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Naloxone API from Indian Manufacturers & Suppliers
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Turkey|
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Produced in
United States|
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CoA
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Produced in
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CoA
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Naloxone | CAS No: 465-65-6 | GMP-certified suppliers
A medication that provides rapid emergency reversal of known or suspected opioid overdose and supports clinical management of opioid‑related respiratory depression across diverse care settings.
Therapeutic categories
Alimentary Tract and MetabolismAlkaloidsAnalgesicsAntidotesCentral Nervous System AgentsCytochrome P-450 CYP2C18 Substrates
Generic name
Naloxone
Molecule type
small molecule
CAS number
465-65-6
DrugBank ID
DB01183
Approval status
Approved drug, Vet_approved drug
ATC code
A06AH04
Primary indications
- Naloxone nasal sprays are indicated for the reversal of an opioid overdose or suspected opioid overdose: it is intended for immediate administration as emergency therapy in settings where opioids may be present
- Intramuscular, intravenous, and subcutaneous injections are indicated for complete or partial reversal of opioid depression, diagnosis of known or suspected opioid overdose, and as an adjunct therapy in the treatment of septic shock
- Sublingual tablets and films are formulated with [buprenorphine] for the treatment of opioid dependence
Product Snapshot
- Naloxone is available as injectable small‑molecule solutions, nasal sprays, and oral combinations with buprenorphine or pentazocine
- Its primary uses are reversal of opioid overdose, reversal of opioid‑induced respiratory/CNS depression, and inclusion in combination products for opioid dependence or severe pain
- It is approved in major markets including the US, Canada, and the EU, with both human and veterinary approvals
Clinical Overview
Naloxone (CAS 465-65-6) is an opioid receptor antagonist indicated for the rapid reversal of known or suspected opioid overdose. It is used across emergency medical, community, and hospital settings to counteract opioid‑induced respiratory and central nervous system depression. Additional approved uses include reversal of opioid effects during diagnostic evaluation, adjunctive management of septic shock, and deterrence against parenteral misuse when co‑formulated with buprenorphine in sublingual products. It is also incorporated with pentazocine for oral analgesic use and has off‑label application for neuraxial opioid‑induced pruritus.
Naloxone exhibits high affinity for the µ‑opioid receptor and functions as a competitive antagonist, rapidly displacing agonists such as morphine, fentanyl, or heroin. It has minimal pharmacological activity in individuals without recent opioid exposure, giving it a wide therapeutic window. Because its duration of action is shorter than that of many opioids, repeated dosing or continuous infusion may be required to maintain reversal.
Following intramuscular or subcutaneous administration, onset typically occurs within minutes. Naloxone undergoes extensive hepatic metabolism, with metabolites excreted largely in urine. It is a substrate for several cytochrome P450 and UGT pathways and is transported by P‑glycoprotein. Its elimination half‑life is shorter than that of most high‑potency synthetic opioids, contributing to the risk of renarcotization.
Safety considerations mainly relate to the rapid induction of opioid withdrawal in dependent individuals, characterized by nausea, vomiting, agitation, sweating, and gastrointestinal symptoms. These effects are uncomfortable but not usually harmful. Naloxone has little effect in opioid‑naïve individuals and is generally well tolerated.
Naloxone is marketed globally in injectable, nasal spray, and autoinjector formats, with Narcan being a widely recognized brand. For formulation and procurement teams, API sourcing should emphasize identity and potency verification, control of stereochemistry, impurity profiling consistent with major pharmacopeial monographs, and assurance of stability to support a wide range of emergency‑use dosage forms.
Naloxone exhibits high affinity for the µ‑opioid receptor and functions as a competitive antagonist, rapidly displacing agonists such as morphine, fentanyl, or heroin. It has minimal pharmacological activity in individuals without recent opioid exposure, giving it a wide therapeutic window. Because its duration of action is shorter than that of many opioids, repeated dosing or continuous infusion may be required to maintain reversal.
Following intramuscular or subcutaneous administration, onset typically occurs within minutes. Naloxone undergoes extensive hepatic metabolism, with metabolites excreted largely in urine. It is a substrate for several cytochrome P450 and UGT pathways and is transported by P‑glycoprotein. Its elimination half‑life is shorter than that of most high‑potency synthetic opioids, contributing to the risk of renarcotization.
Safety considerations mainly relate to the rapid induction of opioid withdrawal in dependent individuals, characterized by nausea, vomiting, agitation, sweating, and gastrointestinal symptoms. These effects are uncomfortable but not usually harmful. Naloxone has little effect in opioid‑naïve individuals and is generally well tolerated.
Naloxone is marketed globally in injectable, nasal spray, and autoinjector formats, with Narcan being a widely recognized brand. For formulation and procurement teams, API sourcing should emphasize identity and potency verification, control of stereochemistry, impurity profiling consistent with major pharmacopeial monographs, and assurance of stability to support a wide range of emergency‑use dosage forms.
Identification & chemistry
| Generic name | Naloxone |
|---|---|
| Molecule type | Small molecule |
| CAS | 465-65-6 |
| UNII | 36B82AMQ7N |
| DrugBank ID | DB01183 |
Pharmacology
| Summary | Naloxone is a competitive antagonist of µ‑opioid receptors that rapidly displaces opioids and reverses their central and peripheral effects; it also interacts with delta‑ and kappa‑opioid receptors with lower affinity. Its pharmacodynamic profile is characterized by rapid onset, short duration relative to many opioids, and minimal activity in the absence of opioid agonists. Naloxone is used across formulations to counteract opioid toxicity and to mitigate opioid effects in combination products for specific therapeutic contexts. |
|---|---|
| Mechanism of action | Naloxone is a competitive inhibitor of the µ-opioid receptor.Naloxone antagonizes the action of opioids, reversing their effects.If a patient has not taken opioids, naloxone does not have a significant effect on patients. |
| Pharmacodynamics | Naloxone is an opioid receptor antagonist indicated in the reversal of opioid overdoses.Naloxone has a shorter duration of action than opioids and multiple doses may be required.The therapeutic window of naloxone is wide, as it has no effect if a patient has not taken opioids.Patients treated with naloxone may experience opioid withdrawal and a person administering naloxone should be aware that reversal of opioid overdoses may not resolve all the symptoms a patient is experiencing if other drugs are involved. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Mu-type opioid receptor | Humans | antagonist |
| Delta-type opioid receptor | Humans | antagonist |
| Kappa-type opioid receptor | Humans | antagonist |
ADME / PK
| Absorption | An intranasal dose of naloxone is 42-47% bioavailable.An 8 mg dose of nasal naloxone reaches a C<sub>max</sub> of 12.3-12.8 ng/mL, with a T<sub>max</sub> of 0.25 hours, and an AUC of 16.7-19.0 h\*ng/mL.A 0.4 mg intramuscular dose reaches a C<sub>max</sub> of 0.876-0.910 ng/mL, with a T<sub>max</sub> of 0.25 hours, and an AUC of 1.94-1.95 h\*ng/mL.A 2 mg intravenous dose reaches a C<sub>max</sub> of 26.2 ng/mL with an AUC of 12.8 h\*ng/mL. |
|---|---|
| Half-life | The mean half life of naloxone hydrochloride is 1.8-2.7 hours intranasally, 1.4 hours intramuscularly, and 1.2 hours intravenously.In neonates, the mean half life is 3.1 ± 0.5 hours. |
| Protein binding | Naloxone is approximately 45% bound to albumin, but there is significant binding to other proteins. |
| Metabolism | Naloxone primarily undergoes glucuronidation to form naloxone-3-glucuronide.Naloxone is also N-dealkylated to noroxymorphone or undergoes 6-keto reduction to naloxol. |
| Route of elimination | After oral or intravenous administration, naloxone is 25-40% eliminated in the urine within 6 hours, 50% in 24 hours, and 60-70% in 72 hours.The metabolites naloxone-3-glucuronide, noroxymorphone, and naloxol are all detected in the urine. |
| Volume of distribution | The volume of distribution of naloxone is 200 L.Naloxone distributes into tissues rapidly.It can also cross the placenta and blood-brain barrier. |
| Clearance | The clearance of naloxone is 2500 L/day. |
Formulation & handling
- Suitable for multiple non-oral delivery systems (injectable, nasal, buccal, sublingual), with aqueous solution formulations enabled by its moderate water solubility.
- Solid-state API is stable for standard handling, but solution formulations require protection from oxidation and should be prepared with appropriate antioxidants or oxygen‑limiting conditions.
- Buccal and sublingual products must account for salivary dissolution kinetics and are sensitive to concurrent food or drink exposure during administration.
Regulatory status
| Lifecycle | Most U.S. patent protection for the API has expired, with the final listed patents scheduled to lapse in March 2025, indicating a transition toward full generic availability. With products already established in the US, Canada, and EU, the market is entering a mature phase characterized by increasing competition. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Naloxone has long-established originators, with numerous U.S.‑based manufacturers and repackagers now supplying finished products across the United States, Canada, and the European Union. Branded formulations such as buprenorphine–naloxone combinations have broad market presence, but most core naloxone patents have already expired or will do so by 2025. This patent landscape supports existing and expanding generic competition across global markets. |
|---|
Safety
| Toxicity | If a patient has not taken opioids, naloxone does not have a significant effect on patients. The oral LD<sub>50</sub> in mice and rats is >1 g/kg.The intraperitoneal LD<sub>50</sub> is 80 mg/kg in mice and 239 mg/kg in rats.The subcutaneous LD<sub>50</sub> is 286 mg/kg in mice and 500 mg/kg in rats. |
|---|
High Level Warnings:
- Exhibits low acute oral toxicity (mouse/rat LD50 ›1 g/kg) but significantly higher toxicity via parenteral routes, with intraperitoneal LD50 values as low as 80 mg/kg in mice, indicating the need for controlled handling of concentrated bulk material
- Pharmacodynamic activity is opioid‑dependent
- Negligible effect in opioid‑naïve subjects reduces the risk of unintended pharmacologic impact during routine laboratory handling
Naloxone is a type of Opioid antagonists
Opioid antagonists are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) that play a vital role in the management and treatment of opioid-related disorders. These powerful substances bind to opioid receptors in the brain, blocking the effects of opioids and reversing their potentially life-threatening effects.
Opioid antagonists work by competitively binding to opioid receptors, preventing opioids from attaching to these receptors and inhibiting their activity. This mechanism of action effectively counteracts the effects of opioids, including pain relief, sedation, and respiratory depression. By blocking the receptors, opioid antagonists can rapidly reverse the effects of opioid overdose, providing a vital emergency intervention.
One of the widely used opioid antagonists is naloxone, a highly effective and fast-acting medication. Naloxone is commonly administered in emergency settings, such as hospitals and ambulances, as well as by first responders and bystanders. Its rapid onset of action and short duration make it an essential tool for reversing opioid overdoses, potentially saving lives.
Opioid antagonists not only serve as a critical intervention for overdose cases but also have applications in the management of opioid addiction. By blocking the rewarding effects of opioids, these pharmaceutical APIs can help reduce cravings and prevent relapse in individuals undergoing opioid dependence treatment.
In conclusion, opioid antagonists are indispensable pharmaceutical APIs in combating the devastating effects of opioids. Their ability to bind to opioid receptors and counteract the effects of opioids makes them essential in both emergency situations and addiction treatment. Naloxone, among other opioid antagonists, stands as a crucial tool in saving lives and addressing the opioid crisis.
Naloxone API manufacturers & distributors
Compare qualified Naloxone API suppliers worldwide. We currently have 12 companies offering Naloxone API, with manufacturing taking place in 9 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 |
|---|---|---|---|---|---|
| Chr. Olesen Group | Distributor | Denmark | Denmark | CoA, GMP, MSDS, USDMF | 252 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Macfarlan Smith | Producer | United Kingdom | Unknown | CEP, CoA, FDA, GMP, USDMF | 23 products |
| Mallinckrodt | Producer | United States | United States | CEP, CoA, FDA, GMP, USDMF | 34 products |
| Noramco | Producer | United States | United States | CoA, USDMF | 18 products |
| Resonance Labs. | Producer | India | India | CoA, GMP, WHO-GMP | 34 products |
| S.A.L.A.R.S. | Producer | Italy | Italy | CEP, CoA, FDA, GMP | 7 products |
| Sanofi | Producer | France | Unknown | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF | 93 products |
| Sun Pharma | Producer | India | India | CEP, CoA, GMP, USDMF, WC | 219 products |
| Temad Co. | Producer | Iran | Iran | CoA, GMP, ISO9001, MSDS, USDMF, WC | 24 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 134 products |
| Vonage Pharma (Former Plu... | Producer | Turkey | Turkey | CoA, GMP, MSDS, USDMF, WC | 28 products |
When sending a request, specify which Naloxone 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 Naloxone 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 Naloxone API
Sourcing
What matters most when sourcing GMP-grade Naloxone?
Key considerations include confirming GMP compliance and meeting regulatory requirements for the United States, Canada, and the European Union. Buyers should verify that manufacturers or repackagers have appropriate approvals and quality systems for these markets. Because Naloxone is supplied by multiple established producers and most core patents have expired or will soon expire, ensuring consistent quality and reliable supply chains is essential.
Which documents are typically required when sourcing Naloxone API?
Request the core API documentation set: CoA (12 companies), GMP (10 companies), USDMF (9 companies), CEP (6 companies), FDA (4 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Naloxone API?
Known or reported manufacturers for Naloxone: Chr. Olesen Group, Vonage Pharma (Former Pluvia Endo), Veeprho Group, LGM Pharma, Temad Co.. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Naloxone 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 Naloxone manufacturers?
Audit reports may be requested for Naloxone: 4 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Naloxone API on Pharmaoffer?
Reported supplier count for Naloxone: 12 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Naloxone API?
Production countries reported for Naloxone: India (2 producers), United States (2 producers), Denmark (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Naloxone usually hold?
Common certifications for Naloxone suppliers: CoA (12 companies), GMP (10 companies), USDMF (9 companies), CEP (6 companies), FDA (4 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Naloxone (CAS 465-65-6) used for?
Naloxone is used to rapidly reverse known or suspected opioid overdose by competitively blocking µ‑opioid receptors and restoring respiratory and central nervous system function. It is also used to reverse opioid effects during diagnostic procedures, as an adjunct in managing septic shock, and to deter parenteral misuse when combined with buprenorphine or pentazocine in specific formulations. Off‑label, it may be used for neuraxial opioid‑induced pruritus.
Which therapeutic class does Naloxone fall into?
Naloxone belongs to the following therapeutic categories: Alimentary Tract and Metabolism, Alkaloids, Analgesics, Antidotes, Central Nervous System Agents. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Naloxone mainly prescribed for?
The primary indications for Naloxone: Naloxone nasal sprays are indicated for the reversal of an opioid overdose or suspected opioid overdose: it is intended for immediate administration as emergency therapy in settings where opioids may be present, Intramuscular, intravenous, and subcutaneous injections are indicated for complete or partial reversal of opioid depression, diagnosis of known or suspected opioid overdose, and as an adjunct therapy in the treatment of septic shock, Sublingual tablets and films are formulated with [buprenorphine] for the treatment of opioid dependence. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Naloxone work?
Naloxone is a competitive inhibitor of the µ-opioid receptor.Naloxone antagonizes the action of opioids, reversing their effects.If a patient has not taken opioids, Naloxone does not have a significant effect on patients.
What should someone know about the safety or toxicity profile of Naloxone?
Naloxone has low acute oral toxicity but shows higher toxicity with parenteral exposure, so concentrated API should be handled with appropriate controls. It produces negligible pharmacologic effects in opioid‑naïve individuals, contributing to a wide safety margin during routine handling and clinical use. The primary safety concern is rapid precipitation of opioid withdrawal in dependent individuals, which is uncomfortable but typically not harmful.
What are important formulation and handling considerations for Naloxone as an API?
Naloxone’s moderate water solubility supports aqueous formulations for injectable, nasal, buccal, and sublingual use, but solution products require protection from oxidation, including use of antioxidants or oxygen‑limiting conditions. The solid-state API is stable under standard handling. Buccal and sublingual formulations must account for salivary dissolution behavior and potential interference from food or drink at the time of administration. Intranasal products should ensure consistent delivery to support reliable systemic absorption.
Is Naloxone a small molecule?
Naloxone is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Naloxone?
Oral Naloxone would follow the known stability characteristics of the API: the solid-state material is stable under standard handling, while any aqueous solution requires protection from oxidation and may need antioxidants or oxygen‑limiting conditions. As with other mucosal routes, formulations exposed to saliva can be affected by dissolution kinetics and concurrent food or drink during administration.
Regulatory
Where is Naloxone approved or in use globally?
Naloxone is reported as approved in the following major regions: US, Canada, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Naloxone right now?
Naloxone is authorized for use in the United States, Canada, and the European Union under established regulatory frameworks. The provided context does not list any active patents, indicating no patent restrictions within this scope.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Naloxone procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Naloxone. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Naloxone included in the PRO Data Insights coverage?
PRO Data Insights coverage for Naloxone: 266 verified transactions across 110 suppliers and 76 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Naloxone?
Market report availability for Naloxone: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
