Overview
Pancrelipase, in general, is composed of a mixture of pancreatic enzymes which include amylases, lipases, and proteases. These enzymes are extracted from porcine pancreatic glands. The pancrelipase lipase is an enzyme secreted by the pancreas that is responsible for the hydrolysis of dietary fat molecules in the human digestive system. The pancrelipase mixture, including pancrelipase lipase, was developed by Ortho-McNeil-Janssen Pharmaceuticals, Inc and FDA approved on April 12, 2010.
Indication
Please refer to Pancrelipase.
Associated Conditions
- Exocrine Pancreatic Insufficiency
- Pancreatic Insufficiency
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/13 | Not Applicable | Not yet recruiting | |||
2022/12/08 | Phase 1 | Active, not recruiting | |||
2010/07/09 | Phase 1 | Terminated | Forest Laboratories |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aimmune Therapeutics, Inc. | 73562-115 | ORAL | 5000 [USP'U] in 1 1 | 10/27/2023 | |
| Physicians Total Care, Inc. | 54868-6435 | ORAL | 10000 [USP'U] in 1 1 | 9/15/2014 | |
| AbbVie Inc. | 0032-2636 | ORAL | 24000 [USP'U] in 1 1 | 3/6/2024 | |
| AbbVie Inc. | 0032-1212 | ORAL | 12000 [USP'U] in 1 1 | 3/6/2024 | |
| AbbVie Inc. | 0032-3016 | ORAL | 36000 [USP'U] in 1 1 | 3/6/2024 | |
| Aimmune Therapeutics, Inc. | 73562-112 | ORAL | 20000 [USP'U] in 1 1 | 10/27/2023 | |
| Atlantic Biologicals Corps | 17856-1212 | ORAL | 12000 [USP'U] in 1 1 | 1/27/2012 | |
| AbbVie Inc. | 0032-2637 | ORAL | 36000 [USP'U] in 1 1 | 3/6/2024 | |
| Physicians Total Care, Inc. | 54868-6067 | ORAL | 12000 [USP'U] in 1 1 | 2/6/2012 | |
| Aimmune Therapeutics, Inc. | 73562-116 | ORAL | 25000 [USP'U] in 1 1 | 10/27/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ENZYPLEX TABLET | SIN06211P | ENTERIC COATED TABLET | 240 u | 5/3/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| TAITIAN STOMACH TAB | N/A | N/A | N/A | 5/17/1999 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Digestive Zyme | 328366 | Interclinical Laboratories Pty Ltd | Medicine | A | 1/8/2020 |
| Multizyme | 350976 | Medicine | A | 12/7/2020 | |
| Ultra Inflamase | 351743 | Medicine | A | 12/15/2020 | |
| NutriVital Professional Digestive Enzyme Balance | 375622 | Medicine | A | 9/30/2021 | |
| Plexus ProBioFit | 353839 | Medicine | A | 1/29/2021 | |
| Bloating Relief | 486010 | Medicine | A | 4/14/2025 | |
| Bio-Film Clear | 290546 | Medicine | A | 6/22/2017 | |
| Eagle Vegie Digestaid | 330721 | Medicine | A | 3/4/2020 | |
| Henry Blooms Complete Digestion | 369253 | Medicine | A | 6/15/2021 | |
| Executive Digestive | 351741 | Medicine | A | 12/15/2020 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| DIGESTAID TAB | anabolic laboratories inc. | 00046728 | Tablet - Oral | 65 MG | 12/31/1964 |
| BROMELAIN-PAPAIN | seroyal international inc. | 00565504 | Tablet - Oral | 50 MG | 12/31/1981 |
| CREON MINIMICROSPHERES 6 | BGP Pharma ULC | 02415194 | Capsule - Oral | 6000 UNIT | 12/20/2013 |
| THERAPY FORMULAS MULTI-ENZYME FORMULA-CAP | general nutrition canada inc. | 02216736 | Capsule - Oral | 50 MG | 10/15/2001 |
| VITAMINS A-C-E PLUS LIPASE TAB | trophic canada ltd. | 00374075 | Tablet - Oral | 10 MG | 12/31/1967 |
| CREON MINIMICROSPHERES 35 | BGP Pharma ULC | 02494639 | Capsule (Delayed Release) - Oral | 35000 UNIT | 1/26/2021 |
| PANCREASE ENTERIC COATED CAP | mcneil pharmaceutical, division of ortho-mcneil inc. | 00591548 | Capsule (Enteric-Coated) - Oral | 4000 UNIT / CAP | 12/31/1984 |
| PANCREASE MT 4 | vivus llc. | 00789445 | Capsule (Delayed Release) - Oral | 4200 UNIT | 12/31/1988 |
| CREON MINIMICROSPHERES 20 | BGP Pharma ULC | 02494620 | Capsule (Delayed Release) - Oral | 20000 UNIT | N/A |
| ULTRESA | Aptalis Pharma Canada ULC | 02045834 | Capsule (Delayed Release) - Oral | 13800 UNIT | 1/20/1998 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
Help Us Improve
Your feedback helps us provide better drug information and insights.