Synopsis
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EU WC
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USP
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JP
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1. 79645-27-5
2. Tobramycin (sulfate)
3. 4-amino-2-[4,6-diamino-3-[3-amino-6-(aminomethyl)-5-hydroxyoxan-2-yl]oxy-2-hydroxycyclohexyl]oxy-6-(hydroxymethyl)oxane-3,5-diol Sulfate
4. Nebramycin Factor 6 (sulfate);deoxykanamycin B (sulfate)
5. 1294492-03-7
6. Hms3371o08
7. Bcp12890
8. Akos015895163
9. Ac-4512
10. Ft-0652844
11. 4-amino-2-[4,6-diamino-3-[3-amino-6-(aminomethyl)-5-hydroxyoxan-2-yl]oxy-2-hydroxycyclohexyl]oxy-6-(hydroxymethyl)oxane-3,5-diol;sulfuric Acid
Molecular Weight | 565.6 g/mol |
---|---|
Molecular Formula | C18H39N5O13S |
Hydrogen Bond Donor Count | 12 |
Hydrogen Bond Acceptor Count | 18 |
Rotatable Bond Count | 6 |
Exact Mass | 565.22650749 g/mol |
Monoisotopic Mass | 565.22650749 g/mol |
Topological Polar Surface Area | 351 Ų |
Heavy Atom Count | 37 |
Formal Charge | 0 |
Complexity | 691 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 14 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
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API Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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RLD : No
TE Code : AP
Brand Name : TOBRAMYCIN SULFATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 40MG BASE/ML
Approval Date : 2016-07-01
Application Number : 206965
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code :
Brand Name : TOBRAMYCIN SULFATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 10MG BASE/ML
Approval Date : 1994-05-31
Application Number : 64021
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Brand Name : NEBCIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1982-01-01
Application Number : 50477
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : NEBCIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1.2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date : 1982-01-01
Application Number : 50519
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : No
TE Code : AP
Brand Name : TOBRAMYCIN SULFATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1.2GM BASE/VIAL
Approval Date : 2004-07-13
Application Number : 50789
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code :
Brand Name : TOBRAMYCIN SULFATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 10MG BASE/ML
Approval Date : 1991-11-27
Application Number : 63128
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 1.6MG BASE/ML
Approval Date : 1993-06-02
Application Number : 63081
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code : AP
Brand Name : TOBRAMYCIN SULFATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 40MG BASE/ML
Approval Date : 1991-04-30
Application Number : 63111
RX/OTC/DISCN : RX
RLD : No
TE Code : AP
RLD : No
TE Code :
Brand Name : TOBRAMYCIN SULFATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 40MG BASE/ML
Approval Date : 1991-05-29
Application Number : 63161
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
Brand Name : TOBRAMYCIN SULFATE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 40MG BASE/ML
Approval Date : 1992-01-30
Application Number : 63100
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
Regulatory Info :
Registration Country : Sweden
Brand Name : Nebcina
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 40 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
Brand Name : Nebcina
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 80 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info :
Registration Country : Sweden
Brand Name : Nebcina
Dosage Form : SOLUTION FOR INJECTION
Dosage Strength : 10 MG / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Prescription
Registration Country : Canada
TOBRAMYCIN (TOBRAMYCIN SULFATE)
Brand Name : TOBI
Dosage Form : SOLUTION
Dosage Strength : 300MG/5ML
Packaging : 5ML
Approval Date :
Application Number : 2239630
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
TOBRAMYCIN (TOBRAMYCIN SULFATE)
Brand Name : TOBRAMYCIN FOR INJECTION
Dosage Form : POWDER FOR SOLUTION
Dosage Strength : 1.2G/VIAL
Packaging : 50ML
Approval Date :
Application Number : 533688
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
TOBRAMYCIN (TOBRAMYCIN SULFATE)
Brand Name : TOBRAMYCIN INJECTION
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging : 2/30 ML
Approval Date :
Application Number : 2230640
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
TOBRAMYCIN (TOBRAMYCIN SULFATE)
Brand Name : TOBRAMYCIN INJECTION USP
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging :
Approval Date :
Application Number : 2533103
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
TOBRAMYCIN (TOBRAMYCIN SULFATE)
Brand Name : TOBRAMYCIN INJECTION USP
Dosage Form : SOLUTION
Dosage Strength : 10MG/ML
Packaging : 10X2ML
Approval Date :
Application Number : 2241209
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
TOBRAMYCIN (TOBRAMYCIN SULFATE)
Brand Name : TOBRAMYCIN INJECTION USP
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging : 10X2ML 1X30ML
Approval Date :
Application Number : 2241210
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
TOBRAMYCIN (TOBRAMYCIN SULFATE)
Brand Name : TOBRAMYCIN INJECTION USP
Dosage Form : SOLUTION
Dosage Strength : 40MG/ML
Packaging :
Approval Date :
Application Number : 2502372
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
TOBRAMYCIN (TOBRAMYCIN SULFATE)
Brand Name : TEVA-TOBRAMYCIN
Dosage Form : SOLUTION
Dosage Strength : 60MG/ML
Packaging : 5ML
Approval Date :
Application Number : 2389622
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info :
Registration Country : Vietnam
Tobramycin Sulfate; DEXAMETHASONE SODIUM PHOSPHATE
Brand Name : Tobrameson
Dosage Form : Ophthalmic Solution
Dosage Strength : 3MG/ML; 1MG/ML
Packaging : Unit & Multi Dose Ophthalmic
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Vietnam
Packaging : Unit & Multi Dose Ophthalmic
Regulatory Info :
Tobramycin Sulfate; DEXAMETHASONE SODIUM PHOSPHATE
Dosage : Ophthalmic Solution
Dosage Strength : 3MG/ML; 1MG/ML
Brand Name : Tobrameson
Approval Date :
Application Number :
Registration Country : Vietnam
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Injection
Dosage Strength : 1.2G
Packaging : Vial
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Packaging : Vial
Regulatory Info :
Dosage : Injection
Dosage Strength : 1.2G
Brand Name :
Approval Date :
Application Number :
Registration Country : China
Regulatory Info : Generic
Registration Country : South Korea
Brand Name : Tobramycin
Dosage Form : Injection
Dosage Strength : 80MG
Packaging : 100ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Korea
Packaging : 100ml
Regulatory Info : Generic
Dosage : Injection
Dosage Strength : 80MG
Brand Name : Tobramycin
Approval Date :
Application Number :
Registration Country : South Korea
Regulatory Info :
Registration Country : Vietnam
Tobramycin Sulfate; Dexamethasone
Brand Name : Torexvis-D
Dosage Form : Eye drops
Dosage Strength : 15MG; 5MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Vietnam
Packaging :
Regulatory Info :
Tobramycin Sulfate; Dexamethasone
Dosage : Eye drops
Dosage Strength : 15MG; 5MG
Brand Name : Torexvis-D
Approval Date :
Application Number :
Registration Country : Vietnam
Regulatory Info :
Registration Country : Vietnam
Brand Name : Torexvis
Dosage Form : Eye drops
Dosage Strength : 15MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Vietnam
Packaging :
Regulatory Info :
Dosage : Eye drops
Dosage Strength : 15MG
Brand Name : Torexvis
Approval Date :
Application Number :
Registration Country : Vietnam
Regulatory Info :
Registration Country : India
Brand Name : Tobramycin Sulphate
Dosage Form : Liquid Injection
Dosage Strength : 40MG/ML
Packaging : 2 ML
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging : 2 ML
Regulatory Info :
Dosage : Liquid Injection
Dosage Strength : 40MG/ML
Brand Name : Tobramycin Sulphate
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Powder/Liquid for Inje...
Dosage Strength : 80MG
Packaging : Vial
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging : Vial
Regulatory Info :
Dosage : Powder/Liquid for Inje...
Dosage Strength : 80MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Powder/Liquid for Inje...
Dosage Strength : 400MG
Packaging : Vial
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Packaging : Vial
Regulatory Info :
Dosage : Powder/Liquid for Inje...
Dosage Strength : 400MG
Brand Name :
Approval Date :
Application Number :
Registration Country : India
Regulatory Info : Generic
Registration Country : India
Brand Name : TOLLCINA
Dosage Form : INJECTION
Dosage Strength : 8MG/ML
Packaging : 2ml amp
Approval Date :
Application Number : 63119
Regulatory Info : Generic
Registration Country : India
Packaging : 2ml amp
Regulatory Info : Generic
Dosage : INJECTION
Dosage Strength : 8MG/ML
Brand Name : TOLLCINA
Approval Date :
Application Number : 63119
Registration Country : India
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ABOUT THIS PAGE
47
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 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).