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Famciclovir | CAS No: 104227-87-4 | GMP-certified suppliers
A medication that treats acute shingles and helps manage recurrent genital and mucocutaneous herpes infections, supporting consistent antiviral treatment requirements across key markets.
Therapeutic categories
Primary indications
- For the treatment of acute herpes zoster (shingles)
- Also for the treatment or suppression of recurrent genital herpes in immunocompetent patients and treatment of recurrent mucocutaneous herpes simplex infections in HIV infected patients
Product Snapshot
- Famciclovir is an oral small‑molecule antiviral supplied as coated and film‑coated tablets
- It is used for acute herpes zoster and for management or suppression of recurrent genital and mucocutaneous herpes infections in defined patient populations
- It is approved in the US and Canada, with additional investigational status noted in some references
Clinical Overview
Famciclovir functions as a prodrug of penciclovir, providing enhanced oral bioavailability relative to the active nucleoside analogue. Following absorption, famciclovir undergoes rapid presystemic and hepatic conversion to penciclovir, which is then phosphorylated in infected cells. Viral thymidine kinase produces the monophosphate intermediate, and host kinases subsequently generate penciclovir triphosphate. This active metabolite competitively inhibits viral DNA polymerase with respect to deoxyguanosine triphosphate, resulting in selective suppression of HSV-1, HSV-2, and VZV DNA synthesis.
Absorption of famciclovir is high, with conversion to penciclovir yielding measurable systemic concentrations. Penciclovir triphosphate demonstrates prolonged intracellular retention in infected cells, supporting sustained antiviral activity. Systemic penciclovir is eliminated largely via renal excretion, and dose adjustments are typically required in renal impairment to avoid accumulation.
Famciclovir is generally well tolerated, with common adverse effects including headache, gastrointestinal discomfort, and fatigue. Renal dysfunction increases systemic exposure, and caution is advised in patients with significant renal impairment. No clinically relevant effects on host DNA polymerases have been demonstrated at therapeutic concentrations, supporting its specificity for viral enzymes.
When sourcing famciclovir API, procurement teams should verify compliance with pharmacopeial specifications, validated impurity controls, and robust stability data. Consistent quality of the prodrug and control of conversion-related impurities are important for reliable downstream formulation and regulatory submission.
Identification & chemistry
| Generic name | Famciclovir |
|---|---|
| Molecule type | Small molecule |
| CAS | 104227-87-4 |
| UNII | QIC03ANI02 |
| DrugBank ID | DB00426 |
Pharmacology
| Summary | Famciclovir is a prodrug converted to penciclovir, an antiviral nucleoside analog that targets herpesvirus-infected cells. Penciclovir is phosphorylated to its active triphosphate form, which competitively inhibits the viral DNA polymerase catalytic subunit. This selective inhibition suppresses DNA synthesis and replication of HSV‑1, HSV‑2, and VZV. |
|---|---|
| Mechanism of action | Famciclovir undergoes rapid biotransformation to the active antiviral compound penciclovir, which has inhibitory activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2) and varicella zoster virus (VZV). In cells infected with HSV-1, HSV-2 or VZV, viral thymidine kinase phosphorylates penciclovir to a monophosphate form that, in turn, is converted to penciclovir triphosphate by cellular kinases. In vitro studies demonstrate that penciclovir triphosphate inhibits HSV-2 DNA polymerase competitively with deoxyguanosine triphosphate. Consequently, herpes viral DNA synthesis and, therefore, replication are selectively inhibited. |
| Pharmacodynamics | Famciclovir is a prodrug that undergoes rapid biotransformation to the active antiviral compound penciclovir. Penciclovir is an anti-viral drug which has inhibitory activity against herpes simplex virus types 1 (HSV-1) and 2 (HSV-2) and varicella zoster virus (VZV). Therefore, herpes viral DNA synthesis and replication are selectively inhibited. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA polymerase catalytic subunit | HHV-1 | inhibitor |
ADME / PK
| Absorption | 77 % |
|---|---|
| Half-life | 10 hours |
| Protein binding | 20-25% |
| Metabolism | Hepatic |
| Route of elimination | Active tubular secretion contributes to the renal elimination of penciclovir. |
| Volume of distribution | * 1.08±0.17 L/kg [healthy male subjects following a single intravenous dose of penciclovir at 400 mg administered as a 1-hour intravenous infusion] |
| Clearance | * 36.6 +/- 6.3 L/hr [healthy male] * 0.48 +/- 0.09 L/hr/kg [healthy male] |
Formulation & handling
- Famciclovir is an oral small‑molecule prodrug with adequate aqueous solubility, supporting conventional tablet formulations without specialized delivery systems.
- Food has minimal impact on absorption, allowing flexible administration and reducing the need for food‑dependent formulation strategies.
- As a purine nucleoside analogue, it is chemically stable in solid form, with standard moisture control sufficient for storage and handling.
Regulatory status
| Lifecycle | Most core U.S. and Canadian patents expired between 2010 and 2016, indicating that the API is well past its primary exclusivity period. With products marketed in both Canada and the United States, the API is in a mature, fully generic market phase. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Famciclovir’s supply landscape includes a small number of originator-linked manufacturers, with additional production and repackaging handled by multiple generic-focused entities. Branded and generic products are established in the US and Canada, indicating mature market availability. All listed US and Canadian patents have expired, consistent with the presence of existing generic competition. |
|---|
Safety
| Toxicity | Symptoms of overdose include constipation, diarrhea, dizziness, fatigue, fever, headache, nausea, and vomiting. |
|---|
- Overexposure may elicit gastrointestinal and neurological disturbances, including constipation or diarrhea, nausea, vomiting, dizziness, headache, and fatigue
- Monitor for febrile responses during material handling, as fever has been noted in overdose contexts
- Implement controls to limit inadvertent ingestion or high-dose exposure due to the compound’s systemic adverse‑effect profile
Famciclovir is a type of Antivirals
Antivirals are a crucial subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a pivotal role in combating viral infections. These specialized compounds are designed to inhibit the growth and replication of viruses within the human body.
Antivirals target various stages of the viral life cycle, including viral attachment, entry, and replication. They can interfere with viral enzymes, block viral receptors, or disrupt viral protein synthesis. By doing so, antivirals effectively suppress the viral infection, reduce symptoms, and improve patient outcomes.
The development of antiviral APIs requires extensive research and scientific expertise. Pharmaceutical companies employ cutting-edge technologies to identify potential antiviral compounds, screen their efficacy, and optimize their therapeutic properties. The most promising candidates undergo rigorous testing in preclinical and clinical trials to ensure their safety and effectiveness.
Antivirals have proven to be indispensable in the management of various viral infections, such as influenza, HIV, hepatitis B and C, herpes, and respiratory syncytial virus (RSV). They not only provide symptomatic relief but also prevent viral transmission and reduce the risk of complications.
With the ongoing global concern over emerging viral diseases and the impact of pandemics, the demand for effective antiviral therapies continues to rise. Pharmaceutical companies and researchers are actively exploring new avenues, such as broad-spectrum antivirals and novel drug delivery systems, to enhance the antiviral arsenal.
In conclusion, antiviral APIs are vital components of the pharmaceutical industry, offering hope in the fight against viral infections. Through continuous innovation and research, these substances contribute to improving public health by mitigating the impact of viral diseases.
Famciclovir (Antivirals), classified under Anti-infective Agents
Anti-infective agents are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various infectious diseases. These agents play a crucial role in combating bacterial, viral, fungal, and parasitic infections. The demand for effective anti-infective APIs has grown significantly due to the increasing prevalence of drug-resistant microorganisms.
Anti-infective APIs encompass a wide range of substances, including antibiotics, antivirals, antifungals, and antiparasitics. Antibiotics are particularly important in fighting bacterial infections and are further categorized into different classes based on their mode of action and target bacteria. Antivirals are designed to inhibit viral replication and are essential in the treatment of viral infections such as influenza and HIV. Antifungals combat fungal infections, while antiparasitics are used to eliminate parasites that cause diseases like malaria and helminthiasis.
The development and production of high-quality anti-infective APIs require stringent manufacturing processes and adherence to regulatory standards. Pharmaceutical companies invest heavily in research and development to discover new and more effective anti-infective agents. Additionally, ensuring the safety, efficacy, and stability of these APIs is of utmost importance.
The global market for anti-infective APIs is driven by factors such as the rising incidence of infectious diseases, the emergence of new and drug-resistant pathogens, and the growing demand for improved healthcare infrastructure. Continuous advancements in pharmaceutical technology and the development of innovative drug delivery systems further contribute to the expansion of this market.
In conclusion, anti-infective agents are a critical category of pharmaceutical APIs that play a pivotal role in treating infectious diseases. Their effectiveness in combating various types of infections makes them essential components in the arsenal of modern medicine.
Famciclovir API manufacturers & distributors
Compare qualified Famciclovir API suppliers worldwide. We currently have 7 companies offering Famciclovir API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, WC | 250 products |
| Cipla | Producer | India | India | CoA, GMP, USDMF, WC | 164 products |
| Hetero Drugs | Producer | India | India | CoA, GMP, JDMF, USDMF, WC | 98 products |
| Inist St Co. | Producer | South Korea | South Korea | CoA, JDMF | 8 products |
| Kolon Life Science | Producer | South Korea | South Korea | CoA | 32 products |
| Signa | Producer | Mexico | Mexico | CoA, USDMF | 42 products |
| Sriam Labs | Producer | India | India | CoA, WC | 4 products |
When sending a request, specify which Famciclovir 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 Famciclovir 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.
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Regulatory
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