Pancrelipase amylase
- Generic Name
- Pancrelipase amylase
- Brand Names
- Cotazym, Creon, Pancrease MT, Pancreaze, Pertzye, Viokace, Zenpep
- Drug Type
- Biotech
- CAS Number
- 9000-90-2
- Unique Ingredient Identifier
- YOJ58O116E
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.
Background
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 Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
ORAL | 63000 [USP'U] in 1 1 | 2023/10/27 | 73562-111 | ||
ORAL | 55000 [USP'U] in 1 1 | 2014/09/15 | 54868-6435 | ||
ORAL | 60000 [USP'U] in 1 1 | 2012/01/27 | 17856-1212 | ||
ORAL | 180000 [USP'U] in 1 1 | 2024/03/06 | 0032-3016 | ||
ORAL | 15000 [USP'U] in 1 1 | 2024/03/06 | 0032-1203 | ||
ORAL | 30000 [USP'U] in 1 1 | 2024/03/06 | 0032-0046 | ||
ORAL | 30000 [USP'U] in 1 1 | 2024/03/06 | 0032-1206 | ||
ORAL | 105000 [USP'U] in 1 1 | 2023/10/27 | 73562-116 | ||
ORAL | 120000 [USP'U] in 1 1 | 2024/03/06 | 0032-1224 | ||
ORAL | 180000 [USP'U] in 1 1 | 2024/03/06 | 0032-2637 |
EMA Approved Products
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
HSA Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. |
|---|---|---|---|---|---|
ENTERIC COATED TABLET | 10000 u | 1991/05/03 | SIN06211P |
NMPA Approved Products
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|
No NMPA products found
No NMPA products found for this drug
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Reg. Date |
|---|---|---|---|---|---|
HK-06544 | unam corporation ltd | Non-Poison | OTC | 1979/06/02 |
TGA Approved Products
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
|---|---|---|---|---|---|
350976 | Active | 2020/12/07 | Amylase | ||
375622 | Active | 2021/09/30 | Amylase | ||
486010 | Active | 2025/04/14 | Amylase | ||
330721 | Active | 2020/03/04 | Amylase | ||
369253 | Active | 2021/06/15 | Amylase | ||
351741 | Active | 2020/12/15 | Amylase | ||
423692 | Active | 2023/10/03 | Amylase | ||
342492 | Regulatory Services Australia | Active | 2020/08/27 | Amylase | |
279841 | Active | 2016/09/02 | Amylase | ||
427214 | Active | 2023/11/01 | Amylase |