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API SUPPLIERS
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DOSAGE - TABLET;ORAL - 100MG
USFDA APPLICATION NUMBER - 16320
DOSAGE - TABLET;ORAL - 400MG
USFDA APPLICATION NUMBER - 16320
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ABOUT THIS PAGE
57
PharmaCompass offers a list of Ethambutol Dihydrochloride 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 Ethambutol Dihydrochloride manufacturer or Ethambutol Dihydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ethambutol Dihydrochloride manufacturer or Ethambutol Dihydrochloride supplier.
PharmaCompass also assists you with knowing the Ethambutol Dihydrochloride API Price utilized in the formulation of products. Ethambutol Dihydrochloride API Price is not always fixed or binding as the Ethambutol Dihydrochloride Price is obtained through a variety of data sources. The Ethambutol Dihydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A C10H24N2O2.2HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of C10H24N2O2.2HCl, including repackagers and relabelers. The FDA regulates C10H24N2O2.2HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. C10H24N2O2.2HCl 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 C10H24N2O2.2HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A C10H24N2O2.2HCl supplier is an individual or a company that provides C10H24N2O2.2HCl active pharmaceutical ingredient (API) or C10H24N2O2.2HCl finished formulations upon request. The C10H24N2O2.2HCl suppliers may include C10H24N2O2.2HCl API manufacturers, exporters, distributors and traders.
click here to find a list of C10H24N2O2.2HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A C10H24N2O2.2HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of C10H24N2O2.2HCl active pharmaceutical ingredient (API) in detail. Different forms of C10H24N2O2.2HCl DMFs exist exist since differing nations have different regulations, such as C10H24N2O2.2HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A C10H24N2O2.2HCl DMF submitted to regulatory agencies in the US is known as a USDMF. C10H24N2O2.2HCl USDMF includes data on C10H24N2O2.2HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The C10H24N2O2.2HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of C10H24N2O2.2HCl 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 C10H24N2O2.2HCl Drug Master File in Japan (C10H24N2O2.2HCl JDMF) empowers C10H24N2O2.2HCl 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 C10H24N2O2.2HCl JDMF during the approval evaluation for pharmaceutical products. At the time of C10H24N2O2.2HCl 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 C10H24N2O2.2HCl 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 C10H24N2O2.2HCl Drug Master File in Korea (C10H24N2O2.2HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of C10H24N2O2.2HCl. The MFDS reviews the C10H24N2O2.2HCl KDMF as part of the drug registration process and uses the information provided in the C10H24N2O2.2HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a C10H24N2O2.2HCl 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 C10H24N2O2.2HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of C10H24N2O2.2HCl suppliers with KDMF on PharmaCompass.
A C10H24N2O2.2HCl CEP of the European Pharmacopoeia monograph is often referred to as a C10H24N2O2.2HCl Certificate of Suitability (COS). The purpose of a C10H24N2O2.2HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of C10H24N2O2.2HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of C10H24N2O2.2HCl to their clients by showing that a C10H24N2O2.2HCl CEP has been issued for it. The manufacturer submits a C10H24N2O2.2HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a C10H24N2O2.2HCl CEP holder for the record. Additionally, the data presented in the C10H24N2O2.2HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the C10H24N2O2.2HCl DMF.
A C10H24N2O2.2HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. C10H24N2O2.2HCl 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 C10H24N2O2.2HCl suppliers with CEP (COS) on PharmaCompass.
A C10H24N2O2.2HCl written confirmation (C10H24N2O2.2HCl WC) is an official document issued by a regulatory agency to a C10H24N2O2.2HCl manufacturer, verifying that the manufacturing facility of a C10H24N2O2.2HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting C10H24N2O2.2HCl APIs or C10H24N2O2.2HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a C10H24N2O2.2HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of C10H24N2O2.2HCl 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 C10H24N2O2.2HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for C10H24N2O2.2HCl 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 C10H24N2O2.2HCl 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 C10H24N2O2.2HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a C10H24N2O2.2HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of C10H24N2O2.2HCl suppliers with NDC on PharmaCompass.
C10H24N2O2.2HCl 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 C10H24N2O2.2HCl 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 C10H24N2O2.2HCl GMP manufacturer or C10H24N2O2.2HCl GMP API supplier for your needs.
A C10H24N2O2.2HCl CoA (Certificate of Analysis) is a formal document that attests to C10H24N2O2.2HCl's compliance with C10H24N2O2.2HCl specifications and serves as a tool for batch-level quality control.
C10H24N2O2.2HCl CoA mostly includes findings from lab analyses of a specific batch. For each C10H24N2O2.2HCl 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.
C10H24N2O2.2HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (C10H24N2O2.2HCl EP), C10H24N2O2.2HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (C10H24N2O2.2HCl USP).
