Synopsis
Synopsis
0
USDMF
0
CEP/COS
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
Listed Suppliers
0
API
0
FDF
0
FDA Orange Book
0
Europe
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
0
EDQM
0
USP
0
JP
0
Others
0
US Patents
0
US Exclusivities
0
Health Canada Patents
0
Data Compilation #PharmaFlow
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
0
News #PharmaBuzz
US Medicaid
NA
Annual Reports
NA
Finished Drug Prices
NA
1. 195833-46-6
2. Lipase Substrate Chromogenic
3. Dtxsid90583514
4. Lipase Substrate, >=95% (hplc)
| Molecular Weight | 752.0 g/mol |
|---|---|
| Molecular Formula | C45H69NO8 |
| XLogP3 | 12.7 |
| Hydrogen Bond Donor Count | 0 |
| Hydrogen Bond Acceptor Count | 9 |
| Rotatable Bond Count | 34 |
| Exact Mass | 751.50231816 g/mol |
| Monoisotopic Mass | 751.50231816 g/mol |
| Topological Polar Surface Area | 110 Ų |
| Heavy Atom Count | 54 |
| Formal Charge | 0 |
| Complexity | 1160 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
ABOUT THIS PAGE
A Lipase Substrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lipase Substrate, including repackagers and relabelers. The FDA regulates Lipase Substrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lipase Substrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Lipase Substrate supplier is an individual or a company that provides Lipase Substrate active pharmaceutical ingredient (API) or Lipase Substrate finished formulations upon request. The Lipase Substrate suppliers may include Lipase Substrate API manufacturers, exporters, distributors and traders.
click here to find a list of Lipase Substrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Lipase Substrate Drug Master File in Japan (Lipase Substrate JDMF) empowers Lipase Substrate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Lipase Substrate JDMF during the approval evaluation for pharmaceutical products. At the time of Lipase Substrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Lipase Substrate suppliers with JDMF on PharmaCompass.
Lipase Substrate 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 Substrate 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 Substrate GMP manufacturer or Lipase Substrate GMP API supplier for your needs.
A Lipase Substrate CoA (Certificate of Analysis) is a formal document that attests to Lipase Substrate's compliance with Lipase Substrate specifications and serves as a tool for batch-level quality control.
Lipase Substrate CoA mostly includes findings from lab analyses of a specific batch. For each Lipase Substrate 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 Substrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Lipase Substrate EP), Lipase Substrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lipase Substrate USP).
LOOKING FOR A SUPPLIER?
