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1. Neomycin
2. Neomycin Palmitate
3. Neomycin Sulfate
1. Neomycin Sulfate
2. 1405-10-3
3. Neomycin Trisulfate Hydrate
4. Akos016010116
Molecular Weight | 712.7 g/mol |
---|---|
Molecular Formula | C23H48N6O17S |
Hydrogen Bond Donor Count | 15 |
Hydrogen Bond Acceptor Count | 23 |
Rotatable Bond Count | 9 |
Exact Mass | 712.27966526 g/mol |
Monoisotopic Mass | 712.27966526 g/mol |
Topological Polar Surface Area | 436 Ų |
Heavy Atom Count | 47 |
Formal Charge | 0 |
Complexity | 953 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 18 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | Neomycin sulfate |
Drug Label | Neomycin Sulfate Tablets, USP, for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomycesfradiae. Structurally, neomycin sulfate may be represented as follows:Chemically, i... |
Active Ingredient | Neomycin sulfate |
Dosage Form | Tablet |
Route | Oral |
Strength | 500mg |
Market Status | Prescription |
Company | Oman Pharm Products; Teva; X Gen Pharms |
2 of 2 | |
---|---|
Drug Name | Neomycin sulfate |
Drug Label | Neomycin Sulfate Tablets, USP, for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomycesfradiae. Structurally, neomycin sulfate may be represented as follows:Chemically, i... |
Active Ingredient | Neomycin sulfate |
Dosage Form | Tablet |
Route | Oral |
Strength | 500mg |
Market Status | Prescription |
Company | Oman Pharm Products; Teva; X Gen Pharms |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
Protein Synthesis Inhibitors
Compounds which inhibit the synthesis of proteins. They are usually ANTI-BACTERIAL AGENTS or toxins. Mechanism of the action of inhibition includes the interruption of peptide-chain elongation, the blocking the A site of ribosomes, the misreading of the genetic code or the prevention of the attachment of oligosaccharide side chains to glycoproteins. (See all compounds classified as Protein Synthesis Inhibitors.)
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13615
Submission : 1998-09-01
Status : Inactive
Type : II
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-26
Pay. Date : 2013-02-13
DMF Number : 13378
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 1999-184 - Rev 03
Issue Date : 2020-04-21
Type : Chemical
Substance Number : 197
Status : Valid
Registration Number : 217MF10976
Registrant's Address : 235 East 42nd Street, New York, NY 10017
Initial Date of Registration : 2005-11-14
Latest Date of Registration :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32091
Submission : 2017-09-08
Status : Active
Type : II
Certificate Number : R1-CEP 2011-029 - Rev 01
Issue Date : 2020-02-27
Type : Chemical and TSE
Substance Number : 197
Status : Valid
Registration Number : 303MF10156
Registrant's Address : No. 8,Ziyang Road,Dianjun District,Yichang City,HubeiProvince,China
Initial Date of Registration : 2021-10-07
Latest Date of Registration :
NDC Package Code : 65876-0005
Start Marketing Date : 2018-05-31
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 6443
Submission : 2021-10-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 124
Submission : 1953-07-23
Status : Inactive
Type : II
NDC Package Code : 0009-5238
Start Marketing Date : 2014-07-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Novartis Korea Ltd.
Registration Date : 2023-08-01
Registration Number : 20230801-211-J-1531
Manufacturer Name : Pharmacia & Upjohn Company LLC
Manufacturer Address : 7000 Portage Road, Kalamazoo, Michigan 49001, USA
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 262
Submission : 1940-01-01
Status : Inactive
Type : II
NDC Package Code : 0009-5238
Start Marketing Date : 2014-07-03
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 : 110
Submission : 1953-05-29
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 264
Submission : 1957-07-26
Status : Inactive
Type : II
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PharmaCompass offers a list of Neomycin 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 Neomycin Sulfate manufacturer or Neomycin Sulfate supplier for your needs.
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A NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1, including repackagers and relabelers. The FDA regulates NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 supplier is an individual or a company that provides NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 active pharmaceutical ingredient (API) or NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 finished formulations upon request. The NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 suppliers may include NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 API manufacturers, exporters, distributors and traders.
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A NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 active pharmaceutical ingredient (API) in detail. Different forms of NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 DMFs exist exist since differing nations have different regulations, such as NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 DMF submitted to regulatory agencies in the US is known as a USDMF. NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 USDMF includes data on NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 Drug Master File in Japan (NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 JDMF) empowers NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 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 NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 JDMF during the approval evaluation for pharmaceutical products. At the time of NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 Drug Master File in Korea (NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1. The MFDS reviews the NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 KDMF as part of the drug registration process and uses the information provided in the NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 KDMF to evaluate the safety and efficacy of the drug.
After submitting a NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 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 NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 API can apply through the Korea Drug Master File (KDMF).
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A NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 CEP of the European Pharmacopoeia monograph is often referred to as a NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 Certificate of Suitability (COS). The purpose of a NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 to their clients by showing that a NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 CEP has been issued for it. The manufacturer submits a NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 CEP holder for the record. Additionally, the data presented in the NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 DMF.
A NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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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 NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 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 NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 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 NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 NDC to their finished compounded human drug products, they may choose to do so.
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NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 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 NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 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 NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 GMP manufacturer or NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 GMP API supplier for your needs.
A NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 CoA (Certificate of Analysis) is a formal document that attests to NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1's compliance with NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 specifications and serves as a tool for batch-level quality control.
NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 CoA mostly includes findings from lab analyses of a specific batch. For each NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 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.
NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 EP), NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (NEOMYCIN; POLYMYXIN B SULFATES; GRAMICIDIN-1 USP).