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Distributor
Produced in
China|
Employees: 50+
|
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Certifications:
GMP
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USDMF|
MSDS|
ISO9001|
CoAAll certificates
GMP
USDMF
MSDS
ISO9001
CoA
Producer
Produced in
Iran|
Employees: 500+
|
Audit Report:
Certifications:
GMP
|
USDMF|
MSDS|
ISO9001|
CoAAll certificates
GMP
USDMF
MSDS
ISO9001
CoA
WC
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Producer
Produced in
China|
Employees: 25+
|
Audit Report:
Certifications:
GMP
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CEP|
USDMF|
MSDS|
BSE/TSEAll certificates
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CEP
USDMF
MSDS
BSE/TSE
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WC
CoA
Distributor
Produced in
India|
Employees: 10
|
Audit Report:
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GMP
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FDA|
MSDS|
BSE/TSE|
CoAAll certificates
GMP
FDA
MSDS
BSE/TSE
CoA
Distributor
Produced in
World|
Employees: 200+
|
Audit Report:
Certifications:
GMP
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CEP|
USDMF|
MSDS|
BSE/TSEAll certificates
GMP
CEP
USDMF
MSDS
BSE/TSE
CoA
Distributor
Produced in
India|
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|
CoAAll certificates
GMP
CoA
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Distributor
Produced in
Turkey|
Employees: 135+
|
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Certifications:
GMP
|
MSDS|
CoAAll certificates
GMP
MSDS
CoA
Distributor
Produced in
United States|
Employees: 50+
|
Audit Report:
Certifications:
GMP
|
MSDS|
BSE/TSE|
ISO9001|
CoAAll certificates
GMP
MSDS
BSE/TSE
ISO9001
CoA
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Distributor
Produced in
Turkey|
Employees: 50+
|
Audit Report:
Certifications:
GMP
|
MSDS|
ISO9001|
CoA|
WCAll certificates
GMP
MSDS
ISO9001
CoA
WC
Distributor
Produced in
India|
Employees: 25
|
Audit Report:
Certifications:
GMP
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FDA|
MSDS|
BSE/TSE|
ISO9001All certificates
GMP
FDA
MSDS
BSE/TSE
ISO9001
CoA
Producer
Produced in
India|
Employees: 5
|
Audit Report:
Certifications:
GMP
|
MSDS|
BSE/TSE|
ISO9001|
CoAAll certificates
GMP
MSDS
BSE/TSE
ISO9001
CoA
Distributor
Produced in
China|
Employees: 200+
|
Audit Report:
Certifications:
GMP
|
FDA|
CEP|
USDMF|
MSDSAll certificates
GMP
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CEP
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MSDS
BSE/TSE
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Distributor
Produced in
China|
Employees: 50+
|
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GMP
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FDA|
CEP|
USDMF|
MSDSAll certificates
GMP
FDA
CEP
USDMF
MSDS
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ISO9001
WC
CoA
Distributor
Produced in
China
,
India|
Employees: 150
|
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MSDS|
CoAAll certificates
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CoA
Producer
Produced in
India|
Employees: 19
|
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FDA|
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GMP
FDA
CoA
Distributor
Produced in
Unknown|
Employees: 275+
|
Audit Report:
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GMP
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MSDS|
BSE/TSE|
ISO9001|
CoAAll certificates
GMP
MSDS
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CoA
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Producer
Produced in
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Distributor
Produced in
China|
Employees: 50+
|
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GMP
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USDMF|
MSDS|
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USDMF
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BSE/TSE
CoA
Producer
Produced in
Japan|
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JDMF
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JDMF
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Producer
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Distributor
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WC|
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Producer
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CEP|
USDMF|
WC|
JDMFAll certificates
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Produced in
India|
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GMP
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CEP|
USDMF|
ISO 9001|
CoAAll certificates
GMP
CEP
USDMF
ISO 9001
CoA
WHO-GMP
WC
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Produced in
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WCAll certificates
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WC
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Acetaminophen | CAS No: 103-90-2 | GMP-certified suppliers
A medication that addresses mild to moderate pain and fever, including use in settings requiring injectable options for managing more severe pain.
Therapeutic categories
Acetaminophen and ProdrugsAmidesAminesAnalgesicsAnalgesics, Non-NarcoticAnilides
Generic name
Acetaminophen
Molecule type
small molecule
CAS number
103-90-2
DrugBank ID
DB00316
Approval status
Approved drug
ATC code
N02BE71
Primary indications
- In general, acetaminophen is used for the treatment of mild to moderate pain and reduction of fever
- It is available over the counter in various forms, the most common being oral forms
- Acetaminophen _injection_ is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever
- [Label]
Product Snapshot
- Acetaminophen is a widely used small‑molecule analgesic and antipyretic available in multiple oral, rectal, topical, and parenteral formulations, including an injectable solution
- Its primary uses are for mild to moderate pain management and fever reduction, with broader use as an adjunct analgesic in hospital settings
- The API is approved in major regulated markets, including the US and Canada
Clinical Overview
Acetaminophen, also known as paracetamol and widely recognized under brands such as Tylenol, is an analgesic and antipyretic indicated for the treatment of mild to moderate pain and the reduction of fever. Injectable formulations are additionally used for moderate to severe pain in combination with opioid analgesics. Its favorable tolerability allows use in patients who cannot take salicylates or who have allergic tendencies, including some individuals with asthma. Pediatric dosing requires strict adherence to age‑ and weight‑specific guidance.
Acetaminophen produces analgesic and antipyretic effects without meaningful peripheral anti-inflammatory activity. It does not affect platelet aggregation, uric acid handling, or acid‑base balance at recommended doses. Allergic reactions occur infrequently.
The precise mechanism remains incompletely defined. Current evidence supports central inhibition of cyclooxygenase pathways involved in prostaglandin synthesis, increasing pain threshold. Acetaminophen indirectly blocks COX activity and may preferentially inhibit a COX variant sometimes referred to as COX‑3, although this classification remains under investigation. Its antipyretic action is linked to effects on hypothalamic heat‑regulating centers, promoting heat dissipation through vasodilation and sweating. Absence of peripheral COX inhibition explains its lack of anti‑inflammatory activity relative to NSAIDs.
Acetaminophen is rapidly absorbed following oral administration and undergoes hepatic metabolism, primarily via glucuronidation and sulfation, with minor CYP‑mediated pathways. CYP2E1‑dependent oxidation can form a reactive metabolite that is detoxified by glutathione, a process central to the risk of hepatotoxicity. Renal excretion of metabolites is the main elimination route. Overdose may lead to acute liver failure, necessitating timely use of established treatment protocols.
Quality considerations for acetaminophen API sourcing focus on compliance with pharmacopoeial specifications, control of process‑related impurities, and ensuring consistent particle properties suitable for different dosage forms. Reliable suppliers should provide robust stability data and verifiable GMP documentation.
Acetaminophen produces analgesic and antipyretic effects without meaningful peripheral anti-inflammatory activity. It does not affect platelet aggregation, uric acid handling, or acid‑base balance at recommended doses. Allergic reactions occur infrequently.
The precise mechanism remains incompletely defined. Current evidence supports central inhibition of cyclooxygenase pathways involved in prostaglandin synthesis, increasing pain threshold. Acetaminophen indirectly blocks COX activity and may preferentially inhibit a COX variant sometimes referred to as COX‑3, although this classification remains under investigation. Its antipyretic action is linked to effects on hypothalamic heat‑regulating centers, promoting heat dissipation through vasodilation and sweating. Absence of peripheral COX inhibition explains its lack of anti‑inflammatory activity relative to NSAIDs.
Acetaminophen is rapidly absorbed following oral administration and undergoes hepatic metabolism, primarily via glucuronidation and sulfation, with minor CYP‑mediated pathways. CYP2E1‑dependent oxidation can form a reactive metabolite that is detoxified by glutathione, a process central to the risk of hepatotoxicity. Renal excretion of metabolites is the main elimination route. Overdose may lead to acute liver failure, necessitating timely use of established treatment protocols.
Quality considerations for acetaminophen API sourcing focus on compliance with pharmacopoeial specifications, control of process‑related impurities, and ensuring consistent particle properties suitable for different dosage forms. Reliable suppliers should provide robust stability data and verifiable GMP documentation.
Identification & chemistry
| Generic name | Acetaminophen |
|---|---|
| Molecule type | Small molecule |
| CAS | 103-90-2 |
| UNII | 362O9ITL9D |
| DrugBank ID | DB00316 |
Pharmacology
| Summary | Acetaminophen is an analgesic and antipyretic agent with a centrally mediated mechanism that is not fully defined but is thought to involve indirect inhibition of COX enzymes and modulation of prostaglandin synthesis in the central nervous system. It shows minimal peripheral COX inhibition, consistent with its lack of anti-inflammatory and antiplatelet activity. Additional proposed targets include COX-1, COX-2, a COX variant sometimes termed COX-3, and TRPV1, supporting its role in pain and temperature regulation. |
|---|---|
| Mechanism of action | According to its FDA labeling, acetaminophen's exact mechanism of action has not been fully established[Label] - despite this, it is often categorized alongside NSAIDs (nonsteroidal anti-inflammatory drugs) due to its ability to inhibit the cyclooxygenase (COX) pathways.It is thought to exert central actions which ultimately lead to the alleviation of pain symptoms. One theory is that acetaminophen increases the pain threshold by inhibiting two isoforms of cyclooxygenase, COX-1 and COX-2, which are involved in prostaglandin (PG) synthesis. Prostaglandins are responsible for eliciting pain sensations.Acetaminophen does not inhibit cyclooxygenase in peripheral tissues and, therefore, has no peripheral anti-inflammatory effects. Though acetylsalicylic acid (aspirin) is an irreversible inhibitor of COX and directly blocks the active site of this enzyme, studies have shown that acetaminophen (paracetamol) blocks COX indirectly.Studies also suggest that acetaminophen selectively blocks a variant type of the COX enzyme that is unique from the known variants COX-1 and COX-2.This enzyme has been referred to as _COX-3_. The antipyretic actions of acetaminophen are likely attributed to direct action on heat-regulating centers in the brain, resulting in peripheral vasodilation, sweating, and loss of body heat.The exact mechanism of action of this drug is not fully understood at this time, but future research may contribute to deeper knowledge. |
| Pharmacodynamics | Animal and clinical studies have determined that acetaminophen has both antipyretic and analgesic effects. This drug has been shown to lack anti-inflammatory effects. As opposed to the _salicylate_ drug class, acetaminophen does not disrupt tubular secretion of uric acid and does not affect acid-base balance if taken at the recommended doses.Acetaminophen does not disrupt hemostasis and does not have inhibitory activities against platelet aggregation.[Label,F4124] Allergic reactions are rare occurrences following acetaminophen use. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Prostaglandin G/H synthase 2 | Humans | inhibitor |
| Prostaglandin G/H synthase 1 | Humans | inhibitor |
| Prostaglandin E synthase 3 | Humans | inhibitor |
ADME / PK
| Absorption | Acetaminophen has 88% oral bioavailability and reaches its highest plasma concentration 90 minutes after ingestion. Peak blood levels of free acetaminophen are not reached until 3 hours after rectal administration of the suppository form of acetaminophen and the peak blood concentration is approximately 50% of the observed concentration after the ingestion of an equivalent oral dose (10-20 mcg/mL). The percentage of a systemically absorbed rectal dose of acetaminophen is inconsistent, demonstrated by major differences in the bioavailability of acetaminophen after a dose administered rectally. Higher rectal doses or an increased frequency of administration may be used to attain blood concentrations of acetaminophen similar to those attained after oral acetaminophen administration.[Label] |
|---|---|
| Half-life | The half-life for adults is 2.5 h after an intravenous dose of 15 mg/kg.[Label] After an overdose, the half-life can range from 4 to 8 hours depending on the severity of injury to the liver, as it heavily metabolizes acetaminophen. |
| Protein binding | The binding of acetaminophen to plasma proteins is low (ranging from 10% to 25%), when given at therapeutic doses.[Label] |
| Metabolism | Acetaminophen is the major metabolite of _phenacetin_ and _acetanilid_.Acetaminophen is mainly metabolized in the liver by first-order kinetics and its metabolism of comprised of 3 pathways: conjugation with glucuronide, conjugation with sulfate, and oxidation through the cytochrome P450 enzyme pathway, mainly CYP2E1, to produce a reactive metabolite (N-acetyl-p-benzoquinone imine or NAPQI). At normal therapeutic doses, NAPQI undergoes fast conjugation with glutathione and is subsequently metabolized to produce both cysteine and mercapturic acid conjugates.[Label] High doses of acetaminophen (overdoses) can lead to hepatic necrosis due to the depletion of glutathione and of binding of high levels of reactive metabolite (NAPQI) to important parts of liver cells. The abovementioned damage to the liver can be prevented by the early administration of sulfhydryl compounds, for example, methionine and N-acetylcysteine. |
| Route of elimination | Acetaminophen metabolites are mainly excreted in the urine. Less than 5% is excreted in the urine as free (unconjugated) acetaminophen and at least 90% of the administered dose is excreted within 24 hours. |
| Volume of distribution | Volume of distribution is about 0.9L/kg. 10 to 20% of the drug is bound to red blood cells.Acetaminophen appears to be widely distributed throughout most body tissues except in fat.[Label] |
| Clearance | Adults: 0.27 L/h/kg following a 15 mg/kg intravenous (IV) dose.[Label] Children: 0.34 L/h/kg following a 15 mg/kg intravenous (IV dose).[Label] |
Formulation & handling
- Solid, water‑soluble small molecule suitable for oral, topical, rectal, and IV formulations, with straightforward incorporation into aqueous solutions and conventional solid dosage forms.
- Oral absorption is not food‑dependent, allowing flexible timing relative to meals in formulation instructions.
- IV solutions require protection from oxidation and control of pH to maintain chemical stability during storage and handling.
Regulatory status
| Lifecycle | Most U.S. patents associated with the API expired between 2011 and 2021, indicating that intellectual‑property protection has lapsed. With products marketed in the United States and Canada, the API is in a mature phase with established generic availability expected. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The supply landscape for acetaminophen is dominated by multiple generic manufacturers, with the original product historically associated with McNeil-originated brands but now broadly produced across many U.S.‑based and multinational firms. Branded and private‑label products are widely available in the United States and Canada, reflecting mature global distribution. All listed U.S. patents have expired, supporting the long‑established presence of extensive generic competition. |
|---|
Safety
| Toxicity | LD50 = 338 mg/kg (oral, mouse); LD50 = 1944 mg/kg (oral, rat) **Overdose and liver toxicity** Acetaminophen overdose may be manifested by renal tubular necrosis, hypoglycemic coma, and thrombocytopenia. Sometimes, liver necrosis can occur as well as liver failure. Death and the requirement of a liver transplant may also occur.[Label] Metabolism by the CYP2E1 pathway releases a toxic acetaminophen metabolite known as _N-acetyl-p-benzoquinoneimine_(NAPQI). The toxic effects caused by this drug are attributed to NAPQI, not acetaminophen alone. **Carcinogenesis** Long-term studies in mice and rats have been completed by the National Toxicology Program to study the carcinogenic risk of acetaminophen. In 2-year feeding studies, F344/N rats and B6C3F1 mice consumed a diet containing acetaminophen up to 6,000 ppm. Female rats showed evidence of carcinogenic activity demonstrated by a higher incidence of mononuclear cell leukemia at doses 0.8 times the maximum human daily dose (MHDD). No evidence of carcinogenesis in male rats (0.7 times) or mice (1.2 to 1.4 times the MHDD) was noted.[Label] The clinical relevance of this finding in humans is unknown. **Mutagenesis** Acetaminophen was not found to be mutagenic in the bacterial reverse mutation assay (Ames test). Despite this finding, acetaminophen tested positive in the in vitro mouse lymphoma assay as well as the in vitro chromosomal aberration assay using human lymphocytes. In published studies, acetaminophen has been reported to be clastogenic (disrupting chromosomes) when given a high dose of 1,500 mg/kg/day to the rat model (3.6 times the MHDD). No clastogenicity was observed at a dose of 750 mg/kg/day (1.8 times the MHDD), indicating that this drug has a threshold before it may cause mutagenesis.[Label] The clinical relevance of this finding in humans is unknown. **Impairment of Fertility** In studies conducted by the National Toxicology Program, fertility assessments have been performed in Swiss mice in a continuous breeding study. No effects on fertility were seen.[Label] **Use in pregnancy and nursing** The FDA label for acetaminophen considers it a pregnancy category C drug, meaning this drug has demonstrated adverse effects in animal studies. No human clinical studies in pregnancy have been done to this date for intravenous acetaminophen.[Label] Use acetaminophen only when necessary during pregnancy.[Label] Epidemiological data on oral acetaminophen use in pregnant women demonstrate no increase in the risk of major congenital malformations.[Label] While prospective clinical studies examining the results of nursing with acetaminophen use have not been conducted, acetaminophen is found secreted in human milk at low concentrations after oral administration. Data from more than 15 nursing mothers taking acetaminophen was obtained, and the calculated daily dose of acetaminophen that reaches the infant is about 1 to 2% of the maternal dose. Caution should be observed when acetaminophen is taken by a nursing woman.[Label] |
|---|
High Level Warnings:
- Oral LD50 values of 338 mg/kg (mouse) and 1944 mg/kg (rat) indicate moderate acute toxicity, with hepatotoxicity driven by CYP2E1‑generated NAPQI as the primary mechanism of injury
- High‑dose exposure is associated with renal tubular necrosis, thrombocytopenia, and potential progression to hepatic necrosis or failure
- Long‑term studies show dose‑dependent carcinogenic signals in female rats and clastogenic effects at supratherapeutic exposures, though relevance to human risk remains uncertain
Paracetamol is a type of 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.
Paracetamol API manufacturers & distributors
Compare qualified Paracetamol API suppliers worldwide. We currently have 34 companies offering Paracetamol API, with manufacturing taking place in 8 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 |
|---|---|---|---|---|---|
| Anqiu Lu'An | Producer | China | China | CEP, CoA, FDA, GMP, USDMF, WC | 1 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| Atabay K.S.V.T. | Producer | Turkey | Turkey | CEP, CoA, FDA, GMP, JDMF | 4 products |
| Atom Pharma | Producer | India | India | BSE/TSE, CoA, GMP, ISO9001, MSDS | 14 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 235 products |
| Chemizo Enterprise | Distributor | India | India | CoA | 19 products |
| Chr. Olesen Group | Distributor | Denmark | China, India | CEP, CoA, GMP, MSDS, USDMF | 252 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Turkey | CoA, GMP, ISO9001, MSDS, WC | 170 products |
| Farmson | Producer | India | India | CEP, CoA, GMP, ISO9001, USDMF, WC, WHO-GMP | 1 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Hachidai Pharmaceutical | Producer | Japan | Japan | CoA, JDMF | 9 products |
| Hebei Jiheng | Producer | China | China | CEP, CoA, FDA, GMP, JDMF, USDMF | 4 products |
| Hänseler AG | Distributor | Switzerland | Turkey | CoA, GMP, MSDS | 174 products |
| Indukern Chemie AG | Distributor | Switzerland | Unknown | CoA | 13 products |
| Iwaki Seiyaku | Producer | Japan | Japan | CoA, JDMF | 21 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lianyungang Kangle | Producer | China | China | CoA, GMP, WC | 1 products |
| Mallinckrodt | Producer | United States | United States | CEP, CoA, FDA, GMP, USDMF | 34 products |
| Meghmani | Producer | India | India | CEP, CoA, WC | 1 products |
| Pharm Rx Chemical Corp | Distributor | United States | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS | 144 products |
| Senova Technology Co., Lt... | Producer | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF, WC | 157 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Temad Co. | Producer | Iran | Iran | CoA, GMP, ISO9001, MSDS, USDMF, WC | 24 products |
| Tenatra Exports Private L... | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, MSDS | 263 products |
| Tresinde Biotech | Producer | India | India | CoA, GMP | 50 products |
| United Pharma Industries ... | Distributor | China | China | CoA | 12 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Zhejiang Kangle Pharma | Producer | China | China | CEP, CoA, FDA, JDMF, USDMF, WC | 3 products |
When sending a request, specify which Paracetamol 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 Paracetamol 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 Paracetamol API
Sourcing
What matters most when sourcing GMP-grade Paracetamol?
When sourcing GMP‑grade Paracetamol, ensure the supplier complies with U.S. and Canadian regulatory requirements and can provide complete GMP documentation. Verify the manufacturer’s qualification status and the consistency of their quality systems. Given the broad generic supply base, assess supply reliability and batch‑to‑batch consistency across producers.
Which documents are typically required when sourcing Paracetamol API?
Request the core API documentation set: CoA (34 companies), GMP (23 companies), MSDS (15 companies), USDMF (14 companies), CEP (13 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Paracetamol API?
Known or reported manufacturers for Paracetamol: Duchefa Farma B.V., Caesar & Loretz GmbH (CAELO), Senova Technology Co., Ltd., Xi'an Tian Guangyuan Biotech Co.,Ltd, Changzhou Comwin Fine Chemicals Co., Ltd, Chr. Olesen Group, Hänseler AG, Aurora Industry Co., Ltd, Tresinde Biotech, Global Pharma Tek, Pharm Rx Chemical Corp, SETV Global, Sinoway industrial Co.,Ltd, Arshine Pharmaceutical Co., Limited, LGM Pharma, Temad Co., Tenatra Exports Private Limited, Rochem International, Inc.. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Paracetamol 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 Paracetamol manufacturers?
Audit reports may be requested for Paracetamol: 6 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Paracetamol API on Pharmaoffer?
Reported supplier count for Paracetamol: 34 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Paracetamol API?
Production countries reported for Paracetamol: China (14 producers), India (9 producers), Turkey (3 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Paracetamol usually hold?
Common certifications for Paracetamol suppliers: CoA (34 companies), GMP (23 companies), MSDS (15 companies), USDMF (14 companies), CEP (13 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Paracetamol (CAS 103-90-2) used for?
Paracetamol is used as an analgesic and antipyretic for the treatment of mild to moderate pain and for reducing fever. Injectable forms are also used for moderate to severe pain when combined with opioid analgesics. It is an option for patients who cannot take salicylates or who have certain allergic tendencies.
Which therapeutic class does Paracetamol fall into?
Paracetamol belongs to the following therapeutic categories: Paracetamol and Prodrugs, Amides, Amines, Analgesics, Analgesics, Non-Narcotic. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Paracetamol mainly prescribed for?
The primary indications for Paracetamol: In general, Paracetamol is used for the treatment of mild to moderate pain and reduction of fever, It is available over the counter in various forms, the most common being oral forms, Paracetamol _injection_ is indicated for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever, [Label]. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Paracetamol work?
According to its FDA labeling, Paracetamol's exact mechanism of action has not been fully established[Label] - despite this, it is often categorized alongside NSAIDs (nonsteroidal anti-inflammatory drugs) due to its ability to inhibit the cyclooxygenase (COX) pathways.It is thought to exert central actions which ultimately lead to the alleviation of pain symptoms.
One theory is that Paracetamol increases the pain threshold by inhibiting two isoforms of cyclooxygenase, COX-1 and COX-2, which are involved in prostaglandin (PG) synthesis. Prostaglandins are responsible for eliciting pain sensations.Paracetamol does not inhibit cyclooxygenase in peripheral tissues and, therefore, has no peripheral anti-inflammatory effects. Though acetylsalicylic acid (aspirin) is an irreversible inhibitor of COX and directly blocks the active site of this enzyme, studies have shown that Paracetamol (Paracetamol) blocks COX indirectly.Studies also suggest that Paracetamol selectively blocks a variant type of the COX enzyme that is unique from the known variants COX-1 and COX-2.This enzyme has been referred to as _COX-3_. The antipyretic actions of Paracetamol are likely attributed to direct action on heat-regulating centers in the brain, resulting in peripheral vasodilation, sweating, and loss of body heat.The exact mechanism of action of this drug is not fully understood at this time, but future research may contribute to deeper knowledge.
What should someone know about the safety or toxicity profile of Paracetamol?
Paracetamol has moderate acute toxicity, with liver injury driven by CYP2E1‑mediated formation of the reactive metabolite NAPQI as the primary concern in overdose. High doses can also cause renal tubular necrosis, thrombocytopenia, and progression to hepatic necrosis or failure. Long‑term studies show dose‑dependent carcinogenic signals in female rats and clastogenic effects at supratherapeutic exposures, though the relevance to humans is unclear. At recommended doses, it is generally well tolerated, but safe use depends on strict adherence to dosing limits.
What are important formulation and handling considerations for Paracetamol as an API?
Important considerations include its good aqueous solubility, which supports use in conventional solid oral forms and aqueous solutions, and the need to control pH and protect IV formulations from oxidation to maintain stability. Rectal products require attention to variable absorption, which can affect systemic exposure. Handling should minimize conditions that promote oxidative degradation. The API’s low protein binding and broad tissue distribution do not pose specific formulation limitations.
Is Paracetamol a small molecule?
Paracetamol is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Paracetamol?
Oral Paracetamol is a stable, water‑soluble small molecule that is readily incorporated into conventional solid dosage forms. It does not require special handling beyond standard protection from moisture and routine storage conditions used for typical oral solids. No unique stability concerns are noted for oral formulations.
Regulatory
Where is Paracetamol approved or in use globally?
Paracetamol 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.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Paracetamol procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Paracetamol. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Paracetamol included in the PRO Data Insights coverage?
PRO Data Insights coverage for Paracetamol: 17238 verified transactions across 2575 suppliers and 1797 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Paracetamol?
Market report availability for Paracetamol: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
