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Glibenclamide Structure

PRODUCT TYPE

API

GRADE

BP/USP

CHEMICAL FORMULA

C₂₃H₂₈ClN₃O₅S

IUPAC NAME

3-ethyl-4-methyl-2-oxo-N-(2-{4-[({[(1r,4r)-4- methylcyclohexyl]carbamoyl} amino)sulfonyl]phenyl}ethyl)-2,5-dihydro-1H-pyrrole-1-carboxamide

CAS NO

93479-97-1

MOLECULAR WEIGHT

490.62 g/mol

CHEMICAL CLASS

Sulfonylurea

THERAPEUTIC CLASS

Anti Diabetic

Synonyms

PHYSIOCHEMICAL PROPERTIES

Appearance White to off-white crystalline powder
Solubility Practically insoluble in water; soluble in dimethyl sulfoxide (DMSO)
Melting Point 170–179°C
pH -

Product Description

Glibenclamide also known as Glyburide in the U.S., is a second-generation sulfonylurea used for the oral treatment of type 2 diabetes mellitus. It lowers blood glucose levels by stimulating the release of insulin from pancreatic β-cells. This is achieved through binding to ATP-sensitive potassium channels on the β-cell membrane, leading to depolarization, calcium influx, and insulin secretion. Glibenclamide is more potent than first-generation sulfonylureas and is often used when lifestyle modifications and other oral agents like metformin are insufficient. Due to its longer duration of action, it is typically taken once or twice daily.

How Glibenclamide Works

Glibenclamide works by stimulating the release of insulin from pancreatic β-cells to lower blood glucose levels in people with type 2 diabetes. It binds to sulfonylurea receptors (SUR1) on ATP-sensitive potassium channels in the β-cell membrane, causing the channels to close. This leads to membrane depolarization and the opening of voltage-gated calcium channels, allowing calcium to enter the cells. The increased intracellular calcium triggers the exocytosis of insulin-containing granules, thereby increasing insulin secretion and reducing blood sugar levels.

Use(s)

Adverse Effects

Why choose Salius for Glibenclamide?

  1. WHO-GMP Certified Manufacturing
    Salius Pharma produces Glibenclamide in facilities certified by the World Health Organization’s Good Manufacturing Practices (WHO-GMP), ensuring the API meets high-quality, safety, and purity standards required globally.
  2. Consistent Quality and Reliability
    They maintain strict quality control protocols to provide consistent, pharmaceutical-grade Glibenclamide. This reliability helps pharmaceutical companies avoid batch failures and regulatory issues.
  3. Global Export Experience & Documentation Support
    Salius regularly exports APIs, provides regulatory documents (DMF, impurity profiles), and supports filings for international clients—even in stringent regulated markets
  4. Documents We Provide
  5. Focus on Chronic Therapy APIs
    Salius specializes in APIs for chronic diseases, demonstrating expertise in producing reliable compounds like Glibenclamide, often used in long-term treatments.
Attribute Why Salius Pharma Is a Good Choice
Quality Certification WHO GMP, ISO 9001:2015, FDA audited facilities
Affordability & Generic Access Cost competitive generics for global supply
Export Experience Proven track record of supplying globally

What You Receive in Our Package

When you order from Salius Pharma, you receive more than just a product — you receive a complete, professionally prepared package that meets international regulatory and quality expectations.

Each Shipment Includes:

Product

Expected Delivery Time

We ensure prompt and reliable shipping worldwide. Delivery times vary depending on destination, order volume, and regulatory requirements.

Overall Delivery Time:

7 to 21 business days from dispatch, depending on your location.

FAQs

Glibenclamide is used to treat type 2 diabetes by stimulating the pancreas to release more insulin and lower blood sugar levels.

Glimepiride should be taken once daily with breakfast or the first main meal of the day, swallowed whole with water, and at the same time each day to maintain stable blood sugar levels. It's important to follow your doctor's prescribed dose exactly and avoid skipping or doubling doses. Eating regularly helps prevent hypoglycemia, especially if you're taking other diabetes medications.

Yes, Glibenclamide can cause low blood sugar (hypoglycemia), which is one of its most common and serious side effects. This happens because it stimulates the pancreas to release insulin regardless of your current blood sugar level. The risk of hypoglycemia increases if you skip meals, exercise excessively, drink alcohol, or take it along with other blood sugar-lowering medications. Symptoms of low blood sugar include sweating, shakiness, dizziness, hunger, confusion, and in severe cases, fainting or seizures. Always take Glibenclamide with food and follow your doctor’s dosing instructions to minimize this risk.

Yes, Salius Pharma Pvt. Ltd. does export Glibenclamide API, and its strategic focus on growing its API business in Africa and the Middle East underscores this availability. They explicitly list Glimepiride among their chronic therapy APIs, and their global expansion strategy includes major markets such as Nigeria, Ghana, Kenya, South Africa, and countries across the Middle East.

Yes, Salius Pharma offers full technical support and regulatory documentation for Glibenclamide API, including DMF, CTD, and CEP formats tailored to international standards. The company supports clients with regulatory submissions such as ANDA, ACTD, and country-specific dossiers, ensuring compliance with WHO-GMP, USFDA, and other global authorities. This enables seamless registration and supply of Glibenclamide API in African and Middle Eastern markets, aligning with Salius Pharma’s strategic export focus in these regions.

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