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USDMF
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39342
Submission : 2023-12-29
Status :
Type : II
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ABOUT THIS PAGE
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PharmaCompass offers a list of Mirogabalin Besilate 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 Mirogabalin Besilate manufacturer or Mirogabalin Besilate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mirogabalin Besilate manufacturer or Mirogabalin Besilate supplier.
PharmaCompass also assists you with knowing the Mirogabalin Besilate API Price utilized in the formulation of products. Mirogabalin Besilate API Price is not always fixed or binding as the Mirogabalin Besilate Price is obtained through a variety of data sources. The Mirogabalin Besilate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mirogabalin Besylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mirogabalin Besylate, including repackagers and relabelers. The FDA regulates Mirogabalin Besylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mirogabalin Besylate 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 Mirogabalin Besylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mirogabalin Besylate supplier is an individual or a company that provides Mirogabalin Besylate active pharmaceutical ingredient (API) or Mirogabalin Besylate finished formulations upon request. The Mirogabalin Besylate suppliers may include Mirogabalin Besylate API manufacturers, exporters, distributors and traders.
click here to find a list of Mirogabalin Besylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mirogabalin Besylate DMF (Drug Master File) is a document detailing the whole manufacturing process of Mirogabalin Besylate active pharmaceutical ingredient (API) in detail. Different forms of Mirogabalin Besylate DMFs exist exist since differing nations have different regulations, such as Mirogabalin Besylate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mirogabalin Besylate DMF submitted to regulatory agencies in the US is known as a USDMF. Mirogabalin Besylate USDMF includes data on Mirogabalin Besylate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mirogabalin Besylate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mirogabalin Besylate suppliers with USDMF 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 Mirogabalin Besylate Drug Master File in Korea (Mirogabalin Besylate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mirogabalin Besylate. The MFDS reviews the Mirogabalin Besylate KDMF as part of the drug registration process and uses the information provided in the Mirogabalin Besylate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mirogabalin Besylate 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 Mirogabalin Besylate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mirogabalin Besylate suppliers with KDMF 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 Mirogabalin Besylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mirogabalin Besylate 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 Mirogabalin Besylate 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 Mirogabalin Besylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mirogabalin Besylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mirogabalin Besylate suppliers with NDC on PharmaCompass.
Mirogabalin Besylate 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 Mirogabalin Besylate 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 Mirogabalin Besylate GMP manufacturer or Mirogabalin Besylate GMP API supplier for your needs.
A Mirogabalin Besylate CoA (Certificate of Analysis) is a formal document that attests to Mirogabalin Besylate's compliance with Mirogabalin Besylate specifications and serves as a tool for batch-level quality control.
Mirogabalin Besylate CoA mostly includes findings from lab analyses of a specific batch. For each Mirogabalin Besylate 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.
Mirogabalin Besylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Mirogabalin Besylate EP), Mirogabalin Besylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mirogabalin Besylate USP).
