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USDMF
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DOSAGE - TABLET;ORAL - 1GM
USFDA APPLICATION NUMBER - 18333
DOSAGE - SUSPENSION;ORAL - 1GM/10ML
USFDA APPLICATION NUMBER - 19183
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ABOUT THIS PAGE
53
PharmaCompass offers a list of Sucralfate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sucralfate manufacturer or Sucralfate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sucralfate manufacturer or Sucralfate supplier.
A Ulsanic manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ulsanic, including repackagers and relabelers. The FDA regulates Ulsanic manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ulsanic 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 Ulsanic manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Ulsanic supplier is an individual or a company that provides Ulsanic active pharmaceutical ingredient (API) or Ulsanic finished formulations upon request. The Ulsanic suppliers may include Ulsanic API manufacturers, exporters, distributors and traders.
click here to find a list of Ulsanic suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Ulsanic DMF (Drug Master File) is a document detailing the whole manufacturing process of Ulsanic active pharmaceutical ingredient (API) in detail. Different forms of Ulsanic DMFs exist exist since differing nations have different regulations, such as Ulsanic USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ulsanic DMF submitted to regulatory agencies in the US is known as a USDMF. Ulsanic USDMF includes data on Ulsanic's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ulsanic USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ulsanic 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 Ulsanic Drug Master File in Japan (Ulsanic JDMF) empowers Ulsanic 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 Ulsanic JDMF during the approval evaluation for pharmaceutical products. At the time of Ulsanic 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 Ulsanic 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 Ulsanic Drug Master File in Korea (Ulsanic KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ulsanic. The MFDS reviews the Ulsanic KDMF as part of the drug registration process and uses the information provided in the Ulsanic KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ulsanic 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 Ulsanic API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ulsanic suppliers with KDMF on PharmaCompass.
A Ulsanic CEP of the European Pharmacopoeia monograph is often referred to as a Ulsanic Certificate of Suitability (COS). The purpose of a Ulsanic CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ulsanic EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ulsanic to their clients by showing that a Ulsanic CEP has been issued for it. The manufacturer submits a Ulsanic CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ulsanic CEP holder for the record. Additionally, the data presented in the Ulsanic CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ulsanic DMF.
A Ulsanic CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ulsanic 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 Ulsanic suppliers with CEP (COS) on PharmaCompass.
A Ulsanic written confirmation (Ulsanic WC) is an official document issued by a regulatory agency to a Ulsanic manufacturer, verifying that the manufacturing facility of a Ulsanic active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ulsanic APIs or Ulsanic finished pharmaceutical products to another nation, regulatory agencies frequently require a Ulsanic WC (written confirmation) as part of the regulatory process.
click here to find a list of Ulsanic 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 Ulsanic as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ulsanic 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 Ulsanic 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 Ulsanic and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ulsanic NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ulsanic suppliers with NDC on PharmaCompass.
Ulsanic 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 Ulsanic GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Ulsanic GMP manufacturer or Ulsanic GMP API supplier for your needs.
A Ulsanic CoA (Certificate of Analysis) is a formal document that attests to Ulsanic's compliance with Ulsanic specifications and serves as a tool for batch-level quality control.
Ulsanic CoA mostly includes findings from lab analyses of a specific batch. For each Ulsanic 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.
Ulsanic may be tested according to a variety of international standards, such as European Pharmacopoeia (Ulsanic EP), Ulsanic JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ulsanic USP).
