Dihydrohydroxycodeinone (Oxycodone) API Manufacturers & Suppliers
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Oxycodone | CAS No: 76-42-6 | GMP-certified suppliers
A medication that supports management of moderate to severe acute and chronic pain, offering reliable analgesic control for diverse clinical needs in regulated healthcare markets.
Therapeutic categories
AlkaloidsAnalgesicsCentral Nervous System AgentsCentral Nervous System DepressantsCytochrome P-450 CYP2D6 SubstratesCytochrome P-450 CYP3A Substrates
Generic name
Oxycodone
Molecule type
small molecule
CAS number
76-42-6
DrugBank ID
DB00497
Approval status
Approved drug, Illicit drug, Investigational drug
ATC code
N02AA56
Primary indications
- Oxycodone is indicated for the treatment of moderate to severe pain
- [Label] There is also an extended release formulation indicated for chronic moderate to severe pain requiring continuous opioid analgesics for an extended period
- [Label]
Product Snapshot
- Oxycodone is an oral and parenteral small‑molecule opioid available in multiple immediate‑ and extended‑release formulations
- It is used for moderate to severe pain, including chronic pain requiring continuous opioid analgesia
- It is approved in the US and Canada, with certain formulations also noted as investigational or subject to illicit market controls
Clinical Overview
Oxycodone (CAS 76-42-6) is a semisynthetic opioid analgesic derived from thebaine. It is indicated for the management of moderate to severe pain, with immediate release products used for acute pain episodes and extended release formulations used in chronic pain requiring continuous opioid therapy. Long-standing clinical use includes products such as Percodan. Oxycodone belongs to the phenanthrene class of opioid alkaloids and functions as a central nervous system depressant with analgesic properties.
Its pharmacodynamic profile reflects opioid receptor activity across multiple organ systems. Beyond analgesia, oxycodone depresses the respiratory centre in a dose-dependent manner, suppresses the cough reflex, induces pupillary constriction, reduces gastrointestinal motility, and can increase colonic tone. Histamine release may contribute to pruritus, flushing, and reductions in blood pressure. Endocrine effects include increased prolactin and decreased cortisol and testosterone. The clinical relevance of immune modulation is not established.
Oxycodone and its active metabolites, including noroxycodone and oxymorphone, act as agonists at mu, kappa, and delta opioid receptors. These compounds cross the blood brain barrier by passive diffusion or possible active transport. Receptor activation initiates G protein signalling and inhibition of N‑type voltage operated calcium channels, reducing neuronal excitability and pain transmission. Opioid receptor upregulation during inflammation may contribute to pharmacologic responsiveness in peripheral tissues.
Oxycodone is metabolized primarily via CYP3A and to a lesser extent CYP2D6, generating metabolites with varying opioid activity. Absorption is efficient following oral administration with measurable first-pass metabolism. The safety profile is characterized by risks of respiratory depression, constipation, sedation, hypotension, and endocrine effects, with severity influenced by dose, co-administered CNS depressants, and patient factors.
For API procurement, quality considerations include verified identity, stereochemical integrity, control of residual solvents, and compliance with pharmacopeial specifications to support consistent performance in finished dosage forms.
Its pharmacodynamic profile reflects opioid receptor activity across multiple organ systems. Beyond analgesia, oxycodone depresses the respiratory centre in a dose-dependent manner, suppresses the cough reflex, induces pupillary constriction, reduces gastrointestinal motility, and can increase colonic tone. Histamine release may contribute to pruritus, flushing, and reductions in blood pressure. Endocrine effects include increased prolactin and decreased cortisol and testosterone. The clinical relevance of immune modulation is not established.
Oxycodone and its active metabolites, including noroxycodone and oxymorphone, act as agonists at mu, kappa, and delta opioid receptors. These compounds cross the blood brain barrier by passive diffusion or possible active transport. Receptor activation initiates G protein signalling and inhibition of N‑type voltage operated calcium channels, reducing neuronal excitability and pain transmission. Opioid receptor upregulation during inflammation may contribute to pharmacologic responsiveness in peripheral tissues.
Oxycodone is metabolized primarily via CYP3A and to a lesser extent CYP2D6, generating metabolites with varying opioid activity. Absorption is efficient following oral administration with measurable first-pass metabolism. The safety profile is characterized by risks of respiratory depression, constipation, sedation, hypotension, and endocrine effects, with severity influenced by dose, co-administered CNS depressants, and patient factors.
For API procurement, quality considerations include verified identity, stereochemical integrity, control of residual solvents, and compliance with pharmacopeial specifications to support consistent performance in finished dosage forms.
Identification & chemistry
| Generic name | Oxycodone |
|---|---|
| Molecule type | Small molecule |
| CAS | 76-42-6 |
| UNII | CD35PMG570 |
| DrugBank ID | DB00497 |
Pharmacology
| Summary | Oxycodone and its active metabolites act primarily as agonists at mu‑opioid receptors, with additional activity at kappa and delta receptors, to modulate nociceptive signaling through inhibition of neurotransmitter release. These actions reduce pain transmission and also engage opioid pathways in multiple peripheral and central tissues, contributing to effects on respiration, gastrointestinal motility, autonomic tone, and endocrine function. The drug’s overall pharmacodynamic profile reflects broad GPCR‑mediated suppression of neuronal excitability across these systems. |
|---|---|
| Mechanism of action | The full mechanism of oxycodone is not known.[Label] Under conditions of inflammation or hyperalgesia, opioid receptors in the heart, lungs, liver, gastrointestinal tract, and reproductive system are upregulated and transported to nerve terminals.Oxycodone and its active metabolites, noroxycodone, oxymorphone, and noroxymorphone are opioid agonists.These compounds passively diffuse across the blood brain barrier or may be actively transported across by an unknown mechanism.Oxycodone and its active metabolites can selectively bind to the mu opioid receptor, but also the kappa and delta opioid receptors in the central nervous system and periphery, and induce a G protein coupled receptor signalling pathway.Activation of mu opioid receptors inhibits N-type voltage operated calcium channels, inhibiting responses to pain. |
| Pharmacodynamics | Oxycodone acts directly on a number of tissues not related to its analgesic effect. These tissues include the respiratory centre in the brain stem, the cough centre in the medulla, muscles of the pupils, gastrointestinal tract, cardiovascular system, endocrine system, and immune system.[Label] Oxycodone's effect on the respiratory centre is dose dependant respiratory depression.[Label] The action on the cough centre is suppression of the cough reflex.[Label] Pupils become miopic or decrease in size, peristalsis of the gastrointestinal tract slows, and muscle tone in the colon may increase causing constipation.[Label] In the cardiovascular system histamine may be released leading to pruritis, red eyes, flushing, sweating, and decreased blood pressure.[Label] Endocrine effects may include increased prolactin, decreased cortisol, and decreased testosterone.[Label] It is not yet known if the effects of opioids on the immune system are clinically significant.[Label] |
Targets
| Target | Organism | Actions |
|---|---|---|
| Mu-type opioid receptor | Humans | agonist |
| Kappa-type opioid receptor | Humans | agonist |
| Delta-type opioid receptor | Humans | agonist |
ADME / PK
| Absorption | Oxycodone has an oral bioavailability of 60% to 87% that is unaffected by food.[Label] The area under the curve is 135ng/mL\*hr, maximum plasma concentration is 11.5ng/mL, and time to maximum concentration is 5.11hr in patients given a 10mg oral immediate release dose of oxycodone.[Label] |
|---|---|
| Half-life | The apparent elimination half life of oxycodone is 3.2 hours for immediate release formulations and 4.5 hours for extended release formulations.[Label] Noroxycodone has a half life of 5.8 hours, oxymorphone has a half life of 8.8 hours, noroxymorphone has a half life of 9 hours. |
| Protein binding | 45%.[Label] Oxycodone is primarily bound to serum albumin and to a lesser degree alpha1-acid glycoprotein. |
| Metabolism | Oxycodone's hepatic metabolism is extensive and completed by 4 main reactions. CYP3A4 and 3A5 perform N-demethylation, CYP2D6 performs O-demethylation, unknown enzymes perform 6-keto-reduction, and unknown enzymes perform conjugation. Oxycodone is metabolized by CYP3A4 and CYP3A5 to noroxycodone and then by CYP2D6 to noroxymorphone.Noroxycodone and noroxymorphone are the primary circulating metabolites.[Label] Noroxycodone can also be 6-keto-reduced to alpha or beta noroxycodol. Oxycodone can be metabolized by CYP2D6 to oxymorphone and then by CYP3A4 to noroxymorphone.Oxymorphone can also be 6-keto-reduced to alpha or beta oxymorphol. Oxycodone can also be 6-keto-reduced to alpha and beta oxycodol. The active metabolites noroxycodone, oxymorphone, and noroxymorphone can all be conjugated before elimination. |
| Route of elimination | Oxycodone and its metabolites are eliminated in the urine.[Label] Unbound noroxycodone makes up 23% of the dose recovered in urine and oxymorphone makes up <1%.[Label] Conjugated oxymorphone makes up 10% of the recovered dose.[Label] Free and conjugated oxycodone makes up 8.9% of the recovered dose, noroxymorphone makes up 14%, and reduced metabolites make up 18%.[Label] |
| Volume of distribution | 2.6L/kg.[Label] |
| Clearance | Total plasma clearance is 1.4L/min in adults.[Label] |
Formulation & handling
- Oral formulations commonly use extended‑release matrices that require controls to prevent dose dumping, especially in the presence of alcohol.
- The small‑molecule API has good aqueous solubility, enabling conventional solution preparation for injectable routes with standard pH and oxidation controls.
- Solid‑state stability supports a wide range of oral tablet and capsule formats with minimal food‑effect considerations during formulation.
Regulatory status
| Lifecycle | Most patent protections for the API in the US and Canada have expired, with the most recent US patent expiring in 2023, indicating that the product is in a late lifecycle stage. With marketing limited to the US and Canada, the market position reflects a mature environment with established generic entry. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Oxycodone is supplied by numerous manufacturers, indicating that originator firms represent only a portion of a broad and mature production base. Branded and generic products are established in North American markets, with distribution evident in both the United States and Canada. Most key patents have expired, with the most recent ending in 2023–2024, supporting the presence of extensive generic competition. |
|---|
Safety
| Toxicity | Patients experiencing an overdose may present with respiratory depression, sleepiness, stupor, coma, skeletal muscle flaccidity, cold sweat, constricted pupils, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death.[Label] Overdose should be treated by maintaining airway, ventilation, and oxygenation.[Label] Oxygen and vasopressor treatment may be necessary to treat circulatory shock and pulmonary edema and defibrillation may be required for cardiac arrest of arrhythmia.[Label] [Naloxone], [nalmefene], or [naltrexone] may be used to counteract the effects of opioids but patients should be monitored in case further doses are required.[Label] The intraperitoneal LD50 in mice is 320mg/kg, the oral LD50 is 426mg/kg.[MSDS] The oral lowest dose causing toxic effects in humans is 0.14mg/kg and subcutaneously in rats it is 1.53mg/kg.[MSDS] Oxycodone is pregnancy category B according to the FDA.[Label] There is a paucity of data regarding oxycodone use in pregnancy, though animal studies show no teratogenic effects.[Label] Rats given oxycodone during lactation showed smaller offspring, though after lactation, they recovered to normal size.[Label] Oxycodone is excreted in breast milk and so patients should not breastfeed while taking oxycodone due to risk of sedation and respiratory depression in infants.[Label] No studies on the carcinogenicity of oxycodone have been performed.[Label] Oxycodone was genotoxic at 50mcg/mL with metabolic activation and at 400mcg/mL without.[Label] It was also clastogenic with metabolic activation at ≥1250mcg/mL.[Label] Oxycodone was not found to be genotoxic in other tests.[Label] Oxycodone does not affect reproduction and fertility in rats at doses of up to 8mg/kg/day.[Label] |
|---|
High Level Warnings:
- Overdose is associated with profound CNS and respiratory depression, hypotension, bradycardia, and potential airway obstruction
- Severe cases may progress to coma or fatal outcomes
- Acute toxicity values include mouse LD50 ranges of 320 mg/kg (intraperitoneal) and 426 mg/kg (oral)
Oxycodone is a type of Opioid analgesics
Opioid analgesics are a subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that are commonly used for pain management. These potent substances interact with specific receptors in the central nervous system, producing analgesic effects and reducing the perception of pain. Opioid analgesics are derived from opium alkaloids or synthetic compounds that mimic their effects. They are classified based on their strength, with some being classified as strong opioids (e.g., morphine, fentanyl) and others as weak opioids (e.g., codeine, tramadol). These APIs work by binding to opioid receptors, primarily located in the brain, spinal cord, and gastrointestinal tract. By activating these receptors, opioid analgesics modulate pain signals, resulting in pain relief. Additionally, they can induce feelings of euphoria, sedation, and respiratory depression, which can be both beneficial and potentially harmful.
Due to their potency and potential for abuse, opioid analgesics are tightly regulated substances. They are primarily prescribed for acute and chronic pain management, such as post-surgical pain, cancer pain, and severe injuries. However, their misuse and addiction potential have led to a public health crisis in many countries.
In conclusion, opioid analgesics are a subcategory of pharmaceutical APIs that play a crucial role in pain management. While they provide effective pain relief, their use requires careful monitoring and adherence to prescribing guidelines to mitigate the risks associated with their potential for abuse and addiction.
Oxycodone (Opioid analgesics), classified under Analgesics
Analgesics are a category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that are commonly used to relieve pain. They are designed to alleviate discomfort by targeting the body's pain receptors or by reducing inflammation. Analgesics are widely utilized in the medical field to manage various types of pain, ranging from mild to severe.
One of the primary classes of analgesics is nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs work by inhibiting the production of prostaglandins, substances that contribute to pain and inflammation. This class includes well-known drugs like ibuprofen and naproxen. Another class of analgesics is opioids, which are derived from opium or synthetic compounds that mimic the effects of opium. Opioids act on the central nervous system to reduce pain perception and provide potent pain relief. Examples of opioids include morphine, codeine, and oxycodone.
Analgesics are available in various forms, such as tablets, capsules, creams, and injections, allowing for different routes of administration based on the patient's needs. They are commonly used to manage pain associated with conditions like arthritis, headaches, dental procedures, and post-operative recovery.
It is important to note that analgesics should be used under medical supervision, as improper use or overuse can lead to adverse effects, including gastrointestinal complications, addiction, and respiratory depression in the case of opioids. Therefore, it is crucial for healthcare professionals to assess each patient's individual needs and prescribe the appropriate analgesic and dosage.
In summary, analgesics are a vital category of pharmaceutical APIs used to alleviate pain by targeting pain receptors or reducing inflammation. With various classes and forms available, they provide valuable options for pain management when used responsibly and under medical guidance.
Frequently asked questions about Oxycodone API
Sourcing
What matters most when sourcing GMP-grade Oxycodone?
Key factors include verifying GMP compliance and ensuring the manufacturer holds valid US and Canadian regulatory approvals for controlled substances. Supply chain robustness is also important given the broad generic market, as it helps maintain consistent availability. Documentation supporting quality, traceability, and controlled‑substance handling should be current and complete.
Which documents are typically required when sourcing Oxycodone API?
Request the core API documentation set: CoA (11 companies), GMP (6 companies), CEP (6 companies), USDMF (6 companies), FDA (5 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Oxycodone API?
Known or reported manufacturers for Oxycodone: Saneca Pharma, Vonage Pharma (Former Pluvia Endo), Temad Co.. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Oxycodone 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 Oxycodone manufacturers?
Audit reports may be requested for Oxycodone: 5 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Oxycodone API on Pharmaoffer?
Reported supplier count for Oxycodone: 11 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Oxycodone API?
Production countries reported for Oxycodone: United States (2 producers), Slovakia (1 producer), Turkey (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Oxycodone usually hold?
Common certifications for Oxycodone suppliers: CoA (11 companies), GMP (6 companies), CEP (6 companies), USDMF (6 companies), FDA (5 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Oxycodone (CAS 76-42-6) used for?
Oxycodone (CAS 76-42-6) is used for the management of moderate to severe pain. Immediate release formulations address acute pain, while extended release products provide continuous analgesia for chronic pain requiring ongoing opioid therapy. Its effects arise from mu‑, kappa‑, and delta‑receptor agonism that reduces neuronal excitability and pain transmission.
Which therapeutic class does Oxycodone fall into?
Oxycodone belongs to the following therapeutic categories: Alkaloids, Analgesics, Central Nervous System Agents, Central Nervous System Depressants, Cytochrome P-450 CYP2D6 Substrates. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Oxycodone mainly prescribed for?
The primary indications for Oxycodone: Oxycodone is indicated for the treatment of moderate to severe pain, [Label] There is also an extended release formulation indicated for chronic moderate to severe pain requiring continuous opioid analgesics for an extended period, [Label]. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Oxycodone work?
The full mechanism of Oxycodone is not known.[Label] Under conditions of inflammation or hyperalgesia, opioid receptors in the heart, lungs, liver, gastrointestinal tract, and reproductive system are upregulated and transported to nerve terminals.Oxycodone and its active metabolites, norOxycodone, oxymorphone, and noroxymorphone are opioid agonists.These compounds passively diffuse across the blood brain barrier or may be actively transported across by an unknown mechanism.Oxycodone and its active metabolites can selectively bind to the mu opioid receptor, but also the kappa and delta opioid receptors in the central nervous system and periphery, and induce a G protein coupled receptor signalling pathway.Activation of mu opioid receptors inhibits N-type voltage operated calcium channels, inhibiting responses to pain.
What should someone know about the safety or toxicity profile of Oxycodone?
Oxycodone’s safety profile is defined by dose‑dependent central nervous system and respiratory depression, which can lead to profound hypoventilation, hypotension, bradycardia, airway obstruction, coma, or death in overdose. Typical adverse effects include sedation, constipation, pupillary constriction, reduced gastrointestinal motility, histamine‑related pruritus or flushing, and endocrine changes such as increased prolactin and decreased cortisol and testosterone. Toxicity data include mouse LD50 values of 320 mg/kg intraperitoneally and 426 mg/kg orally. Risk severity increases with higher doses, co‑administration of other CNS depressants, and patient‑specific factors.
What are important formulation and handling considerations for Oxycodone as an API?
Important considerations include controlling release characteristics in extended‑release oral matrices to prevent dose dumping, including alcohol‑induced acceleration of drug release. The API’s good aqueous solubility supports straightforward solution preparation, but pH and oxidation must be controlled during manufacturing and storage. Its solid‑state stability allows use in standard tablet or capsule formats, with minimal concern for food‑related variability. Proper handling should also account for its potency and the need to limit exposure during processing.
Is Oxycodone a small molecule?
Oxycodone is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Oxycodone?
Oral Oxycodone generally shows solid‑state stability suitable for tablets and capsules. For extended‑release formulations, the main concern is preventing alcohol‑induced dose dumping, so matrix performance must be controlled under hydroalcoholic conditions. Food does not present a significant stability issue for the oral dosage forms described.
Regulatory
Where is Oxycodone approved or in use globally?
Oxycodone 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 Oxycodone right now?
Oxycodone is regulated as an opioid controlled substance in both Canada and the United States, requiring authorization for manufacture, distribution, and prescribing. Its patent position depends on the specific drug products or formulations that use the ingredient, each of which may be covered by different intellectual‑property protections held by their respective manufacturers.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Oxycodone procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Oxycodone. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Oxycodone included in the PRO Data Insights coverage?
PRO Data Insights coverage for Oxycodone: 67 verified transactions across 20 suppliers and 21 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Oxycodone?
Market report availability for Oxycodone: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
