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Linagliptin API Manufacturers & Suppliers

28 verified results
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Commercial-scale Suppliers

Producer
Produced in  Poland
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Employees: 455+

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Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
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FDA
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USDMF
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EDMF/ASMF
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MSDS

All certificates

GMP
FDA
USDMF
EDMF/ASMF
MSDS
BSE/TSE
KDMF
CoA
Producer
Produced in  India
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Employees: 2000+

|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
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FDA
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USDMF
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EDMF/ASMF
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MSDS

All certificates

GMP
FDA
USDMF
EDMF/ASMF
MSDS
BSE/TSE
ISO9001
WC
CoA
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Distributor
Produced in  India
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Employees: 10

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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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MSDS
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BSE/TSE
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CoA

All certificates

GMP
FDA
MSDS
BSE/TSE
CoA
Distributor
Produced in  United States
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Employees: 50+

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Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
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MSDS
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BSE/TSE
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ISO9001
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CoA

All certificates

GMP
MSDS
BSE/TSE
ISO9001
CoA
Producer
Produced in  Turkey
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Employees: 100+

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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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USDMF
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MSDS
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WC
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CoA

All certificates

GMP
USDMF
MSDS
WC
CoA
Distributor
Produced in  India
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Employees: 25

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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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MSDS
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BSE/TSE
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ISO9001

All certificates

GMP
FDA
MSDS
BSE/TSE
ISO9001
CoA
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Distributor
Produced in  World
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Employees: 50

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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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USDMF
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MSDS
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CoA
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ISO9001

All certificates

GMP
USDMF
MSDS
CoA
ISO9001
Distributor
Produced in  China
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Employees: 50+

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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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USDMF
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MSDS
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ISO9001
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CoA

All certificates

GMP
USDMF
MSDS
ISO9001
CoA
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Producer
Produced in  China
|

Employees: 18000+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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CoA
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ISO14001

All certificates

GMP
FDA
CoA
ISO14001
Producer
Produced in  China
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: MSDS
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CoA

All certificates

MSDS
CoA
Producer
Produced in  India
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Employees: 250+

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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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MSDS
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BSE/TSE
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CoA

All certificates

GMP
FDA
MSDS
BSE/TSE
CoA
Producer
Produced in  India
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Employees: 19

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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FDA
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CoA

All certificates

GMP
FDA
CoA
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Producer
Produced in  China
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: USDMF
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CoA

All certificates

USDMF
CoA
Producer
Produced in  China
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
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CoA

All certificates

USDMF
CoA
Producer
Produced in  China
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: coa

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coa
Producer
Produced in  Japan
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: CoA

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CoA
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Producer
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
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CoA

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USDMF
CoA
Producer
Produced in  Unknown
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
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CoA

All certificates

USDMF
CoA
Producer
Produced in  Italy
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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CoA

All certificates

GMP
CoA
Producer
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
|
CoA

All certificates

USDMF
CoA
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Distributor
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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USDMF
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BSE/TSE
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ISO9001
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CoA

All certificates

GMP
USDMF
BSE/TSE
ISO9001
CoA
WHO-GMP
Producer
Produced in  India
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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USDMF
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WC
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CoA

All certificates

GMP
USDMF
WC
CoA
Producer
Produced in  India
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Employees: 21,650

|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
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FDA
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USDMF
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EDMF/ASMF
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MSDS

All certificates

GMP
FDA
USDMF
EDMF/ASMF
MSDS
BSE/TSE
WC
KDMF
CoA
Producer
Produced in  Germany
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CoA

All certificates

GMP
CoA
Not active
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Distributor
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: coa

All certificates

coa
Not active
Producer
Produced in  India
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
USDMF
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WC
|
CoA

All certificates

GMP
USDMF
WC
CoA
Not active
Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
|
CoA

All certificates

USDMF
CoA
Not active
Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
USDMF
|
WC
|
CoA

All certificates

GMP
USDMF
WC
CoA
Not active
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Linagliptin | CAS No: 668270-12-0 | GMP-certified suppliers

A medication that supports improved glycemic control in adults with type 2 diabetes when used alongside diet and exercise, including use within combination treatment regimens.

Therapeutic categories

Agents causing angioedemaAlimentary Tract and MetabolismBlood Glucose Lowering AgentsCytochrome P-450 CYP3A InhibitorsCytochrome P-450 CYP3A SubstratesCytochrome P-450 CYP3A4 Inhibitors
Generic name
Linagliptin
Molecule type
small molecule
CAS number
668270-12-0
DrugBank ID
DB08882
Approval status
Approved drug
ATC code
A10BH05

Primary indications

  • Linagliptin is indicated for the treatment of type II diabetes in addition to diet and exercise
  • It should not be used to treat type I diabetes or in diabetic ketoacidosis
  • An extended-release combination product containing empagliflozin, linagliptin, and metformin was approved by the FDA in January 2020 for the improvement of glycemic control in adults with type 2 diabetes mellitus when used adjunctively with diet and exercise

Product Snapshot

  • Linagliptin is an oral small‑molecule API supplied mainly as film‑coated or extended‑release tablets
  • It is used for glycemic control in adults with type 2 diabetes as an adjunct to diet and exercise, including use in approved combination products
  • The drug is approved in major regulated markets including the US, Canada, and the EU

Clinical Overview

Linagliptin (CAS 668270-12-0) is a xanthine‑based dipeptidyl peptidase 4 inhibitor indicated for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise. It is not appropriate for type 1 diabetes or diabetic ketoacidosis. Beyond monotherapy or dual therapy uses, linagliptin is also incorporated in fixed‑dose combinations, including an extended‑release product with empagliflozin and metformin approved in 2020 for adults requiring additional glycemic control.

Linagliptin is a competitive, reversible DPP‑4 inhibitor that slows enzymatic degradation of glucagon‑like peptide 1 and glucose‑dependent insulinotropic polypeptide. Increased concentrations of these incretin hormones enhance glucose‑dependent insulin secretion and suppress glucagon release, reducing hepatic glycogenolysis and improving postprandial and fasting glycemia. A single 5 mg oral dose produces greater than 80 percent DPP‑4 inhibition for at least 24 hours, supporting once‑daily dosing.

The compound exhibits a non‑linear pharmacokinetic profile with concentration‑dependent protein binding. Absorption is oral, and unlike several other DPP‑4 inhibitors, clearance is not primarily renal, an important consideration for patients with impaired kidney function. Linagliptin is a substrate and inhibitor of CYP3A and P‑glycoprotein transport pathways, so potential interactions should be evaluated when coadministered with agents affecting these systems. It also interacts with organic cation transporters. Elimination occurs mainly via biliary and intestinal routes.

Safety considerations include reports of hypersensitivity reactions, angioedema, pancreatitis, and joint pain within the class. Hypoglycemia risk increases when combined with insulin or insulin secretagogues. Linagliptin is generally weight neutral and has not demonstrated a dose‑dependent effect on QT intervals in available clinical data.

Commercially, linagliptin is marketed in various regions under products such as Tradjenta or as part of combination regimens, though brand names vary globally.

For API procurement, sourcing should prioritize suppliers with demonstrated control of stereochemistry, impurity profiles, and particle size distribution, along with full regulatory documentation to support global registration and finished product manufacturing.

Identification & chemistry

Generic name Linagliptin
Molecule type Small molecule
CAS 668270-12-0
UNII 3X29ZEJ4R2
DrugBank ID DB08882

Pharmacology

SummaryLinagliptin is a competitive, reversible DPP‑4 inhibitor that slows degradation of the incretin hormones GLP‑1 and GIP. By preserving these peptides, it enhances glucose‑dependent insulin secretion and suppresses glucagon release, supporting reduced hepatic glucose output. Its sustained DPP‑4 inhibition leads to increased incretin activity and corresponding improvements in key glycemic biomarkers.
Mechanism of actionLinagliptin is a competitive, reversible DPP-4 inhibitor. Inhibition of this enzyme slows the breakdown of GLP-1 and glucose-dependant insulinotropic polypeptide (GIP). GLP-1 and GIP stimulate the release of insulin from beta cells in the pancreas while inhibiting release of glucagon from pancreatic beta cells. These effects together reduce the breakdown of glycogen in the liver and increase insulin release in response to glucose.
PharmacodynamicsA 5mg oral dose of linagliptin results in >80% inhibition of dipeptidyl peptidase 4 (DPP-4) for ≥24 hours. Inhibition of DPP-4 increases the concentration of glucagon-like peptide 1 (GLP-1), leading to decreased glycosylated hemoglobin and fasting plasma glucose.
Targets
TargetOrganismActions
Dipeptidyl peptidase 4Humansinhibitor

ADME / PK

AbsorptionOral bioavailability of linagliptin is 30%.
Half-lifeThe terminal half life of linagliptin is 155 hours.
Protein bindingLinagliptin is 99% protein bound at a concentration of 1nmol/L and 75-89% protein bound at a concentration of >30nmol/L.
MetabolismAn oral dose of linagliptin is excreted primarily in the feces. 90% of an oral dose is excreted unchanged in the urine and feces. The predominant metabolite in the plasma is CD1790 and the predominant metabolite recovered after excretion was M489(1). Other metabolites are produced through oxidation, oxidative degradation, N-acetylation, glucuronidation, and cysteine adduct formation. Other metabolites have been identified through mass spectrometry though no structures were determined. Metabolism of linagliptin is mediated by cytochrome P450 3A4, aldo-keto reductases, and carbonyl reductases.
Route of elimination84.7% of linagliptin is eliminated in the feces and 5.4% is eliminated in the urine.
Volume of distributionA single intravenous dose of 5mg results in a volume of distribution of 1110L. However an intravenous infusion of 0.5-10mg results in a volume of distribution of 380-1540L.
ClearanceTotal clearance of linagliptin is 374mL/min.

Formulation & handling

  • Oral small‑molecule xanthine derivative with low aqueous solubility, favoring solid oral tablet formulations and potentially requiring solubility‑enhancing excipients.
  • Stable for conventional solid‑dose processing; not a peptide or biologic and does not require special handling beyond standard small‑molecule controls.
  • Food effects are minimal, though high‑fat meals alter absorption parameters without clinically meaningful impact, allowing flexible administration.

Regulatory status

LifecycleMost Canadian and several U.S. patents have already expired, with one remaining U.S. patent scheduled to lapse in late 2025. With products marketed in the US, Canada, and the EU, the API is transitioning toward a mature, largely post‑patent market.
MarketsUS, Canada, EU
Supply Chain
Supply chain summaryLinagliptin is supplied by a single originator manufacturer, with branded combination products such as those marketed in the US, Canada, and the EU. Commercial presence is well established across these major markets. Multiple patents have already expired in the US and Canada, and the remaining US protection ends in late 2025, indicating that generic manufacturing pathways are already open in some regions and likely to broaden as remaining exclusivities lapse.

Safety

ToxicityNo dosage adjustment is necessary based on race, age, weight, sex, renal impairment, or hepatic impairment. Studies of efficacy and safety in pediatric populations were not included in the original drug approvalbut recent clinical trials show linagliptin to be well tolerated in patients 10 to 18 years old. Animal studies showed an increased risk of lymphoma in female rats at over 200 times the clinical dose. Aside from this effect, linagliptin was not shown to be mutagenic, clastogenic, or have an effect on fertility.
High Level Warnings:
  • No clinically relevant toxicity differences were observed across demographic or organ‑function subgroups
  • Pediatric safety data remain limited despite recent tolerability findings in adolescents
  • High‑dose animal studies identified lymphoma incidence in female rats at exposures ›200× human levels

Linagliptin is a type of DPP4-Inhibitors


DPP4-Inhibitors, or dipeptidyl peptidase-4 inhibitors, belong to the subcategory of pharmaceutical active ingredients known for their therapeutic role in managing type 2 diabetes mellitus. These inhibitors work by targeting and inhibiting the action of the enzyme dipeptidyl peptidase-4 (DPP4) in the body.

DPP4 is responsible for breaking down incretin hormones, such as glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). By inhibiting DPP4, DPP4-Inhibitors enhance the levels and activity of these hormones. GLP-1 and GIP play crucial roles in regulating blood sugar levels by stimulating insulin release, inhibiting glucagon secretion, and slowing down gastric emptying.

The main advantage of DPP4-Inhibitors is their ability to improve glycemic control without the risk of hypoglycemia, which is a common side effect of some other diabetes medications. They are typically used as an adjunct therapy in combination with other antidiabetic agents, such as metformin, to achieve optimal glucose management.

Commonly prescribed DPP4-Inhibitors include sitagliptin, saxagliptin, linagliptin, and alogliptin. These drugs are available in oral tablet formulations, allowing for convenient administration. They have shown efficacy in lowering HbA1c levels and have a favorable safety profile.

It is important to note that DPP4-Inhibitors are not suitable for individuals with type 1 diabetes or those with a history of pancreatitis. As with any medication, there may be potential side effects, such as upper respiratory tract infections, headache, and gastrointestinal discomfort, which should be discussed with a healthcare professional.

In conclusion, DPP4-Inhibitors are a subcategory of pharmaceutical APIs that act by inhibiting the enzyme DPP4, thereby enhancing the effects of incretin hormones involved in glucose regulation. They are widely used in the management of type 2 diabetes mellitus, offering glycemic control benefits with a reduced risk of hypoglycemia.


Linagliptin (DPP4-Inhibitors), 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.



Linagliptin API manufacturers & distributors

Compare qualified Linagliptin API suppliers worldwide. We currently have 28 companies offering Linagliptin API, with manufacturing taking place in 10 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
Japan Japan CoA76 products
Distributor
Germany World CoA, GMP, GDP, MSDS, USDMF243 products
Producer
India India BSE/TSE, CoA, FDA, GMP, MSDS52 products
Producer
China China CoA, USDMF10 products
Producer
Italy Italy CoA, GMP14 products
Producer
Germany Germany CoA, GMP35 products
Producer
China China CoA2 products
Producer
India India BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, KDMF, MSDS, USDMF, WC170 products
Producer
China China CoA, MSDS107 products
Producer
China China CoA, USDMF10 products
Distributor
India India BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS484 products
Producer
Germany Unknown CoA, USDMF31 products
Producer
India India CoA, GMP, USDMF, WC30 products
Producer
India India BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, ISO9001, MSDS, USDMF, WC22 products
Producer
India India CoA, GMP, USDMF, WC31 products
Producer
India India CoA, GMP, USDMF, WC201 products
Producer
Poland Poland BSE/TSE, CoA, EDMF/ASMF, FDA, GMP, KDMF, MSDS, USDMF64 products
Distributor
United States United States BSE/TSE, CoA, GMP, ISO9001, MSDS144 products
Producer
India India CoA, FDA, GMP515 products
Producer
China China CoA, USDMF5 products
Distributor
China China CoA162 products
Distributor
China China CoA, GMP, ISO9001, MSDS, USDMF757 products
Distributor
India China BSE/TSE, CoA, GMP, ISO9001, USDMF, WHO-GMP24 products
Producer
India India CoA, USDMF219 products
Distributor
India India BSE/TSE, CoA, FDA, GMP, MSDS263 products
Producer
Turkey Turkey CoA, GMP, MSDS, USDMF, WC28 products
Producer
China China CoA, USDMF12 products
Producer
China China CoA, FDA, GMP, ISO1400134 products

When sending a request, specify which Linagliptin 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 Linagliptin 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 Linagliptin API


Sourcing

What matters most when sourcing GMP-grade Linagliptin?
Key factors include confirming GMP compliance and regulatory alignment for the US, Canada, and the EU. Because Linagliptin is supplied by a single originator, supply chain reliability and traceability are important. It is also necessary to account for regional patent status, as some protections have expired and remaining US exclusivity ends in late 2025.
Which documents are typically required when sourcing Linagliptin API?
Request the core API documentation set: CoA (28 companies), GMP (18 companies), USDMF (16 companies), MSDS (11 companies), FDA (8 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Linagliptin API?
How can I request quotes for Linagliptin API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Linagliptin manufacturers?
Audit reports may be requested for Linagliptin: 6 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Linagliptin API on Pharmaoffer?
Reported supplier count for Linagliptin: 28 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Linagliptin API?
Production countries reported for Linagliptin: India (10 producers), China (10 producers), Poland (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Linagliptin usually hold?
Common certifications for Linagliptin suppliers: CoA (28 companies), GMP (18 companies), USDMF (16 companies), MSDS (11 companies), FDA (8 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Linagliptin (CAS 668270-12-0) used for?
Linagliptin (CAS 668270-12-0) is used to treat type 2 diabetes mellitus as an adjunct to diet and exercise. It improves glycemic control by inhibiting DPP‑4, which increases incretin hormone levels to enhance glucose‑dependent insulin secretion and reduce glucagon. It is also used in fixed‑dose combination products, including formulations with empagliflozin and metformin for adults needing additional glycemic control. It is not used for type 1 diabetes or diabetic ketoacidosis.
Which therapeutic class does Linagliptin fall into?
Linagliptin belongs to the following therapeutic categories: Agents causing angioedema, Alimentary Tract and Metabolism, Blood Glucose Lowering Agents, Cytochrome P-450 CYP3A Inhibitors, Cytochrome P-450 CYP3A Substrates. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Linagliptin mainly prescribed for?
The primary indications for Linagliptin: Linagliptin is indicated for the treatment of type II diabetes in addition to diet and exercise, It should not be used to treat type I diabetes or in diabetic ketoacidosis, An extended-release combination product containing empagliflozin, Linagliptin, and metformin was approved by the FDA in January 2020 for the improvement of glycemic control in adults with type 2 diabetes mellitus when used adjunctively with diet and exercise. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Linagliptin work?
Linagliptin is a competitive, reversible DPP-4 inhibitor. Inhibition of this enzyme slows the breakdown of GLP-1 and glucose-dependant insulinotropic polypeptide (GIP). GLP-1 and GIP stimulate the release of insulin from beta cells in the pancreas while inhibiting release of glucagon from pancreatic beta cells. These effects together reduce the breakdown of glycogen in the liver and increase insulin release in response to glucose.
What should someone know about the safety or toxicity profile of Linagliptin?
Linagliptin has a generally consistent safety profile across demographic and organ‑function subgroups, with class‑associated risks including hypersensitivity reactions, angioedema, pancreatitis, and severe joint pain. Hypoglycemia may occur when it is used with insulin or insulin secretagogues. Pediatric safety information remains limited. High‑dose animal studies showed an increased lymphoma incidence in female rats only at exposures far exceeding those seen in humans.
What are important formulation and handling considerations for Linagliptin as an API?
Linagliptin has low aqueous solubility, so solid oral tablets often require solubility‑enhancing excipients to ensure adequate dissolution. It is stable under standard small‑molecule processing conditions and does not need specialized handling beyond routine controls for potency, uniformity, and contamination. Food has minimal impact on absorption, allowing flexible dosing without formulation adjustments. High protein binding and long half‑life do not generally affect manufacturing but support consistent release from conventional oral dosage forms.
Is Linagliptin a small molecule?
Linagliptin is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Linagliptin?
Linagliptin is a small‑molecule xanthine derivative with low aqueous solubility, so solid oral tablets may use solubility‑enhancing excipients to maintain uniformity and dissolution. It is otherwise stable under standard solid‑dose manufacturing and storage conditions and does not require special handling beyond typical controls for small‑molecule APIs. Food effects on absorption are minimal and do not create stability concerns.

Regulatory

Where is Linagliptin approved or in use globally?
Linagliptin is reported as approved in the following major regions: US, Canada, EU. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Linagliptin right now?
Linagliptin is authorized for use in the United States, Canada, and the European Union. Its regulatory status in these regions supports routine commercial availability under established oversight. Patent protection and exclusivity periods follow the standard frameworks in each jurisdiction, with timelines progressing according to their respective regulatory and intellectual‑property systems.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Linagliptin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Linagliptin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Linagliptin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Linagliptin: 3595 verified transactions across 951 suppliers and 478 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Linagliptin?
Market report availability for Linagliptin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.