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