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Formoterol | CAS No: 73573-87-2 | GMP-certified suppliers
A medication that supports asthma and COPD management by providing reliable bronchodilation in maintenance and exercise‑related use across major global respiratory markets.
Therapeutic categories
Adrenergic AgentsAdrenergic AgonistsAdrenergic beta-2 Receptor AgonistsAdrenergic beta-AgonistsAdrenergics for Systemic UseAdrenergics, Inhalants
Generic name
Formoterol
Molecule type
small molecule
CAS number
73573-87-2
DrugBank ID
DB00983
Approval status
Approved drug, Investigational drug
ATC code
R03AL09
Primary indications
- Formoterol is indicated in various formulations for the treatment of asthma and COPD
- For the treatment of COPD, formoterol is available as a single-entity inhalation solution,in combination with the long-acting muscarinic antagonists (LAMAs) [aclidinium]and [glycopyrronium],and in combination with the corticosteroid [budesonide]
- For the treatment of asthma, formoterol is available in combination with [mometasone furoate] for patients 5 years and olderand with budesonide for patients 6 years and older
- Formoterol may also be used on an as-needed basis for prophylaxis against exercise-induced bronchospasm
Product Snapshot
- Formoterol is an inhaled small‑molecule bronchodilator supplied mainly as metered-dose or dry‑powder aerosol formulations and related inhalation solutions
- It is used for maintenance management of asthma and COPD, including availability as single‑agent and fixed‑dose combination products with LAMAs or inhaled corticosteroids
- It is approved in the US, EU, and Canada, with both fully approved and investigational presentations in these markets
Clinical Overview
Formoterol (CAS 73573-87-2) is a long-acting beta2‑adrenergic receptor agonist used in inhaled formulations for the management of asthma and chronic obstructive pulmonary disease. It is administered as a racemic mixture containing the active R,R‑enantiomer and the less active S,S‑enantiomer. Indications include maintenance treatment of COPD as a single-entity inhalation solution and fixed-dose combinations with long-acting muscarinic antagonists such as aclidinium or glycopyrronium, and with the corticosteroid budesonide. In asthma, it is used in combination with inhaled corticosteroids such as budesonide or mometasone furoate for pediatric and adult patients meeting age criteria. It is also applied as needed for prevention of exercise-induced bronchospasm.
Formoterol produces bronchodilation through selective stimulation of beta2‑adrenergic receptors in bronchial smooth muscle, with approximately 200‑fold greater activity at beta2 over beta1 receptors. Receptor activation increases intracellular cyclic AMP via adenylyl cyclase stimulation, resulting in smooth muscle relaxation and inhibition of inflammatory mediator release from mast cells. Clinically, formoterol has a rapid onset of action of about 2 to 3 minutes and a duration of effect up to 12 hours.
Pharmacokinetic parameters vary by formulation and inhalation technique. Absorption is largely local in the lung with limited systemic exposure at therapeutic doses. Formoterol is metabolized mainly via conjugation pathways including UGT1A9 and UGT2B7, and to a lesser extent through cytochrome P450 isoenzymes such as CYP2D6, CYP2C9, CYP2C19, and CYP2A6. Metabolites and unchanged drug are excreted through renal and fecal routes.
Safety considerations include avoidance of long-acting beta agonist monotherapy in asthma due to an observed increase in asthma-related mortality. Potential systemic effects include tachycardia, tremor, hypokalemia, and QTc prolongation, particularly with excessive dosing or drug interactions.
For API procurement, sourcing should prioritize suppliers with demonstrated control of stereochemistry, impurity profiles, and inhalation-grade specifications supported by regulatory filings such as DMFs or CEPs.
Formoterol produces bronchodilation through selective stimulation of beta2‑adrenergic receptors in bronchial smooth muscle, with approximately 200‑fold greater activity at beta2 over beta1 receptors. Receptor activation increases intracellular cyclic AMP via adenylyl cyclase stimulation, resulting in smooth muscle relaxation and inhibition of inflammatory mediator release from mast cells. Clinically, formoterol has a rapid onset of action of about 2 to 3 minutes and a duration of effect up to 12 hours.
Pharmacokinetic parameters vary by formulation and inhalation technique. Absorption is largely local in the lung with limited systemic exposure at therapeutic doses. Formoterol is metabolized mainly via conjugation pathways including UGT1A9 and UGT2B7, and to a lesser extent through cytochrome P450 isoenzymes such as CYP2D6, CYP2C9, CYP2C19, and CYP2A6. Metabolites and unchanged drug are excreted through renal and fecal routes.
Safety considerations include avoidance of long-acting beta agonist monotherapy in asthma due to an observed increase in asthma-related mortality. Potential systemic effects include tachycardia, tremor, hypokalemia, and QTc prolongation, particularly with excessive dosing or drug interactions.
For API procurement, sourcing should prioritize suppliers with demonstrated control of stereochemistry, impurity profiles, and inhalation-grade specifications supported by regulatory filings such as DMFs or CEPs.
Identification & chemistry
| Generic name | Formoterol |
|---|---|
| Molecule type | Small molecule |
| CAS | 73573-87-2 |
| UNII | 5ZZ84GCW8B |
| DrugBank ID | DB00983 |
Pharmacology
| Summary | Formoterol is a long‑acting agonist of beta‑2 adrenergic receptors that promotes bronchodilation by increasing intracellular cAMP in bronchial smooth muscle. It has substantially higher affinity for beta‑2 than beta‑1 receptors, supporting targeted relaxation of airway smooth muscle and suppression of mediator release from mast cells. Its pharmacologic activity provides rapid onset and prolonged airway smooth‑muscle relaxation relevant to chronic respiratory diseases. |
|---|---|
| Mechanism of action | Formoterol is a relatively selective long-acting agonist of beta<sub>2</sub>-adrenergic receptors,although it does carry some degree of activity at beta<sub>1</sub> and beta<sub>3</sub> receptors.Beta<sub>2</sub> receptors are found predominantly in bronchial smooth muscle (with a relatively minor amount found in cardiac tissue) whereas beta<sub>1</sub> receptors are the predominant adrenergic receptors found in the heart - for this reason, selectivity for beta<sub>2</sub> receptors is desirable in the treatment of pulmonary diseases such as COPD and asthma.Formoterol has demonstrated an approximately 200-fold greater activity at beta<sub>2</sub> receptors over beta<sub>1</sub> receptors. On a molecular level, activation of beta receptors by agonists like formoterol stimulates intracellular adenylyl cyclase, an enzyme responsible for the conversion of ATP to cyclic AMP (cAMP). The increased levels of cAMP in bronchial smooth muscle tissue result in relaxation of these muscles and subsequent dilation of the airways, as well as inhibition of the release of hypersensitivity mediators (e.g. histamine, leukotrienes) from culprit cells, especially mast cells. |
| Pharmacodynamics | Formoterol works locally in the lungs as a bronchodilator, relaxing smooth muscle and opening up the airways. It possesses both a rapid onset of action (approximately 2-3 minutes)and a long duration of action (up to 12 hours).The use of long-acting beta-agonists (LABAs), such as formoterol, without concomitant inhaled corticosteroids in asthmatic patients should be avoided, as LABA monotherapy has been associated with an increased risk of asthma-related death. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Beta-2 adrenergic receptor | Humans | agonist |
| Beta-1 adrenergic receptor | Humans | agonist |
| Beta-3 adrenergic receptor | Humans | agonist |
ADME / PK
| Absorption | The pulmonary bioavailability of formoterol has been estimated to be about 43% of the delivered dose, while the total systemic bioavailability is approximately 60% of the delivered dose (as systemic bioavailability accounts for absorption in the gut). Formoterol is rapidly absorbed into plasma following inhalation. In healthy adults, formoterol T<sub>max</sub> ranged from 0.167 to 0.5 hours.Following a single dose of 10 mcg, C<sub>max</sub> and AUC were 22 pmol/L and 81 pmol.h/L, respectively. In asthmatic adult patients, T<sub>max</sub> ranged from 0.58 to 1.97 hours.Following single-dose administration of 10mcg, C<sub>max</sub> and AUC<sub>0-12h</sub> were 22 pmol/L and 125 pmol.h/L, respectively; following multiple-dose administration of 10 mcg, C<sub>max</sub> and AUC<sub>0-12h</sub> were 41 pmol/L and 226 pmol.h/L, respectively. Absorption appears to be proportional to dose across standard dosing ranges. |
|---|---|
| Half-life | The average terminal elimination half-life of formoterol following inhalation is 7-10 hours, depending on the formulation given.The plasma half-life of formoterol has been estimated to be 3.4 hours following oral administration and 1.7-2.3 hours following inhalation. |
| Protein binding | Plasma protein binding to serum albumin _in vitro_ is approximately 31%-38% over a plasma concentration range of 5-500 ng/mL - it should be noted, however, that these concentrations are higher than that seen following inhalation. |
| Metabolism | Formoterol is metabolized primarily via direct glucuronidation of the parent drug and via O-demethylation of the parent drug followed by glucuronidation.Minor pathways include sulfate conjugation of the parent drug and deformylation of the parent drug followed by sulfate conjugation, though these minor pathways have not been fully characterized. The major pathway of formoterol metabolism is a direct glucuronidation of the parent drug at its phenolic hydroxyl group, while the second most prominent pathway involves O-demethylation following by glucuronidation at the phenolic hydroxyl group. _In vitro_ studies of formoterol disposition indicate that O-demethylation of formoterol involves a number of cytochrome P450 isoenzymes (CYP2D6, CYP2C19, CYP2C9, and CYP2A6) and glucuronidation involves a number of UDP-glucuronosyltransferase isoenzymes (UGT1A1, UGT1A8, UGT1A9, UGT2B7, and UGT2B15), though specific roles for individual enzymes have not been elucidated. |
| Route of elimination | Elimination differs depending on the route and formulation administered. Following oral administration in 2 healthy subjects, approximately 59-62% and 32-34% of an administered dose was eliminated in the urine and feces, respectively.Another study which attempted to mimic inhalation via combined intravenous/oral administration noted approximately 62% of the administered dose in the urine and 24% in the feces.Following inhalation in patients with asthma, approximately 10% and 15-18% of the administered dose was excreted in urine as unchanged parent drug and direct formoterol glucuronides, respectively, and corresponding values in patients with COPD were 7% and 6-9%, respectively. |
| Clearance | Renal clearance of formoterol following inhalation is approximately 157 mL/min. |
Formulation & handling
- Formoterol is a small‑molecule bronchodilator primarily formulated for inhalation, favoring aerosol, solution, and dry‑powder formats due to low aqueous solubility.
- Its moderate LogP and solid-state form support stable powder and capsule-inhalation systems, with attention to achieving uniform aerodynamic particle size distribution.
- Solution and suspension inhalation products require solubilizers or stabilizers to manage limited water solubility and maintain consistent delivery performance.
Regulatory status
| Lifecycle | The API’s core U.S. patents expired between 2016 and 2021, indicating that market exclusivity has lapsed. With products marketed in the US, EU, and Canada, the ingredient is positioned in a mature stage of its lifecycle with established generic availability likely. |
|---|
| Markets | US, EU, Canada |
|---|
Supply Chain
| Supply chain summary | Formoterol is supplied by a small set of originator and established manufacturers, with additional packagers supporting distribution across the US, EU, and Canada. Branded products are widely available in these markets, indicating mature global presence. The listed US patents have all expired, suggesting that generic competition is already established or readily possible. |
|---|
Safety
| Toxicity | The oral LD<sub>50</sub> in rats is 3130 mg/kg. Symptoms of overdose are likely consistent with formoterol's adverse effect profile (i.e. consistent with excessive beta-adrenergic stimulation) and may include angina, hyper or hypotension, tachycardia, arrhythmia, nervousness, headache, tremor, seizures, dry mouth, etc. Patients may experience laboratory abnormalities including hypokalemia, hyperglycemia, and metabolic acidosis.Treatment of overdosage should consist of symptomatic and supportive therapy, with a particular focus on cardiac monitoring. Consider the use of a cardioselective beta-adrenergic blocker to oppose excessive adrenergic stimulation if clinically appropriate. |
|---|
High Level Warnings:
- Oral LD50 in rats is approximately 3130 mg/kg, indicating low acute toxicity but requiring standard controls to limit ingestion and dust exposure
- Excessive beta‑adrenergic stimulation may manifest as tachycardia, arrhythmia, blood‑pressure fluctuations, tremor, or CNS excitation under high exposure conditions
- High systemic levels may be associated with laboratory abnormalities such as hypokalemia, hyperglycemia, and metabolic acidosis, supporting the need for controlled handling environments
Formoterol is a type of Adrenergic agents
Adrenergic agents are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that target the adrenergic system in the body. This system is responsible for regulating various physiological responses, including heart rate, blood pressure, and smooth muscle contraction.
Adrenergic agents can be further divided into two main groups: adrenergic agonists and adrenergic antagonists. Adrenergic agonists stimulate the adrenergic receptors, leading to an increase in sympathetic nervous system activity. This can result in effects such as vasoconstriction, bronchodilation, and increased heart rate. Adrenergic agonists are commonly used in the treatment of conditions such as asthma, hypotension, and cardiac arrest.
On the other hand, adrenergic antagonists block the adrenergic receptors, thereby inhibiting the effects of sympathetic nervous system activation. These agents are often employed to lower blood pressure, treat certain heart conditions, and manage symptoms associated with conditions like benign prostatic hyperplasia. Adrenergic antagonists can be further classified into alpha-adrenergic antagonists and beta-adrenergic antagonists, based on their selectivity for different adrenergic receptor subtypes.
Pharmaceutical companies extensively utilize adrenergic agents as key components in the development of various medications. Adrenergic APIs offer targeted effects on the adrenergic system, allowing for precise modulation of physiological responses. The understanding of adrenergic agents and their mechanisms of action is vital for the design and optimization of drugs used in the treatment of numerous medical conditions. Researchers and scientists continue to explore and innovate within this subcategory to develop new adrenergic agents with enhanced efficacy and fewer side effects, ultimately improving patient outcomes.
Formoterol (Adrenergic agents), classified under Central Nervous System Agents
Central Nervous System (CNS) Agents are a crucial category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that specifically target the central nervous system. The CNS encompasses the brain and spinal cord, playing a vital role in regulating and controlling various bodily functions, including cognition, movement, emotions, and sensory perception. These agents are designed to interact with specific receptors, enzymes, or ion channels within the CNS to modulate neural activity and restore normal functioning.
CNS agents comprise a diverse range of pharmaceutical APIs, including analgesics, anesthetics, antipsychotics, sedatives, hypnotics, anti-epileptics, and antidepressants. Each subcategory addresses distinct neurological disorders and conditions. For instance, analgesics alleviate pain by targeting receptors in the brain and spinal cord, while antipsychotics are employed to manage psychosis symptoms in mental illnesses such as schizophrenia.
The development of CNS agents involves rigorous research, molecular modeling, and extensive clinical trials to ensure safety, efficacy, and specific target engagement. Pharmaceutical companies invest significant resources in identifying novel drug targets, synthesizing new compounds, and optimizing their pharmacological properties. These agents undergo rigorous regulatory evaluations and must adhere to stringent quality standards and guidelines.
Given the prevalence of CNS disorders globally, the market demand for effective CNS agents is substantial. The development of innovative CNS APIs not only improves patient outcomes but also provides valuable commercial opportunities for pharmaceutical companies. Continued advancements in CNS agent research and development hold the promise of groundbreaking therapies that can improve the quality of life for individuals affected by neurological conditions.
Formoterol API manufacturers & distributors
Compare qualified Formoterol API suppliers worldwide. We currently have 11 companies offering Formoterol API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Cipla | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 164 products |
| Coral Drugs | Producer | India | India | CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, USDMF, WC, WHO-GMP | 25 products |
| Farmabios | Producer | Italy | Italy | CEP, CoA, FDA, GMP, USDMF | 58 products |
| Fermion | Producer | Finland | Finland | BSE/TSE, CEP, CoA, Other, MSDS | 29 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Industriale Chimica | Producer | Italy | Unknown | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF | 33 products |
| Lusochimica | Producer | Italy | Italy | CEP, CoA, FDA, GMP, KDMF, USDMF | 23 products |
| Miat | Producer | Italy | Italy | CoA | 10 products |
| MSN Labs. | Producer | India | India | CEP, CoA, GMP, USDMF, WC | 119 products |
| Mylan | Producer | India | India | CEP, CoA, FDA, GMP, KDMF, USDMF, WC | 201 products |
| Vamsi Labs | Producer | India | India | CEP, CoA, FDA, GMP, ISO9001, USDMF, WC, WHO-GMP | 29 products |
When sending a request, specify which Formoterol 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 Formoterol 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 Formoterol API
Sourcing
What matters most when sourcing GMP-grade Formoterol?
When sourcing GMP‑grade Formoterol, the key considerations are compliance with US, EU, and Canadian regulatory standards and verification that the manufacturer operates under recognized GMP. It is important to work with established producers or packagers with a documented quality and regulatory history. Given the mature market and presence of generics, supply chain reliability and consistent documentation are essential.
Which documents are typically required when sourcing Formoterol API?
Request the core API documentation set: CoA (11 companies), CEP (9 companies), GMP (8 companies), USDMF (8 companies), FDA (7 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Formoterol API?
Known or reported manufacturers for Formoterol: Coral Drugs, Vamsi Labs. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Formoterol API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Formoterol manufacturers?
Audit reports may be requested for Formoterol: 8 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Formoterol API on Pharmaoffer?
Reported supplier count for Formoterol: 11 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Formoterol API?
Production countries reported for Formoterol: India (5 producers), Italy (3 producers), Finland (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Formoterol usually hold?
Common certifications for Formoterol suppliers: CoA (11 companies), CEP (9 companies), GMP (8 companies), USDMF (8 companies), FDA (7 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Formoterol (CAS 73573-87-2) used for?
Formoterol is used as an inhaled long‑acting beta2‑adrenergic agonist for maintenance treatment of asthma and chronic obstructive pulmonary disease. It is administered alone for COPD or in fixed‑dose combinations with inhaled corticosteroids or long‑acting muscarinic antagonists for asthma and COPD. It is also used to prevent exercise‑induced bronchospasm.
Which therapeutic class does Formoterol fall into?
Formoterol belongs to the following therapeutic categories: Adrenergic Agents, Adrenergic Agonists, Adrenergic beta-2 Receptor Agonists, Adrenergic beta-Agonists, Adrenergics for Systemic Use. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Formoterol mainly prescribed for?
The primary indications for Formoterol: Formoterol is indicated in various formulations for the treatment of asthma and COPD, For the treatment of COPD, Formoterol is available as a single-entity inhalation solution,in combination with the long-acting muscarinic antagonists (LAMAs) [aclidinium]and [glycopyrronium],and in combination with the corticosteroid [budesonide], For the treatment of asthma, Formoterol is available in combination with [mometasone furoate] for patients 5 years and olderand with budesonide for patients 6 years and older, Formoterol may also be used on an as-needed basis for prophylaxis against exercise-induced bronchospasm. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Formoterol work?
Formoterol is a relatively selective long-acting agonist of beta2-adrenergic receptors,although it does carry some degree of activity at beta1 and beta3 receptors.Beta2 receptors are found predominantly in bronchial smooth muscle (with a relatively minor amount found in cardiac tissue) whereas beta1 receptors are the predominant adrenergic receptors found in the heart - for this reason, selectivity for beta2 receptors is desirable in the treatment of pulmonary diseases such as COPD and asthma.Formoterol has demonstrated an approximately 200-fold greater activity at beta2 receptors over beta1 receptors.
On a molecular level, activation of beta receptors by agonists like Formoterol stimulates intracellular adenylyl cyclase, an enzyme responsible for the conversion of ATP to cyclic AMP (cAMP). The increased levels of cAMP in bronchial smooth muscle tissue result in relaxation of these muscles and subsequent dilation of the airways, as well as inhibition of the release of hypersensitivity mediators (e.g. histamine, leukotrienes) from culprit cells, especially mast cells.
What should someone know about the safety or toxicity profile of Formoterol?
Formoterol has low acute oral toxicity in animal studies, but standard controls are needed to limit ingestion and dust exposure. Excessive beta‑adrenergic stimulation can cause tachycardia, arrhythmias, blood‑pressure changes, tremor, or CNS excitation, and high systemic levels may lead to hypokalemia, hyperglycemia, or metabolic acidosis. Systemic effects such as tachycardia, tremor, and QTc prolongation are more likely with excessive dosing or interacting drugs. Long‑acting beta agonist monotherapy should be avoided in asthma due to an observed increase in asthma‑related mortality.
What are important formulation and handling considerations for Formoterol as an API?
Key considerations include managing Formoterol’s low aqueous solubility, which often requires solubilizers or stabilizers in solution and suspension inhalation products. For dry‑powder and capsule‑based systems, its solid‑state properties and moderate LogP support stable formulations, but achieving uniform aerodynamic particle size distribution is essential for consistent pulmonary delivery. Handling should ensure protection of the powder’s physical stability and blend uniformity to maintain dose reproducibility.
Is Formoterol a small molecule?
Formoterol is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Formoterol?
Oral formulations of Formoterol must address its low aqueous solubility, which can limit dissolution and consistent absorption in the gastrointestinal tract. The compound is otherwise a stable small molecule, so stability concerns center on achieving suitable solubilization and maintaining uniform drug content rather than on chemical degradation.
Regulatory
Where is Formoterol approved or in use globally?
Formoterol is reported as approved in the following major regions: US, EU, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Formoterol right now?
Formoterol is approved for use in the United States, European Union, and Canada. In these regions, it is regulated as a long‑acting beta‑agonist for respiratory indications. Patent status differs by jurisdiction and formulation, with protections typically determined by product‑specific filings rather than the active ingredient alone.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Formoterol procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Formoterol. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Formoterol included in the PRO Data Insights coverage?
PRO Data Insights coverage for Formoterol: 1358 verified transactions across 301 suppliers and 161 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Formoterol?
Market report availability for Formoterol: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
