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K-cab (Tegoprazan) API Manufacturers & Suppliers

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Commercial-scale Suppliers

India

Distributor
Produced in  India
|

Employees: 25

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

All certificates

GMP
FDA
MSDS
BSE/TSE
ISO9001
CoA
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United States

Producer
Produced in  China
|

Employees: 3500

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

All certificates

GMP
MSDS
ISO9001
WC
KDMF
CoA
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Tegoprazan | CAS No: 942195-55-3 | GMP-certified suppliers

A medication that supports management of acid‑related gastrointestinal conditions, including reflux and peptic ulcers, by providing reliable symptom relief through effective gastric acid control.

Therapeutic categories

Alimentary Tract and MetabolismDrugs for Acid Related DisordersDrugs for Peptic Ulcer and Gastro-Oesophageal Reflux Disease (Gord)Gastric Acid Lowering AgentsProton Pump Inhibitors
Generic name
Tegoprazan
Molecule type
small molecule
CAS number
942195-55-3
DrugBank ID
DB16690
Approval status
Investigational drug
ATC code
A02BC09

Product Snapshot

  • Tegoprazan is an oral small‑molecule tablet formulation
  • It is developed for gastric acid–related conditions such as GERD and peptic ulcer disease
  • It remains investigational with no major regulatory approvals to date

Clinical Overview

Tegoprazan, CAS 942195-55-3, is an investigational potassium‑competitive acid blocker developed for the management of acid‑related gastrointestinal diseases such as erosive and non‑erosive reflux conditions and peptic ulcer presentations. Its therapeutic role aligns with the need for rapid and sustained control of intragastric acidity in settings where gastric mucosal injury or persistent reflux symptoms require acid suppression.

The compound exhibits pharmacologic activity through direct, reversible inhibition of the gastric H+/K+‑ATPase. As an acid‑resistant weak base, it accumulates within the acidic canaliculi of parietal cells and inhibits the pump in a potassium‑competitive manner. This mechanism differs from proton pump inhibitors, which require acid‑dependent activation and covalent binding. Tegoprazan does not require conversion to an active intermediate and maintains potency regardless of luminal pH. Slow clearance from gastric glands contributes to sustained suppression of acid secretion, and available evidence indicates activity is not significantly influenced by food intake.

Comprehensive pharmacokinetic parameters such as absorption rate, bioavailability, distribution volume, metabolism pathways, and elimination half‑life have not been fully characterized in publicly available sources. Reported observations describe a rapid onset of action and prolonged pH control, but detailed ADME data remain limited. No definitive toxicity profile has been established; however, as with other potent acid‑suppressive agents, considerations include potential effects on gastric pH‑dependent absorption of other drugs and theoretical risks associated with long‑term acid suppression. Safety findings should therefore be interpreted within investigational study constraints.

Tegoprazan has been developed and marketed in some regions under local brand names, primarily in East Asian markets, though global regulatory statuses vary.

For API procurement, sourcing should prioritize manufacturers with verifiable process controls, impurity profiling, and stability data suitable for regulatory submissions. Batch‑specific analytical documentation and confirmation of compliance with regional GMP standards are essential for formulation and registration activities.

Identification & chemistry

Generic name Tegoprazan
Molecule type Small molecule
CAS 942195-55-3
UNII W017G7IF4S
DrugBank ID DB16690

Pharmacology

SummaryTegoprazan is a potassium‑competitive acid blocker that reversibly inhibits the gastric H+/K+‑ATPase to reduce acid secretion. As an acid‑resistant weak base, it accumulates in the acidic environment of parietal cell canaliculi and directly targets the sodium/potassium‑transporting ATPase without metabolic activation. Its pharmacologic effect centers on selective, reversible suppression of gastric proton pump activity.
Mechanism of actionTegoprazan works as a potassium-competitive acid blocker that is potent and highly selective.Its mechanism of action is different from that of the proton-pump inhibitors as this drug does not require conversion into an active form and can directly inhibit H+/K+‐ATPase in a reversible and K+‐competitive way.This is because it is an acid-resistant weak base with the ability to remain in the highly acidic canaliculi of gastric parietal cells.
Targets
TargetOrganismActions
Sodium/Potassium Transporting ATPaseHumansinhibitor

Formulation & handling

  • Low aqueous solubility may necessitate solubility‑enhancing strategies (e.g., solid dispersion or particle‑size control) for oral tablet formulations.
  • Moderate lipophilicity (LogP ~2.3) supports conventional oral absorption but may require careful excipient selection to maintain dissolution rate.
  • As a small‑molecule acid‑suppressing agent, it should be protected from moisture and processed under standard low‑humidity conditions to preserve stability.

Regulatory status

Tegoprazan is a type of Gastrointestinal Agents


Gastrointestinal Agents belong to the pharmaceutical API category that focuses on treating disorders and ailments related to the digestive system. These agents play a crucial role in addressing various gastrointestinal conditions, such as acid reflux, ulcers, irritable bowel syndrome (IBS), and inflammatory bowel disease (IBD).

One of the key types of gastrointestinal agents is proton pump inhibitors (PPIs), which work by reducing the production of stomach acid. PPIs help in treating conditions like gastroesophageal reflux disease (GERD) and peptic ulcers. Another essential class of agents is antacids, which neutralize excessive stomach acid, providing relief from heartburn and indigestion.

Gastrointestinal agents also include antispasmodics that alleviate abdominal cramps and spasms associated with conditions like IBS. These drugs work by relaxing the smooth muscles of the digestive tract. Additionally, there are drugs categorized as laxatives that aid in relieving constipation by promoting bowel movements.

Moreover, certain gastrointestinal agents act as antiemetics, effectively reducing nausea and vomiting. These drugs are particularly useful for patients undergoing chemotherapy or experiencing motion sickness.

Pharmaceutical companies develop and manufacture a wide range of gastrointestinal agents in various forms, including tablets, capsules, suspensions, and injections. These agents are typically formulated using active pharmaceutical ingredients (APIs) and other excipients to ensure their efficacy and safety.

In conclusion, gastrointestinal agents form a vital category of pharmaceutical APIs, providing relief from digestive disorders and improving overall gastrointestinal health. The availability of diverse agents catering to different conditions ensures that patients can receive targeted treatment for their specific gastrointestinal needs.

Tegoprazan API manufacturers & distributors

Compare qualified Tegoprazan API suppliers worldwide. We currently have 2 companies offering Tegoprazan 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.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
United States China CoA, GMP, ISO9001, KDMF, MSDS, WC197 products
Distributor
India India BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS484 products

When sending a request, specify which Tegoprazan 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 Tegoprazan 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.

We show synonyms and CAS numbers for Tegoprazan API to help you connect with the right supplier. However, a synonym or CAS number does not always mean it is exactly the same specification. Always confirm the final specs directly with the supplier before placing an order.

Frequently asked questions about Tegoprazan API


Sourcing

Which documents are typically required when sourcing Tegoprazan API?
Request the core API documentation set: GMP (2 companies), CoA (2 companies), ISO9001 (2 companies), MSDS (2 companies), BSE/TSE (1 company). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Tegoprazan API?
Known or reported manufacturers for Tegoprazan: Global Pharma Tek, ChemExpress. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Tegoprazan 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 Tegoprazan manufacturers?
Audit reports may be requested for Tegoprazan: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Tegoprazan API on Pharmaoffer?
Reported supplier count for Tegoprazan: 2 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Tegoprazan API?
Production countries reported for Tegoprazan: India (1 producer), China (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Tegoprazan usually hold?
Common certifications for Tegoprazan suppliers: GMP (2 companies), CoA (2 companies), ISO9001 (2 companies), MSDS (2 companies), BSE/TSE (1 company). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Tegoprazan (CAS 942195-55-3) used for?
Tegoprazan is used for the management of acid‑related gastrointestinal disorders, including erosive and non‑erosive reflux conditions and peptic ulcer presentations. It provides rapid and sustained suppression of gastric acid through reversible, potassium‑competitive inhibition of the gastric H+/K+-ATPase.
Which therapeutic class does Tegoprazan fall into?
Tegoprazan belongs to the following therapeutic categories: Alimentary Tract and Metabolism, Drugs for Acid Related Disorders, Drugs for Peptic Ulcer and Gastro-Oesophageal Reflux Disease (Gord), Gastric Acid Lowering Agents, Proton Pump Inhibitors. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
How does Tegoprazan work?
Tegoprazan works as a potassium-competitive acid blocker that is potent and highly selective.Its mechanism of action is different from that of the proton-pump inhibitors as this drug does not require conversion into an active form and can directly inhibit H+/K+‐ATPase in a reversible and K+‐competitive way.This is because it is an acid-resistant weak base with the ability to remain in the highly acidic canaliculi of gastric parietal cells.
What should someone know about the safety or toxicity profile of Tegoprazan?
Tegoprazan’s safety information is limited, as no definitive toxicity profile has been established in publicly available sources. Reported considerations align with other potent acid‑suppressive agents, including potential effects on the absorption of pH‑dependent medications and theoretical risks associated with sustained elevation of gastric pH. Safety findings should be interpreted within the constraints of investigational studies.
What are important formulation and handling considerations for Tegoprazan as an API?
Key considerations include its low aqueous solubility, which often requires solubility‑enhancing approaches such as solid dispersions or particle‑size control for oral tablets. Its moderate lipophilicity (LogP ~2.3) supports oral absorption but calls for excipients that help maintain an adequate dissolution rate. The API should be protected from moisture and handled under low‑humidity conditions to preserve stability.
Is Tegoprazan a small molecule?
Tegoprazan is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Tegoprazan?
Oral Tegoprazan requires protection from moisture, as standard low‑humidity processing is needed to preserve stability. Its low aqueous solubility may also necessitate formulation approaches that maintain an adequate dissolution rate over shelf life. Careful excipient selection is important to avoid changes that could further limit dissolution.

Pharmaoffer

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