Amitriptyline API Manufacturers & Suppliers

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Sinoway industrial Co.,Ltd

Distributor

Produced in China

Employees: 50+

Audit Report:

Certifications: MSDS

ISO9001

CoA

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MSDS

ISO9001

CoA

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LGM Pharma

Distributor

Produced in World

Employees: 200+

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Certifications: GMP

CEP

USDMF

MSDS

BSE/TSE

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GMP

CEP

USDMF

MSDS

BSE/TSE

CoA

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Duchefa Farma B.V.

Distributor

Produced in India

Employees: 50+

Audit Report:

Certifications: GMP

CEP

MSDS

BSE/TSE

ISO9001

All certificates

GMP

CEP

MSDS

BSE/TSE

ISO9001

CoA

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Tenatra Exports Private Limited

Distributor

Produced in India

Employees: 10

Audit Report:

Certifications: GMP

FDA

MSDS

BSE/TSE

CoA

All certificates

GMP

FDA

MSDS

BSE/TSE

CoA

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Vasudha Pharma Chem Ltd.

Producer

Produced in India

Employees: 4,000

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Certifications: GMP

FDA

CEP

USDMF

MSDS

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GMP

FDA

CEP

USDMF

MSDS

KDMF

CoA

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Sun Pharma

Producer

Produced in India

Audit Report:

Certifications: USDMF

CoA

All certificates

USDMF

CoA

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Amitriptyline | CAS No: 50-48-6 | GMP-certified suppliers

A medication that supports adult treatment of major depression, neuropathic pain, and recurrent headaches, while also aiding specialist‑guided management of persistent nocturnal enuresis in children.

Therapeutic categories

Adrenergic alpha-1 Receptor AntagonistsAdrenergic alpha-AntagonistsAdrenergic AntagonistsAdrenergic Uptake InhibitorsAgents producing tachycardiaAgents that produce hypertension

Generic name

Amitriptyline

Molecule type

small molecule

CAS number

50-48-6

DrugBank ID

DB00321

Approval status

Approved drug

ATC code

N06AA09

Primary indications

This drug in indicated for the following conditions [FDA label]:
Major depressive disorder in adults
Management of neuropathic pain in adults
Prophylactic treatment of chronic tension-type headache (CTTH) in adults

Product Snapshot

Amitriptyline is supplied mainly as an oral small‑molecule solid dose with additional intramuscular and topical presentations
It is used for major depressive disorder and for management or prophylaxis of neuropathic pain and certain headache disorders, with ancillary use in refractory nocturnal enuresis
It is an approved product in the United States and Canada

Clinical Overview

Amitriptyline (CAS 50-48-6) is a tricyclic antidepressant of the dibenzocycloheptene class used globally for major depressive disorder and several pain-related conditions. It is also indicated for neuropathic pain, prophylaxis of migraine and chronic tension-type headache, and management of nocturnal enuresis in children when other therapies have failed and specialist oversight is ensured. Off‑label use extends to irritable bowel syndrome, certain sleep disorders, diabetic neuropathy, agitation, fibromyalgia, and insomnia. ELAVIL is a historically recognized branded product.

Amitriptyline exhibits combined antidepressant, analgesic, anticholinergic, and sedative effects. Its clinical activity in depression and pain is associated with centrally mediated neurotransmitter modulation. Cardiovascular effects, including ECG changes, orthostatic hypotension, tachycardia, and potential QTc prolongation, have been documented. Strong anticholinergic activity contributes to dry mouth, blurred vision, constipation, and potential cognitive effects, particularly in older adults. Amitriptyline lowers the seizure threshold and alters EEG and sleep architecture.

The mechanism of action is not fully defined. Available evidence supports inhibition of presynaptic reuptake of norepinephrine and serotonin, increasing synaptic concentrations and enhancing monoaminergic neurotransmission. The relationship between monoamine modulation and its analgesic benefit is not clearly established.

Amitriptyline is metabolized extensively by hepatic cytochrome P450 pathways, including CYP2C19, CYP2D6, and CYP3A isoforms, and shows substrate or inhibitory activity across multiple CYP enzymes. It is also a P‑glycoprotein substrate. These interactions contribute to a narrow therapeutic index and create potential for clinically relevant drug–drug interactions. Renal elimination accounts for metabolites rather than significant unchanged drug.

Safety considerations include dose‑dependent cardiotoxicity, anticholinergic burden, risk of serotonin syndrome when combined with serotonergic agents, and the potential for neurotoxicity at high exposures.

For API procurement, suppliers should provide full documentation of impurity profiles, control of stereochemistry, residual solvent limits, and compliance with relevant pharmacopeial monographs to support global regulatory submissions.

Identification & chemistry

Generic name	Amitriptyline
Molecule type	Small molecule
CAS	50-48-6
UNII	1806D8D52K
DrugBank ID	DB00321

Pharmacology

Summary	Amitriptyline is a tricyclic antidepressant that primarily inhibits norepinephrine and serotonin reuptake transporters, increasing synaptic monoamine levels. It also interacts with multiple receptors, including adrenergic, histaminergic, muscarinic, and several serotonin receptor subtypes, contributing to its analgesic, sedative, and anticholinergic pharmacology. Additional activity at cardiac ion channels and other neuronal targets underlies its effects on cardiac conduction, seizure threshold, and broader central nervous system function.
Mechanism of action	The mechanism of action of this drug is not fully elucidated. It is suggested that amitriptyline inhibits the membrane pump mechanism responsible for the re-uptake of transmitter amines, such as norepinephrine and serotonin, thereby increasing their concentration at the synaptic clefts of the brain [FDA label], . These amines are important in regulating mood. The monoamine hypothesis in depression, one of the oldest hypotheses, postulates that deficiencies of serotonin (5-HT) and/or norepinephrine (NE) neurotransmission in the brain lead to depressive effects . This drug counteracts these mechanisms, and this may be the mechanism of amitriptyline in improving depressive symptoms. Whether its analgesic effects are related to its mood-altering activities or attributable to a different, less obvious pharmacological action (or a combination of both) is unknown .
Pharmacodynamics	Effects in pain and depression Amitriptyline is a tricyclic antidepressant and an analgesic. It has anticholinergic and sedative properties [FDA label]. Clinical studies have shown that oral amitriptyline achieves, at a minimum, good to moderate response in up to 2/3 of patients diagnosed with post-herpetic neuralgia and 3/4 of patients diagnosed with diabetic neuropathic pain, and neurogenic pain syndromes that are frequently unresponsive to narcotic analgesics. Amitriptyline has also shown efficacy in diverse groups of patients with chronic non-malignant pain. There have also been some studies showing efficacy in managing fibromyalgia (an off-label use of this drug) , . Cardiovascular and Anticholinergic Effects Amitriptyline has strong anticholinergic properties and may cause ECG changes and quinidine-like effects on the heart . Amitriptyline may inhibit ion channels, which are necessary for cardiac repolarization (hERG channels), in the upper micromolar range of therapeutic plasma concentrations. Therefore, amitriptyline may increase the risk for cardiac arrhythmia [FDA label]. Orthostatic hypotension and tachycardia can be a problem in elderly patients receiving this drug at normal doses for depression. There is evidence in the literature that these effects may occur, rarely, at the lower dosages utilized in the treatment of pain. As with any other tricyclic antidepressant agent, increased glucose levels can occur with amitriptyline . Effects on seizure threshold This drug also decreases the convulsive threshold and causes alterations in EEG and sleep patterns .

Targets

Target	Organism	Actions
Sodium-dependent noradrenaline transporter	Humans	inhibitor
Sodium-dependent serotonin transporter	Humans	inhibitor
5-hydroxytryptamine receptor 2A	Humans	antagonist

ADME / PK

Absorption	Rapidly absorbed following oral administration (bioavailability is 30-60% due to first pass metabolism). Peak plasma concentrations are reached 2-12 hours after oral or intramuscular administration [FDA label]. Steady-state plasma concentrations vary greatly and this variation may be due to genetic differences .
Half-life	The elimination half-life (t1⁄2 β) amitriptyline after peroral administration is about 25 hours (24.65 ± 6.31 hours; range 16.49-40.36 hours) [FDA Label].
Protein binding	Very highly protein bound (95%) in plasma and tissues [FDA Label].
Metabolism	In vitro, the metabolism of amitriptyline occurs mainly by demethylation (CYP2C19, CYP3A4) as well as hydroxylation (CYP2D6) followed by conjugation with glucuronic acid. Other isozymes involved in amitriptyline metabolism are CYP1A2 and CYP2C9. The metabolism of this drug is subject to genetic polymorphisms. The main active metabolite is the secondary amine, _nortriptyline_ [FDA label]. Nortriptyline is a stronger inhibitor of noradrenaline than of serotonin uptake, while amitriptyline inhibits the uptake of noradrenaline and serotonin with equal efficacy. Other metabolites such as _cis-_ and _trans-10-hydroxyamitriptyline_ and _cis-_ and _trans-10-hydroxynortriptyline_ have the same pharmacologic profile as nortriptyline but are significantly weaker. _Demethylnortriptyline_ and amitriptyline N oxide are only present in plasma in negligible amounts; the latter is mostly inactive [FDA label].
Route of elimination	Amitriptyline and its metabolites are mainly excreted in the urine. Virtually the entire dose is excreted as glucuronide or sulfate conjugate of metabolites, with approximately 2% of unchanged drug appearing in the urine [FDA Label]. 25-50% of a single orally administered dose is excreted in urine as inactive metabolites within 24 hours [FDA label]. Small amounts are excreted in feces via biliary elimination .
Volume of distribution	The apparent volume of distribution (Vd)β estimated after intravenous administration is 1221 L±280 L; range 769-1702 L (16±3 L/kg) [FDA Label]. It is found widely distributed throughout the body . Amitriptyline and the main metabolite _nortriptyline_ pass across the placental barrier and small amounts are present in breast milk [FDA Label].
Clearance	The mean systemic clearance (Cls) is 39.24 ± 10.18 L/h (range: 24.53-53.73 L/h) [FDA Label]. No clear effect of older age on the pharmacokinetics of amitriptyline has been determined, although it is possible that clearance may be decreased .

Formulation & handling

Amitriptyline is a small‑molecule oral and intramuscular API with high lipophilicity and very low aqueous solubility, requiring solubilizers or salt forms for liquid and IM formulations.
Oral solid dosage development may need protective coatings or pH‑modifying excipients to manage poor solubility and gastric irritation.
Solution and IM preparations require attention to chemical stability in aqueous media, as the hydrophobic API can precipitate without appropriate cosolvents or surfactants.

Regulatory status

Lifecycle	The active ingredient is marketed in Canada and the United States, where loss or impending loss of patent protection typically signals transition to a mature, largely genericized market. Market dynamics in both regions generally reflect established competition and stable demand once exclusivity has ended.

Markets	Canada, US

Supply Chain

Supply chain summary	Amitriptyline was originally developed by a single originator company, but the long-standing patent expiry has enabled extensive generic manufacturing by numerous firms across the United States and globally. Branded presence today is limited, with most market activity occurring through generic products in the US and Canada. The mature patent status supports a fully established generic landscape with broad repackaging and distribution networks.

Supply chain summary

Amitriptyline was originally developed by a single originator company, but the long-standing patent expiry has enabled extensive generic manufacturing by numerous firms across the United States and globally. Branded presence today is limited, with most market activity occurring through generic products in the US and Canada. The mature patent status supports a fully established generic landscape with broad repackaging and distribution networks.

Safety

Toxicity	Toxicity Data: Oral TDLO (child): 4167 μg/kg; Oral TDLO (man): 714 μg/kg/1D (intermittent); Oral TDLO (woman): 10 mg/kg . Ingestion of 750 mg or more by an adult may result in severe toxicity. The effects in overdose are further increased by simultaneous ingestion of alcohol and another psychotropic agent [FDA label]. Symptoms of overdose include abnormally low blood pressure, confusion, convulsions, dilated pupils and other eye problems, disturbed concentration, drowsiness, hallucinations, impaired heart function, rapid or irregular heartbeat, reduced body temperature, stupor, and unresponsiveness or coma, among others [FDA label], . Use in pregnancy For amitriptyline, only limited clinical data are available regarding its use in pregnancy. Amitriptyline is not recommended during pregnancy unless clearly required and only after careful consideration of both risks and benefits [FDA label]. Use in breastfeeding Amitriptyline and its metabolites are excreted into breast milk (corresponding to 0.6 % - 1 % of the maternal dose). A risk to the suckling child must be considered. A decision should be made as to whether it is appropriate to discontinue breastfeeding or to discontinue/abstain from the therapy of this medicinal product, considering the benefit of breastfeeding for the child and the benefit of therapy for the woman. Effects on fertility Animal studies have shown reproductive toxicity. No data on the effects of amitriptyline on human fertility are available [FDA label]. Mutagenesis and carcinogenesis The genotoxic potential of amitriptyline has been investigated in various in vitro and in vivo studies. Although these investigations showed some contradictory results, a potential of amitriptyline to lead to chromosome abnormalities cannot be excluded. Long-term carcinogenicity studies have not been performed to this date [FDA label].

Toxicity

**Toxicity Data**: Oral TDLO (child): 4167 μg/kg; Oral TDLO (man): 714 μg/kg/1D (intermittent); Oral TDLO (woman): 10 mg/kg . Ingestion of 750 mg or more by an adult may result in severe toxicity. The effects in overdose are further increased by simultaneous ingestion of alcohol and another psychotropic agent [FDA label]. Symptoms of overdose include abnormally low blood pressure, confusion, convulsions, dilated pupils and other eye problems, disturbed concentration, drowsiness, hallucinations, impaired heart function, rapid or irregular heartbeat, reduced body temperature, stupor, and unresponsiveness or coma, among others [FDA label], . **Use in pregnancy** For amitriptyline, only limited clinical data are available regarding its use in pregnancy. Amitriptyline is not recommended during pregnancy unless clearly required and only after careful consideration of both risks and benefits [FDA label]. **Use in breastfeeding** Amitriptyline and its metabolites are excreted into breast milk (corresponding to 0.6 % - 1 % of the maternal dose). A risk to the suckling child must be considered. A decision should be made as to whether it is appropriate to discontinue breastfeeding or to discontinue/abstain from the therapy of this medicinal product, considering the benefit of breastfeeding for the child and the benefit of therapy for the woman. **Effects on fertility** Animal studies have shown reproductive toxicity. No data on the effects of amitriptyline on human fertility are available [FDA label]. **Mutagenesis and carcinogenesis** The genotoxic potential of amitriptyline has been investigated in various in vitro and in vivo studies. Although these investigations showed some contradictory results, a potential of amitriptyline to lead to chromosome abnormalities cannot be excluded. Long-term carcinogenicity studies have not been performed to this date [FDA label].

High Level Warnings:

Oral toxicity thresholds are low (adult ingestion ≥750 mg linked to severe toxicity)
Overdose manifestations include CNS depression, cardiovascular instability, convulsions, and thermoregulatory impairment
Exhibits reproductive and genotoxic risks in preclinical studies

Amitriptyline is a type of Tricyclic antidepressants

Tricyclic antidepressants (TCAs) are a class of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the treatment of various mental health disorders, especially depression and anxiety. TCAs derive their name from their unique molecular structure, which consists of three interconnected rings.

These antidepressants work by inhibiting the reuptake of neurotransmitters such as serotonin and norepinephrine in the brain, thereby increasing their availability and improving mood regulation. Some commonly prescribed TCAs include amitriptyline, imipramine, and nortriptyline.

The efficacy of TCAs in managing depressive symptoms is well-documented, making them a popular choice among healthcare professionals. Additionally, they exhibit analgesic properties, making them useful in treating chronic pain conditions like neuropathic pain and migraines.

It is important to note that TCAs are associated with a range of side effects, including dry mouth, drowsiness, constipation, and blurred vision. Moreover, they require careful monitoring due to their potential for drug interactions, particularly with monoamine oxidase inhibitors (MAOIs) and selective serotonin reuptake inhibitors (SSRIs).

Despite the availability of newer classes of antidepressants, TCAs remain an essential component of the treatment arsenal for various mental health disorders. Their well-established efficacy, along with ongoing research and development in the field, ensures that TCAs will continue to play a significant role in managing these conditions in the foreseeable future.

Amitriptyline (Tricyclic antidepressants), classified under Antidepressants

Antidepressants are a category of pharmaceutical Active Pharmaceutical Ingredients (APIs) widely used in the treatment of depression and other mood disorders. These medications work by balancing the levels of certain chemicals in the brain called neurotransmitters, such as serotonin, norepinephrine, and dopamine.

There are several types of antidepressants available, each with its own mechanism of action and efficacy. Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed as a first-line treatment for depression. They prevent the reabsorption of serotonin, resulting in increased serotonin levels in the brain. Examples of popular SSRIs include fluoxetine, sertraline, and escitalopram.

Tricyclic antidepressants (TCAs) are another class of antidepressants that work by blocking the reuptake of both serotonin and norepinephrine. They are generally used when SSRIs are ineffective or not well-tolerated. Amitriptyline, nortriptyline, and imipramine are commonly prescribed TCAs.

Other antidepressants include serotonin-norepinephrine reuptake inhibitors (SNRIs), atypical antidepressants, and monoamine oxidase inhibitors (MAOIs). SNRIs, such as venlafaxine and duloxetine, inhibit the reuptake of both serotonin and norepinephrine. Atypical antidepressants, including bupropion and mirtazapine, have diverse mechanisms of action, targeting multiple neurotransmitters. MAOIs, such as phenelzine and tranylcypromine, work by inhibiting the enzyme monoamine oxidase, which breaks down neurotransmitters.

It is important to note that antidepressants may have various side effects and require close monitoring by healthcare professionals. Dosages and treatment duration vary based on individual needs and response. Antidepressants are typically prescribed as part of a comprehensive treatment plan that may include psychotherapy and lifestyle modifications.

In conclusion, antidepressants are a vital category of pharmaceutical APIs used to manage depression and related mood disorders. They act on neurotransmitters in the brain to alleviate symptoms and improve overall well-being. It is crucial to consult with a healthcare provider to determine the most suitable antidepressant and monitor its effects.

Amitriptyline API manufacturers & distributors

Compare qualified Amitriptyline API suppliers worldwide. We currently have 6 companies offering Amitriptyline API, with manufacturing taking place in 3 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
Duchefa Farma B.V.	Distributor	Netherlands	India	BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, WC	170 products
LGM Pharma	Distributor	United States	World	BSE/TSE, CEP, CoA, GMP, MSDS, USDMF	441 products
Sinoway industrial Co.,Lt...	Distributor	China	China	CoA, ISO9001, MSDS	757 products
Sun Pharma	Producer	India	India	CoA, USDMF	219 products
Tenatra Exports Private L...	Distributor	India	India	BSE/TSE, CoA, FDA, GMP, MSDS	263 products
Vasudha Pharma Chem Ltd.	Producer	India	India	CEP, CoA, FDA, GMP, KDMF, MSDS, USDMF, WC	37 products

When sending a request, specify which Amitriptyline 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 Amitriptyline 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 Amitriptyline API

Sourcing

What matters most when sourcing GMP-grade Amitriptyline?

Key considerations include confirming that the manufacturer operates under GMP and meets U.S. and Canadian regulatory requirements for APIs. Reliable documentation such as a DMF or equivalent quality dossier is essential for compliance. Given the mature generic landscape, verifying the supplier’s consistency, traceability, and established distribution practices is also important.

Which documents are typically required when sourcing Amitriptyline API?

Request the core API documentation set: CoA (6 companies), MSDS (5 companies), GMP (4 companies), CEP (3 companies), BSE/TSE (3 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.

Which manufacturers are known to produce Amitriptyline API?

Known or reported manufacturers for Amitriptyline: Duchefa Farma B.V., Sinoway industrial Co.,Ltd, LGM Pharma, Tenatra Exports Private Limited. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.

How can I request quotes for Amitriptyline 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 Amitriptyline manufacturers?

Audit reports may be requested for Amitriptyline: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.

How many suppliers offer Amitriptyline API on Pharmaoffer?

Reported supplier count for Amitriptyline: 6 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.

Which countries are known to manufacture Amitriptyline API?

Production countries reported for Amitriptyline: India (4 producers), China (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.

Which certifications do suppliers of Amitriptyline usually hold?

Common certifications for Amitriptyline suppliers: CoA (6 companies), MSDS (5 companies), GMP (4 companies), CEP (3 companies), BSE/TSE (3 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Amitriptyline (CAS 50-48-6) used for?

Amitriptyline is used for major depressive disorder and for pain‑related indications such as neuropathic pain and the prevention of migraine or chronic tension‑type headache. It is also used to manage nocturnal enuresis in children when other therapies have failed and specialist oversight is in place. Additional off‑label uses include irritable bowel syndrome, certain sleep disorders, diabetic neuropathy, agitation, fibromyalgia, and insomnia.

Which therapeutic class does Amitriptyline fall into?

Amitriptyline belongs to the following therapeutic categories: Adrenergic alpha-1 Receptor Antagonists, Adrenergic alpha-Antagonists, Adrenergic Antagonists, Adrenergic Uptake Inhibitors, Agents producing tachycardia. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.

What conditions is Amitriptyline mainly prescribed for?

The primary indications for Amitriptyline: This drug in indicated for the following conditions [FDA label]:, Major depressive disorder in adults, Management of neuropathic pain in adults, Prophylactic treatment of chronic tension-type headache (CTTH) in adults. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.

How does Amitriptyline work?

The mechanism of action of this drug is not fully elucidated. It is suggested that Amitriptyline inhibits the membrane pump mechanism responsible for the re-uptake of transmitter amines, such as norepinephrine and serotonin, thereby increasing their concentration at the synaptic clefts of the brain [FDA label], . These amines are important in regulating mood. The monoamine hypothesis in depression, one of the oldest hypotheses, postulates that deficiencies of serotonin (5-HT) and/or norepinephrine (NE) neurotransmission in the brain lead to depressive effects . This drug counteracts these mechanisms, and this may be the mechanism of Amitriptyline in improving depressive symptoms. Whether its analgesic effects are related to its mood-altering activities or attributable to a different, less obvious pharmacological action (or a combination of both) is unknown .

What should someone know about the safety or toxicity profile of Amitriptyline?

Amitriptyline has a narrow therapeutic index, with adult ingestions of 750 mg or more associated with severe toxicity. Overdose can cause central nervous system depression, cardiovascular instability, seizures, and impaired thermoregulation. Its strong anticholinergic activity, dose‑dependent cardiotoxicity, serotonergic interaction potential, and ability to lower the seizure threshold are key safety concerns. Preclinical data also indicate reproductive and genotoxic risks at high exposures.

What are important formulation and handling considerations for Amitriptyline as an API?

Amitriptyline’s low aqueous solubility and high lipophilicity require use of solubilizers, cosolvents, or suitable salt forms to maintain drug availability, particularly in liquid and intramuscular formulations. Oral solid products may need pH‑modifying excipients or protective coatings to manage poor solubility and reduce gastric irritation. Aqueous solutions must be formulated to prevent precipitation and to maintain chemical stability. Handling typically requires controls that limit exposure to light and moisture to preserve API integrity.

Is Amitriptyline a small molecule?

Amitriptyline is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.

Are there special stability concerns for oral Amitriptyline?

Oral Amitriptyline has stability considerations mainly related to its high lipophilicity and very low aqueous solubility, which can lead to dissolution challenges in solid dosage forms. Protective coatings or pH‑modifying excipients may be needed to limit degradation and manage gastric irritation. In contrast to liquid or IM preparations, precipitation is less of a concern in oral solids, but maintaining adequate solubility and consistent release remains important.

Regulatory

Where is Amitriptyline approved or in use globally?

Amitriptyline is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.

What’s the regulatory and patent landscape for Amitriptyline right now?

Amitriptyline is an established, approved drug substance in both Canada and the United States. It is marketed generically, and its original patents and regulatory exclusivities have long expired. As a result, no active patent protections or exclusivity periods currently restrict its manufacture or sale in these markets.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Amitriptyline procurement?

Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Amitriptyline. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.

Is Amitriptyline included in the PRO Data Insights coverage?

PRO Data Insights coverage for Amitriptyline: 2373 verified transactions across 565 suppliers and 242 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.

Where can I access the API market report for Amitriptyline?

Market report availability for Amitriptyline: . The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.