Synopsis
Synopsis
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USDMF
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CEP/COS
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JDMF
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EU WC
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KDMF
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NDC API
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Australia
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South Africa
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| Molecular Weight | 238.20 g/mol |
|---|---|
| Molecular Formula | C11H9N3NaO2+ |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 2 |
| Exact Mass | 238.05924582 g/mol |
| Monoisotopic Mass | 238.05924582 g/mol |
| Topological Polar Surface Area | 74.6 A^2 |
| Heavy Atom Count | 17 |
| Formal Charge | 1 |
| Complexity | 371 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 1 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 6 | |
|---|---|
| Drug Name | ULTRESA |
| Active Ingredient | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) |
| Company | FOREST LABS INC (Application Number: N022222) |
| 2 of 6 | |
|---|---|
| Drug Name | VIOKACE |
| Active Ingredient | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) |
| Company | FOREST LABS INC (Application Number: N022542) |
| 3 of 6 | |
|---|---|
| Drug Name | ZENPEP |
| Active Ingredient | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) |
| Company | FOREST LABS INC (Application Number: N022210. Patents: 7658918, 8221747, 8246950, 8562978, 8562979, 8562980, 8562981) |
| 4 of 6 | |
|---|---|
| Drug Name | CREON |
| Active Ingredient | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) |
| Company | ABBVIE (Application Number: N020725. Patent: 9198871) |
| 5 of 6 | |
|---|---|
| Drug Name | PANCREAZE |
| Active Ingredient | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) |
| Company | JANSSEN PHARMS (Application Number: N022523. Patents: 8221747, 8562978, 8562979, 8562980, 8562981) |
| 6 of 6 | |
|---|---|
| Drug Name | PERTZYE |
| Active Ingredient | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) |
| Company | DIGESTIVE CARE INC (Application Number: N022175) |
API SUPPLIERS
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| Importing Country | Total Quantity (KGS) |
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FDF Dossiers
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Market Place
ABOUT THIS PAGE
A Lipase manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lipase, including repackagers and relabelers. The FDA regulates Lipase manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lipase API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Lipase manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lipase supplier is an individual or a company that provides Lipase active pharmaceutical ingredient (API) or Lipase finished formulations upon request. The Lipase suppliers may include Lipase API manufacturers, exporters, distributors and traders.
click here to find a list of Lipase suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
Lipase Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Lipase GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Lipase GMP manufacturer or Lipase GMP API supplier for your needs.
A Lipase CoA (Certificate of Analysis) is a formal document that attests to Lipase's compliance with Lipase specifications and serves as a tool for batch-level quality control.
Lipase CoA mostly includes findings from lab analyses of a specific batch. For each Lipase CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Lipase may be tested according to a variety of international standards, such as European Pharmacopoeia (Lipase EP), Lipase JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lipase USP).
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