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API SUPPLIERS
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USDMF
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Emedastine Difumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Emedastine Difumarate, including repackagers and relabelers. The FDA regulates Emedastine Difumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Emedastine Difumarate 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 Emedastine Difumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Emedastine Difumarate supplier is an individual or a company that provides Emedastine Difumarate active pharmaceutical ingredient (API) or Emedastine Difumarate finished formulations upon request. The Emedastine Difumarate suppliers may include Emedastine Difumarate API manufacturers, exporters, distributors and traders.
click here to find a list of Emedastine Difumarate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Emedastine Difumarate DMF (Drug Master File) is a document detailing the whole manufacturing process of Emedastine Difumarate active pharmaceutical ingredient (API) in detail. Different forms of Emedastine Difumarate DMFs exist exist since differing nations have different regulations, such as Emedastine Difumarate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Emedastine Difumarate DMF submitted to regulatory agencies in the US is known as a USDMF. Emedastine Difumarate USDMF includes data on Emedastine Difumarate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Emedastine Difumarate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Emedastine Difumarate 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 Emedastine Difumarate Drug Master File in Japan (Emedastine Difumarate JDMF) empowers Emedastine Difumarate 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 Emedastine Difumarate JDMF during the approval evaluation for pharmaceutical products. At the time of Emedastine Difumarate 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 Emedastine Difumarate 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 Emedastine Difumarate Drug Master File in Korea (Emedastine Difumarate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Emedastine Difumarate. The MFDS reviews the Emedastine Difumarate KDMF as part of the drug registration process and uses the information provided in the Emedastine Difumarate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Emedastine Difumarate 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 Emedastine Difumarate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Emedastine Difumarate suppliers with KDMF 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 Emedastine Difumarate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Emedastine Difumarate 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 Emedastine Difumarate 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 Emedastine Difumarate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Emedastine Difumarate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Emedastine Difumarate suppliers with NDC on PharmaCompass.
Emedastine Difumarate 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 Emedastine Difumarate 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 Emedastine Difumarate GMP manufacturer or Emedastine Difumarate GMP API supplier for your needs.
A Emedastine Difumarate CoA (Certificate of Analysis) is a formal document that attests to Emedastine Difumarate's compliance with Emedastine Difumarate specifications and serves as a tool for batch-level quality control.
Emedastine Difumarate CoA mostly includes findings from lab analyses of a specific batch. For each Emedastine Difumarate 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.
Emedastine Difumarate may be tested according to a variety of international standards, such as European Pharmacopoeia (Emedastine Difumarate EP), Emedastine Difumarate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Emedastine Difumarate USP).
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