Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Octreotide API Manufacturers & Suppliers
17 verified resultsSmall-Quantity API Packs
Commercial-scale Suppliers
Employees: 50+
All certificates
Employees: 1500+
All certificates
Employees: 10+
All certificates
Employees: 200
All certificates
Employees: 50+
All certificates
Employees: 373
All certificates
Employees: 1000+
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Octreotide | CAS No: 83150-76-9 | GMP-certified suppliers
A medication that manages acromegaly and alleviates flushing and diarrhea symptoms associated with carcinoid and VIPoma tumors through hormone secretion control.
Therapeutic categories
Primary indications
- Octreotide by injection is used for the treatment of acromegaly and the reduction of flushing and diarrhea symptoms related to carcinoid tumors and/or vasoactive intestinal peptide (VIPoma) tumors
- The delayed-release oral formulation is used for the long-term treatment of acromegaly in patients who tolerate and respond adequately to injectable octreotide and [lanreotide]
Product Snapshot
- Octreotide is formulated as injectable solutions, powders for suspension, and delayed-release oral capsules
- It is primarily indicated for acromegaly treatment and symptom control in carcinoid and vasoactive intestinal peptide tumors
- Octreotide is approved in key regulatory markets including the US, EU, and Canada
Clinical Overview
Pharmacologically, octreotide mimics endogenous somatostatin by binding to somatostatin receptors, leading to inhibition of GH secretion. Its mechanism involves activation of G protein-coupled somatostatin receptors linked to phospholipase C, triggering intracellular signaling cascades that reduce GH release. Octreotide also suppresses the secretion of multiple gastrointestinal hormones including serotonin, gastrin, vasoactive intestinal peptide (VIP), secretin, motilin, and pancreatic polypeptide, thereby alleviating symptoms such as flushing and diarrhea associated with carcinoid tumors and VIPomas. Additionally, octreotide reduces splanchnic blood flow, contributing further to symptom control in these tumor types.
Absorption, distribution, metabolism, and excretion (ADME) data indicate that octreotide has been traditionally administered via injection, allowing for systemic exposure sufficient to control hormone levels. More recently, a delayed-release oral formulation (branded as Mycapssa, approved by the FDA in 2020 and developed by Chiasma Inc.) has been introduced for long-term maintenance treatment of acromegaly in patients who respond to injectable somatostatin analogs.
Safety considerations include potential reduction in gallbladder contractility and bile secretion, and inhibition of thyroid-stimulating hormone (TSH) release. Clinical monitoring is advised for gallbladder-related adverse events and vitamin B12 levels, as decreases have been reported during treatment. Octreotide may prolong QT interval, and its inhibitory effects on cytochrome P450 CYP3A4 and P-glycoprotein substrates warrant careful review of concomitant medications.
When sourcing octreotide API, attention to stringent quality control, including purity and potency testing, is essential. Manufacturers should comply with relevant pharmacopeial standards and regulatory guidelines to ensure consistent clinical performance and patient safety.
Identification & chemistry
| Generic name | Octreotide |
|---|---|
| Molecule type | Biotech |
| CAS | 83150-76-9 |
| UNII | RWM8CCW8GP |
| DrugBank ID | DB00104 |
Pharmacology
| Summary | Octreotide is a somatostatin receptor agonist that inhibits the secretion of growth hormone, glucagon, and various gastrointestinal peptides through G protein-coupled receptor modulation and downstream calcium channel effects. It is primarily used to manage acromegaly by suppressing growth hormone release and to alleviate flushing and diarrhea associated with carcinoid and VIPoma tumors by reducing splanchnic blood flow and hormone secretion. The pharmacodynamic profile includes modulation of hormonal pathways involved in metabolic and gastrointestinal symptom control. |
|---|---|
| Mechanism of action | Octreotide binds to somatostatin receptors coupled to phospholipase C through G proteins and leads to smooth muscle contraction in the blood vessels. Downstream effects that stimulate phospholipase C, the production of 1, 4,5-inositol triphosphate, and action on the L-type calcium channels lead to the inhibition of growth hormone, treating the various growth-hormone and metabolic effects of acromegaly. Octreotide's suppression of luteinizing hormone (LH), reduction in splanchnic blood flow, and inhibition of serotonin, gastrin, vasoactive intestinal peptide, secretin, motilin, and pancreatic polypeptide provide relief for the gastrointestinal and flushing symptoms of carcinoid and/or VIPoma tumors. |
| Pharmacodynamics | Octreotide mimics the naturally occurring hormone known as somatostatin. Like somatostatin, it demonstrates activity against growth hormone and glucagon, treating the disordered tissue growth and insulin regulation in patients with acromegaly. In addition, octreotide relieves the flushing and diarrhea associated with gastrointestinal tumors by reducing splanchnic blood flow and various gastrointestinal hormones associated with diarrhea. Product labeling warns that octreotide may reduce gallbladder contractility, bile secretion, and the release of thyroid-stimulating hormone (TSH) in healthy volunteers. In addition, reports of decreased vitamin B12 in patients treated with octreotide have been made. Ensure to monitor vitamin B12 levels in patients taking octreotide. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Somatostatin receptor | Humans | agonist |
ADME / PK
| Absorption | After a subcutaneous dose, octreotide is absorbed completely upon administration. After the administration of an oral delayed-release capsule, peak concentrations were found to be 33% lower than after subcutaneous administration. The Cmax was attained at 1.67–2.5 hours after oral administration versus 30 minutes for the subcutaneous route. At 20 mg twice a day in patients with acromegaly, peak concentration was 2.5 mg/nL versus 5.30 ng/mL at 40 mg twice a day. AUC increases in proportion with the dose, regardless of the route. |
|---|---|
| Half-life | After a subcutaneous dose, the plasma half-life is estimated to be 0.2 hours. The average elimination half-lives for subcutaneous and oral administration ranged from 2.3 - 2.7 hours and did not differ significantly. One pharmacokinetic study revealed a plasma half-life ranging from 72-113 minutes. |
| Protein binding | Approximately 65% of the dose is bound in the plasma to lipoproteins and albumin. |
| Metabolism | Octreotide has been reported to be heavily metabolized in the liver. |
| Route of elimination | About 32% of an oral octreotide dose is excreted into the urine and 30-40% is excreted by the liver into the feces.. About 11% of the unchanged parent drug is found in the urine, and 2% of the unchanged parent drug can be recovered in the feces. |
| Volume of distribution | In a pharmacokinetic study, the volume of distribution was 13.6 L in healthy volunteers. One pharmacokinetic study revealed a volume of distribution ranging from 18.1-30.4L after intravenous administration in healthy volunteers. |
| Clearance | The total body clearance of octreotide is 7-10 L/h. One pharmacokinetic study revealed a total body clearance of 11.4 L/h. |
Formulation & handling
- Octreotide is a biotech peptide available primarily as parenteral injections including subcutaneous, intravenous, and intramuscular routes, with some oral delayed-release capsule formulations. Oral bioavailability is significantly reduced by food, thus oral capsules should be administered on an empty stomach. Being a peptide, octreotide requires careful handling to maintain stability, especially in solution and powder forms intended for injection.
Regulatory status
| Lifecycle | The API's key patents expired between 2011 and 2017 across the United States and Canada, indicating it is in the mature phase of its lifecycle in these markets. It is also marketed in the European Union, where similar patent expirations likely allow for generic competition. |
|---|
| Markets | US, EU, Canada |
|---|
Supply Chain
| Supply chain summary | Octreotide is supplied by multiple manufacturers, including both originator and generic companies, reflecting a diverse manufacturing landscape. Its branded products are available across the US, EU, and Canadian markets, supported by several packaging entities. The presence of patents with expiration dates primarily between 2011 and 2017 indicates that generic competition is currently established or emerging in these regions. |
|---|
Safety
| Toxicity | There is limited information regarding cases of octreotide overdose aside from case reports of an overdose with injectable octreotide. The dose ranged from 2.4 mg/day to 6 mg/day administered by continuous infusion or subcutaneous administration of 1.5 mg three times daily. Effects of an overdose with octreotide may include hypotension, brain hypoxia, arrhythmia, cardiac arrest, lactic acidosis, pancreatitis, hepatomegaly, diarrhea, flushing, lethargy, and weakness. |
|---|
- Overdose cases may result in severe cardiovascular and metabolic adverse effects, including hypotension, arrhythmia, lactic acidosis, and cardiac arrest
- Potential toxicities include pancreatitis, hepatomegaly, and neurological impairment such as brain hypoxia and lethargy
- Handling should minimize exposure due to risk of systemic adverse reactions upon unintended contact or improper dosing
Octreotide is a type of Somatostatin Analogs
Somatostatin analogs are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various medical conditions. These analogs are synthetic versions of somatostatin, a hormone naturally produced in the body.
Somatostatin analogs are primarily used in the management of conditions such as acromegaly, a hormonal disorder characterized by excessive growth hormone production, and neuroendocrine tumors (NETs), which are tumors that arise from the neuroendocrine cells.
These analogs function by mimicking the actions of somatostatin in the body. Somatostatin normally inhibits the release of several hormones, including growth hormone, insulin, glucagon, and gastrin. By imitating somatostatin's inhibitory effects, somatostatin analogs help regulate the production and release of these hormones.
One commonly used somatostatin analog is octreotide, which is available in various formulations, including injectable and long-acting depot formulations. Octreotide is administered to control symptoms associated with acromegaly and NETs, such as excessive growth, hormone overproduction, and tumor growth.
Other somatostatin analogs like lanreotide and pasireotide have also been developed and are used for similar indications. These analogs offer an extended duration of action and can be administered via subcutaneous injections.
In summary, somatostatin analogs are a crucial category of APIs utilized in the management of conditions like acromegaly and neuroendocrine tumors. They act by replicating the inhibitory effects of somatostatin and are available in various formulations to meet different patient needs. Octreotide, lanreotide, and pasireotide are examples of commonly used somatostatin analogs in clinical practice.
Octreotide (Somatostatin Analogs), classified under Hormonal Agents
Hormonal agents are a prominent category of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the medical field. These substances play a crucial role in regulating and modulating hormonal functions within the body. Hormonal agents are designed to mimic or manipulate the effects of naturally occurring hormones, allowing healthcare professionals to treat various endocrine disorders and hormonal imbalances.
Hormonal agents are commonly employed in the treatment of conditions such as hypothyroidism, hyperthyroidism, diabetes, and hormonal cancers. These APIs work by interacting with specific hormone receptors, either by stimulating or inhibiting their activity, to restore the balance of hormones in the body. They can be administered orally, intravenously, or through other routes depending on the specific medication and patient needs.
Pharmaceutical companies employ rigorous manufacturing processes and quality control measures to ensure the purity, potency, and safety of hormonal agent APIs. These APIs are synthesized using chemical or biotechnological methods, often starting from natural hormone sources or through recombinant DNA technology. Stringent regulatory guidelines are in place to guarantee the efficacy and safety of hormonal agent APIs, ensuring that patients receive high-quality medications.
As the demand for hormone-related therapies continues to grow, ongoing research and development efforts focus on enhancing the effectiveness and reducing the side effects of hormonal agent APIs. This includes the exploration of novel delivery systems, advanced formulations, and targeted drug delivery methods. By continuously advancing our understanding and capabilities in hormonal agents, the medical community can improve patient outcomes and quality of life for individuals with hormonal disorders.
Octreotide API manufacturers & distributors
Compare qualified Octreotide API suppliers worldwide. We currently have 17 companies offering Octreotide 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 |
|---|---|---|---|---|---|
| ALP PHARM | Producer | China | China | CoA, USDMF | 33 products |
| AMBIOPHARM | Producer | United States | Unknown | CoA, USDMF | 10 products |
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, FDA, MSDS, USDMF | 229 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS | 250 products |
| BCN Peptides | Producer | Spain | Spain | CoA, USDMF | 13 products |
| Chemi S.p.A. | Producer | Italy | Italy | CoA, JDMF, USDMF | 18 products |
| Chengdu Shengnuo Biopharm... | Producer | China | China | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 33 products |
| Hainan Shuangcheng | Producer | China | China | CoA | 11 products |
| Hemmo Pharma | Producer | India | India | CoA, GMP, WC | 13 products |
| Hybio Pharmaceutical Co L... | Producer | China | China | BSE/TSE, CEP, CoA, GMP, MSDS | 34 products |
| Mylan | Producer | India | India | CoA, USDMF | 201 products |
| Polypeptide Labs | Producer | Sweden | Unknown | CoA, USDMF | 21 products |
| Reali Tide Biological Tec... | Producer | China | China | BSE/TSE, CoA, MSDS, USDMF | 57 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF, WC | 757 products |
| Sun Pharma | Producer | India | India | CoA, GMP, JDMF, USDMF, WC | 219 products |
| Suzhou Tianma Pharma Grou... | Producer | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, GMP, JDMF, KDMF, MSDS, USDMF | 25 products |
| USV | Producer | India | India | CoA, FDA, GMP, USDMF, WC | 35 products |
When sending a request, specify which Octreotide 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 Octreotide 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.
