Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
FDF
0
Europe
0
Canada
0
Australia
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
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
API SUPPLIERS
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USDMF
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API Imports and Exports
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Fillers, Diluents & Binders
Controlled & Modified Release
Thickeners and Stabilizers
Lubricants & Glidants
Direct Compression
Granulation
Topical
Film Formers & Plasticizers
Taste Masking
Co-Processed Excipients
Disintegrants & Superdisintegrants
Solubilizers
Empty Capsules
API Stability Enhancers
Chewable & Orodispersible Aids
Parenteral
Vegetarian Capsules
Coloring Agents
Emulsifying Agents
Rheology Modifiers
Surfactant & Foaming Agents
Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Papain manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Papain, including repackagers and relabelers. The FDA regulates Papain manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Papain 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 Papain manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Papain supplier is an individual or a company that provides Papain active pharmaceutical ingredient (API) or Papain finished formulations upon request. The Papain suppliers may include Papain API manufacturers, exporters, distributors and traders.
click here to find a list of Papain suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Papain DMF (Drug Master File) is a document detailing the whole manufacturing process of Papain active pharmaceutical ingredient (API) in detail. Different forms of Papain DMFs exist exist since differing nations have different regulations, such as Papain USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Papain DMF submitted to regulatory agencies in the US is known as a USDMF. Papain USDMF includes data on Papain's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Papain USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Papain suppliers with USDMF on PharmaCompass.
Papain 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 Papain 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 Papain GMP manufacturer or Papain GMP API supplier for your needs.
A Papain CoA (Certificate of Analysis) is a formal document that attests to Papain's compliance with Papain specifications and serves as a tool for batch-level quality control.
Papain CoA mostly includes findings from lab analyses of a specific batch. For each Papain 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.
Papain may be tested according to a variety of international standards, such as European Pharmacopoeia (Papain EP), Papain JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Papain USP).
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