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Pancrelipase bulk supplier for pharma manufacturers

Pancrelipase Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 3,000; 6,000; 12,000; 24,000; 36,000

Reference Brands: Creon (USA/EU), Zenpep (USA), Pancreaze (USA)

Category: Gastrointestinal Drugs

Pancrelipase is a mixture of digestive enzymes (lipase, protease, and amylase) derived from porcine pancreas. It helps break down fats, proteins, and carbohydrates in patients with exocrine pancreatic insufficiency (EPI) due to conditions such as cystic fibrosis, chronic pancreatitis, or pancreatic surgery. The therapy aids digestion and nutrient absorption when the pancreas cannot produce enough enzymes.

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Product Description:

Pancrelipase is a standardised mixture of pancreatic enzymes — lipase, protease and amylase — extracted from porcine pancreas. It replaces the enzymes the pancreas can no longer supply in exocrine pancreatic insufficiency caused by cystic fibrosis, chronic pancreatitis, pancreatic surgery or pancreatic cancer. Without it fat is poorly absorbed, leading to steatorrhoea, weight loss and deficiency of fat-soluble vitamins.

Dosing is by lipase units, taken with every meal and snack. Most products are enteric-coated microspheres or minitablets inside capsules, protecting the enzymes from stomach acid until they reach the duodenum. Capsules can be opened and the contents mixed with acidic soft food, but must not be crushed or chewed. Very high doses — above about 10,000 lipase units per kilogram per meal — have been associated with fibrosing colonopathy in children with cystic fibrosis. Hyperuricaemia and oral irritation from chewed beads are also recognised.

Sourcing notes. Because the product is a biological extract, brands are not interchangeable unit-for-unit, and in the US every product has required its own approval since 2010. Porcine origin raises halal and kosher questions in some markets, and viral safety of the source material is a regulatory focus. Strengths are expressed in lipase units, and the specification must state activity for all three enzymes.

Pancrelipase — third party manufacturing & bulk supply

Pancrelipase is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

Indicative minimum order quantity

Pancrelipase is supplied as Capsules — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Pancrelipase listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Pancrelipase is listed as Capsules in 3,000; 6,000; 12,000; 24,000; 36,000. Further strengths and pack presentations are confirmed with the manufacturer at RFQ stage.

Pancrelipase is referenced against Creon (USA/EU), Zenpep (USA), Pancreaze (USA). Reference brands are shown for identification only and remain the property of their respective trademark owners.

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