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