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Terbinafine | CAS No: 91161-71-6 | GMP-certified suppliers
A medication that treats a broad range of fungal skin and nail infections, providing effective coverage against common dermatophyte and yeast pathogens for diverse formulation needs.
Therapeutic categories
Primary indications
- Terbinafine hydrochloride is indicated to treat fungal skin and nail infections caused by _Trichophyton_ species, _Microsporum canis_, _Epidermophyton floccosum_,and _Tinea_ species
- Terbinafine hydrochloride also treats yeast infections of the skin caused by _Candida_ species and _Malassezia furfur_
Product Snapshot
- Terbinafine is supplied as an oral small‑molecule tablet and multiple topical formulations including creams, gels, sprays, and solutions
- It is used for sourcing programs targeting dermatophyte and yeast-related skin and nail infections
- It is approved in the US and Canada, with additional investigational and veterinary statuses in some markets
Clinical Overview
Terbinafine exhibits potent fungicidal activity through selective inhibition of fungal squalene monooxygenase. This blockade prevents the conversion of squalene to 2,3‑oxydosqualene in the ergosterol synthesis pathway, resulting in decreased ergosterol content and accumulation of intracellular squalene. Disruption of lipid homeostasis weakens fungal cell membranes and contributes to cell death. Formation of squalene-rich vesicles may further destabilize membrane integrity.
The drug is highly lipophilic, leading to extensive distribution into skin, nails, and adipose tissues. Tissue retention supports a long terminal elimination phase and sustained pharmacologic activity after dosing discontinuation. Terbinafine is a substrate and inhibitor of multiple cytochrome P450 enzymes, including CYP2D6, which may influence concomitant drug metabolism. It undergoes hepatic metabolism, and baseline liver function assessment is recommended before treatment initiation due to the risk of hepatotoxicity. Reports of overdose are uncommon, and the therapeutic index is considered wide based on clinical experience.
Safety considerations focus on hepatic adverse effects, drug–drug interaction potential associated with CYP modulation, and vigilance in patients with preexisting liver disease. Topical formulations have limited systemic exposure and fewer systemic risks.
For API procurement, suppliers should provide consistent control of polymorphic form, residual solvents, and particle characteristics suitable for oral or topical formulation requirements. Verification of compliance with pharmacopoeial specifications and robust impurity profiling is essential for regulatory submissions and global distribution.
Identification & chemistry
| Generic name | Terbinafine |
|---|---|
| Molecule type | Small molecule |
| CAS | 91161-71-6 |
| UNII | G7RIW8S0XP |
| DrugBank ID | DB00857 |
Pharmacology
| Summary | Terbinafine is an allylamine antifungal that inhibits squalene monooxygenase, blocking ergosterol synthesis and causing intracellular squalene accumulation. These changes disrupt fungal cell membrane integrity and lead to cell death. The drug shows sustained activity due to extensive tissue distribution and a long terminal elimination phase. |
|---|---|
| Mechanism of action | Terbinafine inhibits the enzyme squalene monooxygenase (also called squalene epoxidase), preventing the conversion of squalene to 2,3-oxydosqualene, a step in the synthesis of ergosterol.This inhibition leads to decreased ergosterol, which would normally be incorporated into the cell wall, and accumulation of squalene. Generation of a large number of squalene containing vesicles in the cytoplasm may leach other lipids away from, and further weaken, the cell wall. |
| Pharmacodynamics | Terbinafine is an allylamine antifungal that inhibits squalene epoxidase (also known as squalene monooxygenase) to prevent the formation of ergosterol and cause an accumulation of squalene, weakening the cell wall of fungal cells.Terbinafine distributes into tissues and has a long terminal elimination half life, so the duration of action is long.Overdose with terbinafine is rare, even above the therapeutic dose, so the therapeutic index is wide.Patients taking oral terbinafine should have liver function tests performed prior to treatment to reduce the risk of liver injury. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Squalene monooxygenase | Yeast | inhibitor |
| Squalene monooxygenase | Humans | inhibitor |
ADME / PK
| Absorption | Oral terbinafine is >70% absorbed but only 40% bioavailable after first pass metabolism, reaching a C<sub>max</sub> of 1µg/mL with a T<sub>max</sub> of 2 hours an an AUC of 4.56µg\*h/mL.Over the course of a week, 1% topical terbinafine's C<sub>max</sub> increases from 949-1049ng/cm<sup>2</sup> and the AUC increases from 9694-13,492ng/cm<sup>2</sup>/h. |
|---|---|
| Half-life | Oral terbinafine has an effective half life of approximately 36 hours.However, the terminal half life ranges from 200-400 hours as it distributes into skin and adipose tissue.1% topical terbinafine's half life increases over the first seven days from approximately 10-40 hours. |
| Protein binding | Terbinafine is >99% bound to proteins in plasma,mostly to serum albumin,high and low density lipoproteins,and alpha-1-acid glycoprotein to a lesser extent. |
| Metabolism | Terbinafine can be deaminated to 1-naphthaldehyde by CYP2C9, 2B6, 2C8, 1A2, 3A4, and 2C19.1-naphthaldehyde is then oxidized to 1-naphthoic acid or reduced to 1-naphthalenemethanol. Terbinafine can also be hydroxylated by CYP1A2, 2C9, 2C8, 2B6, and 2C19 to hydroxyterbinafine.Hydroxyterbinafine is then oxidized to carboxyterbinafine or N-demethylated by CYP3A4, 2B6, 1A2, 2C9, 2C8, and 2C19 to desmethylhydroxyterbinafine. Terbinafine can be N-demethylated to desmethylterbinafine.Desmethylterbinafine is then dihydroxylated to a desmethyldihydrodiol or hydroxylated to desmethylhydroxyterbinafine. Finally, terbinafine can be dihydroxylated to a dihydrodiol which is then N-demethylated to a desmethyldihydrodiol. |
| Route of elimination | Terbinafine is approximately 80% eliminated in urine, while the remainder is eliminated in feces.The unmetabolized parent drug is not present in urine. |
| Volume of distribution | A single 250mg oral dose of terbinafine has a volume of distribution at steady state of 947.5L or 16.6L/kg. |
| Clearance | A single 250mg oral dose of terbinafine has a clearance of 76L/h or 1.11L/h/kg. |
Formulation & handling
- Oral formulations require solubility‑enhancing approaches due to very low aqueous solubility and high lipophilicity (logP ~5.5).
- Topical and cutaneous products rely on the solid, lipophilic nature of the API and typically use solvent or emulsified systems to improve skin penetration.
- The small‑molecule API is chemically stable in solid form, with no special biologic‑handling requirements.
Regulatory status
| Lifecycle | Most core patents for the API expired between 2012 and 2015 in the United States and Canada, indicating that the product is well into a mature, post‑exclusivity phase. In both markets, the landscape is consistent with widespread generic availability and stable late‑lifecycle conditions. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Terbinafine was originally developed by a single originator, but its patents have long expired, and the market is now supplied by a broad set of generic manufacturers and packagers. Branded and generic products are widely available in the US and Canada, indicating mature global distribution beyond the originator’s footprint. Patent expiries in both the US and Canada (2012–2015) confirm that generic competition is well‑established. |
|---|
Safety
| Toxicity | The subcutaneous LD<sub>50</sub> in rats and mice is >2g/kg.The TDLO for women is 210mg/kg/6W. Overdose data with terbinafine is rare, however symptoms are expected to be nausea, vomiting, abdominal pain, dizziness, rash, frequent urination, and headache.Treat overdose with activated charcoal as well as symptomatic and supportive therapy. |
|---|
- High-dose toxicology shows a subcutaneous LD50 in rodents exceeding 2 g/kg and a reported human TDLO of 210 mg/kg over six weeks, indicating low acute lethality but potential for dose‑related systemic effects
- Overexposure may elicit gastrointestinal, neurologic, and dermatologic reactions such as nausea, dizziness, and rash
- Monitor for nonspecific CNS or GI stressors during material handling
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.
Terbinafine is a type of Antimycotics
Antimycotics, a subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs), are essential in the treatment of various fungal infections. These powerful medications target and eliminate harmful fungi that can cause infections in humans.
Antimycotics are classified into two main types: systemic and topical. Systemic antimycotics are administered orally or intravenously and work by circulating throughout the body, treating systemic fungal infections that affect internal organs or spread throughout the bloodstream. On the other hand, topical antimycotics are applied externally to treat localized fungal infections such as athlete's foot or yeast infections.
The efficacy of antimycotics lies in their ability to disrupt fungal cell membranes, inhibit the synthesis of fungal DNA or proteins, or interfere with essential metabolic processes specific to fungi. This targeted action minimizes damage to human cells, making these medications relatively safe for patients.
Commonly prescribed antimycotics include azoles, polyenes, allylamines, and echinocandins. Azoles inhibit the synthesis of ergosterol, a vital component of fungal cell membranes, while polyenes bind to ergosterol, resulting in the formation of pores that lead to cell death. Allylamines disrupt the synthesis of ergosterol and inhibit the activity of squalene epoxidase, an enzyme involved in ergosterol production. Echinocandins target the synthesis of β-(1,3)-D-glucan, an essential component of the fungal cell wall.
Antimycotics play a crucial role in the management of fungal infections, offering relief to patients and aiding in their recovery. As with any medication, it is important to follow healthcare professionals' guidance regarding dosage, duration of treatment, and potential side effects to ensure optimal therapeutic outcomes.
Terbinafine (Antimycotics), classified under Antifungals
Antifungals are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) designed to combat fungal infections. These medications are developed to target and eliminate fungi, including yeasts and molds, which can cause a range of diseases in humans and animals.
Antifungals work by interfering with specific components or processes essential for fungal growth and reproduction. They may inhibit the synthesis of fungal cell walls or disrupt the production of ergosterol, a crucial component of fungal cell membranes. By targeting these key mechanisms, antifungal APIs effectively hinder the growth and spread of fungal infections.
The diversity within the antifungal category is reflected in the various classes of antifungal APIs available. Azoles, polyenes, echinocandins, and allylamines are common classes of antifungals. Each class exhibits unique mechanisms of action and targets specific types of fungi. This diversity enables healthcare professionals to tailor treatment plans to the specific fungal infection, optimizing therapeutic outcomes.
Antifungal APIs find application in various pharmaceutical formulations, including oral medications, topical creams, ointments, and intravenous solutions. They are crucial for the treatment of common fungal infections like athlete's foot, ringworm, vaginal yeast infections, and oral thrush. Additionally, antifungals play a crucial role in managing serious systemic fungal infections that can pose significant health risks, especially in immunocompromised individuals.
Overall, antifungal APIs are indispensable tools in the fight against fungal infections, offering effective treatment options and improving the quality of life for patients suffering from these conditions. With ongoing research and development, the antifungal category continues to evolve, providing innovative solutions to combat the ever-changing landscape of fungal pathogens.
Terbinafine API manufacturers & distributors
Compare qualified Terbinafine API suppliers worldwide. We currently have 22 companies offering Terbinafine API, with manufacturing taking place in 8 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 |
|---|---|---|---|---|---|
| Amino Chemicals | Producer | Malta | Malta | CEP, CoA, FDA, GMP, USDMF | 20 products |
| Chr. Olesen Group | Distributor | Denmark | Denmark | CEP, CoA, GMP, JDMF | 252 products |
| Chromo Labs. | Producer | India | India | CEP, CoA, GMP, USDMF, WC | 11 products |
| Cipla | Producer | India | India | CEP, CoA, KDMF, USDMF, WC | 164 products |
| Derivados Quimicos | Producer | Spain | Spain | CoA, GMP, JDMF | 18 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, JDMF, KDMF, MSDS, USDMF, WC | 170 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Gedeon Richter | Producer | Hungary | Unknown | CEP, CoA, FDA, GMP, JDMF, USDMF | 48 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Hetero Labs | Producer | India | India | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 90 products |
| Inist St Co. | Producer | South Korea | South Korea | CoA, JDMF | 8 products |
| Jinan Mingxin | Producer | China | China | CoA, WC | 7 products |
| MSN Labs. | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 119 products |
| Mylan | Producer | India | India | CoA, USDMF | 201 products |
| Qilu Antibiotics | Producer | China | China | CoA, USDMF, WC | 33 products |
| Quimica Sintetica | Producer | Spain | Unknown | CEP, CoA, GMP, USDMF | 51 products |
| SEDANAH | Distributor | Jordan | World | CoA, GMP | 70 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, ISO9001, USDMF | 157 products |
| Shandong Boyuan | Producer | China | China | BSE/TSE, CoA, MSDS, USDMF | 55 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Weijie Pharmaceuticals | Producer | China | China | CoA, USDMF | 15 products |
| Zhejiang East-Asia Pharma | Producer | China | China | CEP, CoA, KDMF | 7 products |
When sending a request, specify which Terbinafine 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 Terbinafine 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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Technical
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Regulatory
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