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DOSAGE - POWDER;INTRAVENOUS - 350MG/VIAL
USFDA APPLICATION NUMBER - 209949
DOSAGE - POWDER;INTRAVENOUS - 500MG/VIAL **Fe...DOSAGE - POWDER;INTRAVENOUS - 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 21572
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ABOUT THIS PAGE
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PharmaCompass offers a list of Daptomycin 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 Daptomycin manufacturer or Daptomycin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Daptomycin manufacturer or Daptomycin supplier.
PharmaCompass also assists you with knowing the Daptomycin API Price utilized in the formulation of products. Daptomycin API Price is not always fixed or binding as the Daptomycin Price is obtained through a variety of data sources. The Daptomycin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Daptomicina manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Daptomicina, including repackagers and relabelers. The FDA regulates Daptomicina manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Daptomicina 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 Daptomicina manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Daptomicina supplier is an individual or a company that provides Daptomicina active pharmaceutical ingredient (API) or Daptomicina finished formulations upon request. The Daptomicina suppliers may include Daptomicina API manufacturers, exporters, distributors and traders.
click here to find a list of Daptomicina suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Daptomicina DMF (Drug Master File) is a document detailing the whole manufacturing process of Daptomicina active pharmaceutical ingredient (API) in detail. Different forms of Daptomicina DMFs exist exist since differing nations have different regulations, such as Daptomicina USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Daptomicina DMF submitted to regulatory agencies in the US is known as a USDMF. Daptomicina USDMF includes data on Daptomicina's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Daptomicina USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Daptomicina 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 Daptomicina Drug Master File in Japan (Daptomicina JDMF) empowers Daptomicina 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 Daptomicina JDMF during the approval evaluation for pharmaceutical products. At the time of Daptomicina 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 Daptomicina 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 Daptomicina Drug Master File in Korea (Daptomicina KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Daptomicina. The MFDS reviews the Daptomicina KDMF as part of the drug registration process and uses the information provided in the Daptomicina KDMF to evaluate the safety and efficacy of the drug.
After submitting a Daptomicina 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 Daptomicina API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Daptomicina suppliers with KDMF 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 Daptomicina as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Daptomicina 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 Daptomicina 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 Daptomicina and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Daptomicina NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Daptomicina suppliers with NDC on PharmaCompass.
Daptomicina 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 Daptomicina 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 Daptomicina GMP manufacturer or Daptomicina GMP API supplier for your needs.
A Daptomicina CoA (Certificate of Analysis) is a formal document that attests to Daptomicina's compliance with Daptomicina specifications and serves as a tool for batch-level quality control.
Daptomicina CoA mostly includes findings from lab analyses of a specific batch. For each Daptomicina 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.
Daptomicina may be tested according to a variety of international standards, such as European Pharmacopoeia (Daptomicina EP), Daptomicina JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Daptomicina USP).
