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 amylases are enzymes that help in the chemical process of digestion by hydrolizing starch into more available saccharide forms. The pancrelipase amylase is a single polypeptide chain containing two SH groups and four disulfide bridges. The pancrelipase mixture, including pancrelipase amylase, 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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2006/05/11 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Aimmune Therapeutics, Inc. | 73562-115 | ORAL | 24000 [USP'U] in 1 1 | 10/27/2023 | |
| Physicians Total Care, Inc. | 54868-6435 | ORAL | 55000 [USP'U] in 1 1 | 9/15/2014 | |
| AbbVie Inc. | 0032-2636 | ORAL | 120000 [USP'U] in 1 1 | 3/6/2024 | |
| AbbVie Inc. | 0032-1212 | ORAL | 60000 [USP'U] in 1 1 | 3/6/2024 | |
| AbbVie Inc. | 0032-3016 | ORAL | 180000 [USP'U] in 1 1 | 3/6/2024 | |
| Aimmune Therapeutics, Inc. | 73562-112 | ORAL | 84000 [USP'U] in 1 1 | 10/27/2023 | |
| Atlantic Biologicals Corps | 17856-1212 | ORAL | 60000 [USP'U] in 1 1 | 1/27/2012 | |
| AbbVie Inc. | 0032-2637 | ORAL | 180000 [USP'U] in 1 1 | 3/6/2024 | |
| Physicians Total Care, Inc. | 54868-6067 | ORAL | 60000 [USP'U] in 1 1 | 2/6/2012 | |
| Aimmune Therapeutics, Inc. | 73562-116 | ORAL | 105000 [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 | 10000 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 |
|---|---|---|---|---|---|
| ENZYPLEX TAB | N/A | unam corporation ltd | N/A | N/A | 6/2/1979 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Multizyme | 350976 | Medicine | A | 12/7/2020 | |
| NutriVital Professional Digestive Enzyme Balance | 375622 | Medicine | A | 9/30/2021 | |
| Bloating Relief | 486010 | Medicine | A | 4/14/2025 | |
| 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 | |
| Bioglan Platinum Digest Eze | 423692 | Medicine | A | 10/3/2023 | |
| PM Essentials | 342492 | Regulatory Services Australia | Medicine | A | 8/27/2020 |
| Formula IV | 279841 | Medicine | A | 9/2/2016 | |
| Nourex Professional Digestive Enzymes | 427214 | Medicine | A | 11/1/2023 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| ENZYME TABLETS | general nutrition canada inc. | 02181312 | Tablet - Oral | 130 MG | 10/20/2001 |
| BROMELAIN-PAPAIN | seroyal international inc. | 00565504 | Tablet - Oral | 25 MG | 12/31/1981 |
| CREON MINIMICROSPHERES 6 | BGP Pharma ULC | 02415194 | Capsule - Oral | 30000 UNIT | 12/20/2013 |
| THERAPY FORMULAS MULTI-ENZYME FORMULA-CAP | general nutrition canada inc. | 02216736 | Capsule - Oral | 50 MG | 10/15/2001 |
| METAZYME CAP | 00837059 | Capsule - Oral | 4400 UNIT / CAP | 12/29/1996 | |
| CREON MINIMICROSPHERES 35 | BGP Pharma ULC | 02494639 | Capsule (Delayed Release) - Oral | 35700 UNIT | 1/26/2021 |
| PANCREASE ENTERIC COATED CAP | mcneil pharmaceutical, division of ortho-mcneil inc. | 00591548 | Capsule (Enteric-Coated) - Oral | 20000 UNIT / CAP | 12/31/1984 |
| PANCREASE MT 4 | vivus llc. | 00789445 | Capsule (Delayed Release) - Oral | 17500 UNIT | 12/31/1988 |
| CREON MINIMICROSPHERES 20 | BGP Pharma ULC | 02494620 | Capsule (Delayed Release) - Oral | 22400 UNIT | N/A |
| ULTRESA | Aptalis Pharma Canada ULC | 02045834 | Capsule (Delayed Release) - Oral | 58800 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. | |||||
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