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Phenacetin API from Chinese Manufacturers & Suppliers

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Employees: 50+

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CoA

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Phenacetin | CAS No: 62-44-2 | GMP-certified suppliers

A medication that provides non‑narcotic relief for mild to moderate pain and fever, supporting sourcing needs for analgesic formulations in relevant therapeutic applications.

Therapeutic categories

AcetanilidesAmidesAminesAnalgesicsAnalgesics, Non-NarcoticAnilides
Generic name
Phenacetin
Molecule type
small molecule
CAS number
62-44-2
DrugBank ID
DB03783
Approval status
Withdrawn drug
ATC code
N02BE73

Primary indications

  • Used principally as an analgesic

Product Snapshot

  • Phenacetin is an oral small‑molecule analgesic compound
  • Its primary historical use was for pain relief
  • It is withdrawn from major regulatory markets and is not FDA or EMA approved

Clinical Overview

Phenacetin (CAS 62-44-2) is an acetanilide derivative formerly used worldwide as a non‑narcotic analgesic and antipyretic. Its principal clinical role was the management of mild to moderate pain and fever, and it appeared in combination analgesic preparations in multiple regions before being withdrawn from numerous markets. In Canada, market withdrawal occurred in 1973 due to evidence of analgesic‑associated nephropathy.

Pharmacologically, phenacetin exerts central analgesic effects and has been described as acting at the spinal cord level to modulate nociceptive processing. It also demonstrates negative inotropic activity, although this effect did not constitute its therapeutic intent. Reported historical uses included symptomatic treatment of subacute rheumatoid arthritis, intercostal neuralgia, and certain ataxic conditions. Phenacetin is a substrate for several cytochrome P450 isoenzymes, including CYP1A2, CYP2A6, CYP2C19, CYP2C9, CYP2D6, CYP2E1, and CYP3A4, indicating extensive hepatic biotransformation. A portion of its activity is attributable to metabolic conversion to acetaminophen.

The mechanism of action has not been fully defined. Available evidence indicates involvement of central prostaglandin synthesis modulation via its metabolite, but phenacetin itself shows distinct pharmacodynamic characteristics compared with acetaminophen.

ADME characteristics include oral absorption with hepatic metabolism through multiple oxidative pathways, followed by renal elimination of metabolites. The compound is also reported to inhibit OAT1/SLC22A6, which may influence renal handling of coadministered substrates.

Safety concerns have centered on cumulative renal toxicity, including papillary necrosis and chronic interstitial nephritis associated with long‑term use. Epidemiological data also link prolonged exposure to increased risks of urothelial malignancy when used in certain combination analgesic formulations. These findings prompted global regulatory withdrawal. Residual use today is limited to historical context and analytical reference applications.

Phenacetin was previously incorporated into branded combination analgesic products, though no therapeutic products remain authorized. For API procurement, sourcing should focus on verified analytical‑grade material, ensuring full compliance with regional controls due to its withdrawn status and safety profile.

Identification & chemistry

Generic name Phenacetin
Molecule type Small molecule
CAS 62-44-2
UNII ER0CTH01H9
DrugBank ID DB03783

Pharmacology

SummaryPhenacetin exerts analgesic and antipyretic effects primarily through inhibition of prostaglandin G/H synthase 1, reducing prostaglandin‑mediated pain and fever signaling. Its activity includes central analgesic actions at the spinal cord and negative inotropic effects on cardiac tissue. Therapeutically, it has been used for pain relief in conditions such as subacute rheumatoid arthritis and certain neuralgias.
PharmacodynamicsPhenacetin was the first NSAID and fever reducer to go on the market. It acts as an analgesic at the spinal cord as well as a negative inotrope at the heart. It can be used to treat subacute rheumatoid arthritis, intercostal neuralgia, and ataxias.
Targets
TargetOrganismActions
Prostaglandin G/H synthase 1Humans

ADME / PK

MetabolismMetabolised in the body to paracetamol.

Formulation & handling

  • Moderate aqueous solubility and small‑molecule properties support conventional oral solid‑dose formulations, though dissolution enhancement may be required for consistent performance.
  • Solid-state stability is generally good, but control of particle size and avoidance of moisture uptake are useful for ensuring uniformity in bulk handling.
  • Withdrawn status limits therapeutic use, but material may still be handled in R&D settings with standard controls for aromatic acetanilides.

Regulatory status

Safety

ToxicityAcute oral toxicity (LD50): 866 mg/kg [Mouse].
High Level Warnings:
  • Exhibits moderate acute oral toxicity (mouse LD50 ~866 mg/kg), indicating the need for controlled exposure in manufacturing environments
  • High-dose exposure may be associated with CNS and hepatic stress responses typical of small‑molecule analgesics
  • Dust or concentrated material may pose irritation or systemic toxicity risks if accidentally ingested or inhaled during handling

Phenacetin is a type of Non-opioid analgesics


Non-opioid analgesics are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that are widely used for the management of pain. Unlike opioids, which are known to have addictive properties, non-opioid analgesics offer pain relief without the risk of dependence or addiction.

These APIs work by inhibiting the production of prostaglandins, which are substances in the body that contribute to pain and inflammation. Non-opioid analgesics are typically available over-the-counter (OTC) and come in various forms such as tablets, capsules, creams, and gels.

One of the most common non-opioid analgesics is acetaminophen, which is highly effective in relieving mild to moderate pain. It is commonly used to alleviate headaches, toothaches, and musculoskeletal pain. Another popular non-opioid analgesic is non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen. These medications not only reduce pain but also have anti-inflammatory properties, making them particularly useful for conditions such as arthritis.

Non-opioid analgesics are generally well-tolerated but can have potential side effects, including gastrointestinal disturbances and, in rare cases, liver or kidney damage. It is important to follow recommended dosages and consult a healthcare professional if there are any concerns or underlying medical conditions.

In conclusion, non-opioid analgesics are a vital category of pharmaceutical APIs that offer effective pain relief without the risk of addiction. Their accessibility, diverse formulations, and relatively favorable safety profile make them a popular choice for individuals seeking relief from various types of pain.


Phenacetin (Non-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.



Phenacetin API manufacturers & distributors

Compare qualified Phenacetin API suppliers worldwide. We currently have 2 companies offering Phenacetin API, with manufacturing taking place in 1 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

SupplierTypeCountryProduct originCertificationsPortfolio
Distributor
China China BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC250 products
Producer
China China CoA, GMP12 products

When sending a request, specify which Phenacetin 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 Phenacetin 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 Phenacetin API


Sourcing

Which documents are typically required when sourcing Phenacetin API?
Request the core API documentation set: CoA (2 companies), GMP (2 companies), USDMF (1 company), CEP (1 company), WC (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Phenacetin API?
Known or reported manufacturers for Phenacetin: Aurora Industry Co., Ltd. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Phenacetin 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 Phenacetin manufacturers?
Audit reports may be requested for Phenacetin: 1 GMP audit report available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Phenacetin API on Pharmaoffer?
Reported supplier count for Phenacetin: 2 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Phenacetin API?
Production countries reported for Phenacetin: China (2 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Phenacetin usually hold?
Common certifications for Phenacetin suppliers: CoA (2 companies), GMP (2 companies), USDMF (1 company), CEP (1 company), WC (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Phenacetin (CAS 62-44-2) used for?
Phenacetin was formerly used as a non‑narcotic analgesic and antipyretic for mild to moderate pain and fever, including use in combination analgesic products. Reported historical indications also included symptomatic management of subacute rheumatoid arthritis, intercostal neuralgia, and certain ataxic conditions. Due to renal toxicity and other safety concerns, it has been withdrawn from therapeutic use, and current application is limited to analytical reference purposes.
Which therapeutic class does Phenacetin fall into?
Phenacetin belongs to the following therapeutic categories: Acetanilides, Amides, Amines, Analgesics, Analgesics, Non-Narcotic. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Phenacetin mainly prescribed for?
The primary indications for Phenacetin: Used principally as an analgesic. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Phenacetin work?
Phenacetin was the first NSAID and fever reducer to go on the market. It acts as an analgesic at the spinal cord as well as a negative inotrope at the heart. It can be used to treat subacute rheumatoid arthritis, intercostal neuralgia, and ataxias.
What should someone know about the safety or toxicity profile of Phenacetin?
Phenacetin shows moderate acute oral toxicity, and concentrated dust can cause irritation or systemic effects if inhaled or ingested during handling. Its principal safety concerns relate to cumulative renal injury, including papillary necrosis and chronic interstitial nephritis, with epidemiological links to urothelial malignancy after prolonged exposure. High doses may also elicit CNS and hepatic stress responses. These risks led to its withdrawal from therapeutic use, so any handling requires controlled conditions and adherence to appropriate regulatory measures.
What are important formulation and handling considerations for Phenacetin as an API?
Phenacetin’s moderate aqueous solubility supports conventional oral solid‑dose formats, though dissolution‑rate enhancement may be needed for consistent performance. Its solid‑state stability is generally good, but controlling particle size and limiting moisture uptake help maintain uniformity during bulk handling. As an aromatic acetanilide with withdrawn therapeutic status, it should be managed in R&D settings using standard controls appropriate for this chemical class.
Is Phenacetin a small molecule?
Phenacetin is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Phenacetin?
Solid‑state stability of Phenacetin is generally good, and it is suitable for conventional oral solid‑dose forms. The main concerns are controlling particle size and limiting moisture uptake to maintain uniformity during bulk handling and manufacturing. Dissolution enhancement may be needed to ensure consistent oral performance due to its moderate aqueous solubility.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Phenacetin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Phenacetin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Phenacetin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Phenacetin: 261 verified transactions across 79 suppliers and 72 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Phenacetin?
Market report availability for Phenacetin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.