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Bimatoprost | CAS No: 155206-00-1 | GMP-certified suppliers
A medication that supports management of open‑angle glaucoma and ocular hypertension by lowering intraocular pressure, while also addressing eyelash hypotrichosis in eligible patients.
Therapeutic categories
Primary indications
- Bimatoprost is used for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
- These patients must be intolerant to other intraocular pressure lowering medications or inadequately responsive to other treatments
- Bimatoprost is also indicated to treat eyelash hypotrichosis
Product Snapshot
- Bimatoprost is an ophthalmic small‑molecule solution primarily supplied as sterile eye drops and other topical ocular formulations
- It is used for lowering intraocular pressure in open-angle glaucoma or ocular hypertension and for managing eyelash hypotrichosis
- It is approved in the US, EU, and Canada, with some investigational listings in additional markets
Clinical Overview
The compound reduces the risk of glaucomatous visual field loss by producing sustained reductions in intraocular pressure. Pharmacodynamic activity includes stimulation of aqueous humor outflow through both the trabecular meshwork and the uveoscleral pathways. This effect is linked to decreased tonographic resistance. Bimatoprost does not influence aqueous humor production.
Systemic exposure after ocular administration is low, and available data indicate rapid ocular distribution with minimal systemic accumulation. Bimatoprost is metabolized through pathways that include CYP3A isoenzymes, although systemic concentrations after topical use are generally limited. Elimination occurs predominantly via the renal route as metabolites. No additional ADME parameters are added when unavailable.
The mechanism of action reflects its prostamide mimetic activity, which enhances aqueous humor drainage and thereby lowers intraocular pressure. For eyelash hypotrichosis, increased growth, length, and pigmentation are observed, arising from prostaglandin‑related effects on hair follicles rather than a distinct pharmacological target.
Safety considerations include the potential for gradual, sometimes irreversible, changes in iris pigmentation, periocular skin darkening, and increased eyelash pigmentation or thickness. Conjunctival hyperemia, ocular pruritus, and eyelid changes may also occur. These effects can be asymmetric when only one eye is treated.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of impurity profiles characteristic of prostaglandin‑related molecules, robust handling of light‑ and temperature‑sensitive materials, and documentation supporting regulatory compliance and batch consistency.
Identification & chemistry
| Generic name | Bimatoprost |
|---|---|
| Molecule type | Small molecule |
| CAS | 155206-00-1 |
| UNII | QXS94885MZ |
| DrugBank ID | DB00905 |
Pharmacology
| Summary | Bimatoprost is a prostamide analog that activates prostaglandin-related receptors to enhance aqueous humor outflow through the trabecular meshwork and uveoscleral pathways, lowering elevated intraocular pressure. Its pharmacodynamic effect centers on reducing pressure‑related stress on the optic nerve in conditions such as open‑angle glaucoma and ocular hypertension. The drug also stimulates eyelash growth through receptor‑mediated effects on hair follicles. |
|---|---|
| Mechanism of action | Bimatoprost imitates the effects of prostamides, specifically prostaglandin F2α.Bimatoprost mildly stimulates aqueous humor outflow, relieving elevated intraocular pressure and decreasing the risk of optic nerve damage. It is thought that bimatoprost reduces intraocular pressure (IOP) in humans by causing an increase in outflow of the aqueous humor via the trabecular meshwork and uveoscleral pathways.It achieves the above effects by decreasing tonographic resistance to aqueous humor outflow.Bimatoprost does not affect aqueous humor production. |
| Pharmacodynamics | High intraocular pressure is a major risk factor for glaucoma-related visual field loss. A linear relationship exists between intraocular pressure and the risk of damaging the optic nerve, which can lead to considerable visual impairment.Therefore, conditions such as ocular hypertension and glaucoma can cause dangerous elevations of intraocular pressure. Bimatoprost rapidly decreases intraocular pressure and reduces the risk for visual field loss from ocular hypertension due to various causes. Other effects of this drug may include gradual changes in eyelid pigmentation, changes in iris pigmentation, changes in eyelash pigmentation, growth and thickness.Patients should be informed of these possible effects, especially if this drug is only administered to one eye, which may noticeably change in appearance with bimatoprost treatment. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin F2-alpha receptor | Humans | agonist |
| Prostaglandin E2 receptor EP1 subtype | Humans | agonist |
| Prostaglandin E2 receptor EP3 subtype | Humans | agonist |
ADME / PK
| Absorption | This drug is absorbed systemically when administered to the eye. A study was performed on 15 healthy volunteers and bimatoprost ophthalmic solution 0.03% was administered once daily for 14 days. The mean Cmax was approximately 0.08 ng/mL and AUC0-24hr was approximately 0.09 on days 7 and 14 of the study.By 10 minutes, peak blood concentration was achieved. Bimatoprost was not detectable at 1.5 hours after administration in most subjects. The maximum blood concentration in a study of 6 healthy volunteers was determined to be 12.2 ng/mL. Steady state was reached in the first week of dosing. One drug label mentions that onset of decreased intraocular pressure occurs approximately 4 hours after the first administration and the peak effect occurs in the range of 8-12 hours. Bimatoprost effects may last up to 24 hours. |
|---|---|
| Half-life | The elimination half-life of bimatoprost is approximately 45 minutes. |
| Protein binding | Bimatoprost is about 88%-90% bound to plasma proteins. |
| Metabolism | Bimatoprost is hydrolyzed to its active form, bimatoprost acid, in the eye.Bimatoprost undergoes oxidation, N-deethylation, and glucuronidation after it is systemically absorbed, and this leads to the production of various metabolites.In vitro studies show that CYP3A4 is an enzyme that participates in the metabolism of bimatoprost. Despite this, many enzymes and pathways metabolize bimatoprost, therefore, no significant drug-drug interactions are likely to occur.Glucuronidated metabolites comprise most of the excreted drug product in the blood, urine, and feces in rats. |
| Route of elimination | One pharmacokinetic study of bimatoprost in 6 healthy volunteers determined that 67% of the administered dose was found to be excreted in the urine while 25% of the dose was recovered in the feces. |
| Volume of distribution | The volume of distribution at steady state is 0.67 L/kg.. It penetrates the human cornea and sclera. |
| Clearance | The clearance was measured to be 1.5 L/hr/kg in healthy subjects receiving IV administration of bimatoprost dosed at 3.12 ug/kg. |
Formulation & handling
- Bimatoprost is a small‑molecule prostaglandin analog primarily formulated as ophthalmic solutions, requiring excipients that support ocular permeability and minimize irritation.
- Low aqueous solubility necessitates use of solubilizers or emulsified systems to maintain stability and clarity in drop formulations.
- The compound is chemically sensitive to hydrolysis and oxidation, so formulations typically require controlled pH and protection from light and oxidative stress during handling and storage.
Regulatory status
| Lifecycle | Key U.S. patents have already expired or will lapse by 2025, and Canadian protection ends in 2026, indicating that the ingredient is nearing full generic exposure. With products marketed in Canada, the US, and the EU, the API is transitioning into a mature market phase across all major regions. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Bimatoprost is primarily associated with a single originator company, with downstream packaging handled by the same firm and an additional contract packager. The product is marketed across major regulated regions, including the United States, Canada, and the European Union, indicating broad global distribution. Several key US and Canadian patents have already expired, with remaining protections ending between 2025 and 2026, suggesting established or imminent generic participation in the supply landscape. |
|---|
Safety
| Toxicity | No information is available at this time regarding bimatoprost overdose in humans. Provide supportive symptomatic treatment if an overdose occurs. |
|---|
- Human overdose data are limited
- Available reports note no defined toxicity profile, so handling protocols should emphasize standard controls for prostaglandin analogs
- Exposure may elicit class‑related ocular effects (e
Bimatoprost 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.
Bimatoprost (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.
Bimatoprost API manufacturers & distributors
Compare qualified Bimatoprost API suppliers worldwide. We currently have 17 companies offering Bimatoprost API, with manufacturing taking place in 7 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 | CoA, EDMF/ASMF, GMP, GDP, MSDS, USDMF | 243 products |
| Biocon | Producer | India | India | CoA, GMP, WC | 36 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 |
| Industriale Chimica | Producer | Italy | Unknown | CoA, USDMF | 33 products |
| Jiangxi Bioman Pharma Lim... | Producer | China | China | CoA | 15 products |
| Kyowa Pharma Chem. | Producer | Japan | Unknown | CoA, JDMF, USDMF | 12 products |
| Laurus Labs | Producer | India | India | CoA, GMP, USDMF, WC | 50 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 |
| Piramal Healthcare | Producer | United Kingdom | Unknown | CoA, JDMF | 31 products |
| Shanghai Techwell Biophar... | Producer | China | China | CoA | 4 products |
| Shanghai Tianwei Biology ... | Producer | China | China | CoA, JDMF | 6 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, MSDS, WC | 762 products |
| Yonsung Fine Chem. | Producer | South Korea | South Korea | CoA, USDMF | 13 products |
When sending a request, specify which Bimatoprost 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 Bimatoprost 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 Bimatoprost API
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Regulatory
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Pharmaoffer
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