- Raw materials
- Anti-diabetics
- Insulin
- Insulin Aspart
Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Insulin Aspart API Manufacturers & Suppliers
3 verified results
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Commercial-scale Suppliers
Employees: 4000+
All certificates
Employees: 10+
All certificates
Employees: 10000
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Insulin aspart | CAS No: 116094-23-6 | GMP-certified suppliers
A medication that improves glycemic control in adults and children with Type 1 and Type 2 diabetes by providing rapid-acting insulin to manage postprandial blood glucose levels.
Therapeutic categories
Primary indications
- Insulin aspart is indicated to improve glycemic control in adults and children with diabetes mellitus
Product Snapshot
- Insulin aspart is an injectable peptide formulation available primarily as a solution for parenteral administration
- It is indicated for glycemic control in patients with diabetes mellitus
- The product is approved for use in key regulatory markets including the US, Canada, and the EU
Clinical Overview
Pharmacologically, insulin aspart binds to the insulin receptor (IR), a heterotetrameric protein on target cells, stimulating intrinsic tyrosine kinase activity. This activation triggers a cascade of intracellular signaling via insulin receptor substrates and downstream effectors such as PI3 kinase and Akt. Akt modulates glucose transporter 4 (GLUT4) and protein kinase C, which promote glucose uptake, glycogen synthesis, protein synthesis, and lipid metabolism. Insulin aspart’s single amino acid substitution of proline with aspartic acid at position B28 reduces hexamer formation, resulting in a faster absorption rate and more rapid onset of action compared to native human insulin.
After subcutaneous administration, insulin aspart typically begins to act within 10-15 minutes, peaks between 30 and 90 minutes, and has a duration of approximately 4 to 5 hours. This pharmacokinetic profile classifies it as a bolus insulin, which is often used in combination with long-acting basal insulins to approximate physiological insulin secretion and avoid fluctuations in blood glucose levels.
Clinically, insulin aspart is significant for patients with Type 1 Diabetes, who lack endogenous insulin production due to autoimmune destruction of pancreatic beta cells. It is also utilized in Type 2 Diabetes when oral antihyperglycemic agents fail to maintain adequate glycemic control. Safety considerations include monitoring for hypoglycemia, the most common adverse effect, and awareness of ketoacidosis risk in the context of insulin deficiency.
Insulin aspart is produced via recombinant DNA technology in genetically modified Saccharomyces cerevisiae. When sourcing this API, quality considerations include verification of peptide purity, consistent biological potency, and compliance with regulatory guidelines for recombinant proteins. Reliable supply chain management is essential to ensure batch-to-batch consistency and to meet the stringent standards required for injectable insulin preparations.
Identification & chemistry
| Generic name | Insulin aspart |
|---|---|
| Molecule type | Biotech |
| CAS | 116094-23-6 |
| UNII | D933668QVX |
| DrugBank ID | DB01306 |
Pharmacology
| Summary | Insulin aspart is a rapid-acting insulin analogue that targets the insulin receptor to regulate glucose metabolism. It activates the receptor’s tyrosine kinase activity, initiating intracellular signaling cascades that promote glucose uptake, glycogenesis, and protein synthesis. The structural modification reduces hexamer formation, enabling faster absorption and onset of action to mimic physiological postprandial insulin response. |
|---|---|
| Mechanism of action | Insulin aspart binds to the insulin receptor (IR), a heterotetrameric protein consisting of two extracellular alpha units and two transmembrane beta units. The binding of insulin to the alpha subunit of IR stimulates the tyrosine kinase activity intrinsic to the beta subunit of the receptor. The bound receptor autophosphorylates and phosphorylates numerous intracellular substrates such as insulin receptor substrates (IRS) proteins, Cbl, APS, Shc and Gab 1. Activation of these proteins leads to the activation of downstream signaling molecules including PI3 kinase and Akt. Akt regulates the activity of glucose transporter 4 (GLUT4) and protein kinase C (PKC), both of which play critical roles in metabolism and catabolism. In humans, insulin is stored in the form of hexamers; however, only insulin monomers are able to interact with IR. Substitution of the proline residue at B28 with aspartic acid reduces the tendency to form hexamers and results in a faster rate of absorption and onset of action and shorter duration of action. |
| Pharmacodynamics | Insulin is a natural hormone produced by beta cells of the pancreas. In non-diabetic individuals, a basal level of insulin is supplemented with insulin spikes following meals. Postprandial insulin spikes are responsible for the metabolic changes that occur as the body transitions from a postabsorptive to absorptive state. Insulin promotes cellular uptake of glucose, particularly in muscle and adipose tissues, promotes energy storage via glycogenesis, opposes catabolism of energy stores, increases DNA replication and protein synthesis by stimulating amino acid uptake by liver, muscle and adipose tissue, and modifies the activity of numerous enzymes involved in glycogen synthesis and glycolysis. Insulin also promotes growth and is required for the actions of growth hormone (e.g. protein synthesis, cell division, DNA synthesis). Insulin aspart is a rapid-acting insulin analogue used to mimic postprandial insulin spikes in diabetic individuals. The onset of action of insulin aspart is 10-15 minutes. Its activity peaks 60-90 minutes following subcutaneous injection and its duration of action is 4-5 hours. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Insulin receptor | Humans | agonist |
| Insulin-like growth factor 1 receptor | Humans | activator |
ADME / PK
| Absorption | In studies of healthy volunteers and patients with type 1 diabetes, the median time to maximum concentration of insulin aspart in these trials was 40 to 50 minutes versus 80 to 120 minutes, for regular human insulin respectively. Compared to human insulin, insulin aspart has a faster absorption, a faster onset of action, and a shorter duration of action than regular human insulin after subcutaneous injection. It takes 40 - 50 minutes to reach maximum concentration. When a dose of 0.15 U/kg body weight was injected in type 1 diabetes patients, the mean maximum concentration (Cmax) was 82 mU/L. The site of injection has no impact on extent or speed of absorption. |
|---|---|
| Half-life | Elimination half-life was found to be 81 minutes (following subcutaneous administration in healthy subjects). |
| Protein binding | Insulin aspart has a low binding affinity to plasma proteins (<10%), similar to that seen with regular human insulin. |
| Clearance | 1.2 L/h/kg |
Formulation & handling
- Insulin aspart is a biotech peptide formulated as a liquid injection primarily for subcutaneous or intravenous administration.
- Dosage form stability requires cold chain management due to protein sensitivity and the risk of denaturation or aggregation.
- Food intake influences insulin aspart efficacy; formulation scientists should consider meal timing and composition in dosing protocols.
Regulatory status
| Lifecycle | The API is currently in a mature market phase in the US, Canada, and EU, with initial key patents having expired between 2014 and 2022, while additional patents remain active through 2032, potentially extending market exclusivity in certain indications. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for insulin aspart involves multiple originator companies engaged in packaging and distribution within key markets including the US, Canada, and the EU. Branded products are established across these regions, with several formulations available. The presence of multiple active patents extending into the 2020s and beyond indicates ongoing proprietary protection, suggesting limited generic competition at present. |
|---|
Safety
| Toxicity | Inappropriately high dosages relative to food intake and/or energy expenditure may result in severe and sometimes prolonged and life-threatening hypoglycemia. Neurogenic (autonomic) signs and symptoms of hypoglycemia include trembling, palpitations, sweating, anxiety, hunger, nausea and tingling. Neuroglycopenic signs and symptoms of hypoglycemia include difficulty concentrating, lethargy/weakness, confusion, drowsiness, vision changes, difficulty speaking, headache, and dizziness. Mild hypoglycemia is characterized by the presence of autonomic symptoms. Moderate hypoglycemia is characterized by the presence of autonomic and neuroglycopenic symptoms. Individuals may become unconscious in severe cases of hypoglycemia. |
|---|
- Handle with care to avoid exposure to doses exceeding recommended levels, which may induce severe hypoglycemia
- Use appropriate protective equipment to prevent accidental contact, as symptoms of hypoglycemia can progress rapidly to neuroglycopenic impairment
- Ensure secure containment to mitigate risk of unintended release and exposure, given the potential for life-threatening adverse reactions
Insulin Aspart is a type of Insulin
Insulin is a vital pharmaceutical Active Pharmaceutical Ingredient (API) that plays a crucial role in managing diabetes. It is a hormone produced by the pancreas and is responsible for regulating blood sugar levels in the body. Insulin is used extensively in the treatment of diabetes, a chronic condition characterized by insufficient insulin production or impaired insulin action.
As an API, insulin is available in various forms, including human insulin and analog insulin. Human insulin is derived from recombinant DNA technology, where it is synthesized using genetically engineered bacteria or yeast. Analog insulin, on the other hand, is a modified version of human insulin that is designed to mimic the body's natural insulin action more closely.
Insulin APIs are utilized in the production of pharmaceutical formulations such as insulin injections, insulin pens, and insulin pumps. These formulations are essential for individuals with diabetes who require regular insulin administration to maintain proper blood sugar control.
The development and production of insulin APIs require stringent quality control measures to ensure their safety and efficacy. Manufacturing processes must adhere to Good Manufacturing Practices (GMP) to guarantee the purity, potency, and consistency of the API. Additionally, regulatory bodies such as the Food and Drug Administration (FDA) closely monitor the production and distribution of insulin APIs to maintain high standards of quality and patient safety.
In summary, insulin APIs are critical components in the management of diabetes. They are manufactured using advanced biotechnological methods and are utilized in the production of various insulin formulations. Rigorous quality control and regulatory compliance are essential to ensure the effectiveness and safety of insulin APIs for patients with diabetes.
Insulin Aspart (Insulin), classified under Anti-diabetics
Anti-diabetics, belonging to the pharmaceutical API (Active Pharmaceutical Ingredient) category, are a group of compounds designed to manage and treat diabetes mellitus, a chronic metabolic disorder characterized by high blood sugar levels. These medications play a vital role in controlling diabetes and preventing complications associated with the disease.
Anti-diabetics encompass a wide range of drug classes, including biguanides, sulfonylureas, thiazolidinediones, dipeptidyl peptidase-4 (DPP-4) inhibitors, sodium-glucose cotransporter-2 (SGLT2) inhibitors, and glucagon-like peptide-1 (GLP-1) receptor agonists. Each class works through different mechanisms to regulate blood sugar levels and improve insulin sensitivity.
Biguanides, such as metformin, reduce glucose production by the liver and enhance insulin sensitivity in peripheral tissues. Sulfonylureas, like glipizide, stimulate insulin secretion from pancreatic beta cells. Thiazolidinediones, including pioglitazone, improve insulin sensitivity in muscle and adipose tissues. DPP-4 inhibitors, such as sitagliptin, increase insulin release and inhibit glucagon secretion. SGLT2 inhibitors, like dapagliflozin, decrease renal glucose reabsorption, leading to increased urinary glucose excretion. GLP-1 receptor agonists, such as exenatide, enhance insulin secretion, suppress glucagon release, slow gastric emptying, and promote satiety.
These anti-diabetic APIs serve as the foundational ingredients for the formulation of various oral tablets, capsules, and injectable medications used in the treatment of diabetes. By targeting different aspects of glucose regulation, they help patients achieve and maintain optimal blood sugar levels, thus reducing the risk of diabetic complications, such as cardiovascular disease, neuropathy, and nephropathy.
It is crucial for healthcare professionals to prescribe and administer these anti-diabetic medications appropriately, considering factors like the patient's medical history, co-existing conditions, and potential drug interactions. Regular monitoring of blood glucose levels and close medical supervision are necessary to ensure effective diabetes management.
In conclusion, anti-diabetics form a critical category of pharmaceutical APIs used for the treatment of diabetes. These compounds, encompassing various drug classes, work through distinct mechanisms to regulate blood sugar levels and improve insulin sensitivity. By facilitating glucose control, anti-diabetic APIs help mitigate the risk of complications associated with diabetes mellitus, ultimately promoting better health outcomes for patients.
Insulin Aspart API manufacturers & distributors
Compare qualified Insulin Aspart API suppliers worldwide. We currently have 3 companies offering Insulin Aspart API, with manufacturing taking place in 2 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, CoA, GMP, MSDS, USDMF | 229 products |
| Biocon | Producer | India | India | CoA, GMP | 36 products |
| Yifan Pharmaceutical Co.,... | Producer | China | China | BSE/TSE, CoA, ISO9001, MSDS, USDMF | 14 products |
When sending a request, specify which Insulin Aspart 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 Insulin Aspart 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.
