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