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Phenylephrine | CAS No: 59-42-7 | GMP-certified suppliers
A medication that supports management of anesthesia‑ or shock‑related hypotension, facilitates ocular dilation, and relieves nasal or anorectal congestion across diverse formulation needs.
Therapeutic categories
Primary indications
- Phenylephrine is available in various drug formulations, which have different indications
- Phenylephrine injections are indicated to treat hypotension caused by shock or anesthesia
- The ophthalmic formulation is indicated to induce mydriasis and conjunctival vasoconstriction
- The intranasal formulation is used to treat congestion, and a topical formulation is used to treat hemorrhoids
Product Snapshot
- Phenylephrine is a small‑molecule API supplied in multiple formulations including injectable solutions, oral solid and liquid forms, ophthalmic drops, nasal sprays, and topical preparations
- It is used for anesthesia‑ or shock‑related hypotension, ocular mydriasis and vasoconstriction, nasal congestion management, and local vasoconstrictive applications
- It is approved and marketed in the US, Canada, and the EU
Clinical Overview
Phenylephrine increases vascular tone through selective alpha‑1 receptor activation. Systemic administration raises systolic and diastolic blood pressure and increases peripheral vascular resistance. Reflex vagal activation may follow, resulting in bradycardia. Ophthalmic administration facilitates mydriasis without significant cycloplegia. The compound’s pharmacology is consistent with its functional classes, including adrenergic agonists, sympathomimetics, vasoconstrictors, and nasal decongestants.
Absorption and disposition vary by route. Intravenous dosing produces rapid hemodynamic effects with an effective half‑life of approximately 5 minutes and an elimination half‑life of about 2.5 hours. Ophthalmic formulations exert local effects for 3 to 8 hours. Phenylephrine metabolism involves monoamine oxidase pathways, and systemic exposure is typically limited following intranasal or topical administration.
Safety considerations depend on formulation and route. Intravenous use requires monitoring for bradycardia, hypertension, extravasation with risk of tissue injury, hypersensitivity reactions, and interactions with oxytocic agents. Ophthalmic use may cause arrhythmia, hypertension, or rebound miosis. Systemic sympathomimetic effects should be considered in patients with cardiovascular disease.
Phenylephrine is marketed globally in numerous branded and generic products spanning injectable vasopressors, ophthalmic drops, and decongestant preparations.
For API procurement, consistent stereochemical identity, impurity control, and compliance with pharmacopeial specifications are essential. Suppliers should provide robust analytical data and evidence of GMP manufacturing suitable for diverse dosage forms.
Identification & chemistry
| Generic name | Phenylephrine |
|---|---|
| Molecule type | Small molecule |
| CAS | 59-42-7 |
| UNII | 1WS297W6MV |
| DrugBank ID | DB00388 |
Pharmacology
| Summary | Phenylephrine is an alpha‑1 adrenergic receptor agonist that produces vasoconstriction and increases peripheral vascular resistance, leading to elevated blood pressure. Its activity at alpha‑1A, alpha‑1B, and alpha‑1D receptors also supports indication‑specific effects such as mydriasis and localized vascular constriction. Pharmacodynamic responses vary by route, reflecting differences in systemic exposure and tissue‑selective receptor engagement. |
|---|---|
| Mechanism of action | Phenylephrine is an alpha-1 adrenergic agonist that mediates vasoconstrictionand mydriasisdepending on the route and location of administration. Systemic exposure to phenylephrine also leads to agonism of alpha-1 adrenergic receptors, raising systolic and diastolic pressure as well as peripheral vascular resistance.Increased blood pressure stimulates the vagus nerve, causing reflex bradycardia. |
| Pharmacodynamics | Phenylephrine is an alpha-1 adrenergic agonist that raises blood pressure,dilates the pupils,and causes local vasoconstriction.Ophthalmic formulations of phenylephrine act for 3-8 hourswhile intravenous solutions have an effective half life of 5 minutes and an elimination half life of 2.5 hours.Patients taking ophthalmic formulations of phenylephrine should be counselled about the risk of arrhythmia, hypertension, and rebound miosis.Patients taking an intravenous formulation should be counselled regarding the risk of bradycardia, allergic reactions, extravasation causing necrosis or tissue sloughing, and the concomitant use of oxytocic drugs. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Alpha-1A adrenergic receptor | Humans | agonist |
| Alpha-1B adrenergic receptor | Humans | agonist |
| Alpha-1D adrenergic receptor | Humans | agonist |
ADME / PK
| Absorption | Phenylephrine is 38% orally bioavailable.Clinically significant systemic absorption of ophthalmic formulations is possible, especially at higher strengths and when the cornea is damaged. |
|---|---|
| Half-life | Intravenous phenylephrine has an effective half life of 5 minutes and an elimination half life of 2.5 hours. |
| Protein binding | Data regarding the protein binding of phenylephrine in serum is not readily available. |
| Metabolism | Phenylephrine is mainly metabolized by monoamine oxidase A, monoamine oxidase B, and SULT1A3.The major metabolite is the inactive meta-hydroxymandelic acid, followed by sulfate conjugates.Phenylephrine can also be metabolized to phenylephrine glucuronide. |
| Route of elimination | 86% of a dose of phenylephrine is recovered in the urinewith 16% as the unmetabolized drug, 57% as the inactive meta-hydroxymendelic acid, and 8% as inactive sulfate conjugates. |
| Volume of distribution | The volume of distribution of phenylephrine is 340L. |
| Clearance | Phenylephrine has an average clearance of 2100mL/min. |
Formulation & handling
- High aqueous solubility and low LogP support straightforward development of oral liquids, effervescent forms, and aqueous nasal/ophthalmic solutions without solubility enhancers.
- Parenteral formulations typically use simple aqueous vehicles; the small‑molecule nature and solid-state stability ease sterile manufacturing and minimize specialized handling needs.
- For inhalation, nasal, and ophthalmic products, attention to oxidative degradation and pH control is important to maintain solution stability and limit discoloration.
Regulatory status
| Lifecycle | Most U.S. patents for this API expired in early 2024, with later‑expiring protections extending into 2033–2034, indicating a shift from early generic entry toward a remaining period of limited exclusivity. Across the US, Canada, and the EU, the product is moving into a mixed‑maturity phase with partial loss of exclusivity alongside ongoing later‑term patent coverage. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Phenylephrine is an established active ingredient with no single dominant originator, and its supply is driven largely by a broad base of U.S.‑focused manufacturers and repackagers, reflecting a mature and highly genericized market. Branded and private‑label products are widely available in the United States, Canada, and the EU. Several U.S. patents expired in 2024, while others extend into the early 2030s, suggesting that core substance protection has lapsed and any remaining patents likely relate to specific formulations or delivery technologies, allowing continued or expanded generic competition. |
|---|
Safety
| Toxicity | Patients experiencing and overdose may present with headache, hypertension, reflex bradycardia, tingling limbs, cardiac arrhythmias, and a feeling of fullness in the head.Overdose may be treated by supportive care and discontinuing phenylephrine, chronotropic medications, and vasodilators.Subcutaneous phentolamine may be used to treat tissue extravasation. |
|---|
- High systemic exposure may elicit hypertensive responses, reflex bradycardia, limb paresthesias, and arrhythmogenic effects
- Local extravasation can produce intense vasoconstriction and tissue injury risk
- Monitor for CNS and cardiovascular load, as overdose presentations include headache and marked cranial pressure sensations
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.
Phenylephrine is a type of Nasal decongestants
Nasal decongestants belong to the pharmaceutical API (Active Pharmaceutical Ingredient) subcategory used for alleviating nasal congestion. They are commonly employed to relieve symptoms associated with various respiratory conditions, including allergies, colds, and sinusitis.
These decongestants work by constricting the blood vessels in the nasal passages, thereby reducing inflammation and swelling. The main mechanism of action involves stimulating alpha-adrenergic receptors, which leads to the narrowing of blood vessels and decreases blood flow to the nasal mucosa.
One of the widely used nasal decongestants is oxymetazoline, available in both over-the-counter and prescription-strength formulations. It exhibits a rapid onset of action and provides long-lasting relief from nasal congestion. Oxymetazoline acts selectively on alpha-adrenergic receptors, ensuring localized effects without significant systemic absorption.
Another common nasal decongestant is phenylephrine, which is often found in over-the-counter nasal sprays and oral formulations. Phenylephrine constricts blood vessels in the nasal passages, promoting nasal decongestion. However, its efficacy may be somewhat limited compared to other nasal decongestants.
Nasal decongestants come in various formulations, including nasal sprays, drops, and oral tablets. It is important to follow the recommended dosage instructions and not exceed the recommended duration of use to avoid potential rebound congestion or other adverse effects.
Before using nasal decongestants, it is advisable to consult a healthcare professional, especially for individuals with certain medical conditions or those taking other medications, to ensure their safe and effective use.
Overall, nasal decongestants play a crucial role in providing temporary relief from nasal congestion and improving breathing comfort for individuals suffering from respiratory ailments.
Phenylephrine (Nasal decongestants ), classified under Respiratory Tract Agents
Respiratory Tract Agents are a vital category of pharmaceutical APIs (Active Pharmaceutical Ingredients) designed to treat respiratory conditions and diseases. These agents are specifically formulated to target the respiratory system, which includes the lungs, airways, and nasal passages. They play a crucial role in managing various respiratory disorders, such as asthma, chronic obstructive pulmonary disease (COPD), and allergic rhinitis.
Respiratory Tract Agents encompass a wide range of medications, including bronchodilators, corticosteroids, antihistamines, and mucolytics. Bronchodilators are commonly used to relieve airway constriction and facilitate smooth breathing by relaxing the muscles in the airways. Corticosteroids help reduce inflammation in the respiratory system, alleviating symptoms and preventing exacerbations. Antihistamines work by blocking histamine receptors, thus mitigating allergic reactions that often impact the respiratory tract. Mucolytics aid in loosening and thinning mucus, making it easier to expel from the airways.
These APIs are developed through rigorous research and development processes, ensuring their efficacy, safety, and compliance with regulatory standards. Pharmaceutical manufacturers rely on advanced technologies and stringent quality control measures to produce high-quality Respiratory Tract Agents. These APIs are subsequently incorporated into various dosage forms, including inhalers, nasal sprays, nebulizers, and oral medications.
Respiratory Tract Agents are essential in the management of respiratory conditions, providing relief from symptoms, improving lung function, and enhancing the overall quality of life for patients. They are prescribed by healthcare professionals and often used in combination therapies to achieve optimal results. As respiratory disorders continue to affect a significant portion of the global population, the development and availability of effective Respiratory Tract Agents play a vital role in addressing these health challenges and improving patient outcomes.
Phenylephrine API manufacturers & distributors
Compare qualified Phenylephrine API suppliers worldwide. We currently have 24 companies offering Phenylephrine 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 |
|---|---|---|---|---|---|
| Apex Healthcare | Producer | India | India | CoA, WC | 9 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Boehringer Ingelheim | Producer | Germany | Unknown | CEP, CoA, FDA, GMP, KDMF, USDMF | 35 products |
| Cheng Fong Chemical | Producer | Taiwan | Taiwan | CEP, CoA, FDA, KDMF, USDMF | 6 products |
| Chifeng Arker Tech. | Producer | China | China | CoA, WC | 8 products |
| Chr. Olesen Group | Distributor | Denmark | India | CEP, CoA, USDMF | 252 products |
| Divis Labs. | Producer | India | India | CEP, CoA, FDA, GMP, ISO9001, Other, KDMF, USDMF, WC | 47 products |
| G.C. Chemie Pharmie Ltd | Producer | India | India | CoA | 21 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| Iwaki Seiyaku | Producer | Japan | Japan | CEP, CoA, FDA, JDMF, KDMF, USDMF | 21 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Malladi Drugs & Pharma | Producer | India | India | CEP, CoA, GMP, KDMF, USDMF, WC | 14 products |
| Novus Fine Chem. | Producer | United States | United States | CoA, USDMF | 2 products |
| Pharm Rx Chemical Corp | Distributor | United States | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Sai-Tech Pharmaceuticals ... | Producer | India | India | CoA | 8 products |
| Shilpa Medicare Ltd | Producer | India | India | CoA, FDA, GMP, ISO9001 | 54 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, MSDS | 764 products |
| Syn-tech Chem | Producer | Taiwan | Taiwan | CoA, KDMF, USDMF | 22 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Unichem Labs. | Producer | India | India | CEP, CoA, GMP, USDMF, WC | 62 products |
| Valence Labs | Producer | India | India | CoA, GMP | 32 products |
| ZCL Chemicals | Producer | India | India | CoA, Other, FDA, ISO9001 | 30 products |
| Zhejiang Hisoar | Producer | China | China | CEP, CoA, USDMF, WC | 10 products |
When sending a request, specify which Phenylephrine 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 Phenylephrine 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 Phenylephrine API
Sourcing
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Technical
What is Phenylephrine (CAS 59-42-7) used for?
Which therapeutic class does Phenylephrine fall into?
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How does Phenylephrine work?
What should someone know about the safety or toxicity profile of Phenylephrine?
What are important formulation and handling considerations for Phenylephrine as an API?
Is Phenylephrine a small molecule?
Are there special stability concerns for oral Phenylephrine?
Regulatory
Where is Phenylephrine approved or in use globally?
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Pharmaoffer
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