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API SUPPLIERS
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USDMF
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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Status : Withdrawn by Holder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
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Cromolyn Sodium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cromolyn Sodium, including repackagers and relabelers. The FDA regulates Cromolyn Sodium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cromolyn Sodium 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 Cromolyn Sodium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cromolyn Sodium supplier is an individual or a company that provides Cromolyn Sodium active pharmaceutical ingredient (API) or Cromolyn Sodium finished formulations upon request. The Cromolyn Sodium suppliers may include Cromolyn Sodium API manufacturers, exporters, distributors and traders.
click here to find a list of Cromolyn Sodium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cromolyn Sodium DMF (Drug Master File) is a document detailing the whole manufacturing process of Cromolyn Sodium active pharmaceutical ingredient (API) in detail. Different forms of Cromolyn Sodium DMFs exist exist since differing nations have different regulations, such as Cromolyn Sodium USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cromolyn Sodium DMF submitted to regulatory agencies in the US is known as a USDMF. Cromolyn Sodium USDMF includes data on Cromolyn Sodium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cromolyn Sodium USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cromolyn Sodium 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 Cromolyn Sodium Drug Master File in Japan (Cromolyn Sodium JDMF) empowers Cromolyn Sodium 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 Cromolyn Sodium JDMF during the approval evaluation for pharmaceutical products. At the time of Cromolyn Sodium 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 Cromolyn Sodium suppliers with JDMF on PharmaCompass.
A Cromolyn Sodium CEP of the European Pharmacopoeia monograph is often referred to as a Cromolyn Sodium Certificate of Suitability (COS). The purpose of a Cromolyn Sodium CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Cromolyn Sodium EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Cromolyn Sodium to their clients by showing that a Cromolyn Sodium CEP has been issued for it. The manufacturer submits a Cromolyn Sodium CEP (COS) as part of the market authorization procedure, and it takes on the role of a Cromolyn Sodium CEP holder for the record. Additionally, the data presented in the Cromolyn Sodium CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Cromolyn Sodium DMF.
A Cromolyn Sodium CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Cromolyn Sodium 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 Cromolyn Sodium 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 Cromolyn Sodium as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Cromolyn Sodium 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 Cromolyn Sodium 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 Cromolyn Sodium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Cromolyn Sodium NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Cromolyn Sodium suppliers with NDC on PharmaCompass.
Cromolyn Sodium 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 Cromolyn Sodium 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 Cromolyn Sodium GMP manufacturer or Cromolyn Sodium GMP API supplier for your needs.
A Cromolyn Sodium CoA (Certificate of Analysis) is a formal document that attests to Cromolyn Sodium's compliance with Cromolyn Sodium specifications and serves as a tool for batch-level quality control.
Cromolyn Sodium CoA mostly includes findings from lab analyses of a specific batch. For each Cromolyn Sodium 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.
Cromolyn Sodium may be tested according to a variety of international standards, such as European Pharmacopoeia (Cromolyn Sodium EP), Cromolyn Sodium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cromolyn Sodium USP).
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