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Bupivacaine | CAS No: 38396-39-3 | GMP-certified suppliers
A medication that provides reliable local and regional anesthesia and postsurgical analgesia across surgical, dental, and obstetrical procedures to support consistent perioperative pain control.
Therapeutic categories
Agents that reduce seizure thresholdAmidesAminesAnestheticsAnesthetics, LocalAnilides
Generic name
Bupivacaine
Molecule type
small molecule
CAS number
38396-39-3
DrugBank ID
DB00297
Approval status
Approved drug, Investigational drug
ATC code
N01BB01
Primary indications
- As an implant, bupivacaine is indicated in adults for placement into the surgical site to produce postsurgical analgesia for up to 24 hours following open inguinal hernia repair
- Bupivacaine, in liposome suspension, is indicated in patients aged 6 years and older for single-dose infiltration to produce postsurgical local analgesia
- In adults, it is also indicated as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia
Product Snapshot
- Bupivacaine is an injectable small‑molecule local anesthetic available in standard, liposomal, and implant formulations for infiltration, regional blocks, and epidural use
- It is used for local and regional anesthesia and postsurgical analgesia across a range of surgical settings, including orthopedic, abdominal, dental, and soft‑tissue procedures
- It is approved in the US, Canada, and the EU, with both established products and some investigational presentations in development
Clinical Overview
Bupivacaine (CAS 38396-39-3) is an amide local anesthetic used for local and regional anesthesia and postoperative analgesia across surgical specialties. It is an alpha amino acid amide classified within the amide-type local anesthetics and is approved in multiple formulations, including standard solutions, liposomal suspensions, and fixed-dose combinations.
Clinically, bupivacaine is indicated for postsurgical analgesia when used as an implant after open inguinal hernia repair, and as a single-dose infiltration analgesic in patients aged 6 years and older when formulated as a liposome suspension. In adults, the liposomal formulation is also used for interscalene brachial plexus nerve block. A combination product with meloxicam extends analgesia for up to 72 hours following select orthopedic and abdominal procedures. Conventional bupivacaine, alone or with epinephrine, is used for local or regional anesthesia in surgical, dental, diagnostic, and obstetrical settings, with concentration-dependent applicability to specific block types.
Bupivacaine produces sensory and motor blockade through inhibition of voltage‑gated sodium channels in neuronal membranes. By entering the neuron and binding to intracellular channel regions, it prevents sodium influx and stabilizes the membrane, generating a use‑dependent conduction block. Clinical loss of function progresses from pain perception to motor tone. Additional analgesic activity may relate to interactions with prostaglandin E2 EP1 receptors.
Bupivacaine has a long duration of action but exhibits dose‑dependent systemic toxicity. Elevated plasma concentrations can depress cardiac conduction and contractility, potentially causing arrhythmias, atrioventricular block, or cardiac arrest. Central nervous system stimulation or depression may also occur with systemic exposure. Cardiovascular toxicity has driven the adoption of less cardiotoxic analogs such as ropivacaine and levobupivacaine.
Key pharmacokinetic pathways include hepatic metabolism involving CYP3A and CYP2D6, with systemic absorption influenced by dose, vascularity of the injection site, and use of vasoconstrictors.
For API procurement, sourcing must ensure strict control of stereochemical purity, low residual solvents, and compliance with pharmacopeial specifications to support consistent potency, safety, and regulatory acceptability.
Clinically, bupivacaine is indicated for postsurgical analgesia when used as an implant after open inguinal hernia repair, and as a single-dose infiltration analgesic in patients aged 6 years and older when formulated as a liposome suspension. In adults, the liposomal formulation is also used for interscalene brachial plexus nerve block. A combination product with meloxicam extends analgesia for up to 72 hours following select orthopedic and abdominal procedures. Conventional bupivacaine, alone or with epinephrine, is used for local or regional anesthesia in surgical, dental, diagnostic, and obstetrical settings, with concentration-dependent applicability to specific block types.
Bupivacaine produces sensory and motor blockade through inhibition of voltage‑gated sodium channels in neuronal membranes. By entering the neuron and binding to intracellular channel regions, it prevents sodium influx and stabilizes the membrane, generating a use‑dependent conduction block. Clinical loss of function progresses from pain perception to motor tone. Additional analgesic activity may relate to interactions with prostaglandin E2 EP1 receptors.
Bupivacaine has a long duration of action but exhibits dose‑dependent systemic toxicity. Elevated plasma concentrations can depress cardiac conduction and contractility, potentially causing arrhythmias, atrioventricular block, or cardiac arrest. Central nervous system stimulation or depression may also occur with systemic exposure. Cardiovascular toxicity has driven the adoption of less cardiotoxic analogs such as ropivacaine and levobupivacaine.
Key pharmacokinetic pathways include hepatic metabolism involving CYP3A and CYP2D6, with systemic absorption influenced by dose, vascularity of the injection site, and use of vasoconstrictors.
For API procurement, sourcing must ensure strict control of stereochemical purity, low residual solvents, and compliance with pharmacopeial specifications to support consistent potency, safety, and regulatory acceptability.
Identification & chemistry
| Generic name | Bupivacaine |
|---|---|
| Molecule type | Small molecule |
| CAS | 38396-39-3 |
| UNII | Y8335394RO |
| DrugBank ID | DB00297 |
Pharmacology
| Summary | Bupivacaine is an amide local anesthetic that blocks voltage‑gated sodium channels from the intracellular side, inhibiting action‑potential initiation and conduction to produce localized loss of sensation. Its channel block is use‑dependent, leading to sustained membrane stabilization and interruption of neurotransmission, with functional effects that follow the characteristic fiber‑size and myelination hierarchy. Additional activity at EP1 prostaglandin receptors may contribute to reduced inflammatory sensitization. |
|---|---|
| Mechanism of action | Like [lidocaine], bupivacaine is an amide local anesthetic that provides local anesthesia through blockade of nerve impulse generation and conduction.These impulses, also known as action potentials, critically depend on membrane depolarization produced by the influx of sodium ions into the neuron through voltage-gated sodium channels.Bupivacaine crosses the neuronal membrane and exerts its anesthetic action through blockade of these channels at the intracellular portion of their pore-forming transmembrane segments.The block is use-dependent, where repetitive or prolonged depolarization increases sodium channel blockade.Without sodium ions passing through the channel’s pore, bupivacaine stabilizes the membrane at rest and therefore prevents neurotransmission. In general, the progression of anesthesia is related to the diameter, myelination and conduction velocity of affected nerve fibers.Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone. While it is well-established that the main action of bupivacaine is through sodium channel block, additional analgesic effects of bupivacaine are thought to potentially be due to its binding to the prostaglandin E2 receptors, subtype EP1 (PGE2EP1), which inhibits the production of prostaglandins, thereby reducing fever, inflammation, and hyperalgesia. |
| Pharmacodynamics | Bupivacaine is a widely used local anesthetic agent. Bupivacaine is often administered by spinal injection prior to total hip arthroplasty. It is also commonly injected into surgical wound sites to reduce pain for up to 20 hours after surgery. In comparison to other local anesthetics it has a long duration of action. It is also the most toxic to the heart when administered in large doses. This problem has led to the use of other long-acting local anaesthetics:ropivacaine and levobupivacaine. Levobupivacaine is a derivative, specifically an enantiomer, of bupivacaine. Systemic absorption of local anesthetics produces effects on the cardiovascular and central nervous systems. At blood concentrations achieved with therapeutic doses, changes in cardiac conduction, excitability, refractoriness, contractility, and peripheral vascular resistance are minimal. However, toxic blood concentrations depress cardiac conduction and excitability, which may lead to atrioventricular block, ventricular arrhythmias and to cardiac arrest, sometimes resulting in fatalities. In addition, myocardial contractility is depressed and peripheral vasodilation occurs, leading to decreased cardiac output and arterial blood pressure. Following systemic absorption, local anesthetics can produce central nervous system stimulation, depression or both. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Sodium channel protein type 10 subunit alpha | Humans | inhibitor |
| Prostaglandin E2 receptor EP1 subtype | Humans | other/unknown |
ADME / PK
| Absorption | Systemic absorption of local anesthetics is dose- and concentration-dependendent on the total drug administered. Other factors that affect the rate of systemic absorption include the route of administration, blood flow at the administration site, and the presence or absence of epinephrine in the anesthetic solution. Bupivacaine formulated for instillation with [meloxicam] produced varied systemic measures following a single dose of varying strength. In patients undergoing bunionectomy, 60 mg of bupivacaine produced a C<sub>max</sub> of 54 ± 33 ng/mL, a median T<sub>max</sub> of 3 h, and an AUC<sub>∞</sub> of 1718 ± 1211 ng\*h/mL. For a 300 mg dose used in herniorrhaphy, the corresponding values were 271 ± 147 ng/mL, 18 h, and 15,524 ± 8921 ng\*h/mL. Lastly, a 400 mg dose used in total knee arthroplasty produced values of 695 ± 411 ng/mL, 21 h, and 38,173 ± 29,400 ng\*h/mL. |
|---|---|
| Half-life | 2.7 hours in adults and 8.1 hours in neonates. Bupivacaine applied together with [meloxicam] for postsurgical analgesia had a median half-life of 15-17 hours, depending on dose and application site. |
| Protein binding | Bupivacaine is ~95% protein bound. |
| Metabolism | Amide-type local anesthetics such as bupivacaine are metabolized primarily in the liver via conjugation with glucuronic acid. The major metabolite of bupivacaine is 2,6-pipecoloxylidine, which is mainly catalyzed via cytochrome P450 3A4. |
| Route of elimination | Only 6% of bupivacaine is excreted unchanged in the urine. |
Formulation & handling
- Parenteral-only local anesthetic requiring aqueous solution formulation despite low water solubility, often necessitating acidified vehicles to maintain solubility.
- Hydrophobic small‑molecule amide anesthetic with high logP, supporting sustained‑release or liposomal depot formats for infiltration use.
- Solutions are generally stable as sterile liquids but require protection from particulate contamination and pH shifts that can precipitate the free base.
Regulatory status
| Lifecycle | The product shows a mature market presence in the US, Canada, and EU, with most US patents expired between 2018 and 2021. Remaining US protection through 2029 suggests limited residual exclusivity while broader markets are largely in a post‑exclusivity phase. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Bupivacaine is produced by multiple established manufacturers, with packaging handled by a broad network of distributors, reflecting a mature and highly genericized supply base. Branded and unbranded products are available across the US, Canada, and the EU, indicating wide global market penetration. Most compound‑level patents have expired, and while one U.S. patent extends to 2029, the overall landscape supports existing generic competition. |
|---|
Safety
| Toxicity | The mean seizure dosage of bupivacaine in rhesus monkeys was found to be 4.4 mg/kg with mean arterial plasma concentration of 4.5 mcg/mL. The intravenous and subcutaneous LD 50 in mice is 6 to 8 mg/kg and 38 to 54 mg/kg respectively. Recent clinical data from patients experiencing local anesthetic induced convulsions demonstrated rapid development of hypoxia, hypercarbia, and acidosis with bupivacaine within a minute of the onset of convulsions. These observations suggest that oxygen consumption and carbon dioxide production are greatly increased during local anesthetic convulsions and emphasize the importance of immediate and effective ventilation with oxygen which may avoid cardiac arrest. |
|---|
High Level Warnings:
- Seizure liability is notable, with convulsive effects observed near 4–5 mg/kg (arterial plasma ~4
- 5 mcg/mL in primates)
- Associated metabolic disturbances include rapid-onset hypoxia, hypercarbia, and acidosis
Certificate of Suitability
CEP (also known as COS) is a certificate that proves that qualifies to the relevant monograph of the European Pharmacopoeia. It links the monograph in the Ph.Eur. to the API itself. A CEP is submitted by the manufacturer as part of the market authorization process, and they will become the CEP holder of the document. Being a European certificate, the CEP is granted by the EDQM but is recognized by other countries or institutes such as the FDA in the US. Furthermore, just like the DMF, the data as submitted in the CEP is handled strictly confidential and provides a centralized system recognized by many countries.
Bupivacaine is a type of Local anesthetics
Local anesthetics are a category of pharmaceutical Active Pharmaceutical Ingredients (APIs) commonly used to numb a specific area of the body during medical procedures or surgeries. They work by blocking the transmission of nerve signals, preventing the sensation of pain in the targeted region. Local anesthetics are vital for various medical applications, including dental procedures, minor surgeries, and childbirth.
The main mechanism of action for local anesthetics involves the reversible inhibition of sodium channels, which are responsible for the conduction of nerve impulses. By binding to these channels, local anesthetics prevent the influx of sodium ions, which blocks the generation and propagation of nerve signals. This results in temporary loss of sensation in the area where the medication is administered.
Local anesthetics can be categorized into two main types: esters and amides. Esters, such as procaine and benzocaine, are metabolized by plasma esterases, while amides, including lidocaine and bupivacaine, undergo hepatic metabolism. The choice of local anesthetic depends on factors such as the duration of action required, the specific procedure being performed, and the patient's medical history.
It is important to note that local anesthetics should be administered with caution, as they can have potential side effects, including allergic reactions, systemic toxicity, and nerve damage if used improperly. Therefore, proper dosage and administration techniques must be followed to ensure patient safety.
In summary, local anesthetics are essential pharmaceutical APIs used to temporarily block nerve signals, providing localized pain relief during medical procedures. Understanding the different types and their mechanisms of action allows healthcare professionals to select the most appropriate local anesthetic for each patient and procedure, ensuring optimal outcomes and patient comfort.
Bupivacaine API manufacturers & distributors
Compare qualified Bupivacaine API suppliers worldwide. We currently have 14 companies offering Bupivacaine 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 |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Asence Pharma | Producer | India | India | CoA, WC | 6 products |
| Cambrex, Karlskoga | Producer | Sweden | Sweden | CEP, CoA, FDA, GMP, USDMF | 8 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Switzerland | CoA, GMP, ISO9001, MSDS | 170 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Medigraph Pharma | Producer | India | India | CEP, CoA, WC | 5 products |
| Moehs | Producer | Spain | Spain | CEP, CoA, EDMF/ASMF, GMP, USDMF | 50 products |
| Nortec Química | Producer | Brazil | Brazil | CoA, USDMF | 2 products |
| S.I.M.S. | Producer | Italy | Italy | CEP, CoA, FDA, GMP, USDMF | 18 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, GMP, ISO9001, USDMF | 157 products |
| Shandong Boyuan | Producer | China | China | BSE/TSE, CoA, MSDS | 55 products |
| Shandong Chenghui Shuangd... | Producer | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, WC | 98 products |
When sending a request, specify which Bupivacaine 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 Bupivacaine 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 Bupivacaine API
Sourcing
What matters most when sourcing GMP-grade Bupivacaine?
The key considerations are supplier compliance with GMP and the regulatory requirements of the US, Canada, and the EU. Given the mature, genericized market, confirming a stable supply chain and appropriate packaging controls through established distributors is important. It is also relevant to verify that any remaining U.S. patent constraints do not affect the intended use.
Which documents are typically required when sourcing Bupivacaine API?
Request the core API documentation set: CoA (14 companies), GMP (10 companies), CEP (7 companies), USDMF (7 companies), MSDS (6 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Bupivacaine API?
Known or reported manufacturers for Bupivacaine: Duchefa Farma B.V., Senova Technology Co., Ltd., Global Pharma Tek, Shandong Chenghui Shuangda Pharmaceutical Co. Ltd., Apollo Healthcare Resources (Singapore), LGM Pharma, Shandong Boyuan, Gonane Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Bupivacaine 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 Bupivacaine manufacturers?
Audit reports may be requested for Bupivacaine: 1 GMP audit report available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Bupivacaine API on Pharmaoffer?
Reported supplier count for Bupivacaine: 14 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Bupivacaine API?
Production countries reported for Bupivacaine: India (4 producers), China (3 producers), Switzerland (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Bupivacaine usually hold?
Common certifications for Bupivacaine suppliers: CoA (14 companies), GMP (10 companies), CEP (7 companies), USDMF (7 companies), MSDS (6 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Bupivacaine (CAS 38396-39-3) used for?
Bupivacaine is used for local and regional anesthesia and for postoperative analgesia in surgical, dental, diagnostic, and obstetrical procedures. It is also used for postsurgical analgesia as an implant after open inguinal hernia repair and, in liposomal form, for single‑dose infiltration in patients aged 6 years and older and for interscalene brachial plexus block in adults. A fixed‑dose combination with meloxicam provides extended analgesia after select orthopedic and abdominal surgeries.
Which therapeutic class does Bupivacaine fall into?
Bupivacaine belongs to the following therapeutic categories: Agents that reduce seizure threshold, Amides, Amines, Anesthetics, Anesthetics, Local. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Bupivacaine mainly prescribed for?
The primary indications for Bupivacaine: As an implant, Bupivacaine is indicated in adults for placement into the surgical site to produce postsurgical analgesia for up to 24 hours following open inguinal hernia repair, Bupivacaine, in liposome suspension, is indicated in patients aged 6 years and older for single-dose infiltration to produce postsurgical local analgesia, In adults, it is also indicated as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Bupivacaine work?
Like [lidocaine], Bupivacaine is an amide local anesthetic that provides local anesthesia through blockade of nerve impulse generation and conduction.These impulses, also known as action potentials, critically depend on membrane depolarization produced by the influx of sodium ions into the neuron through voltage-gated sodium channels.Bupivacaine crosses the neuronal membrane and exerts its anesthetic action through blockade of these channels at the intracellular portion of their pore-forming transmembrane segments.The block is use-dependent, where repetitive or prolonged depolarization increases sodium channel blockade.Without sodium ions passing through the channel’s pore, Bupivacaine stabilizes the membrane at rest and therefore prevents neurotransmission.
In general, the progression of anesthesia is related to the diameter, myelination and conduction velocity of affected nerve fibers.Clinically, the order of loss of nerve function is as follows: (1) pain, (2) temperature, (3) touch, (4) proprioception, and (5) skeletal muscle tone.
While it is well-established that the main action of Bupivacaine is through sodium channel block, additional analgesic effects of Bupivacaine are thought to potentially be due to its binding to the prostaglandin E2 receptors, subtype EP1 (PGE2EP1), which inhibits the production of prostaglandins, thereby reducing fever, inflammation, and hyperalgesia.
What should someone know about the safety or toxicity profile of Bupivacaine?
Bupivacaine has a dose‑dependent toxicity profile characterized by central nervous system and cardiovascular effects when systemic plasma concentrations rise. Seizure liability is notable, with convulsive activity observed near 4–5 mg/kg, accompanied by rapid‑onset hypoxia, hypercarbia, and acidosis. High exposures can depress cardiac conduction and contractility, leading to arrhythmias, atrioventricular block, or cardiac arrest. Careful dosing, injection technique, and awareness of factors that increase systemic absorption are important to limit toxicity.
What are important formulation and handling considerations for Bupivacaine as an API?
Formulation requires an aqueous, usually acidified, sterile solution to keep the poorly water‑soluble free base in solution and prevent pH‑dependent precipitation. Handling should minimize particulate contamination and maintain controlled pH to preserve solubility and stability. Its hydrophobicity also supports use in sustained‑release or liposomal depot formats for infiltration applications.
Is Bupivacaine a small molecule?
Bupivacaine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Bupivacaine?
Bupivacaine is formulated only for parenteral use, and its stability depends on maintaining it in an aqueous, usually acidified, solution to keep the drug soluble. Shifts in pH can precipitate the free base, and solutions require protection from particulate contamination. These characteristics indicate that an oral formulation would face the same solubility and pH‑related stability issues.
Regulatory
Where is Bupivacaine approved or in use globally?
Bupivacaine 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.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Bupivacaine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Bupivacaine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Bupivacaine included in the PRO Data Insights coverage?
PRO Data Insights coverage for Bupivacaine: 697 verified transactions across 269 suppliers and 153 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Bupivacaine?
Market report availability for Bupivacaine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
