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