Gastrointestinal & Antiulcer

UlinastatinThird Party Manufacturing in India

Looking to get Ulinastatin manufactured under your brand? Our WHO-GMP certified partner facilities support PCD franchise partners and global export opportunities structured across 25+ countries.

WHO-GMP Certified
Export Ready
PCD Franchise Available
CAS Number
80449-31-6
Drug Class
Serine protease inhibitor (Kunitz-type)
Molecular Formula
Glycoprotein (C₁₃H₁₆O₃ for active fragment)
Molecular Weight
220.27 g/mol (active fragment)
Grade Standards
IP, USP, EP
Therapeutic Category
Gastrointestinal & Antiulcer
MOQ
Contact us for MOQ — varies by strength and batch size
Dosage Forms
Injection

Mechanism of Action

Ulinastatin works by blocking the activity of several serine proteases, which are enzymes that break down proteins in the body. It is a natural substance originally found in human urine and is also known as urinary trypsin inhibitor. The main way it works is by attaching to and inactivating trypsin, chymotrypsin, and other pancreatic proteases that can cause tissue damage when they become overactive. This inhibition helps prevent the chain reaction of inflammation that occurs when these enzymes spill into surrounding tissues. By calming this inflammatory cascade, ulinastatin helps protect organs from injury during severe illness. It also reduces the release of inflammatory signaling molecules called cytokines, which are responsible for the widespread inflammation seen in conditions like sepsis and pancreatitis. Additionally, ulinastatin helps stabilize cell membranes and reduce the activity of neutrophils, a type of white blood cell that can cause collateral damage during an immune response. Unlike steroids, which broadly suppress the immune system, ulinastatin works more selectively by targeting specific enzymes involved in the inflammatory process. This makes it a valuable option for managing severe inflammatory conditions without completely shutting down the body's natural defenses.

Therapeutic Uses & Indications

Therapeutic Uses

Ulinastatin is prescribed for the treatment of:

  • Acute Pancreatitis: Ulinastatin reduces pancreatic inflammation by inhibiting digestive enzymes that cause self-digestion of pancreatic tissue. Clinical studies show it significantly lowers mortality and prevents new organ dysfunction in severe acute pancreatitis.
  • Severe Sepsis and Septic Shock: By modulating the systemic inflammatory response, ulinastatin helps prevent multiple organ dysfunction syndrome (MODS) in critically ill patients with sepsis.
  • Acute Respiratory Distress Syndrome (ARDS): Its anti-inflammatory properties help reduce lung tissue damage and improve oxygenation in patients with ARDS.
  • Systemic Inflammatory Response Syndrome (SIRS): Ulinastatin is used to control the overwhelming inflammatory response following major surgery, trauma, or burns.
  • Circulatory Failure: It helps stabilize hemodynamics in acute circulatory failure by reducing inflammatory mediator release.

Why Manufacturers Choose Ulinastatin

Ulinastatin is a high-value biological drug with growing demand across India, China, Japan, and other Asian markets. As a protease inhibitor derived from human urine, it requires specialized manufacturing capabilities for extraction, purification, and quality control. The molecule has demonstrated significant clinical benefits in reducing mortality from severe pancreatitis and sepsis, making it an essential medicine in critical care settings. Indian manufacturers have established strong capabilities in producing injectable biologicals, positioning ulinastatin as a strategic product for hospitals and intensive care units. The growing awareness of its benefits over traditional steroids has driven consistent demand from both domestic and export markets.

This makes Ulinastatin one of the most sought-after molecules for third party manufacturing in India, with consistent demand from critical care specialists and hospital supply chains.

Dosage Forms We Manufacture

Injection
1 Lac IU/vial

Frequently Asked Questions

What is the minimum order quantity for Ulinastatin?
Minimum order quantity for Ulinastatin is Contact us for MOQ — varies by strength and batch size. Please contact us for bulk pricing and custom quantities.
What dosage forms of Ulinastatin can you manufacture?
We manufacture Ulinastatin as: Injection (1 Lac IU/vial).
Are your manufacturing facilities WHO-GMP certified?
Yes. Celesta Healthcare works exclusively with WHO-GMP certified partner production facilities. All manufacturing batches are subject to strict quality control and documentation.
Can you manufacture Ulinastatin for export?
Yes. We provide export-ready Ulinastatin formulations structured across 25+ countries. We provide full export documentation including Certificate of Analysis (CoA), Certificate of Origin, and regulatory dossiers on request.
What grade standards do you follow for Ulinastatin?
We manufacture Ulinastatin to IP, USP, EP pharmacopoeial standards.
Third Party Manufacturing

Get Ulinastatin made under your brand

  • WHO-GMP certified facilities
  • Quote within 24 hours
  • Low MOQ, export ready
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Our Manufacturing Capabilities

  • WHO-GMP Certified Partner Plants
  • 25+ years of pharma industry experience
  • PCD Franchise with monopoly rights
  • Export support across 25+ countries
  • Small batch to commercial scale
  • Custom formulation development

Packaging Options

Vial (lyophilized powder for injection), Ampoule, Single-dose vial. Packaging customized to client brand guidelines.

Start Manufacturing Ulinastatin Today

Celesta Healthcare provides WHO-GMP certified third-party manufacturing for Ulinastatin across all dosage forms. PCD franchise and export orders welcome.

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