Description

Pancreatin Enteric-Coated Tablets / Minimicrospheres (10,000 / 25,000 Lipase Units)

Healthy Inc is a specialized global supplier and exporter of advanced gastroenterological, metabolic, and biological enzyme therapeutics. We provide ultra-high-purity, kinetically stabilized Pancreatin Enteric-Coated Tablets & Capsules (10,000 / 25,000 USP Lipase Units), manufactured in WHO–GMP certified, temperature-controlled, biological oral solid dosage facilities. This “Exocrine Pancreatic Enzyme Replacement Therapy (PERT)” is a massive-volume, life-sustaining export to gastroenterology clinics, cystic fibrosis NGOs, pediatric care networks, and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated intervention for the prevention of severe malnutrition and steatorrhea in patients with compromised pancreatic function.

Product Overview

This highly advanced formulation contains Pancreatin, a concentrated, high-grade porcine-derived extract containing a precise, standardized triad of biological enzymes required to break down the core macronutrients of the human diet.

The “Biological Digestion & Exocrine Replacement” Specialist:

• Mechanism 1 (The Tri-Enzyme Digestion Catalyst): In conditions like Chronic Pancreatitis or Cystic Fibrosis, the pancreas is physically destroyed or its ducts are permanently blocked, meaning zero digestive enzymes reach the intestines. Patients literally starve to death while eating massive amounts of food because they cannot absorb it. Pancreatin physically replaces these missing enzymes: Lipase aggressively breaks down complex fats, Protease dismantles proteins into absorbable amino acids, and Amylase converts starches into simple sugars.
• Mechanism 2 (The Enteric Survival Shield – CRITICAL): These biological enzymes are violently destroyed by stomach acid. To survive the transit through the stomach, the Pancreatin is engineered with a strict Gastro-Resistant (Enteric) Coating. This polymer shield remains absolutely solid in the acidic stomach but rapidly dissolves the moment it hits the alkaline environment of the duodenum (small intestine), unleashing the enzymes precisely where food absorption occurs.
• The Steatorrhea Reversal: By effectively digesting dietary fats, Pancreatin immediately halts steatorrhea (frequent, foul-smelling, fatty, liquid stools), drastically improving the patient’s quality of life, arresting dangerous weight loss, and allowing the absorption of critical fat-soluble vitamins (A, D, E, and K).

Product Composition & Strength

We supply this product as a Precision-Engineered Enteric-Coated Tablet or Hard Capsule (containing Enteric Minimicrospheres), packed exclusively in highly secure, moisture-resistant Alu-Alu blisters or desiccant-lined HDPE bottles to ensure the absolute stability of the biological proteins.

*Pack Sizes: Bottles of 100 or 10×10 Alu-Alu Blisters (Optimized specifically for strict, high-volume daily dispensing where patients may consume 3 to 10 units daily with every meal and snack).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Gastroenterology Distributors, and Hospital Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Cold-Process Biological Engineering: Because Pancreatin is a complex of live-action proteins, standard high-heat pharmaceutical drying or high-friction tableting will permanently denature the enzymes. Our facilities utilize advanced cold-process granulation, strictly chilled fluid-bed coating systems, and intense moisture-control suites. This extreme care guarantees that every single unit of Lipase, Protease, and Amylase remains 100% biologically active from our production line to the patient’s digestive tract.

Therapeutic Indications (Human Use)

Indicated for the targeted management of severe pancreatic exocrine deficiency:

• Exocrine Pancreatic Insufficiency (EPI): Treatment of EPI caused by Cystic Fibrosis, Chronic Pancreatitis, Pancreatic Cancer, or Gastrointestinal Bypass Surgery (e.g., Billroth II).
• Post-Pancreatectomy: Essential lifelong replacement therapy following partial or total surgical removal of the pancreas.

Dosage & Administration

Recommended Dosage (Strictly as per Gastroenterologist Guidelines):

• Dosing is Highly Individualized: The dose must be meticulously calculated based on the patient’s body weight, the fat content of the specific meal, and the severity of the steatorrhea.
• Administration (THE MEALTIME RULE – CRITICAL): The enzymes must physically mix with the food to digest it. Tablets/Capsules MUST be swallowed completely whole, during or immediately after every single meal and snack.
• The Mucosal Burn Warning: The medication must never be chewed or crushed. If the enteric coating is broken in the mouth, the highly active proteases will immediately begin digesting the mucosal lining of the patient’s mouth and esophagus, causing severe, painful ulcerations.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• Fibrosing Colonopathy (Strict Dose Limits): In pediatric patients with Cystic Fibrosis, utilizing massive, excessive doses of high-strength Pancreatin has been linked to Fibrosing Colonopathy (a severe, irreversible thickening and scarring of the large intestine requiring surgical resection). Doses should strictly not exceed 10,000 Lipase Units per kilogram of body weight per day.
• Hyperuricemia & Gout: Porcine pancreatic extracts contain high levels of purines. Long-term, high-dose therapy can significantly raise blood and urine uric acid levels, potentially triggering painful gout attacks or uric acid kidney stones.
• Viral Transmission Risk: While highly purified and subjected to rigorous viral inactivation protocols during API extraction, because it is an animal-derived biological product, a theoretical risk of transmitting porcine viruses (like porcine parvovirus) exists.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and NGO Health Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Gastroenterological and Biological Enzyme Formulations. Whether you are looking for a reliable Government Tender Supplier for cystic fibrosis programs in the CIS or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.