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Alogliptin | CAS No: 850649-61-5 | GMP-certified suppliers
A medication that supports improved glycemic control in adults with type 2 diabetes, serving as an adjunct to lifestyle measures for reliable blood glucose management.
Therapeutic categories
Primary indications
- Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
Product Snapshot
- Oral small‑molecule API supplied as film‑coated tablet formulations
- Used for glycemic control applications in type 2 diabetes portfolios
- Approved in the US, EU, and Canada for commercial supply
Clinical Overview
The compound enhances endogenous incretin activity by preventing the degradation of GLP‑1 and GIP. This increases glucose‑dependent insulin secretion from pancreatic beta cells and suppresses glucose‑dependent glucagon release. In controlled studies, peak DPP‑4 inhibition occurs within 2 to 3 hours, exceeding 93 percent across a wide dose range. Inhibition remains above 80 percent for at least 24 hours at doses of 25 mg or higher, supporting once‑daily administration. Alogliptin also increases postprandial active GLP‑1 levels and reduces postprandial glucagon without producing QTc prolongation.
Alogliptin shows high oral bioavailability and moderate distribution, with plasma protein binding of approximately 20 to 30 percent. It undergoes minimal hepatic metabolism and is excreted primarily unchanged in the urine. The terminal elimination half‑life is about 21 hours. Renal clearance is the dominant elimination route, and dose adjustment is required in patients with reduced kidney function.
Safety considerations include the potential for hypersensitivity reactions such as angioedema and rare cases of pancreatitis. Clinicians also monitor for hypoglycemia when alogliptin is used with agents that independently increase insulin levels. As a DPP‑4 inhibitor with limited CYP involvement, the risk of drug interactions is comparatively low, though caution is advised in polypharmacy settings.
Alogliptin is available globally as single‑agent products such as Nesina and in fixed‑dose combinations with metformin or pioglitazone.
For API procurement, sourcing should prioritize confirmation of enantiomeric purity, control of benzoate salt form, and verification of impurities aligned with ICH guidelines, given the low therapeutic dose and prolonged systemic exposure.
Identification & chemistry
| Generic name | Alogliptin |
|---|---|
| Molecule type | Small molecule |
| CAS | 850649-61-5 |
| UNII | JHC049LO86 |
| DrugBank ID | DB06203 |
Pharmacology
| Summary | Alogliptin is a DPP‑4 inhibitor that increases active GLP‑1 and GIP levels by preventing their enzymatic degradation. This enhances glucose‑dependent insulin secretion and reduces glucose‑dependent glucagon release, supporting improved glycemic control in type 2 diabetes. Its pharmacodynamic profile is characterized by rapid, sustained DPP‑4 inhibition and associated increases in postprandial active incretin levels. |
|---|---|
| Mechanism of action | Alogliptin inhibits dipeptidyl peptidase 4 (DPP-4), which normally degrades the incretins glucose-dependent insulinotropic polypeptide (GIP) and glucagon like peptide 1 ( GLP-1). The inhibition of DPP-4 increases the amount of active plasma incretins which helps with glycemic control. GIP and GLP-1 stimulate glucose dependent secretion of insulin in pancreatic beta cells. GLP-1 has the additional effects of suppressing glucose dependent glucagon secretion, inducing satiety, reducing food intake, and reducing gastric emptying. |
| Pharmacodynamics | Peak inhibition of DPP-4 occurs within 2-3 hours after a single-dose administration to healthy subjects. The peak inhibition of DPP-4 exceeded 93% across doses of 12.5 mg to 800 mg. Inhibition of DPP-4 remained above 80% at 24 hours for doses greater than or equal to 25 mg. Alogliptin also demonstrated decreases in postprandial glucagon while increasing postprandial active GLP-1 levels compared to placebo over an 8-hour period following a standardized meal. Alogliptin does not affect the QTc interval. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Dipeptidyl peptidase 4 | Humans | inhibitor |
ADME / PK
| Absorption | The pharmacokinetics of NESINA was also shown to be similar in healthy subjects and in patients with type 2 diabetes. When single, oral doses up to 800 mg in healthy subjects and type 2 diabetes patients are given, the peak plasma alogliptin concentration (median Tmax) occurred 1 to 2 hours after dosing. Accumulation of aloglipin is minimal. The absolute bioavailability of NESINA is approximately 100%. Food does not affect the absorption of alogliptin. |
|---|---|
| Half-life | Terminal half-life = 21 hours |
| Protein binding | Alogliptin is 20% bound to plasma proteins. |
| Metabolism | Alogliptin does not undergo extensive metabolism. Two minor metabolites that were detected are N-demethylated alogliptin (<1% of parent compound) and N-acetylated alogliptin (<6% of parent compound). The N-demethylated metabolite is active and an inhibitor of DPP-4. The N-acetylated metabolite is inactive. Cytochrome enzymes that are involved with the metabolism of alogliptin are CYP2D6 and CYP3A4 but the extent to which this occurs is minimal. Approximately 10-20% of the dose is hepatically metabolized by cytochrome enzymes. |
| Route of elimination | Renal excretion (76%) and feces (13%). 60% to 71% of the dose is excreted as unchanged drug in the urine. |
| Volume of distribution | Following a single, 12.5 mg intravenous infusion of alogliptin to healthy subjects, the volume of distribution during the terminal phase was 417 L, indicating that the drug is well distributed into tissues. |
| Clearance | Renal clearance = 9.6 L/h (this value indicates some active renal tubular secretion); Systemic clearance = 14.0 L/h. |
Formulation & handling
- Oral small‑molecule API suitable for conventional tablet formulations, with moderate aqueous solubility that may require standard solubility‑enhancing excipients for robust dissolution.
- Stable solid benzonitrile derivative with no special handling requirements beyond typical protection from moisture for hygroscopic control.
- Food has minimal impact on absorption, allowing flexible administration without formulation adjustments for food effects.
Regulatory status
| Lifecycle | The API’s key U.S. patents expired in 2016, indicating that it is now in a mature post‑exclusivity phase. With products marketed in the US, EU, and Canada, the ingredient operates in well‑established, competitive markets. |
|---|
| Markets | US, EU, Canada |
|---|
Supply Chain
| Supply chain summary | Alogliptin is supplied by a single originator manufacturer, with branded products marketed in the US, EU, and Canada. With all listed US patents expiring in 2016, the compound is off‑patent and positioned for established or expanding generic participation. This landscape supports a shift from exclusive originator control toward broader multi‑source manufacturing. |
|---|
Safety
| Toxicity | Common adverse reactions (reported in ≥4% of patients treated with alogliptin 25 mg and more frequently than in patients who received placebo) are: nasopharyngitis, headache, and upper respiratory tract infection. |
|---|
- Monitor for increased incidence of nasopharyngitis, headache, and upper respiratory tract infection, which occurred more frequently at the 25 mg exposure level
- Incorporate controls to document and manage mild inflammatory or respiratory responses observed in clinical exposure settings
- Maintain standard precautions to limit personnel exposure to dust or aerosols, consistent with agents associated with upper‑airway irritation
Good Manufacturing Practices
Active pharmaceutical ingredients are made in GMP-certified manufacturing facilities. GMP stands for Good Manufacturing Practices and is the main standard in the pharmaceutical industry. cGMP or Current GMP means that the company complies with the most recent requirements/version of GMP. The WHO has its own guideline for GMP, the World Health Organization or WHO GMP. The authority that has audited the company can also be from a country like China (Chinese GMP) or from the EU (EU GMP), every authority has different GMP requirements.
Alogliptin is a type of Glycemic Agents
Glycemic agents are a category of pharmaceutical active pharmaceutical ingredients (APIs) that are widely used in the treatment of diabetes mellitus. These agents play a crucial role in managing blood glucose levels and improving glycemic control in individuals with diabetes.
One of the key classes of glycemic agents is oral hypoglycemic agents, which are taken by mouth and help lower blood sugar levels. This class includes various subclasses such as sulfonylureas, biguanides, meglitinides, and alpha-glucosidase inhibitors. Sulfonylureas stimulate the release of insulin from the pancreas, while biguanides decrease the production of glucose in the liver and improve insulin sensitivity. Meglitinides work by stimulating insulin secretion, and alpha-glucosidase inhibitors slow down the absorption of carbohydrates from the intestine.
Another important class of glycemic agents is injectable insulin. Insulin is a hormone that regulates glucose metabolism in the body. It is administered via subcutaneous injections and comes in different forms, including short-acting, intermediate-acting, and long-acting insulin. These different formulations allow for precise control of blood glucose levels throughout the day.
Glycemic agents are prescribed based on various factors such as the type of diabetes, severity of the condition, and individual patient characteristics. They are typically used in combination with dietary modifications and lifestyle changes to achieve optimal glycemic control.
Overall, glycemic agents are vital components in the management of diabetes, helping individuals maintain stable blood sugar levels and reducing the risk of complications associated with uncontrolled diabetes.
Alogliptin API manufacturers & distributors
Compare qualified Alogliptin API suppliers worldwide. We currently have 16 companies offering Alogliptin API, with manufacturing taking place in 4 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 |
| Beijing Huikang Boyuan | Producer | China | China | CoA, USDMF | 10 products |
| Fuxing Long Rui Pharma | Producer | China | China | CoA, USDMF | 10 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
| HEC Pharm | Producer | Germany | Unknown | CoA, USDMF | 31 products |
| Honour Lab | Producer | India | India | CoA, GMP, USDMF, WC | 30 products |
| Indoco Remedies | Producer | India | India | CoA, USDMF | 19 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| MSN Labs. | Producer | India | India | CoA, GMP, USDMF, WC | 119 products |
| Senova Technology Co., Lt... | Producer | China | China | BSE/TSE, CoA, ISO9001, MSDS | 157 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001 | 757 products |
| Tianjin Minxiang | Producer | China | China | CoA | 10 products |
| Wisdom Pharma | Producer | China | China | CoA, USDMF | 12 products |
| Zydus Takeda Healthcare | Producer | India | India | CoA, WC | 7 products |
When sending a request, specify which Alogliptin 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 Alogliptin 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 Alogliptin API
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Technical
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Regulatory
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