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