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API SUPPLIERS
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
AMI Lifesciences is Driven by Chemistry. Powered by People.
KDMF 
HRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.
Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
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USDMF
AMI Lifesciences is Driven by Chemistry. Powered by People.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39342
Submission : 2023-12-29
Status :
Type : II
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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 ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE, including repackagers and relabelers. The FDA regulates ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE 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 ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE supplier is an individual or a company that provides ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE active pharmaceutical ingredient (API) or ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE finished formulations upon request. The ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE suppliers may include ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE API manufacturers, exporters, distributors and traders.
click here to find a list of ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE DMF (Drug Master File) is a document detailing the whole manufacturing process of ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE active pharmaceutical ingredient (API) in detail. Different forms of ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE DMFs exist exist since differing nations have different regulations, such as ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE DMF submitted to regulatory agencies in the US is known as a USDMF. ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE USDMF includes data on ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE 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 ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE Drug Master File in Korea (((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE. The MFDS reviews the ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE KDMF as part of the drug registration process and uses the information provided in the ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE KDMF to evaluate the safety and efficacy of the drug.
After submitting a ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE 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 ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE 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 ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE 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 ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE 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 ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE suppliers with NDC on PharmaCompass.
((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE 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 ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE 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 ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE GMP manufacturer or ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE GMP API supplier for your needs.
A ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE CoA (Certificate of Analysis) is a formal document that attests to ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE's compliance with ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE specifications and serves as a tool for batch-level quality control.
((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE CoA mostly includes findings from lab analyses of a specific batch. For each ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE 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.
((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE may be tested according to a variety of international standards, such as European Pharmacopoeia (((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE EP), ((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (((1R,5S,6S)-6-(AMINOMETHYL)-3-ETHYLBICYCLO(3.2.0)HEPT-3-EN-6-YL)ACETIC ACID MONOBENZENESULFONATE USP).
