Synopsis
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
FDF
0
FDF Dossiers
0
FDA Orange Book
0
Europe
0
Canada
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
API SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
Upgrade, download data, analyse, strategize, subscribe with us 
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Digital Content
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
ABOUT THIS PAGE
A Pancrelipase manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pancrelipase, including repackagers and relabelers. The FDA regulates Pancrelipase manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pancrelipase 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 Pancrelipase manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pancrelipase supplier is an individual or a company that provides Pancrelipase active pharmaceutical ingredient (API) or Pancrelipase finished formulations upon request. The Pancrelipase suppliers may include Pancrelipase API manufacturers, exporters, distributors and traders.
click here to find a list of Pancrelipase suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pancrelipase DMF (Drug Master File) is a document detailing the whole manufacturing process of Pancrelipase active pharmaceutical ingredient (API) in detail. Different forms of Pancrelipase DMFs exist exist since differing nations have different regulations, such as Pancrelipase USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pancrelipase DMF submitted to regulatory agencies in the US is known as a USDMF. Pancrelipase USDMF includes data on Pancrelipase's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pancrelipase USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pancrelipase suppliers with USDMF on PharmaCompass.
A Pancrelipase CEP of the European Pharmacopoeia monograph is often referred to as a Pancrelipase Certificate of Suitability (COS). The purpose of a Pancrelipase CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pancrelipase EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pancrelipase to their clients by showing that a Pancrelipase CEP has been issued for it. The manufacturer submits a Pancrelipase CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pancrelipase CEP holder for the record. Additionally, the data presented in the Pancrelipase CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pancrelipase DMF.
A Pancrelipase CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pancrelipase CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Pancrelipase suppliers with CEP (COS) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Pancrelipase as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Pancrelipase API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Pancrelipase as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Pancrelipase and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Pancrelipase NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Pancrelipase suppliers with NDC on PharmaCompass.
Pancrelipase 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 Pancrelipase 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 Pancrelipase GMP manufacturer or Pancrelipase GMP API supplier for your needs.
A Pancrelipase CoA (Certificate of Analysis) is a formal document that attests to Pancrelipase's compliance with Pancrelipase specifications and serves as a tool for batch-level quality control.
Pancrelipase CoA mostly includes findings from lab analyses of a specific batch. For each Pancrelipase 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.
Pancrelipase may be tested according to a variety of international standards, such as European Pharmacopoeia (Pancrelipase EP), Pancrelipase JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Pancrelipase USP).
LOOKING FOR A SUPPLIER?
