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Travoprost | CAS No: 157283-68-6 | GMP-certified suppliers
A medication that reduces elevated intraocular pressure in patients with open-angle glaucoma and ocular hypertension, including pediatric cases, by improving aqueous humor outflow.
Therapeutic categories
Primary indications
- Travoprost is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
- [L49434, L49429, L49515] It is also used in pediatric patients aged two months to less than 18 years
Product Snapshot
- Travoprost is formulated as an ophthalmic solution or drops intended for topical ocular administration
- It is primarily used for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, including pediatric populations
- The product is approved for use in major regulatory markets including the US (FDA), EU (EMA), and Canada
Clinical Overview
Pharmacologically, travoprost exhibits high affinity and full agonist activity for the prostaglandin FP receptor, with no significant interaction with other prostanoid or non-prostanoid receptors. The intraocular pressure reduction effect typically begins approximately two hours following administration, reaches its maximum after about 12 hours, and can be sustained for more than 24 hours with a single dose.
Upon topical ocular administration, travoprost penetrates the cornea and is hydrolyzed to its active form, travoprost free acid. This metabolite facilitates increased aqueous humour outflow via both the trabecular meshwork and uveoscleral pathways, which is the presumed mechanism underlying its intraocular pressure lowering effect. The ester prodrug design improves corneal permeability, enhancing drug delivery to target tissues.
Key absorption, distribution, metabolism, and excretion (ADME) parameters relate to the rapid corneal absorption and efficient metabolic conversion to the active acid; detailed systemic pharmacokinetic data are limited due to the primarily local route of administration.
Safety considerations include monitoring for ocular side effects typical of prostaglandin analogues, such as conjunctival hyperemia. The selective FP receptor agonism of travoprost is associated with a lower incidence of off-target effects compared to less selective prostaglandin analogues.
Notable brand names for travoprost formulations include various globally marketed ophthalmic solutions approved for glaucoma management.
For API procurement, attention to synthetic route reproducibility, impurity profile control, and compliance with relevant pharmacopeial standards is critical. Ensuring consistent stereochemical purity and an ester linkage integrity is important for maintaining pharmacological activity. Reliable sourcing should also consider supply chain transparency and rigorous quality assurance to support regulatory submissions and formulation development.
Identification & chemistry
| Generic name | Travoprost |
|---|---|
| Molecule type | Small molecule |
| CAS | 157283-68-6 |
| UNII | WJ68R08KX9 |
| DrugBank ID | DB00287 |
Pharmacology
| Summary | Travoprost is a prostaglandin analog prodrug that is hydrolyzed to its active free acid form, which selectively and fully agonizes prostaglandin FP receptors. Activation of these receptors enhances aqueous humor outflow through the trabecular meshwork and uveoscleral pathways, leading to a reduction in intraocular pressure. Its pharmacodynamic profile is characterized by high receptor specificity and prolonged intraocular pressure-lowering effects. |
|---|---|
| Mechanism of action | Travoprost is a prodrug. Upon administration, travoprost is absorbed through the cornea and hydrolyzed to its active metabolite, travoprost free acid. The ester moiety of the free acid allows for enhanced penetration into the aqueous humour. While the exact mechanism of travoprost is largely unknown, it is believed to be related to its full agonist activity for the prostaglandin FP receptor. By binding to the FP receptor, travoprost free acid increases the outflow of aqueous humour via the trabecular meshwork and uveoscleral pathways, thereby reducing the intraocular pressure.[A262899, L5146, L49434] |
| Pharmacodynamics | Travoprost demonstrates preferential affinity and full agonist activity for the prostaglandin FP receptor in the nanomolar range. Travoprost shows no significant affinity for other prostanoid or non-prostanoid receptors. Travoprost-induced reduction of intraocular pressure is observed about two hours after administration, and the maximum effect is reached after 12 hours. Significant lowering of intraocular pressure can be maintained for periods exceeding 24 hours with a single dose. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin F2-alpha receptor | Humans | agonist |
ADME / PK
| Absorption | Following ophthalmic administration, travoprost is absorbed through the cornea. In many patients in multiple-dose pharmacokinetic studies, the plasma concentrations of the free acid were below 0.01 ng/mL, which was the quantitation limit of the assay. In these studies, the mean plasma C<sub>max</sub> of travoprost free acid was 0.018 ± 0.007 ng/mL (ranging from 0.01 to 0.052 ng/mL), and the T<sub>max</sub> was about 30 minutes. |
|---|---|
| Half-life | The terminal elimination half-life of travoprost free acid was estimated from fourteen subjects and ranged from 17 minutes to 86 minutes with the mean half-life of 45 minutes. |
| Protein binding | No information is available. |
| Metabolism | Travoprost, an isopropyl ester prodrug, is hydrolyzed by esterases in the cornea to its biologically active free acid. Systemically, travoprost free acid is metabolized to inactive metabolites via beta-oxidation of the α (carboxylic acid) chain to give the 1,2-dinor and 1,2,3,4-tetranor analogs, via oxidation of the 15-hydroxyl moiety, as well as via reduction of the 13, 14 double bond.[L5146, L49434] |
| Route of elimination | The elimination of travoprost free acid from plasma is rapid. The levels of travoprost free acid were generally below the limit of quantification within one hour after dosing. Less than 2% of the topical ocular dose of travoprost was excreted in the urine within 4 hours as the travoprost free acid. |
| Volume of distribution | No information is available. |
| Clearance | No information is available. |
Formulation & handling
- Travoprost is a small molecule prostaglandin analogue formulated primarily for ophthalmic solution use.
- Its low water solubility requires careful formulation to ensure stability and bioavailability in liquid eye drops.
- Being administered topically to the eye, systemic sensitivity to food is not a relevant consideration.
Regulatory status
| Lifecycle | The API has multiple patents expired between 2012 and 2015 in the United States and Canada, allowing generic competition in these markets, while an active patent in the US extends exclusivity until 2029. The product is marketed in Canada, the EU, and the US, with varied market maturity due to differing patent protections. |
|---|
| Markets | Canada, EU, US |
|---|
Supply Chain
| Supply chain summary | Travoprost is primarily manufactured and packaged by a limited number of originator companies, with Alcon playing a central role in production and packaging. Its branded products have a broad global presence, including markets in the US, EU, and Canada. The latest patent expiry date of 2029 indicates that generic competition is not imminent and is likely to emerge only after this period. |
|---|
Safety
| Toxicity | No cases of overdose have been reported for travoprost, as overdose from topical or ophthalmic administration is not likely to occur. Overdose from topical administration should be responded to with flushing of the eyes with lukewarm water. Treatment of an oral overdose should be symptomatic and supportive. |
|---|
- Overdose cases from topical or ophthalmic administration of travoprost have not been reported
- Systemic toxicity is unlikely
- In case of ocular exposure beyond recommended use, flush eyes with lukewarm water to mitigate local irritation
Travoprost is a type of Ocular preparations
Ocular preparations are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) used in the formulation of medications and treatments for various eye conditions. These specialized formulations are designed to deliver therapeutic agents directly to the eye, ensuring maximum effectiveness and minimal systemic absorption.
Ocular preparations encompass a wide range of products, including eye drops, ointments, gels, and inserts. These formulations may contain API components such as antibiotics, corticosteroids, antihistamines, lubricants, or mydriatics, depending on the intended therapeutic purpose.
Eye drops are the most common form of ocular preparations, delivering medications in liquid form directly onto the eye surface. They are often used to treat conditions like dry eyes, glaucoma, allergies, and infections. Ointments and gels provide a more viscous consistency, enabling longer contact time with the eye surface and prolonged drug release. Inserts, such as punctal plugs, are used to deliver sustained-release medications.
Ocular preparations are formulated to ensure compatibility with the delicate structures of the eye and to enhance drug penetration. Factors like pH, osmolality, and viscosity are carefully controlled to optimize drug delivery and patient comfort. Additionally, preservatives are often added to prevent microbial contamination and maintain product stability.
In summary, ocular preparations are crucial in treating various eye conditions effectively. They provide targeted drug delivery and ensure optimal therapeutic outcomes with minimal side effects. Whether in the form of eye drops, ointments, gels, or inserts, these pharmaceutical APIs play a vital role in promoting eye health and improving patient well-being.
Travoprost (Ocular preparations), classified under Ophthalmic Agents
Ophthalmic agents belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category specifically designed for ophthalmic applications. These agents are formulated to treat various eye conditions and disorders. Ophthalmic agents encompass a wide range of medications, including eye drops, ointments, gels, and intraocular implants.
These agents are developed to address specific therapeutic needs related to the eyes, such as reducing intraocular pressure in glaucoma, treating inflammation and infection, relieving dryness and itching, and managing allergies. They may also be used to dilate the pupils during diagnostic procedures or surgeries.
Ophthalmic agents are formulated with precise concentrations of active ingredients to ensure efficacy and safety. Common classes of ophthalmic agents include beta-blockers, prostaglandin analogs, carbonic anhydrase inhibitors, corticosteroids, and antihistamines.
When administering ophthalmic agents, it is crucial to follow proper application techniques to ensure optimal drug delivery and minimize side effects. Eye drops, for example, are typically applied as a gentle instillation into the conjunctival sac, while ointments are applied along the lower eyelid.
These pharmaceutical API ophthalmic agents undergo rigorous quality control and regulatory scrutiny to meet industry standards and ensure patient safety. Manufacturers must comply with Good Manufacturing Practices (GMP) and adhere to stringent quality assurance protocols.
Overall, ophthalmic agents play a vital role in the management and treatment of various eye conditions, providing patients with targeted relief and improving ocular health. It is important to consult with a healthcare professional to determine the appropriate ophthalmic agent for individual needs and to receive proper guidance on usage and potential side effects.
Travoprost API manufacturers & distributors
Compare qualified Travoprost API suppliers worldwide. We currently have 12 companies offering Travoprost 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 |
|---|---|---|---|---|---|
| AXXO GmbH | Distributor | Germany | European Union | CEP, CoA, EDMF/ASMF, GMP, GDP, MSDS, USDMF | 243 products |
| Biocon | Producer | India | India | CoA, USDMF | 36 products |
| Cedarburg Pharma | Producer | United States | United States | CoA, USDMF | 12 products |
| Chinoin | Producer | Hungary | Unknown | CoA, GMP, JDMF, USDMF | 21 products |
| Chirogate International | Producer | Taiwan | Taiwan | CoA, EDMF/ASMF, FDA, GMP, USDMF | 17 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Jiangxi Bioman Pharma Lim... | Producer | China | China | CoA | 15 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| MSN Labs. | Producer | India | India | CoA, USDMF | 119 products |
| Quimdis | Distributor | France | Unknown | CoA | 17 products |
| Yonsung Fine Chem. | Producer | South Korea | South Korea | CoA, JDMF, USDMF | 13 products |
When sending a request, specify which Travoprost 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 Travoprost 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.
