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Minoxidil | CAS No: 38304-91-5 | GMP-certified suppliers
A medication that addresses severe hypertension and supports treatment of androgenic alopecia by providing therapeutic support for cardiovascular management and hair regrowth needs.
Therapeutic categories
Primary indications
- For the treatment of severe hypertension and in the topical treatment (regrowth) of androgenic alopecia in males and females and stabilisation of hair loss in patients with androgenic alopecia
Product Snapshot
- Minoxidil is available as an oral small‑molecule tablet and in multiple topical formulations such as solutions, foams, and lotions
- It is used for severe hypertension and for topical management of androgenic alopecia and hair‑loss stabilization
- It is approved in the US and Canada, with both approved and investigational statuses depending on the specific formulation
Clinical Overview
Pharmacodynamically, oral minoxidil enhances or maintains microcirculatory blood flow across vascular beds. In clinical settings, renal blood flow and glomerular filtration rate are preserved, with reductions observed in forearm and renal vascular resistance. The arterial vasodilatory action is predominant, and venous dilation is minimal, contributing to a lower incidence of postural hypotension. Antihypertensive activity is attributed to the active sulfate metabolite, minoxidil sulfate.
Mechanistically, minoxidil opens ATP‑sensitive potassium channels in vascular smooth muscle cells, leading to membrane hyperpolarization and relaxation of arteriolar smooth muscle. In the hair follicle, minoxidil is thought to prolong the anagen phase by activating ERK and Akt pathways and by increasing the Bcl‑2 to Bax ratio, supporting cell survival in dermal papilla cells. These proliferative and anti‑apoptotic effects are considered central to its use in androgenetic alopecia.
Absorption after oral administration is generally high, with hepatic metabolism contributing to formation of the active sulfate conjugate. The drug is primarily eliminated renally as metabolites. Key safety considerations include the risk of reflex tachycardia, fluid retention, and rare cases of pericardial effusion when used systemically; topical use may cause localized irritation.
Minoxidil is available globally in oral formulations for hypertension and in topical solutions or foams for alopecia, with widely recognized brands used as reference products. For API procurement, suppliers should demonstrate control of sulfate‑forming impurities, confirmed identity of the base compound, and compliance with regional pharmacopeial specifications to support formulation and regulatory submissions.
Identification & chemistry
| Generic name | Minoxidil |
|---|---|
| Molecule type | Small molecule |
| CAS | 38304-91-5 |
| UNII | 5965120SH1 |
| DrugBank ID | DB00350 |
Pharmacology
| Summary | Minoxidil exerts its primary effects by opening ATP‑sensitive potassium channels, producing arterial vasodilation and reducing peripheral vascular resistance through its active sulfate metabolite. In hair follicles, it promotes dermal papilla cell survival and proliferation by activating ERK and Akt pathways and enhancing anti‑apoptotic signaling, which supports prolongation of the anagen phase. These combined vascular and cellular actions underlie its use in severe hypertension and androgenetic alopecia. |
|---|---|
| Mechanism of action | Minoxidil is thought to promote the survival of human dermal papillary cells (DPCs) or hair cells by activating both extracellular signal-regulated kinase (ERK) and Akt and by preventing cell death by increasing the ratio of BCl<sup>-</sup>2/Bax. Minoxidil may stimulate the growth of human hairs by prolonging anagen through these proliferative and anti-apoptotic effects on DPCs. Minoxidil, when used as a vasodilator, acts by opening adenosine triphosphate-sensitive potassium channels in vascular smooth muscle cells. This vasodilation may also improve the viability of hair cells or hair follicles. |
| Pharmacodynamics | Minoxidil is an orally effective direct acting peripheral vasodilator that reduces elevated systolic and diastolic blood pressure by decreasing peripheral vascular resistance. Minoxidil is also used topically to treat androgenetic alopecia. Microcirculatory blood flow in animals is enhanced or maintained in all systemic vascular beds. In man, forearm and renal vascular resistance decline; forearm blood flow increases while renal blood flow and glomerular filtration rate are preserved. The predominant site of minoxidil action is arterial. Venodilation does not occur with minoxidil; thus, postural hypotension is unusual with its administration. The antihypertensive activity of minoxidil is due to its sulphate metabolite, minoxidil sulfate. |
Targets
| Target | Organism | Actions |
|---|---|---|
| ATP-sensitive inward rectifier potassium channel 1 | Humans | inducer |
| Renin | Humans | |
| Prostaglandin G/H synthase 1 | Humans | inducer |
ADME / PK
| Absorption | Minoxidil is at least 90% absorbed from the GI tract in experimental animals and man. |
|---|---|
| Half-life | 4.2 hours |
| Protein binding | Minoxidil does not bind to plasma proteins. |
| Metabolism | Approximately 90% of the administered drug is metabolized, predominantly by conjugation with glucuronic acid at the N-oxide position in the pyrimidine ring, but also by conversion to more polar products. Known metabolites exert much less pharmacologic effect than minoxidil itself. |
Formulation & handling
- Topical formulations dominate and require vehicles that enhance scalp penetration; the API’s high water solubility allows use in aqueous or hydroalcoholic systems.
- Oral tablets use the small‑molecule solid API with no food‑related absorption issues, simplifying excipient selection for conventional solid‑dose manufacturing.
- The compound is chemically stable as a solid and in solution but formulations should control oxidation and maintain pH to avoid degradation in aqueous systems.
Regulatory status
| Lifecycle | The active ingredient’s primary U.S. patent expired in 2019, indicating that the product is in a mature stage of its lifecycle. With availability in the US and Canada and no remaining patent exclusivity, the market is likely characterized by established generic competition. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Minoxidil’s supply landscape is dominated by numerous generic manufacturers and repackagers, with the original development attributed to Pharmacia & Upjohn before widespread generic entry. Branded and generic topical formulations are broadly available in the US and Canada. The key US patent listed (expiring in 2019) has lapsed, supporting the extensive generic competition already present in the market. |
|---|
Safety
| Toxicity | Oral LD<sub>50</sub> in rats has ranged from 1321-3492 mg/kg; in mice, 2456-2648 mg/kg. Side effects include cardiovascular effects associated with hypotension such as sudden weight gain, rapid heart beat, faintness or dizziness. |
|---|
- Oral LD50 values in rodents indicate low acute toxicity but a wide dose range
- Handle bulk material with controls appropriate for compounds exhibiting systemic exposure potential
- Known cardiovascular effects include hypotension-related responses such as tachycardia, fluid retention, and dizziness
Minoxidil is a type of Vasodilators
Vasodilators are a crucial subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a significant role in the management of various cardiovascular conditions. These medications work by widening the blood vessels, promoting increased blood flow and reducing peripheral resistance.
Vasodilators are commonly prescribed to treat hypertension (high blood pressure), angina (chest pain), and heart failure. They are designed to relax and dilate the smooth muscle cells in the walls of blood vessels, leading to improved circulation and reduced strain on the heart.
One widely used class of vasodilators is calcium channel blockers, which prevent calcium from entering the muscle cells of blood vessels. This action inhibits muscle contraction, resulting in widened arteries and enhanced blood flow. Another class is nitric oxide (NO) donors, which release NO, a potent vasodilator, to promote relaxation of vascular smooth muscles.
The therapeutic benefits of vasodilators extend beyond cardiovascular disorders. Some vasodilators, such as minoxidil, have been repurposed for treating male pattern baldness. These medications stimulate hair growth by dilating blood vessels around hair follicles, enhancing nutrient and oxygen delivery.
As with any pharmaceutical API, vasodilators must meet strict quality standards and regulatory guidelines to ensure safety and efficacy. Manufacturers employ sophisticated production processes and stringent quality control measures to guarantee the purity, potency, and stability of these APIs.
In conclusion, vasodilators are a vital subcategory of pharmaceutical APIs used to manage cardiovascular conditions. By expanding blood vessels and enhancing blood flow, vasodilators contribute to improved patient outcomes and play a critical role in the treatment of hypertension, angina, heart failure, and even hair loss.
Minoxidil (Vasodilators), classified under Antihypertensive agents
Antihypertensive agents are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) used to treat high blood pressure, also known as hypertension. These medications are designed to lower blood pressure and reduce the risk of associated cardiovascular complications.
Antihypertensive agents function by targeting various mechanisms involved in blood pressure regulation. Some common classes of antihypertensive agents include angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs), beta-blockers, calcium channel blockers (CCBs), and diuretics.
ACE inhibitors work by inhibiting the enzyme responsible for converting angiotensin I to angiotensin II, a hormone that constricts blood vessels. ARBs, on the other hand, block the receptors to which angiotensin II binds, thereby preventing its vasoconstrictive effects.
Beta-blockers reduce blood pressure by blocking the effects of adrenaline and noradrenaline, which are responsible for increasing heart rate and constricting blood vessels. CCBs inhibit calcium from entering the smooth muscles of blood vessels, resulting in relaxation and vasodilation. Diuretics promote the elimination of excess fluid and sodium from the body, reducing blood volume and thereby lowering blood pressure.
Antihypertensive agents are typically prescribed based on the individual patient's condition and specific needs. They can be used alone or in combination to achieve optimal blood pressure control. It is important to note that antihypertensive agents should be taken regularly as prescribed by a healthcare professional and may require periodic monitoring to ensure their effectiveness and manage any potential side effects.
In summary, antihypertensive agents play a vital role in the management of hypertension by targeting various mechanisms involved in blood pressure regulation. These medications offer significant benefits in reducing the risk of cardiovascular complications associated with high blood pressure.
Minoxidil API manufacturers & distributors
Compare qualified Minoxidil API suppliers worldwide. We currently have 22 companies offering Minoxidil API, with manufacturing taking place in 6 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 |
|---|---|---|---|---|---|
| Atilus Pharma | Producer | India | India | BSE/TSE, CEP, CoA, FDA, GMP, HALAL, Kosher, MSDS | 11 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, cDMF, CoA, GMP, ISO14001, ISO9001, MSDS, WC | 235 products |
| Changzhou Tianhua | Producer | China | China | CoA, WC | 5 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Italy | CoA, GMP, ISO9001, MSDS, WC | 170 products |
| Flamma | Producer | Italy | Italy | CEP, CoA, FDA, GMP, USDMF | 6 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Hunan Huateng Pharmaceuti... | Producer | China | China | CoA, GMP, ISO9001, MSDS | 7 products |
| Hänseler AG | Distributor | Switzerland | Italy | CoA, GMP | 174 products |
| ICROM | Producer | Italy | Italy | CoA, GMP, USDMF | 19 products |
| Kumar Organic | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 3 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Metapharmaceutical Indust... | Producer | Spain | India | BSE/TSE, CEP, CoA, GDP, GMP, MSDS, WC, WHO-GMP | 21 products |
| Nanjing Hemu Haohai Biote... | Producer | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, GMP, MSDS, USDMF | 23 products |
| Pharm Rx Chemical Corp | Distributor | United States | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| S.P. Quimica | Producer | Spain | Spain | CoA, GMP | 11 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Sichuan Benepure | Producer | China | China | CoA | 23 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
When sending a request, specify which Minoxidil 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 Minoxidil 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 Minoxidil API
Sourcing
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Technical
What is Minoxidil (CAS 38304-91-5) used for?
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What conditions is Minoxidil mainly prescribed for?
How does Minoxidil work?
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Is Minoxidil a small molecule?
Are there special stability concerns for oral Minoxidil?
Regulatory
Where is Minoxidil approved or in use globally?
Pharmaoffer
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