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