Liraglutide API Manufacturers & Suppliers
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Liraglutide | CAS No: 204656-20-2 | GMP-certified suppliers
A medication that supports chronic weight management and improves control of type 2 diabetes while helping reduce cardiovascular risk across key patient groups.
Therapeutic categories
Primary indications
- Saxenda, a formulation of liraglutide intended for weight loss, is indicated as an adjunct to diet and exercise for chronic weight management in adult patients who are obese (BMI≥30 kg/m<sup>2</sup>), or who are overweight (BMI≥27 kg/m<sup>2</sup>) and have at least one weight-related comorbidity
- It is also indicated for chronic weight management in pediatric patients ≥12 years old who weigh ≥60 kg and have an initial BMI corresponding to obesity based on international cut-offs
- Victoza, a formulation of liraglutide used in diabetes, is indicated as an adjunct to diet and exercise to improve glycemic control in patients ≥10 years old with type 2 diabetes mellitus
Product Snapshot
- Liraglutide is a subcutaneous injectable peptide supplied as ready-to-use solutions
- Its primary uses are chronic weight management and glycemic control in type 2 diabetes, including cardiovascular risk‑reduction applications
- It is an approved API in major regulated markets including the US, EU, and Canada
Clinical Overview
Liraglutide is a synthetic GLP‑1 analog with 97% homology to endogenous GLP‑1. A C‑16 fatty acid chain attached to the peptide confers reversible albumin binding, prolonging residence time in subcutaneous tissue and systemic circulation. This modification slows renal degradation and enables once‑daily dosing.
Pharmacologically, liraglutide enhances glucose‑dependent insulin secretion, suppresses inappropriate glucagon release under hyperglycemic conditions, and slows gastric emptying. It does not impair counter‑regulatory glucagon release during hypoglycemia. These actions contribute to improved postprandial and fasting glycemic control.
Absorption after subcutaneous administration is gradual due to albumin association. Distribution is largely influenced by plasma protein binding. Metabolism occurs via general proteolytic pathways without a single dominant metabolic route. Elimination is slow relative to native GLP‑1, consistent with its acylation‑mediated stabilization.
Safety considerations include gastrointestinal adverse effects such as nausea, vomiting, and diarrhea, which are dose‑dependent and typically transient. Risks of pancreatitis, gallbladder disease, and heart rate increases have been reported. Liraglutide carries warnings related to thyroid C‑cell tumors based on rodent findings, though relevance to humans remains undetermined. Hypoglycemia risk is low when used without insulin or sulfonylureas.
Victoza and Saxenda are widely recognized product contexts for clinical use.
For API procurement, suppliers should provide validated peptide synthesis controls, impurity profiles specific to acylated GLP‑1 analogs, and evidence of stability under refrigerated storage conditions to meet regulatory and formulation requirements.
Identification & chemistry
| Generic name | Liraglutide |
|---|---|
| Molecule type | Biotech |
| CAS | 204656-20-2 |
| UNII | 839I73S42A |
| DrugBank ID | DB06655 |
Pharmacology
| Summary | Liraglutide is an acylated GLP‑1 receptor agonist that enhances glucose‑dependent insulin secretion, suppresses glucose‑dependent glucagon release, and slows gastric emptying. Its fatty‑acid modification enables reversible albumin binding, prolonging systemic exposure and sustaining GLP‑1 receptor signaling. These actions support its therapeutic use in glycemic regulation and chronic weight management. |
|---|---|
| Mechanism of action | Liraglutide is an acylated synthetic glucagon-like peptide-1 analog[Label,A6932,A177673]. Liraglutide is an agonist of the glucagon-like peptide-1 receptor which is coupled to adenylate cyclase[Label]. The increase in cyclic AMP stimulates the glucose dependant release of insulin, inhibits the glucose dependant release of glucagon, and slows gastric emptying to increase control of blood sugar[Label,A6930]. |
| Pharmacodynamics | Liraglutide is a once-daily GLP-1 derivative for the treatment of type 2 diabetes[Label,A177673]. The prolonged action of liraglutide is achieved by attaching a fatty acid molecule at position 26 of the GLP-1 molecule, enabling it to bind reversibly to albumin within the subcutaneous tissue and bloodstream and be released slowly over time[Label,A177673,A6930]. Binding with albumin results in slower degradation and reduced elimination of liraglutide from the circulation by the kidneys compared to GLP-1. The effect of liraglutide is the increased secretion of insulin and decreased secretion of glucagon in response to glucose as well as slower gastric emptying[Label]. Liraglutide also does not adversely affect glucagon secretion in response to low blood sugar[Label,A177673]. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Glucagon-like peptide 1 receptor | Humans | agonist |
ADME / PK
| Absorption | Bioavailability of liraglutide after subcutaneous injection is approximately 55%[Label] and maximum concentrations are reached after 11.7 hours. |
|---|---|
| Half-life | Terminal half life of 13 hours. |
| Protein binding | >98%[Label]. |
| Metabolism | Liraglutide is less sensitive to metabolism than the endogenous GLP-1 and so is more slowly metabolized by dipeptidyl peptidase-4 and neutral endopeptidase to various smaller polypeptides which have not all been structurally determined. A portion of Liraglutide may be completely metabolized to carbon dioxide and water. |
| Route of elimination | 6% excreted in urine and 5% excreted in feces. |
| Volume of distribution | 13L[Label]. |
| Clearance | 1.2L/h[Label]. |
Formulation & handling
- Liraglutide is a peptide biologic supplied as an aqueous solution for subcutaneous injection, requiring protection from physical stress such as shaking.
- Cold‑chain handling is required to maintain peptide stability, with sensitivity to prolonged exposure to elevated temperatures.
- Oral delivery is not suitable due to enzymatic degradation and low gastrointestinal bioavailability, favoring parenteral formulation only.
Regulatory status
| Lifecycle | The API shows a mature presence in the EU, US, and Canada, with Canadian protection already expired and several US patents expired or nearing expiry. Remaining US patent protection extends to 2032, indicating a gradual shift toward increased generic entry as later‑expiring patents lapse. |
|---|
| Markets | EU, US, Canada |
|---|
Supply Chain
| Supply chain summary | Liraglutide is produced primarily by a single originator, with branded formulations such as Saxenda marketed across the US, EU, and Canada. Its global presence is well established, but the patent set includes both expired protections and several long‑dated US patents extending into the late 2020s and early 2030s. These remaining patents limit broad generic entry until the later expiries. |
|---|
Safety
| Toxicity | There is no clinical significance of race or ethnicity on the safety or efficacy of liraglutide[Label]. Geriatric patients do not experience clinically significant differences in pharmacokinetics though patients at an especially advanced age may be more susceptible to adverse effects[Label]. Female patients have reduced clearance of liraglutide but no dose adjustment is necessary[Label]. The risk and benefit of liraglutide in pregnancy must be weighed before prescribing[Label]. In animal studies, liraglutide is associated with an increased risk of embryonic death and fetal abnormalities though an HbA1c > 7 is also associated with a 20-25% risk of birth defects[Label]. In animal studies, liraglutide is present in the milk of lactating rats at half the plasma concentration of the mother but these results may not translate to humans[Label]. Because it is not known if liraglutide is present in breast milk and the effects on infants are also unknown, the risk and benefit of liraglutide in breastfeeding must be considered before prescribing[Label]. Liraglutide was shown to be safe and effective in patients up to 160kg in weight but has not been studied in patients at a higher weight[Label]. A patient's weight significantly affects the pharmacokinetics of liraglutide[Label]. Liraglutide has not been investigated for use in pediatric patients[Label]. No dosage adjustments are necessary in patients with renal impairment but studies have not been performed in patients with end stage renal disease[Label]. There are no recommendations on dosage adjustment in patients with hepatic impairment, though caution should still be exercised when prescribing to this population[Label]. |
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- Pharmacokinetic variability is influenced by body weight and sex, with reduced clearance in females and altered exposure in very high‑weight individuals
- Data are lacking for patients above 160 kg and for pediatric populations
- Animal studies show embryotoxicity and fetal abnormalities, and drug transfer into rat milk has been observed
Liraglutide is a type of GLP1 agonists
GLP-1 agonists, short for glucagon-like peptide-1 agonists, are a subcategory of pharmaceutical APIs (active pharmaceutical ingredients) commonly used in the treatment of type 2 diabetes mellitus. These medications mimic the actions of GLP-1, a naturally occurring hormone in the body that helps regulate blood sugar levels.
GLP-1 agonists work by binding to GLP-1 receptors in the pancreas, promoting insulin secretion and inhibiting glucagon release. This mechanism of action leads to improved glucose control, reduced fasting and postprandial blood glucose levels, and decreased hemoglobin A1c levels.
One of the key advantages of GLP-1 agonists is their ability to promote weight loss in patients with type 2 diabetes. These medications slow down gastric emptying, increase satiety, and reduce food intake, resulting in modest but significant weight reduction.
Additionally, GLP-1 agonists have shown cardiovascular benefits, including a reduction in the risk of major adverse cardiovascular events, such as heart attack and stroke. They also exhibit a lower risk of hypoglycemia compared to some other antidiabetic medications.
Some commonly prescribed GLP-1 agonists include exenatide, liraglutide, dulaglutide, and semaglutide. These APIs are typically administered via subcutaneous injection, either once or twice daily, or in some cases, as weekly formulations.
In conclusion, GLP-1 agonists are a valuable class of pharmaceutical APIs used in the management of type 2 diabetes. Their mechanism of action, which includes glucose control, weight loss promotion, and cardiovascular benefits, makes them a favorable choice for patients seeking effective and safe antidiabetic therapy.
Liraglutide (GLP1 agonists), 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.
Liraglutide API manufacturers & distributors
Compare qualified Liraglutide API suppliers worldwide. We currently have 17 companies offering Liraglutide 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, USDMF | 229 products |
| Chengdu Shengnuo Biopharm... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 33 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, MSDS, USDMF, WC | 170 products |
| Genohope Biotechnology Co... | Producer | China | China | CoA | 4 products |
| Hainan Shuangcheng | Producer | China | China | CoA | 11 products |
| Hybio Pharmaceutical | Producer | China | China | CoA, USDMF | 8 products |
| Hybio Pharmaceutical Co L... | Producer | China | China | BSE/TSE, CoA, FDA, GMP, MSDS, USDMF | 34 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Reali Tide Biological Tec... | Producer | China | China | BSE/TSE, CoA, MSDS | 57 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Senova Technology Co., Lt... | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS | 157 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, ISO9001, USDMF | 757 products |
| Suzhou Tianma Pharma Grou... | Producer | China | China | BSE/TSE, CoA, EDMF/ASMF, GMP, JDMF, KDMF, MSDS, USDMF | 25 products |
| Xiushi Biopharma | Producer | China | China | BSE/TSE, CoA, ISO9001, MSDS | 4 products |
| Yifan Pharmaceutical Co.,... | Producer | China | China | BSE/TSE, CoA, ISO9001, MSDS | 14 products |
When sending a request, specify which Liraglutide 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 Liraglutide 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.
