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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
US Medicaid
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API Imports and Exports
Drugs in Development
Lead Product(s) : Omadacycline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Paratek Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Collaboration
Novasep And Paratek Enhance Collaboration to Manufacture Omadacycline (NUZYRA®), A Novel Tetracyc...
Details : Under the terms of the collaboration, Novasep and Paratek will manufacture NUZYRA® (omadacycline), an FDA-approved tetracycline-class, once-daily oral and intravenous antibiotic for the treatment of adults with CABP and acute bacterial skin and skin str...
Product Name : Nuzyra
Product Type : Small molecule
Upfront Cash : Undisclosed
February 15, 2022
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PharmaCompass offers a list of Omadacycline 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 Omadacycline manufacturer or Omadacycline supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Omadacycline manufacturer or Omadacycline supplier.
PharmaCompass also assists you with knowing the Omadacycline API Price utilized in the formulation of products. Omadacycline API Price is not always fixed or binding as the Omadacycline Price is obtained through a variety of data sources. The Omadacycline Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Omadacycline Tosylate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Omadacycline Tosylate, including repackagers and relabelers. The FDA regulates Omadacycline Tosylate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Omadacycline Tosylate 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 Omadacycline Tosylate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Omadacycline Tosylate supplier is an individual or a company that provides Omadacycline Tosylate active pharmaceutical ingredient (API) or Omadacycline Tosylate finished formulations upon request. The Omadacycline Tosylate suppliers may include Omadacycline Tosylate API manufacturers, exporters, distributors and traders.
click here to find a list of Omadacycline Tosylate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Omadacycline Tosylate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Omadacycline Tosylate 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 Omadacycline Tosylate 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 Omadacycline Tosylate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Omadacycline Tosylate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Omadacycline Tosylate suppliers with NDC on PharmaCompass.
Omadacycline Tosylate 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 Omadacycline Tosylate 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 Omadacycline Tosylate GMP manufacturer or Omadacycline Tosylate GMP API supplier for your needs.
A Omadacycline Tosylate CoA (Certificate of Analysis) is a formal document that attests to Omadacycline Tosylate's compliance with Omadacycline Tosylate specifications and serves as a tool for batch-level quality control.
Omadacycline Tosylate CoA mostly includes findings from lab analyses of a specific batch. For each Omadacycline Tosylate 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.
Omadacycline Tosylate may be tested according to a variety of international standards, such as European Pharmacopoeia (Omadacycline Tosylate EP), Omadacycline Tosylate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Omadacycline Tosylate USP).
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