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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 |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-12-09
Pay. Date : 2014-06-23
DMF Number : 27841
Submission : 2013-12-23
Status : Active
Type : II
NDC Package Code : 42513-0009
Start Marketing Date : 2020-04-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16810
Submission : 2003-08-20
Status : Inactive
Type : II
NDC Package Code : 45932-0012
Start Marketing Date : 2000-09-12
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17109
Submission : 2004-01-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13513
Submission : 1998-09-01
Status : Inactive
Type : II
Registrant Name : Daebong LS Co., Ltd.
Registration Date : 2020-07-16
Registration Number : 20200716-91-E-166-06
Manufacturer Name : Daebong LS Co., Ltd. @ [Tobramycin Manufacturing Plant] Livzon New North River Pharmaceutical Co., Ltd
Manufacturer Address : 123, Neungheodae-ro 649beon-gil, Namdong-gu, Incheon Metropolitan City @ [Tobramycin Manufacturing Plant] Renmin One Road, Qingyuan, Guangdong Province, PR China
About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
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Related Excipient Companies
Excipients by Applications
Global Sales Information
Company : App-Premierpro
Tobramycin Sulfate
Drug Cost (USD) : 1,708
Year : 2023
Prescribers : 12
Prescriptions : 52
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Company : App/Fresenius K
Tobramycin Sulfate
Drug Cost (USD) : 158,865
Year : 2023
Prescribers : 1021
Prescriptions : 2526
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Company : Claris/Baxter
Tobramycin Sulfate
Drug Cost (USD) : 89,426
Year : 2023
Prescribers : 802
Prescriptions : 1752
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Company : Fosun Pharma Us
Tobramycin Sulfate
Drug Cost (USD) : 685,162
Year : 2023
Prescribers : 322
Prescriptions : 381
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Company : Fresenius Kabi
Tobramycin Sulfate
Drug Cost (USD) : 337
Year : 2023
Prescribers :
Prescriptions : 11
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Company : Hospira/Pfizer
Tobramycin Sulfate
Drug Cost (USD) : 60,320
Year : 2023
Prescribers : 460
Prescriptions : 1000
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Company : Mylan Instituti
Tobramycin Sulfate
Drug Cost (USD) : 192,372
Year : 2023
Prescribers : 1403
Prescriptions : 4017
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Company : X-Gen Pharmaceu
Tobramycin Sulfate
Drug Cost (USD) : 362,922
Year : 2023
Prescribers : 244
Prescriptions : 350
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Company : Xiromed, LLC
Tobramycin Sulfate
Drug Cost (USD) : 403,789
Year : 2023
Prescribers : 117
Prescriptions : 176
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Company : App/Premierpro
Tobramycin Sulfate
Drug Cost (USD) : 4,120
Year : 2022
Prescribers : 45
Prescriptions : 124
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Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 40MG BASE/ML
Price Per Pack :
Published in :
Country : USA
RX/OTC/DISCN : RX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 40MG BASE/ML
Price Per Pack :
Published in :
Country : USA
RX/OTC/DISCN : RX
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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 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.
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).