Synopsis
0
KDMF
0
VMF
DRUG PRODUCT COMPOSITIONS
0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Click Us!
NDC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-15
Pay. Date : 2013-12-24
DMF Number : 22664
Submission : 2009-03-23
Status :
Type : II
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] EU WC
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/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Australia
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Thickeners and Stabilizers
Direct Compression
Granulation
Controlled & Modified Release
Coating Systems & Additives
Solubilizers
Lubricants & Glidants
Co-Processed Excipients
Topical
Disintegrants & Superdisintegrants
Taste Masking
Chewable & Orodispersible Aids
Film Formers & Plasticizers
Parenteral
Coloring Agents
Rheology Modifiers
Emulsifying Agents
Digital Content
DATA COMPILATION #PharmaFlow
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
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
82
PharmaCompass offers a list of Mesna API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Mesna manufacturer or Mesna supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mesna manufacturer or Mesna supplier.
PharmaCompass also assists you with knowing the Mesna API Price utilized in the formulation of products. Mesna API Price is not always fixed or binding as the Mesna Price is obtained through a variety of data sources. The Mesna Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mucofluid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mucofluid, including repackagers and relabelers. The FDA regulates Mucofluid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mucofluid 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 Mucofluid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mucofluid supplier is an individual or a company that provides Mucofluid active pharmaceutical ingredient (API) or Mucofluid finished formulations upon request. The Mucofluid suppliers may include Mucofluid API manufacturers, exporters, distributors and traders.
click here to find a list of Mucofluid suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mucofluid DMF (Drug Master File) is a document detailing the whole manufacturing process of Mucofluid active pharmaceutical ingredient (API) in detail. Different forms of Mucofluid DMFs exist exist since differing nations have different regulations, such as Mucofluid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mucofluid DMF submitted to regulatory agencies in the US is known as a USDMF. Mucofluid USDMF includes data on Mucofluid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mucofluid USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mucofluid suppliers with USDMF 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 Mucofluid Drug Master File in Japan (Mucofluid JDMF) empowers Mucofluid 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 Mucofluid JDMF during the approval evaluation for pharmaceutical products. At the time of Mucofluid 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 Mucofluid suppliers with JDMF on PharmaCompass.
A Mucofluid CEP of the European Pharmacopoeia monograph is often referred to as a Mucofluid Certificate of Suitability (COS). The purpose of a Mucofluid CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mucofluid EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mucofluid to their clients by showing that a Mucofluid CEP has been issued for it. The manufacturer submits a Mucofluid CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mucofluid CEP holder for the record. Additionally, the data presented in the Mucofluid CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mucofluid DMF.
A Mucofluid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mucofluid 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 Mucofluid suppliers with CEP (COS) on PharmaCompass.
A Mucofluid written confirmation (Mucofluid WC) is an official document issued by a regulatory agency to a Mucofluid manufacturer, verifying that the manufacturing facility of a Mucofluid active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mucofluid APIs or Mucofluid finished pharmaceutical products to another nation, regulatory agencies frequently require a Mucofluid WC (written confirmation) as part of the regulatory process.
click here to find a list of Mucofluid suppliers with Written Confirmation (WC) 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 Mucofluid as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mucofluid 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 Mucofluid 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 Mucofluid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mucofluid NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mucofluid suppliers with NDC on PharmaCompass.
Mucofluid 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 Mucofluid 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 Mucofluid GMP manufacturer or Mucofluid GMP API supplier for your needs.
A Mucofluid CoA (Certificate of Analysis) is a formal document that attests to Mucofluid's compliance with Mucofluid specifications and serves as a tool for batch-level quality control.
Mucofluid CoA mostly includes findings from lab analyses of a specific batch. For each Mucofluid 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.
Mucofluid may be tested according to a variety of international standards, such as European Pharmacopoeia (Mucofluid EP), Mucofluid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mucofluid USP).
