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Ganciclovir | CAS No: 82410-32-0 | GMP-certified suppliers
A medication that supports treatment of CMV retinitis and severe CMV infections in immunocompromised patients, helping manage vision‑threatening and systemic complications.
Therapeutic categories
Primary indications
- For induction and maintenance in the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients, including patients with acquired immunodeficiency syndrome (AIDS)
- Also used in the treatment of severe cytomegalovirus (CMV) disease, including CMV pneumonia, CMV gastrointestinal disease, and disseminated CMV infections, in immunocompromised patients
Product Snapshot
- Ganciclovir is available as oral small‑molecule capsules, ophthalmic gels, and parenteral injectable/lyophilized formulations for systemic or ocular administration
- It is used for cytomegalovirus infections in immunocompromised patients, including CMV retinitis and severe systemic CMV disease
- It is approved in the US and Canada, with some presentations also noted as investigational
Clinical Overview
Ganciclovir is a synthetic nucleoside analogue of 2'-deoxyguanosine with antiviral activity driven by selective activation in virus‑infected cells. Viral thymidine kinase converts the parent compound to ganciclovir monophosphate, which is subsequently converted by cellular kinases to the active triphosphate. The triphosphate form competes with dATP for incorporation into viral DNA by viral DNA polymerase, producing defective DNA and halting elongation. This targeted inhibition is more potent for viral polymerases than for host enzymes.
Pharmacokinetics are characterized by low oral bioavailability for the parent compound, extensive intracellular activation, and predominant renal elimination. Systemic clearance is strongly influenced by renal function, and accumulation can occur in impairment. The intracellular half‑life of the triphosphate contributes to prolonged antiviral activity.
Safety considerations include bone marrow suppression, particularly neutropenia and thrombocytopenia, which are dose‑limiting in many patients. Additional concerns include renal toxicity, CNS effects such as headache or confusion, and the potential to lower seizure threshold. Reproductive toxicity has been observed, and appropriate precautions are recommended in handling and clinical use. Drug interactions may occur with agents affecting renal transport pathways, including OAT and MATE substrates or inhibitors.
Ganciclovir is available in various systemic and ophthalmic formulations, including long‑standing use in CMV management in advanced HIV disease and transplant settings.
For API procurement, sourcing should emphasize control of impurity profiles, particle size consistency, and validated processes for handling a cytotoxic nucleoside analogue. Suppliers should maintain GMP-compliant production and provide complete regulatory documentation to support global filings.
Identification & chemistry
| Generic name | Ganciclovir |
|---|---|
| Molecule type | Small molecule |
| CAS | 82410-32-0 |
| UNII | P9G3CKZ4P5 |
| DrugBank ID | DB01004 |
Pharmacology
| Summary | Ganciclovir is a guanosine analogue prodrug that is selectively activated by viral thymidine kinase and further phosphorylated by host enzymes to its triphosphate form. The active metabolite competitively inhibits viral DNA polymerase and becomes incorporated into viral DNA, disrupting chain elongation and replication. Its pharmacologic activity is directed primarily against CMV and other herpesviruses through inhibition of DNA synthesis in infected cells. |
|---|---|
| Mechanism of action | Ganciclovir's antiviral activity inhibits virus replication. This inhibitory action is highly selective as the drug must be converted to the active form by a virus-encoded cellular enzyme, thymidine kinase (TK). TK catalyzes phosphorylation of ganciclovir to the monophosphate, which is then subsequently converted into the diphosphate by cellular guanylate kinase and into the triphosphate by a number of cellular enzymes. <i>In vitro</i>, ganciclovir triphosphate stops replication of herpes viral DNA. When used as a substrate for viral DNA polymerase, ganciclovir triphosphate competitively inhibits dATP leading to the formation of 'faulty' DNA. This is where ganciclovir triphosphate is incorporated into the DNA strand replacing many of the adenosine bases. This results in the prevention of DNA synthesis, as phosphodiester bridges can longer to be built, destabilizing the strand. Ganciclovir inhibits viral DNA polymerases more effectively than it does cellular polymerase, and chain elongation resumes when ganciclovir is removed. |
| Pharmacodynamics | Ganciclovir is a synthetic nucleoside analogue of 2'-deoxyguanosine that inhibits replication of herpes viruses both <i>in vitro</i> and <i>in vivo</i>. Sensitive human viruses include cytomegalovirus (CMV), herpes simplex virus -1 and -2 (HSV-1, HSV-2), Epstein-Barr virus (EBV) and varicella zoster virus (VZV), however clinical studies have been limited to assessment of efficacy in patients with CMV infection. Ganciclovir is a prodrug that is structurally similar to acyclovir. It inhibits virus replication by its encorporation into viral DNA. This encorporation inhibits dATP and leads to defective DNA, ceasing or retarding the viral machinery required to spread the virus to other cells. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA polymerase catalytic subunit | HHV-1 | inhibitor |
| DNA | Humans | incorporation into and destabilization |
| Thymidine kinase | HHV-1 | substrate |
ADME / PK
| Absorption | Poorly absorbed systemically following oral administration. Bioavailability under fasting conditions is approximately 5%, and when administered with food, 6 to 9% (about 30% with a fatty meal). |
|---|---|
| Half-life | 2.5 to 3.6 hours (mean 2.9 hours) when administered intravenously in adults. 3.1 to 5.5 hours when administered orally in adults. Renal function impairment causes a marked increase in half life (9 to 30 hours intravenously, 15.7 to 18.2 hours orally). |
| Protein binding | 1 to 2% |
| Metabolism | Little to no metabolism, about 90% of plasma ganciclovir is eliminated unchanged in the urine. |
| Route of elimination | Renal excretion of unchanged drug by glomerular filtration and active tubular secretion is the major route of elimination of ganciclovir. |
| Volume of distribution | * 0.74 ± 0.15 L/kg |
| Clearance | * 128 +/- 63 mL/min [Patients with Renal Impairment (Clcr=50-79 mL/min)] * 57+/- 8 mL/min [Patients with Renal Impairment (Clcr=25-49 mL/min)] * 30 +/- 13 mL/min [Patients with Renal Impairment (Clcr<25 mL/min)] * 4.7+/- 2.2 mL/min/kg [pediatric patients, aged 9 months to 12 years] |
Formulation & handling
- Oral forms show increased bioavailability with food, so formulations should consider GI absorption variability.
- High aqueous solubility and solid-state stability enable straightforward reconstitution for injectable and ophthalmic preparations, including lyophilized powders.
- Parenteral, intraventricular, and intravitreal uses require sterile, low‑particulate handling and protection from degradation during reconstitution and short-term storage.
Regulatory status
| Lifecycle | The API shows a mixed lifecycle, with one U.S. patent expired in 2012 and another providing protection until 2034. In the U.S. and Canada, this likely supports continued market presence under remaining patent coverage while allowing some mature‑market dynamics where protection has lapsed. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Ganciclovir’s supply landscape includes the original developer alongside multiple generic manufacturers and packagers, indicating a mature and diversified production base. Branded products are established primarily in the US and Canada, with no explicit data on EU markets. The expiration of an early core patent in 2012 supports the presence of generics, while a later patent extending to 2034 may relate to specific formulations or uses rather than the base API. |
|---|
Safety
| Toxicity | Oral, mouse LD<sub>50</sub>: > 2g/kg. Intravenous, dog LD<sub>50</sub>: > 150mg/kg. Symptoms of overdose include irreversible pancytopenia, worsening GI symptoms, and acute renal failure. Suspected cancer agent. |
|---|
- High acute‑dose tolerance in rodents and dogs, but overdose is associated with severe hematologic suppression (irreversible pancytopenia) and multisystem toxicity
- Exposure to high concentrations may precipitate significant gastrointestinal and renal injury
- Appropriate controls should address these organ‑specific hazards
Certificate of Suitability
CEP (also known as COS) is a certificate that proves that qualifies to the relevant monograph of the European Pharmacopoeia. It links the monograph in the Ph.Eur. to the API itself. A CEP is submitted by the manufacturer as part of the market authorization process, and they will become the CEP holder of the document. Being a European certificate, the CEP is granted by the EDQM but is recognized by other countries or institutes such as the FDA in the US. Furthermore, just like the DMF, the data as submitted in the CEP is handled strictly confidential and provides a centralized system recognized by many countries.
Ganciclovir 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.
Ganciclovir (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.
Ganciclovir API manufacturers & distributors
Compare qualified Ganciclovir API suppliers worldwide. We currently have 9 companies offering Ganciclovir API, with manufacturing taking place in 3 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, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Bakul Pharma Private Limi... | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, MSDS | 52 products |
| Hetero Drugs | Producer | India | India | CoA, GMP, WC | 98 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shanghai Pharma Group | Producer | China | China | CoA, USDMF | 3 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001 | 762 products |
| Zhejiang Charioteer | Producer | China | China | CEP, CoA, FDA, GMP, USDMF | 9 products |
When sending a request, specify which Ganciclovir 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 Ganciclovir 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 Ganciclovir API
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