In the pharmaceutical industry, Ursodeoxycholic Acid (UDCA) 300 mg is a naturally occurring bile acid used as a first-line hepatoprotective agent. As a pharmacist and manufacturer, I view it as a “bile-enhancing” medication that shifts the balance of the body’s bile pool toward a less toxic, more protective state.
At your WHO-GMP facility in Mumbai, this 300 mg SKU is a core component of your gastroenterology and hepatology portfolio, especially for international B2B export to regions prioritizing non-surgical gallbladder treatments.
Primary Clinical Indications
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Gallstone Dissolution: Specifically for small-to-medium (<20 mm) cholesterol-rich gallstones in patients who are unsuitable for surgery or wish to avoid it.
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Primary Biliary Cholangitis (PBC): The only FDA-approved drug for treating this chronic autoimmune liver disease. It significantly delays disease progression and reduces the need for liver transplantation.
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Cystic Fibrosis-Related Liver Disease: Used in children (ages 6–18) to improve bile flow and protect the liver from mucus-induced clogging.
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Prevention of Gallstones: Often prescribed during rapid weight loss or for obese patients undergoing bariatric surgery to prevent the formation of new stones.
Mechanism: Bile Enrichment & Cytoprotection
UDCA works by replacing toxic bile acids with a “friendly” alternative.
Cholesterol Reduction: It inhibits the absorption of cholesterol in the intestine and its secretion by the liver, lowering the “cholesterol saturation index” of bile.
Stone Solubilization: By reducing cholesterol levels in the bile, it allows the cholesterol already trapped in gallstones to gradually dissolve back into the bile.
Hepatocyte Protection: It displaces toxic, hydrophobic bile acids that can damage liver cell membranes, effectively “diluting” the harmful elements in the liver.
Choleretic Effect: It stimulates the secretion of bile, improving flow through the ducts and preventing the buildup (cholestasis) that causes liver injury.
The Pharmacist’s “Technical Warning”
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The “Aluminium” Interference: Patients must avoid taking aluminium-containing antacids concurrently, as they bind to UDCA and prevent its absorption. Advise a gap of at least 2 hours.
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Biliary Obstruction: It is strictly contraindicated in patients with a completely blocked bile duct or acute gallbladder inflammation.
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Monitoring: For chronic conditions like PBC, liver function tests (ALT, AST, Bilirubin) should be monitored every month for the first 3 months of treatment.
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“Orange” Side Effect: Common side effects include mild diarrhea or pasty stools, which usually resolve as the body adjusts to the increased bile flow.
The Manufacturer’s Perspective: Technical & Export
From a production and B2B standpoint at your facility in Mumbai:
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The “300 mg” USP: On your marketplace, market the 300 mg tablet as the “Standard Weight-Based Dose.” Typical adult dosing is 10–15 mg/kg daily, making 300 mg (twice or thrice daily) the most practical strength for most patients.
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Stability for Export: UDCA is stable but sensitive to high heat. Utilizing Alu-Alu blister packaging is essential for maintaining a 36-month shelf life in Zone IVb tropical regions.
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Dossier Support: We provide full CTD/eCTD Dossiers to support your firm’s registration in international health tenders and for bidding on gastro-specialty contracts.