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Salmon calcitonin | CAS No: 47931-85-1 | GMP-certified suppliers
A medication that treats symptomatic Paget’s disease, post-menopausal osteoporosis, and acutely lowers elevated serum calcium levels in patients with intolerance to alternative therapies.
Therapeutic categories
Primary indications
- Used in the treatment of symptomatic Paget's disease for patients unresponsive to alternate treatments or intolerant to such treatments
- In addition, it is used in emergency situations when serum calcium levels must be decreased quickly until the underlying condition is identified
- It can also be added to existing therapeutic regimens for hypercalcemia such as intravenous fluids and furosemide, oral phosphate or corticosteroids, or other agents
- Calcitonin can be used in patients with azotemia and cases where intravenous fluids would be contraindicated due to limited cardiac reserves
Product Snapshot
- Salmon calcitonin is available primarily as injectable and nasal spray peptide formulations
- It is indicated for the treatment of symptomatic Paget's disease, hypercalcemia, and post-menopausal osteoporosis
- The product is approved and marketed in key regulatory regions including the US, Canada, and the EU
Clinical Overview
Pharmacodynamically, salmon calcitonin acts by inhibiting osteoclastic bone resorption while promoting osteoblastic bone formation, resulting in increased bone mass and a corresponding decrease in plasma calcium concentrations. It also facilitates renal excretion of multiple ions including calcium, phosphate, sodium, magnesium, and potassium by reducing their tubular reabsorption, which contributes to enhanced jejunal secretion of electrolytes and water.
The mechanism of action involves binding to calcitonin receptors located predominantly on osteoclasts. This receptor interaction activates intracellular signaling pathways including adenylyl cyclase and the phosphatidyl-inositol-calcium cascade. Moreover, receptor engagement increases the activity of vitamin D metabolizing enzymes such as 25-hydroxyvitamin D-24-hydroxylase, which may facilitate improved calcium retention and bone density.
From an ADME perspective, salmon calcitonin is primarily eliminated via renal excretion. Safety considerations include monitoring for hypersensitivity reactions and local nasal irritation when administered intranasally. Usage should be carefully evaluated in patients with renal impairment and those with pre-existing cardiac conditions.
Several branded formulations of salmon calcitonin nasal spray have regulatory approval in various markets, often prescribed within specialist settings for bone metabolic disorders.
In sourcing salmon calcitonin API, stringent controls on peptide purity, absence of microbial contamination, and reproducibility of synthetic manufacturing processes are essential. Due to its peptide nature, cold chain logistics and validated stability data are critical to maintaining API integrity during procurement and distribution. Compliance with pharmacopeial standards and regulatory guidelines remains a key quality consideration.
Identification & chemistry
| Generic name | Salmon calcitonin |
|---|---|
| Molecule type | Biotech |
| CAS | 47931-85-1 |
| UNII | 7SFC6U2VI5 |
| DrugBank ID | DB00017 |
Pharmacology
| Summary | Calcitonin acts primarily on calcitonin receptors located on osteoclasts, inhibiting bone resorption and promoting bone formation, resulting in increased bone mass and reduced plasma calcium levels. Its mechanism involves activation of adenylyl cyclase and phosphatidyl-inositol-calcium signaling pathways, as well as enhancement of vitamin D metabolizing enzymes. Pharmacodynamically, calcitonin also promotes renal excretion of calcium and other ions, contributing to its role in managing calcium homeostasis. |
|---|---|
| Mechanism of action | Calcitonin binds to the calcitonin receptor (found primarily in osteoclasts) which then enhances the production of vitamin D producing enzymes (25-hydroxyvitamine D-24-hydroxylase), leading to greater calcium retention and enhanced bone density. Binding of calcitonin to its receptor also activates adenylyl cyclase and the phosphatidyl-inositol-calcium pathway. |
| Pharmacodynamics | Calcitonin inhibits bone resorption by osteoclasts (bone remodeling cells) and promotes bone formation by osteoblasts. This leads to a net increase in bone mass and a reduction in plasma calcium levels. It also promotes the renal excretion of ions such as calcium, phosphate, sodium, magnesium, and potassium by decreasing tubular reabsorption. In consequence, there is an increase in the jejunal secretion of water, sodium, potassium, and chloride. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Calcitonin receptor | Humans | agonist |
ADME / PK
| Absorption | Salmon calcitonin is rapidly absorbed with bioavailability of 71% following subcutaneous injection and 66% following intramuscular injection in humans. Via the nasal route, the bioavailability varies between 3 to 5% relative to IM. |
|---|---|
| Half-life | Half-life elimination (terminal): I.M. 58 minutes; SubQ 59 to 64 minutes; Nasal: ~18 to 23 minutes |
| Protein binding | Protein binding is about 30 to 40%. |
| Metabolism | Salmon calcitonin primarily undergoes degradation in the kidneys to form pharmacologically inactive metabolites. It is also metabolized in the blood and the peripheral tissue. |
| Route of elimination | Urine. Studies with injectable calcitonin show increases in the excretion of filtered phosphate, calcium, and sodium by decreasing their tubular reabsorption in the kidney. |
| Volume of distribution | 0.15 to 0.3 L/kg |
Formulation & handling
- Salmon calcitonin is a peptide biotech API formulated primarily for parenteral (intramuscular, subcutaneous, intravenous) and nasal administration.
- This API is sensitive to enzymatic degradation, necessitating careful handling and storage to maintain peptide stability in liquid or solution forms.
- Concurrent administration of calcium and vitamin D supplements is recommended for therapeutic use in osteoporosis, highlighting the importance of formulation compatibility and patient management.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient’s primary patents expired in the United States between 2015 and 2021, allowing for generic competition in the US, Canada, and EU markets. As a result, the API is in a mature market phase across these regions. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Salmon calcitonin is manufactured and packaged by multiple companies, including originators and generic producers, with established presence in North American and European markets. Branded products are available across the US, EU, and Canada, reflecting a broad global reach. Patent expirations occurred between 2015 and 2021, indicating that generic competition is currently present or emerging in the market. |
|---|
Safety
| Toxicity | Salmon calcitonin was shown to inhibit lactation in animals and is not recommend in nursing mothers. While research in animals have shown a decrease in fetal weight, no studies have yet shown similar results in humans. It is recommended however to proceed carefully when administering salmon calcitonin to pregnant women and consider if the benefits outweigh the risks. Because of its protein nature, salmon calcitonin may provoke an allergy reaction (bronchospams and swelling of the tongue/throat) that can turn into a full-blown anaphylactic response. The manufacturer also reports an increase in the risk of malignancies from oral route (0.7%) to intranasal route (2.4%) compared to placebo. The same may apply to IV, IM and SC routes since the systemic exposure is higher in those cases. Nausea is noticeable in some patients but tends to decrease with continued administration. Rhinitis, headaches and back pain have also been reported among others. |
|---|
- Salmon calcitonin may induce hypersensitivity reactions including bronchospasm and anaphylaxis due to its protein nature
- Animal studies indicate potential fetal toxicity
- Use with caution during pregnancy considering benefit-risk assessment
Salmon Calcitonin is a type of Calcium regulators
Calcium regulators are a vital subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) used in the field of medicine. These compounds play a crucial role in maintaining the balance of calcium levels within the body. Calcium is an essential mineral that participates in numerous physiological processes, including muscle contraction, nerve transmission, and bone health.
Pharmaceutical APIs classified as calcium regulators are designed to modulate the levels of calcium in the body, either by increasing or decreasing its concentration as needed. These APIs act by targeting specific mechanisms involved in calcium regulation, such as calcium channels, transporters, or enzymes.
Calcium regulators find application in the treatment of various medical conditions. For instance, drugs that promote calcium absorption or enhance bone mineral density can be employed to manage osteoporosis, a condition characterized by weak and brittle bones. Conversely, medications that inhibit calcium channels or reduce calcium levels are used in the treatment of conditions like hypertension or cardiac arrhythmias.
The development of calcium regulators involves extensive research and rigorous testing to ensure their safety and efficacy. Pharmaceutical companies invest significant resources in the discovery, synthesis, and optimization of these APIs. Additionally, regulatory authorities closely monitor the production and distribution of calcium regulators to ensure compliance with stringent quality standards.
In summary, calcium regulators are a specialized category of pharmaceutical APIs that play a crucial role in maintaining calcium balance within the body. These compounds are integral to the treatment of various medical conditions and require rigorous research and testing to ensure their effectiveness and safety.
Salmon Calcitonin (Calcium regulators), classified under Metabolic Bone Disease Agents
Metabolic Bone Disease Agents are a category of pharmaceutical active pharmaceutical ingredients (APIs) that are specifically designed to treat and manage conditions related to the bones and their metabolism. These agents play a crucial role in the treatment of various metabolic bone diseases, including osteoporosis, Paget's disease, and rickets.
The primary function of Metabolic Bone Disease Agents is to regulate bone remodeling and maintain bone health. They achieve this by targeting specific pathways involved in bone metabolism, such as osteoclast and osteoblast activity, calcium regulation, and vitamin D metabolism.
These APIs are commonly used in the development of medications, including oral tablets, injectables, and topical formulations, for the effective treatment of metabolic bone diseases. They are carefully formulated to optimize their pharmacokinetic and pharmacodynamic properties, ensuring maximum efficacy and minimal side effects.
Metabolic Bone Disease Agents encompass a range of substances, including bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin, and vitamin D analogs. These APIs act through different mechanisms to address specific aspects of bone health, such as inhibiting bone resorption, promoting bone formation, or regulating calcium levels.
In conclusion, Metabolic Bone Disease Agents are a vital category of pharmaceutical APIs used in the development of medications for the treatment and management of various metabolic bone diseases. These agents target specific pathways involved in bone metabolism to regulate bone remodeling, enhance bone health, and alleviate the symptoms associated with these conditions.
Salmon Calcitonin API manufacturers & distributors
Compare qualified Salmon Calcitonin API suppliers worldwide. We currently have 7 companies offering Salmon Calcitonin 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 |
|---|---|---|---|---|---|
| BCN Peptides | Producer | Spain | Spain | CEP, CoA, FDA, GMP, USDMF | 13 products |
| Chr. Olesen Group | Distributor | Denmark | Sweden | CEP, CoA, GMP, MSDS, USDMF | 252 products |
| Hemmo Pharma | Producer | India | India | CEP, CoA, FDA, WC | 13 products |
| Hybio Pharmaceutical Co L... | Producer | China | China | CoA, GMP | 34 products |
| Polypeptide Labs | Producer | Sweden | Denmark | CEP, CoA, FDA, GMP, USDMF | 21 products |
| Shanghai Soho-Yiming | Producer | China | China | CEP, CoA, FDA | 2 products |
| Sun Pharma | Producer | India | India | CoA, GMP, WC | 219 products |
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