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Distributor
Produced in
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Latvia|
Employees: 150
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Audit Report:
Certifications:
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|
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USDMF|
MSDS|
CoAAll certificates
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CoA
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China|
Employees: 50+
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CoA
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Employees: 25+
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MSDS|
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ISO9001|
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CoA
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Employees: 10+
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CoA
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Employees: 1500+
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MSDS|
BSE/TSE|
CoAAll certificates
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BSE/TSE
CoA
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Employees: 200
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Audit Report:
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BSE/TSE|
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CoA
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CoA
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Employees: 1000+
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Oxytocin | CAS No: 50-56-6 | GMP-certified suppliers
A medication that supports medically indicated labor induction or augmentation, aids management of uterine inertia or incomplete abortion, and helps control postpartum bleeding in obstetric care.
Therapeutic categories
Amino Acids, Peptides, and ProteinsGenito Urinary System and Sex HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsIncreased Uterine Smooth Muscle Contraction or ToneOxytocin and Analogues
Generic name
Oxytocin
Molecule type
biotech
CAS number
50-56-6
DrugBank ID
DB00107
Approval status
Approved drug, Vet_approved drug
ATC code
G02AC01
Primary indications
- Administration of exogenous oxytocin is indicated in the antepartum period to initiate or improve uterine contractions for vaginal delivery in situations where there is fetal or maternal concern
- For example, It may be used to induce labor in cases of Rh sensitization, maternal diabetes, preeclampsia at or near term, and when delivery is indicated due to prematurely ruptured membranes
- Importantly, oxytocin is not approved or indicated for elective induction of labor
- Oxytocin may be used to reinforce labor in select cases of uterine inertia and as adjunctive therapy in the management of incomplete or inevitable abortion
Product Snapshot
- Oxytocin is an injectable peptide hormone supplied mainly as sterile solutions for intramuscular or intravenous administration
- It is used for induction or augmentation of labor, management of abortion, and control of postpartum uterine atony and hemorrhage
- It is approved for human and veterinary use in the US and Canada
Clinical Overview
Oxytocin (CAS 50-56-6) is a cyclic nonapeptide hormone used extensively in obstetric practice. Clinically, exogenous oxytocin is indicated in the antepartum period to initiate or augment uterine contractions when maternal or fetal conditions warrant delivery, such as Rh sensitization, maternal diabetes, preeclampsia near term, or prelabor rupture of membranes. It may also be used to manage uterine inertia, support the management of incomplete or inevitable abortion, and induce contractions during the third stage of labor to control postpartum bleeding. It is not indicated for elective induction of labor.
Oxytocin exerts pleiotropic physiological effects. Beyond its established role in parturition and lactation, receptor expression in peripheral tissues and several central nervous system regions supports functions in cardiovascular regulation, metabolic homeostasis, social cognition, and stress responses.
The mechanism of action involves binding to oxytocin receptors on the myometrium, which are upregulated during pregnancy and peak in early labor. Receptor activation triggers phospholipase C signaling, inositol trisphosphate–mediated calcium release, and increased intracellular calcium within uterine myofibrils, enhancing contraction force and frequency. Oxytocin release during labor follows a positive feedback loop initiated by cervical stretch, a rare example of physiologic positive feedback in humans.
Oxytocin is rapidly cleared, with a short plasma half-life due to hepatic and renal peptide degradation. It does not cross the placenta in clinically significant amounts and has minimal oral bioavailability, requiring parenteral administration.
Safety considerations include risks of uterine hyperstimulation, fetal distress secondary to excessive contractions, water intoxication from antidiuretic effects at high doses, and cardiovascular instability. Use requires careful titration and continuous clinical monitoring. It is approved for human and veterinary use, with widespread availability in injectable formulations.
For API procurement, suppliers should provide robust controls for peptide purity, correct disulfide bridging, low levels of related peptides, and validated cold-chain handling where required. Regulatory documentation should align with pharmacopeial specifications for peptide hormones.
Oxytocin exerts pleiotropic physiological effects. Beyond its established role in parturition and lactation, receptor expression in peripheral tissues and several central nervous system regions supports functions in cardiovascular regulation, metabolic homeostasis, social cognition, and stress responses.
The mechanism of action involves binding to oxytocin receptors on the myometrium, which are upregulated during pregnancy and peak in early labor. Receptor activation triggers phospholipase C signaling, inositol trisphosphate–mediated calcium release, and increased intracellular calcium within uterine myofibrils, enhancing contraction force and frequency. Oxytocin release during labor follows a positive feedback loop initiated by cervical stretch, a rare example of physiologic positive feedback in humans.
Oxytocin is rapidly cleared, with a short plasma half-life due to hepatic and renal peptide degradation. It does not cross the placenta in clinically significant amounts and has minimal oral bioavailability, requiring parenteral administration.
Safety considerations include risks of uterine hyperstimulation, fetal distress secondary to excessive contractions, water intoxication from antidiuretic effects at high doses, and cardiovascular instability. Use requires careful titration and continuous clinical monitoring. It is approved for human and veterinary use, with widespread availability in injectable formulations.
For API procurement, suppliers should provide robust controls for peptide purity, correct disulfide bridging, low levels of related peptides, and validated cold-chain handling where required. Regulatory documentation should align with pharmacopeial specifications for peptide hormones.
Identification & chemistry
| Generic name | Oxytocin |
|---|---|
| Molecule type | Biotech |
| CAS | 50-56-6 |
| UNII | 1JQS135EYN |
| DrugBank ID | DB00107 |
Pharmacology
| Summary | Oxytocin is an endogenous nonapeptide that activates oxytocin receptors on uterine smooth muscle, increasing intracellular calcium and promoting coordinated uterine contractions. Receptor density in the myometrium rises during pregnancy, enhancing its contractile response near labor onset. Exogenous oxytocin produces the same receptor‑mediated effects as endogenous hormone and is used to support uterine contraction when clinically indicated in the antepartum and postpartum periods. |
|---|---|
| Mechanism of action | Oxytocin plays a vital role in labour and delivery.The hormone is produced in the hypothalamus and is secreted from the paraventricular nucleus to the posterior pituitary where it is stored.It is then released in pulses during childbirth to induce uterine contractions. The concentration of oxytocin receptors on the myometrium increases significantly during pregnancy and reaches a peak in early labor.Activation of oxytocin receptors on the myometrium triggers a downstream cascade that leads to increased intracellular calcium in uterine myofibrils which strengthens and increases the frequency of uterine contractions. In humans, most hormones are regulated by negative feedback; however, oxytocin is one of the few that is regulated by positive feedback.The head of the fetus pushing on the cervix signals the release of oxytocin from the posterior pituitary of the mother.Oxytocin then travels to the uterus where it stimulates uterine contractions.The elicited uterine contractions will then stimulate the release of increasing amounts of oxytocin.This positive feedback loop will continue until parturition. Since exogenously administered and endogenously secreted oxytocin result in the same effects on the female reproductive system, synthetic oxytocin may be used in specific instances during the antepartum and postpartum period to induce or improve uterine contractions. |
| Pharmacodynamics | Oxytocin is a nonapeptide, pleiotropic hormone that exerts important physiological effects.It is most well known to stimulate parturition and lactation, but also has important physiological influences on metabolic and cardiovascular functions, sexual and maternal behaviour, pair bonding, social cognition, and fear conditioning. It is worth noting that oxytocin receptors are not limited to the reproductive system but can be found in many peripheral tissues and in central nervous system structures including the brain stem and amygdala. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Oxytocin receptor | Humans | agonist |
ADME / PK
| Absorption | Oxytocin is administered parenterally and is fully bioavailable. It takes approximately 40 minutes for oxytocin to reach steady-state concentrations in the plasma after parenteral administration. |
|---|---|
| Half-life | The plasma half-life of oxytocin ranges from 1-6 minutes. The half-life is decreased in late pregnancy and during lactation. |
| Metabolism | Oxytocin is rapidly removed from the plasma by the liver and kidney.The enzyme oxytocinase is largely responsible for the metabolism and regulation of oxytocin levels in pregnancy and only a small percentage of the neurohormone is excreted in the urine unchanged.Oxytocinase activity increases throughout pregnancy and peaks in the plasma, placenta and uterus near term.The placenta is a key source of oxytocinase during gestation and produces increasing amounts of the enzyme in response to increasing levels of oxytocin produced by the mother.Oxytocinase activity is also expressed in mammary glands, heart, kidney, and the small intestine.Lower levels of activity can be found in the brain, spleen, liver, skeletal muscle, testes, and colon.The level of oxytocin degradation is negligible in non-pregnant women, men, and cord blood. |
| Route of elimination | The enzyme oxytocinase is largely responsible for the metabolism and regulation of oxytocin levels in pregnancy; only a small percentage of the neurohormone is excreted in the urine unchanged. |
| Clearance | In a study that observed 10 women who were given oxytocin to induce labor, the mean metabolic clearance rate was 7.87 mL/min. |
Formulation & handling
- Oxytocin is a small peptide hormone formulated primarily as aqueous injectable solutions for parenteral use, requiring protection from oxidation and peptide degradation.
- The peptide is not orally viable due to rapid enzymatic breakdown, so formulations rely on intramuscular or intravenous delivery with controlled pH and preservative considerations.
- Refrigerated storage and light protection are typically required to maintain peptide stability in multidose or diluted infusion preparations.
Regulatory status
| Lifecycle | Patent‑expiry details were not provided, but with products already established in the US and Canada, the API is likely in a mature phase of its lifecycle. Market presence in both countries suggests a stable, post‑launch position with limited remaining exclusivity unless protected by still‑active patents. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Multiple established pharmaceutical manufacturers supply oxytocin for the U.S. and Canadian markets, with production supported by a broad network of packagers that includes large hospital‑focused service providers as well as smaller compounding and distribution entities. Branded oxytocin products are present in both markets, but global commercialization patterns suggest no remaining patent protections. As a result, oxytocin is supplied almost entirely in generic form with longstanding, mature competition. |
|---|
Safety
| Toxicity | Administration of supratherapeutic doses of exogenous oxytocin can lead to myocardial ischemia, tachycardia, and arrhythmias.High doses can also lead to uterine spasms, hypertonicity, or rupture.Oxytocin has antidiuretic properties, thus, high daily doses (as a single dose or administered slowly over 24 hours) may lead to extreme water intoxication resulting in maternal seizures, coma, and even death.The risk of antidiuresis and water intoxication in the mother appears to be greater when fluids are given orally. |
|---|
High Level Warnings:
- Supratherapeutic exposure may precipitate cardiovascular events, including tachyarrhythmias and myocardial ischemia
- Excessive dosing can provoke marked uterine hypertonicity or spasm with risk of uterine rupture
- Prolonged or high-dose administration has antidiuretic effects that may cause severe water intoxication, manifesting as seizures or coma
Oxytocin is a type of Hormones
Hormones are a vital category of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a crucial role in regulating various physiological processes in the human body. These chemical messengers are produced by endocrine glands and are responsible for maintaining homeostasis, growth, metabolism, and reproductive functions.
Pharmaceutical hormones are synthetic or naturally derived compounds that mimic the structure and function of endogenous hormones. They are widely used in the treatment of hormonal disorders, such as hypothyroidism, diabetes, and hormonal imbalances.
Common examples of hormone APIs include insulin, thyroid hormones (such as levothyroxine), glucocorticoids (such as prednisone), and sex hormones (such as estrogen and testosterone). These APIs are carefully synthesized, purified, and formulated to ensure optimal efficacy, stability, and bioavailability.
Hormone APIs are typically produced through advanced chemical synthesis or biotechnological processes, involving the use of genetically engineered microorganisms or mammalian cell cultures. Stringent quality control measures and regulatory guidelines ensure the purity, potency, and safety of hormone APIs.
Pharmaceutical companies and research institutions invest significant resources in developing hormone APIs, as they are fundamental for the treatment of various endocrine disorders. The demand for hormone APIs continues to grow, driven by the rising prevalence of hormonal diseases and an aging population.
In conclusion, hormone APIs are essential components of pharmaceuticals that help restore hormonal balance and alleviate various endocrine disorders. Their significance in healthcare makes them a crucial category in the pharmaceutical industry.
Oxytocin API manufacturers & distributors
Compare qualified Oxytocin API suppliers worldwide. We currently have 19 companies offering Oxytocin API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CEP, CoA, USDMF | 229 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, ISO9001, MSDS | 250 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, EDMF/ASMF, GMP, ISO9001, USDMF | 235 products |
| Chengdu Shengnuo Biopharm... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS | 33 products |
| Chifeng Pharma | Producer | China | China | CoA, WC | 3 products |
| Chr. Olesen Group | Distributor | Denmark | China, Latvia | CEP, CoA, GMP, MSDS, USDMF | 252 products |
| CSBio | Producer | United States | United States | CoA, JDMF | 2 products |
| Fuzhou Medcore Pharmaceut... | Distributor | China | China | BSE/TSE, CoA, MSDS | 9 products |
| Hemmo Pharma | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 13 products |
| Hybio Pharmaceutical Co L... | Producer | China | China | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 34 products |
| J.S.C. Grindeks | Producer | Latvia | Latvia | CEP, CoA, GMP | 6 products |
| Reali Tide Biological Tec... | Producer | China | China | BSE/TSE, CoA, MSDS | 57 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Senova Technology Co., Lt... | Producer | China | China | BSE/TSE, CEP, CoA, ISO9001, MSDS | 157 products |
| Shanghai Soho-Yiming | Producer | China | China | CEP, CoA, FDA | 2 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Socosur | Distributor | France | Unknown | CoA | 21 products |
| Suzhou Tianma Pharma Grou... | Producer | China | China | BSE/TSE, CoA, EDMF/ASMF, GMP, JDMF, KDMF, MSDS, USDMF | 25 products |
When sending a request, specify which Oxytocin 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 Oxytocin 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 Oxytocin API
Sourcing
What matters most when sourcing GMP-grade Oxytocin?
Key considerations include confirming compliance with U.S. and Canadian regulatory requirements and verifying that the manufacturer operates under appropriate GMP standards. Given the mature, generic market, assessing supplier reliability and consistency of quality is essential. It is also important to ensure that packaging and distribution partners have established capabilities for hospital‑focused products.
Which documents are typically required when sourcing Oxytocin API?
Request the core API documentation set: CoA (18 companies), CEP (9 companies), MSDS (9 companies), BSE/TSE (9 companies), GMP (8 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Oxytocin API?
Known or reported manufacturers for Oxytocin: Senova Technology Co., Ltd., Changzhou Comwin Fine Chemicals Co., Ltd, Chr. Olesen Group, Aurora Industry Co., Ltd, Apino Pharma Co., Ltd., Fuzhou Medcore Pharmaceutical Technology Co. Ltd, Sinoway industrial Co.,Ltd, Chengdu Shengnuo Biopharm Co., Ltd., Reali Tide Biological Technology (Weihai) Co., Ltd, Suzhou Tianma Pharma Group Tianji Bio-Pharmaceutical Co., Ltd, Rochem International, Inc.. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Oxytocin 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 Oxytocin manufacturers?
Audit reports may be requested for Oxytocin: 4 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Oxytocin API on Pharmaoffer?
Reported supplier count for Oxytocin: 18 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Oxytocin API?
Production countries reported for Oxytocin: China (13 producers), Latvia (2 producers), United States (2 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Oxytocin usually hold?
Common certifications for Oxytocin suppliers: CoA (18 companies), CEP (9 companies), MSDS (9 companies), BSE/TSE (9 companies), GMP (8 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Oxytocin (CAS 50-56-6) used for?
Oxytocin is used to induce or augment labor when maternal or fetal conditions warrant delivery and to manage uterine inertia or incomplete or inevitable abortion. It is also administered during the third stage of labor to promote uterine contractions and control postpartum bleeding.
Which therapeutic class does Oxytocin fall into?
Oxytocin belongs to the following therapeutic categories: Amino Acids, Peptides, and Proteins, Genito Urinary System and Sex Hormones, Hormones, Hormones, Hormone Substitutes, and Hormone Antagonists, Increased Uterine Smooth Muscle Contraction or Tone. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Oxytocin mainly prescribed for?
The primary indications for Oxytocin: Administration of exogenous Oxytocin is indicated in the antepartum period to initiate or improve uterine contractions for vaginal delivery in situations where there is fetal or maternal concern, For example, It may be used to induce labor in cases of Rh sensitization, maternal diabetes, preeclampsia at or near term, and when delivery is indicated due to prematurely ruptured membranes, Importantly, Oxytocin is not approved or indicated for elective induction of labor, Oxytocin may be used to reinforce labor in select cases of uterine inertia and as adjunctive therapy in the management of incomplete or inevitable abortion. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Oxytocin work?
Oxytocin plays a vital role in labour and delivery.The hormone is produced in the hypothalamus and is secreted from the paraventricular nucleus to the posterior pituitary where it is stored.It is then released in pulses during childbirth to induce uterine contractions.
The concentration of Oxytocin receptors on the myometrium increases significantly during pregnancy and reaches a peak in early labor.Activation of Oxytocin receptors on the myometrium triggers a downstream cascade that leads to increased intracellular calcium in uterine myofibrils which strengthens and increases the frequency of uterine contractions.
In humans, most hormones are regulated by negative feedback; however, Oxytocin is one of the few that is regulated by positive feedback.The head of the fetus pushing on the cervix signals the release of Oxytocin from the posterior pituitary of the mother.Oxytocin then travels to the uterus where it stimulates uterine contractions.The elicited uterine contractions will then stimulate the release of increasing amounts of Oxytocin.This positive feedback loop will continue until parturition.
Since exogenously administered and endogenously secreted Oxytocin result in the same effects on the female reproductive system, synthetic Oxytocin may be used in specific instances during the antepartum and postpartum period to induce or improve uterine contractions.
What should someone know about the safety or toxicity profile of Oxytocin?
Oxytocin can cause uterine hyperstimulation, leading to uterine spasm or rupture if dosing is excessive. High or prolonged doses may also produce antidiuretic effects, resulting in severe water intoxication with neurologic symptoms such as seizures or coma. Supratherapeutic exposure can precipitate cardiovascular events, including tachyarrhythmias and myocardial ischemia. Safe use requires careful titration and continuous clinical monitoring to limit maternal and fetal risks.
What are important formulation and handling considerations for Oxytocin as an API?
Oxytocin is formulated as an aqueous parenteral solution because the peptide is not stable or bioavailable by the oral route. Protection from oxidation and peptide degradation is essential, with controlled pH and appropriate preservatives used to maintain stability. Refrigerated storage and light protection are typically required, including for multidose or diluted infusion preparations. Handling should minimize exposure to conditions that can accelerate peptide breakdown.
Is Oxytocin a biotech?
Oxytocin is classified as a biotech. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Oxytocin?
Yes. Oxytocin is not orally viable because it undergoes rapid enzymatic breakdown in the gastrointestinal tract, leading to extensive peptide degradation. This instability prevents reliable absorption and is the primary barrier to oral formulation.
Regulatory
Where is Oxytocin approved or in use globally?
Oxytocin is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Oxytocin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Oxytocin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Oxytocin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Oxytocin: 1578 verified transactions across 265 suppliers and 202 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Oxytocin?
Market report availability for Oxytocin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
