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PharmaCompass offers a list of Propofol 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 Propofol manufacturer or Propofol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Propofol manufacturer or Propofol supplier.
PharmaCompass also assists you with knowing the Propofol API Price utilized in the formulation of products. Propofol API Price is not always fixed or binding as the Propofol Price is obtained through a variety of data sources. The Propofol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A AM-149 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AM-149, including repackagers and relabelers. The FDA regulates AM-149 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AM-149 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 AM-149 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A AM-149 supplier is an individual or a company that provides AM-149 active pharmaceutical ingredient (API) or AM-149 finished formulations upon request. The AM-149 suppliers may include AM-149 API manufacturers, exporters, distributors and traders.
click here to find a list of AM-149 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A AM-149 DMF (Drug Master File) is a document detailing the whole manufacturing process of AM-149 active pharmaceutical ingredient (API) in detail. Different forms of AM-149 DMFs exist exist since differing nations have different regulations, such as AM-149 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A AM-149 DMF submitted to regulatory agencies in the US is known as a USDMF. AM-149 USDMF includes data on AM-149's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AM-149 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of AM-149 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 AM-149 Drug Master File in Japan (AM-149 JDMF) empowers AM-149 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 AM-149 JDMF during the approval evaluation for pharmaceutical products. At the time of AM-149 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 AM-149 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 AM-149 Drug Master File in Korea (AM-149 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AM-149. The MFDS reviews the AM-149 KDMF as part of the drug registration process and uses the information provided in the AM-149 KDMF to evaluate the safety and efficacy of the drug.
After submitting a AM-149 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 AM-149 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of AM-149 suppliers with KDMF on PharmaCompass.
A AM-149 CEP of the European Pharmacopoeia monograph is often referred to as a AM-149 Certificate of Suitability (COS). The purpose of a AM-149 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AM-149 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AM-149 to their clients by showing that a AM-149 CEP has been issued for it. The manufacturer submits a AM-149 CEP (COS) as part of the market authorization procedure, and it takes on the role of a AM-149 CEP holder for the record. Additionally, the data presented in the AM-149 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AM-149 DMF.
A AM-149 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AM-149 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 AM-149 suppliers with CEP (COS) on PharmaCompass.
A AM-149 written confirmation (AM-149 WC) is an official document issued by a regulatory agency to a AM-149 manufacturer, verifying that the manufacturing facility of a AM-149 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting AM-149 APIs or AM-149 finished pharmaceutical products to another nation, regulatory agencies frequently require a AM-149 WC (written confirmation) as part of the regulatory process.
click here to find a list of AM-149 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 AM-149 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for AM-149 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 AM-149 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 AM-149 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AM-149 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of AM-149 suppliers with NDC on PharmaCompass.
AM-149 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 AM-149 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 AM-149 GMP manufacturer or AM-149 GMP API supplier for your needs.
A AM-149 CoA (Certificate of Analysis) is a formal document that attests to AM-149's compliance with AM-149 specifications and serves as a tool for batch-level quality control.
AM-149 CoA mostly includes findings from lab analyses of a specific batch. For each AM-149 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.
AM-149 may be tested according to a variety of international standards, such as European Pharmacopoeia (AM-149 EP), AM-149 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AM-149 USP).
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