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PharmaCompass offers a list of Arbekacin 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 Arbekacin manufacturer or Arbekacin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Arbekacin manufacturer or Arbekacin supplier.
PharmaCompass also assists you with knowing the Arbekacin API Price utilized in the formulation of products. Arbekacin API Price is not always fixed or binding as the Arbekacin Price is obtained through a variety of data sources. The Arbekacin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A DKB-AHB manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DKB-AHB, including repackagers and relabelers. The FDA regulates DKB-AHB manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DKB-AHB 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 DKB-AHB manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A DKB-AHB supplier is an individual or a company that provides DKB-AHB active pharmaceutical ingredient (API) or DKB-AHB finished formulations upon request. The DKB-AHB suppliers may include DKB-AHB API manufacturers, exporters, distributors and traders.
click here to find a list of DKB-AHB suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A DKB-AHB DMF (Drug Master File) is a document detailing the whole manufacturing process of DKB-AHB active pharmaceutical ingredient (API) in detail. Different forms of DKB-AHB DMFs exist exist since differing nations have different regulations, such as DKB-AHB USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A DKB-AHB DMF submitted to regulatory agencies in the US is known as a USDMF. DKB-AHB USDMF includes data on DKB-AHB's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DKB-AHB USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of DKB-AHB 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 DKB-AHB Drug Master File in Japan (DKB-AHB JDMF) empowers DKB-AHB 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 DKB-AHB JDMF during the approval evaluation for pharmaceutical products. At the time of DKB-AHB 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 DKB-AHB suppliers with JDMF on PharmaCompass.
DKB-AHB 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 DKB-AHB 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 DKB-AHB GMP manufacturer or DKB-AHB GMP API supplier for your needs.
A DKB-AHB CoA (Certificate of Analysis) is a formal document that attests to DKB-AHB's compliance with DKB-AHB specifications and serves as a tool for batch-level quality control.
DKB-AHB CoA mostly includes findings from lab analyses of a specific batch. For each DKB-AHB 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.
DKB-AHB may be tested according to a variety of international standards, such as European Pharmacopoeia (DKB-AHB EP), DKB-AHB JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DKB-AHB USP).
