Coben Pharmaceut... | Producer | China | China | CoA, GMP, ISO9001 | 7 products |
| Hetero Drugs | Producer | India | India | CoA, GMP, WC | 98 products |
| Hetero Labs | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 90 products |
| Laurus Labs | Producer | India | India | CEP, CoA, GMP, JDMF, USDMF, WC | 50 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CoA, GMP, USDMF, WC | 155 products |
| Mylan | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 201 products |
| Pen Tsao Chemical Industr... | Producer | Germany | China | CoA | 18 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shandong Zhanhua Yonghao | Producer | China | China | CoA | 10 products |
| Shanghai Acebright | Producer | China | China | CoA | 23 products |
| Shanghai Desano Chem. | Producer | China | China | CEP, CoA, FDA, USDMF | 22 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Shijiazhuang Lonzeal | Producer | China | China | CoA, USDMF | 1 products |
| Signa | Producer | Mexico | Mexico | CoA, USDMF | 42 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Sun Pharma | Producer | India | India | CoA, GMP, WC | 219 products |
| Wisdom Pharma | Producer | China | China | CoA, USDMF | 12 products |
When sending a request, specify which Lamivudine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Lamivudine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Lamivudine API
Sourcing
What matters most when sourcing GMP-grade Lamivudine?
Key considerations include verifying compliance with GMP requirements recognized in the US, EU, and Canada and confirming that the manufacturer maintains appropriate regulatory documentation. Given limited originator production and broad generic participation, it is important to assess supplier qualification, traceability, and consistency of quality systems. Patent status generally permits generic sourcing, but attention to the remaining later‑expiring U.S. patent is needed for products intended for that market. Reliable supply chain controls are essential due to the mix of originator manufacturers and multiple repackagers.
Which documents are typically required when sourcing Lamivudine API?
Request the core API documentation set: CoA (22 companies), GMP (14 companies), USDMF (13 companies), CEP (8 companies), FDA (7 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Lamivudine API?
Known or reported manufacturers for Lamivudine: SETV Global, Sinoway industrial Co.,Ltd, Arshine Pharmaceutical Co., Limited, LGM Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Lamivudine API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Lamivudine manufacturers?
Audit reports may be requested for Lamivudine: 8 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Lamivudine API on Pharmaoffer?
Reported supplier count for Lamivudine: 22 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Lamivudine API?
Production countries reported for Lamivudine: China (11 producers), India (8 producers), Mexico (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Lamivudine usually hold?
Common certifications for Lamivudine suppliers: CoA (22 companies), GMP (14 companies), USDMF (13 companies), CEP (8 companies), FDA (7 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Lamivudine (CAS 134678-17-4) used for?
Lamivudine is used to treat HIV‑1 infection and chronic hepatitis B virus infection. It acts as a nucleoside reverse transcriptase inhibitor, and its triphosphate metabolite terminates viral DNA synthesis. In HIV therapy it is given as part of combination antiretroviral regimens, while for HBV it may be used as monotherapy or in combination according to regional treatment guidance.
Which therapeutic class does Lamivudine fall into?
Lamivudine belongs to the following therapeutic categories: Agents Causing Muscle Toxicity, Anti-HIV Agents, Anti-Infective Agents, Anti-Retroviral Agents, Antiinfectives for Systemic Use. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Lamivudine mainly prescribed for?
The primary indications for Lamivudine: For the treatment of HIV infection and chronic hepatitis B (HBV). These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Lamivudine work?
Lamivudine is a synthetic nucleoside analogue and is phosphorylated intracellularly to its active 5'-triphosphate metabolite, Lamivudine triphosphate (L-TP). This nucleoside analogue is incorporated into viral DNA by HIV reverse transcriptase and HBV polymerase, resulting in DNA chain termination.
What should someone know about the safety or toxicity profile of Lamivudine?
Lamivudine is generally well tolerated, but nucleoside analogues can cause mitochondrial toxicity, with rare reports of lactic acidosis and hepatic steatosis. Discontinuation in HBV‑infected individuals may lead to hepatitis exacerbation and requires clinical monitoring. Occupational exposure to the API may cause CNS and gastrointestinal symptoms or respiratory irritation, so containment and ventilation controls are recommended to limit inhalation or dermal contact. Drug‑interaction concerns mainly involve transporter‑mediated competition affecting renal elimination.
What are important formulation and handling considerations for Lamivudine as an API?
Lamivudine’s high aqueous solubility supports straightforward development of oral tablets, solutions, and syrups without pH‑dependent solubility adjustments. Its chemical stability and minimal metabolism reduce the need for specialized release‑controlling excipients. Because food slows absorption but does not meaningfully affect overall exposure, formulations do not require food‑dependent design. Routine handling focuses on maintaining standard conditions that preserve API integrity in solid and liquid forms.
Is Lamivudine a small molecule?
Lamivudine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Lamivudine?
Lamivudine is highly water‑soluble and generally stable in conventional oral solid and liquid formulations. Its solutions and syrups are straightforward to prepare, and no special pH‑dependent solubility or food‑related considerations affect stability. No additional formulation‑specific stability concerns are noted in the provided context.
Regulatory
Where is Lamivudine approved or in use globally?
Lamivudine is reported as approved in the following major regions: Canada, US, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Lamivudine right now?
Lamivudine is regulated and approved for use in Canada, the United States, and the European Union. Its patent landscape depends on the specific formulation and jurisdiction, as multiple products containing Lamivudine have followed standard patent expiration and generic entry pathways in these regions.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Lamivudine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Lamivudine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Lamivudine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Lamivudine: 1687 verified transactions across 362 suppliers and 191 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Lamivudine?
Market report availability for Lamivudine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
