Synopsis
0
EU WC
0
KDMF
0
VMF
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
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
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Certificate Number : R1-CEP 2001-421 - Rev 03
Status : Valid
Issue Date : 2019-05-03
Type : Chemical
Substance Number : 562
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : R0-CEP 1999-199 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2004-10-06
Type : Chemical
Substance Number : 562
With Fermion, start the journey of your innovative API.
Certificate Number : R1-CEP 2013-136 - Rev 00
Status : Valid
Issue Date : 2021-02-11
Type : Chemical
Substance Number : 562
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]INTERMEDIATES SUPPLIERS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]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
Parenteral
Solubilizers
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
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Sodium Cromoglicate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sodium Cromoglicate, including repackagers and relabelers. The FDA regulates Sodium Cromoglicate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sodium Cromoglicate 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 Sodium Cromoglicate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sodium Cromoglicate supplier is an individual or a company that provides Sodium Cromoglicate active pharmaceutical ingredient (API) or Sodium Cromoglicate finished formulations upon request. The Sodium Cromoglicate suppliers may include Sodium Cromoglicate API manufacturers, exporters, distributors and traders.
click here to find a list of Sodium Cromoglicate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Sodium Cromoglicate DMF (Drug Master File) is a document detailing the whole manufacturing process of Sodium Cromoglicate active pharmaceutical ingredient (API) in detail. Different forms of Sodium Cromoglicate DMFs exist exist since differing nations have different regulations, such as Sodium Cromoglicate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Sodium Cromoglicate DMF submitted to regulatory agencies in the US is known as a USDMF. Sodium Cromoglicate USDMF includes data on Sodium Cromoglicate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Sodium Cromoglicate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Sodium Cromoglicate 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 Sodium Cromoglicate Drug Master File in Japan (Sodium Cromoglicate JDMF) empowers Sodium Cromoglicate 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 Sodium Cromoglicate JDMF during the approval evaluation for pharmaceutical products. At the time of Sodium Cromoglicate 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 Sodium Cromoglicate suppliers with JDMF on PharmaCompass.
A Sodium Cromoglicate CEP of the European Pharmacopoeia monograph is often referred to as a Sodium Cromoglicate Certificate of Suitability (COS). The purpose of a Sodium Cromoglicate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Sodium Cromoglicate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Sodium Cromoglicate to their clients by showing that a Sodium Cromoglicate CEP has been issued for it. The manufacturer submits a Sodium Cromoglicate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Sodium Cromoglicate CEP holder for the record. Additionally, the data presented in the Sodium Cromoglicate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Sodium Cromoglicate DMF.
A Sodium Cromoglicate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Sodium Cromoglicate 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 Sodium Cromoglicate 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 Sodium Cromoglicate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Sodium Cromoglicate 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 Sodium Cromoglicate 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 Sodium Cromoglicate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Sodium Cromoglicate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Sodium Cromoglicate suppliers with NDC on PharmaCompass.
Sodium Cromoglicate 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 Sodium Cromoglicate 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 Sodium Cromoglicate GMP manufacturer or Sodium Cromoglicate GMP API supplier for your needs.
A Sodium Cromoglicate CoA (Certificate of Analysis) is a formal document that attests to Sodium Cromoglicate's compliance with Sodium Cromoglicate specifications and serves as a tool for batch-level quality control.
Sodium Cromoglicate CoA mostly includes findings from lab analyses of a specific batch. For each Sodium Cromoglicate 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.
Sodium Cromoglicate may be tested according to a variety of international standards, such as European Pharmacopoeia (Sodium Cromoglicate EP), Sodium Cromoglicate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Sodium Cromoglicate USP).
LOOKING FOR A SUPPLIER?
