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ABOUT THIS PAGE
A Ketotifen Fumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ketotifen Fumarate, including repackagers and relabelers. The FDA regulates Ketotifen Fumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ketotifen Fumarate 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 Ketotifen Fumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ketotifen Fumarate supplier is an individual or a company that provides Ketotifen Fumarate active pharmaceutical ingredient (API) or Ketotifen Fumarate finished formulations upon request. The Ketotifen Fumarate suppliers may include Ketotifen Fumarate API manufacturers, exporters, distributors and traders.
click here to find a list of Ketotifen Fumarate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ketotifen Fumarate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ketotifen Fumarate active pharmaceutical ingredient (API) in detail. Different forms of Ketotifen Fumarate DMFs exist exist since differing nations have different regulations, such as Ketotifen Fumarate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ketotifen Fumarate DMF submitted to regulatory agencies in the US is known as a USDMF. Ketotifen Fumarate USDMF includes data on Ketotifen Fumarate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ketotifen Fumarate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ketotifen Fumarate 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 Ketotifen Fumarate Drug Master File in Japan (Ketotifen Fumarate JDMF) empowers Ketotifen Fumarate 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 Ketotifen Fumarate JDMF during the approval evaluation for pharmaceutical products. At the time of Ketotifen Fumarate 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 Ketotifen Fumarate suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ketotifen Fumarate Drug Master File in Korea (Ketotifen Fumarate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ketotifen Fumarate. The MFDS reviews the Ketotifen Fumarate KDMF as part of the drug registration process and uses the information provided in the Ketotifen Fumarate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ketotifen Fumarate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ketotifen Fumarate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ketotifen Fumarate suppliers with KDMF on PharmaCompass.
A Ketotifen Fumarate CEP of the European Pharmacopoeia monograph is often referred to as a Ketotifen Fumarate Certificate of Suitability (COS). The purpose of a Ketotifen Fumarate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ketotifen Fumarate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ketotifen Fumarate to their clients by showing that a Ketotifen Fumarate CEP has been issued for it. The manufacturer submits a Ketotifen Fumarate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ketotifen Fumarate CEP holder for the record. Additionally, the data presented in the Ketotifen Fumarate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ketotifen Fumarate DMF.
A Ketotifen Fumarate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ketotifen Fumarate 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 Ketotifen Fumarate 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 Ketotifen Fumarate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ketotifen Fumarate 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 Ketotifen Fumarate 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 Ketotifen Fumarate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ketotifen Fumarate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ketotifen Fumarate suppliers with NDC on PharmaCompass.
Ketotifen Fumarate 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 Ketotifen Fumarate 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 Ketotifen Fumarate GMP manufacturer or Ketotifen Fumarate GMP API supplier for your needs.
A Ketotifen Fumarate CoA (Certificate of Analysis) is a formal document that attests to Ketotifen Fumarate's compliance with Ketotifen Fumarate specifications and serves as a tool for batch-level quality control.
Ketotifen Fumarate CoA mostly includes findings from lab analyses of a specific batch. For each Ketotifen Fumarate 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.
Ketotifen Fumarate may be tested according to a variety of international standards, such as European Pharmacopoeia (Ketotifen Fumarate EP), Ketotifen Fumarate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ketotifen Fumarate USP).
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