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