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