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