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Nevirapine | CAS No: 129618-40-2 | GMP-certified suppliers
A medication that supports combination therapy for HIV‑1 infection, helping manufacturers supply reliable antiretroviral options across major regulated markets.
Therapeutic categories
Primary indications
- For use in combination with other antiretroviral drugs in the ongoing treatment of HIV-1 infection
Product Snapshot
- Oral small‑molecule antiretroviral available mainly as standard and extended‑release tablets and oral suspension
- Used in combination regimens for ongoing management of HIV‑1 infection
- Approved in major regulated markets including the US, EU, and Canada
Clinical Overview
Nevirapine acts by binding directly to HIV‑1 reverse transcriptase at an allosteric site. This interaction disrupts the catalytic domain responsible for RNA‑dependent and DNA‑dependent DNA polymerase activities. Its activity does not compete with nucleoside triphosphates or nucleic acid templates. Nevirapine shows selectivity for HIV‑1 reverse transcriptase and does not inhibit HIV‑2 reverse transcriptase or major human DNA polymerases.
Following oral administration, nevirapine is well absorbed, with high bioavailability and extensive hepatic metabolism. It is a substrate and inducer of multiple cytochrome P450 isoenzymes, notably CYP3A and CYP2B6, and can influence the clearance of coadministered drugs metabolized through these pathways. Autoinduction of metabolism occurs with continued dosing, reducing systemic exposure over time. Distribution is broad, including penetration into cerebrospinal fluid. Elimination occurs primarily via hepatic biotransformation, with renal excretion of metabolites.
Clinically relevant safety considerations include hepatotoxicity, which may present as elevated transaminases or clinically significant hepatic injury. Rash, including severe cutaneous reactions, has also been reported. Monitoring of hepatic function is important, especially during early treatment. Drug–drug interactions are common due to P450 induction or inhibition.
Nevirapine has been available globally in multiple oral formulations under various brand names for use in combination antiretroviral therapy.
For API procurement, sourcing should prioritize verified suppliers with demonstrated control of impurity profiles, consistent polymorphic form, and compliance with current Good Manufacturing Practice to support formulation robustness and regulatory submission requirements.
Identification & chemistry
| Generic name | Nevirapine |
|---|---|
| Molecule type | Small molecule |
| CAS | 129618-40-2 |
| UNII | 99DK7FVK1H |
| DrugBank ID | DB00238 |
Pharmacology
| Summary | Nevirapine is a non‑nucleoside reverse transcriptase inhibitor that binds directly to HIV‑1 reverse transcriptase and disrupts its catalytic site, blocking both RNA‑dependent and DNA‑dependent DNA polymerase activities. Its pharmacologic effect stems from selective inhibition of HIV‑1 reverse transcriptase/RNase H without competing with nucleoside substrates or affecting human DNA polymerases. It is used in combination antiretroviral regimens to suppress HIV‑1 replication. |
|---|---|
| Mechanism of action | Nevirapine binds directly to reverse transcriptase (RT) and blocks the RNA-dependent and DNA-dependent DNA polymerase activities by causing a disruption of the enzyme's catalytic site. The activity of nevirapine does not compete with template or nucleoside triphosphates. |
| Pharmacodynamics | Nevirapine is a non-nucleoside reverse transcriptase inhibitor (nNRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1). HIV-2 RT and eukaryotic DNA polymerases (such as human DNA polymerases alpha, beta, or sigma) are not inhibited by nevirapine. Nevirapine is, in general, only prescribed after the immune system has declined and infections have become evident. It is always taken with at least one other HIV medication such as Retrovir or Videx. The virus can develop resistance to nevirapine if the drug is taken alone, although even if used properly, nevirapine is effective for only a limited time. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Reverse transcriptase/RNaseH | Human immunodeficiency virus 1 | inhibitor |
ADME / PK
| Absorption | Nevirapine is readily absorbed (greater than 90%) after oral administration in healthy subjects and adults with HIV-1 infection. The absolute bioavailability in healthy adults following a single dose administration is 93 ± 9% (mean ± SD) for a 50 mg tablet and 91 ± 8% for an oral solution. Peak plasma nevirapine concentrations of 2 ± 0.4 mcg/mL (7.5 micromolar) were attained by 4 hours following a single 200 mg dose. Nevirapine tablets and suspension have been shown to be comparably bioavailable and interchangeable at doses up to 200 mg. When the oral tablet is given with a high-fat meal, the extent of absorption is compared to that of the fasted-state. |
|---|---|
| Half-life | 45 hours |
| Protein binding | 60% bound to plasma protein. |
| Metabolism | Hepatic. In vivo studies in humans and in vitro studies with human liver microsomes have shown that nevirapine is extensively biotransformed via cytochrome P450 3A4 metabolism to several hydroxylated metabolites. |
| Route of elimination | Thus cytochrome P450 metabolism, glucuronide conjugation, and urinary excretion of glucuronidated metabolites represent the primary route of nevirapine biotransformation and elimination in humans. Only a small fraction (<5%) of the radioactivity in urine (representing <3% of the total dose) was made up of parent compound; therefore, renal excretion plays a minor role in elimination of the parent compound. |
| Volume of distribution | * 1.21 ± 0.09 L/kg [apparent volume of distribution, healthy adults, IV] Nevirapine is capable of crossing the placenta and is found in breast milk. |
Formulation & handling
- Nevirapine is an orally delivered small‑molecule API with adequate lipophilicity but low aqueous solubility, requiring solubility‑enhancing strategies for solid and liquid formulations.
- Extended‑release tablets rely on controlled‑release matrices; the API’s moderate LogP supports sustained‑release designs without major food‑effect concerns.
- Oral suspensions require wetting and dispersion aids to address low solubility and ensure uniform dosing during handling and storage.
Regulatory status
| Lifecycle | Most core patent protection in Canada and parts of the US has lapsed, suggesting a mature market with established generic presence in those regions, while a remaining US patent expiring in 2029 may limit full generic entry for certain protected aspects. Across Canada, the US, and the EU, the product overall appears to be in a late‑lifecycle stage. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Nevirapine’s supply landscape is anchored by a single originator manufacturer, with a wide network of repackagers and distributors supporting availability across the US, Canada, and EU. Branded and co‑formulated products are present in multiple global markets, indicating established international distribution. Most early patents have expired, and while one US patent extends to 2029, the presence of multiple branded and non‑originator products suggests existing or mature generic competition. |
|---|
Safety
| Toxicity | Symptoms of overdose include edema, erythema nodosum, fatigue, fever, headache, insomnia, nausea, pulmonaryinfiltrates, rash, vertigo, vomiting, and weight decrease. The most common adverse reaction is rash. |
|---|
- Overexposure has been associated with systemic effects such as fever, fatigue, pulmonary infiltrates, gastrointestinal disturbances, vertigo, and weight reduction, indicating the need for controlled handling conditions
- Dermatologic reactions, particularly rash, are the most frequently observed adverse events and may serve as an early indicator of compound intolerance
- High-dose exposure can produce inflammatory responses, including edema and erythema nodosum, highlighting the importance of minimizing unnecessary contact during processing
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.
Nevirapine is a type of Anti HIV
The Anti-HIV pharmaceutical API subcategory encompasses a range of active pharmaceutical ingredients (APIs) specifically designed to combat the human immunodeficiency virus (HIV), which causes acquired immunodeficiency syndrome (AIDS). These APIs play a vital role in the development of effective antiretroviral therapy (ART) regimens used to manage and treat HIV infections.
The primary objective of Anti-HIV APIs is to target the various stages of the HIV life cycle, inhibiting viral replication and reducing the viral load in the patient's body. These APIs typically act through mechanisms such as reverse transcriptase inhibition, protease inhibition, integrase inhibition, and fusion inhibition.
Common Anti-HIV APIs include nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), protease inhibitors (PIs), integrase inhibitors (INIs), and fusion inhibitors. Each class of API targets different stages of the virus's replication cycle, thereby preventing its spread and reducing the viral load.
These APIs undergo rigorous testing and are subject to strict regulatory guidelines to ensure their safety and efficacy. Pharmaceutical companies and research institutions employ advanced techniques like high-performance liquid chromatography (HPLC), mass spectrometry, and nuclear magnetic resonance (NMR) to analyze the purity, potency, and quality of Anti-HIV APIs.
The development and production of Anti-HIV APIs require expertise in synthetic organic chemistry, process optimization, and quality control. Pharmaceutical manufacturers must adhere to stringent quality standards, good manufacturing practices (GMP), and follow international guidelines to ensure the consistent production of high-quality Anti-HIV APIs.
Overall, Anti-HIV APIs are crucial components in the development of effective antiretroviral medications, playing a vital role in managing HIV infections and improving the quality of life for millions of people living with HIV/AIDS.
Nevirapine (Anti HIV), 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.
Nevirapine API manufacturers & distributors
Compare qualified Nevirapine API suppliers worldwide. We currently have 10 companies offering Nevirapine 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 |
|---|---|---|---|---|---|
| Anhui Biochem United Phar... | Producer | China | China | CoA, GMP, USDMF | 6 products |
| Cipla | Producer | India | India | CEP, CoA, USDMF, WC | 164 products |
| Hetero Labs | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 90 products |
| Laurus Labs | Producer | India | India | CoA, GMP, WC | 50 products |
| Mylan | Producer | India | Unknown | CEP, CoA, USDMF, WC | 201 products |
| Shandong Zhanhua Yonghao | Producer | China | China | CoA | 10 products |
| Shanghai Acebright | Producer | China | China | CoA | 23 products |
| Shanghai Desano Chem. | Producer | China | China | CoA, USDMF | 22 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sun Pharma | Producer | India | India | CEP, CoA, WC | 219 products |
When sending a request, specify which Nevirapine 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 Nevirapine 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 Nevirapine API
Sourcing
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Technical
What is Nevirapine (CAS 129618-40-2) used for?
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How does Nevirapine work?
What should someone know about the safety or toxicity profile of Nevirapine?
What are important formulation and handling considerations for Nevirapine as an API?
Is Nevirapine a small molecule?
Are there special stability concerns for oral Nevirapine?
Regulatory
Where is Nevirapine approved or in use globally?
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Pharmaoffer
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