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