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