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    Chemistry

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    Also known as: Neomycin sulfate, 1405-10-3, Neomycin trisulfate hydrate, Akos016010116
    Molecular Formula
    C23H48N6O17S
    Molecular Weight
    712.7  g/mol
    InChI Key
    OIXVKQDWLFHVGR-VTSVPHRWSA-N
    Neomycin Sulfate
    Aminoglycoside antibiotic complex produced by Streptomyces fradiae. It is composed of neomycins A, B, and C, and acts by inhibiting translation during protein synthesis.
    1 2D Structure

    Neomycin Sulfate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2R,3R,4R,5R,6R)-5-amino-2-(aminomethyl)-6-[(1R,2S,3S,4R,6S)-4,6-diamino-2-[(2S,3R,4R,5R)-4-[(3R,4R,5R,6S)-3-amino-6-(aminomethyl)-4,5-dihydroxyoxan-2-yl]oxy-3-hydroxy-5-(hydroxymethyl)oxolan-2-yl]oxy-3-hydroxycyclohexyl]oxyoxane-3,4-diol;sulfuric acid
    2.1.2 InChI
    InChI=1S/C23H46N6O13.H2O4S/c24-2-7-13(32)15(34)10(28)21(37-7)40-18-6(27)1-5(26)12(31)20(18)42-23-17(36)19(9(4-30)39-23)41-22-11(29)16(35)14(33)8(3-25)38-22;1-5(2,3)4/h5-23,30-36H,1-4,24-29H2;(H2,1,2,3,4)/t5-,6+,7-,8+,9-,10-,11-,12+,13+,14+,15-,16-,17-,18-,19+,20+,21-,22?,23+;/m1./s1
    2.1.3 InChI Key
    OIXVKQDWLFHVGR-VTSVPHRWSA-N
    2.1.4 Canonical SMILES
    C1C(C(C(C(C1N)OC2C(C(C(C(O2)CN)O)O)N)OC3C(C(C(O3)CO)OC4C(C(C(C(O4)CN)O)O)N)O)O)N.OS(=O)(=O)O
    2.1.5 Isomeric SMILES
    C1[C@H]([C@@H]([C@@H]([C@@H]([C@H]1N)O[C@@H]2[C@@H]([C@H]([C@H]([C@H](O2)CN)O)O)N)O[C@H]3[C@@H]([C@H]([C@H](O3)CO)OC4[C@@H]([C@H]([C@H]([C@@H](O4)CN)O)O)N)O)O)N.OS(=O)(=O)O
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Neomycin

    2. Neomycin Palmitate

    3. Neomycin Sulfate

    2.2.2 Depositor-Supplied Synonyms

    1. Neomycin Sulfate

    2. 1405-10-3

    3. Neomycin Trisulfate Hydrate

    4. Akos016010116

    2.3 Create Date
    2013-05-31
    3 Chemical and Physical Properties
    Molecular Weight 712.7 g/mol
    Molecular Formula C23H48N6O17S
    Hydrogen Bond Donor Count15
    Hydrogen Bond Acceptor Count23
    Rotatable Bond Count9
    Exact Mass712.27966526 g/mol
    Monoisotopic Mass712.27966526 g/mol
    Topological Polar Surface Area436 Ų
    Heavy Atom Count47
    Formal Charge0
    Complexity953
    Isotope Atom Count0
    Defined Atom Stereocenter Count18
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameNeomycin sulfate
    Drug LabelNeomycin 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 IngredientNeomycin sulfate
    Dosage FormTablet
    RouteOral
    Strength500mg
    Market StatusPrescription
    CompanyOman Pharm Products; Teva; X Gen Pharms

    2 of 2  
    Drug NameNeomycin sulfate
    Drug LabelNeomycin 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 IngredientNeomycin sulfate
    Dosage FormTablet
    RouteOral
    Strength500mg
    Market StatusPrescription
    CompanyOman Pharm Products; Teva; X Gen Pharms

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    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.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Aminoglycosides [CS]; Aminoglycoside Antibacterial [EPC]

    API Reference Price

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    14-May-2021
    03-Mar-2025
    KGS
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG ...DOSAGE - OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

    USFDA APPLICATION NUMBER - 50065

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    DOSAGE - OINTMENT;TOPICAL - 400 UNITS/GM;1%;E...DOSAGE - OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50168

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    DOSAGE - CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/G...DOSAGE - CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50218

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    DOSAGE - SUSPENSION/DROPS;OTIC - EQ 3MG BASE/...DOSAGE - SUSPENSION/DROPS;OTIC - EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML

    USFDA APPLICATION NUMBER - 50356

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    DOSAGE - OINTMENT;OPHTHALMIC - 400 UNITS/GM;E...DOSAGE - OINTMENT;OPHTHALMIC - 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

    USFDA APPLICATION NUMBER - 50417

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    ABOUT THIS PAGE

    Looking for 1405-10-3 / Neomycin Sulfate API manufacturers, exporters & distributors?

    Neomycin Sulfate manufacturers, exporters & distributors 1

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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.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Neomycin Sulfate manufacturer or Neomycin Sulfate supplier.

    PharmaCompass also assists you with knowing the Neomycin Sulfate API Price utilized in the formulation of products. Neomycin Sulfate API Price is not always fixed or binding as the Neomycin Sulfate Price is obtained through a variety of data sources. The Neomycin Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Neomycin Sulfate

    Synonyms

    1405-10-3, Neomycin trisulfate hydrate, Akos016010116

    Cas Number

    1405-10-3

    About Neomycin Sulfate

    Aminoglycoside antibiotic complex produced by Streptomyces fradiae. It is composed of neomycins A, B, and C, and acts by inhibiting translation during protein synthesis.

    COLY-MYCIN S-2 Manufacturers

    A COLY-MYCIN S-2 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of COLY-MYCIN S-2, including repackagers and relabelers. The FDA regulates COLY-MYCIN S-2 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. COLY-MYCIN S-2 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 COLY-MYCIN S-2 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    COLY-MYCIN S-2 Suppliers

    A COLY-MYCIN S-2 supplier is an individual or a company that provides COLY-MYCIN S-2 active pharmaceutical ingredient (API) or COLY-MYCIN S-2 finished formulations upon request. The COLY-MYCIN S-2 suppliers may include COLY-MYCIN S-2 API manufacturers, exporters, distributors and traders.

    click here to find a list of COLY-MYCIN S-2 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    COLY-MYCIN S-2 USDMF

    A COLY-MYCIN S-2 DMF (Drug Master File) is a document detailing the whole manufacturing process of COLY-MYCIN S-2 active pharmaceutical ingredient (API) in detail. Different forms of COLY-MYCIN S-2 DMFs exist exist since differing nations have different regulations, such as COLY-MYCIN S-2 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A COLY-MYCIN S-2 DMF submitted to regulatory agencies in the US is known as a USDMF. COLY-MYCIN S-2 USDMF includes data on COLY-MYCIN S-2's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The COLY-MYCIN S-2 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of COLY-MYCIN S-2 suppliers with USDMF on PharmaCompass.

    COLY-MYCIN S-2 JDMF

    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 COLY-MYCIN S-2 Drug Master File in Japan (COLY-MYCIN S-2 JDMF) empowers COLY-MYCIN S-2 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 COLY-MYCIN S-2 JDMF during the approval evaluation for pharmaceutical products. At the time of COLY-MYCIN S-2 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 COLY-MYCIN S-2 suppliers with JDMF on PharmaCompass.

    COLY-MYCIN S-2 KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a COLY-MYCIN S-2 Drug Master File in Korea (COLY-MYCIN S-2 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of COLY-MYCIN S-2. The MFDS reviews the COLY-MYCIN S-2 KDMF as part of the drug registration process and uses the information provided in the COLY-MYCIN S-2 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a COLY-MYCIN S-2 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 COLY-MYCIN S-2 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of COLY-MYCIN S-2 suppliers with KDMF on PharmaCompass.

    COLY-MYCIN S-2 CEP

    A COLY-MYCIN S-2 CEP of the European Pharmacopoeia monograph is often referred to as a COLY-MYCIN S-2 Certificate of Suitability (COS). The purpose of a COLY-MYCIN S-2 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of COLY-MYCIN S-2 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of COLY-MYCIN S-2 to their clients by showing that a COLY-MYCIN S-2 CEP has been issued for it. The manufacturer submits a COLY-MYCIN S-2 CEP (COS) as part of the market authorization procedure, and it takes on the role of a COLY-MYCIN S-2 CEP holder for the record. Additionally, the data presented in the COLY-MYCIN S-2 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the COLY-MYCIN S-2 DMF.

    A COLY-MYCIN S-2 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. COLY-MYCIN S-2 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of COLY-MYCIN S-2 suppliers with CEP (COS) on PharmaCompass.

    COLY-MYCIN S-2 NDC

    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 COLY-MYCIN S-2 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for COLY-MYCIN S-2 API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    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 COLY-MYCIN S-2 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.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain COLY-MYCIN S-2 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a COLY-MYCIN S-2 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of COLY-MYCIN S-2 suppliers with NDC on PharmaCompass.

    COLY-MYCIN S-2 GMP

    COLY-MYCIN S-2 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 COLY-MYCIN S-2 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 COLY-MYCIN S-2 GMP manufacturer or COLY-MYCIN S-2 GMP API supplier for your needs.

    COLY-MYCIN S-2 CoA

    A COLY-MYCIN S-2 CoA (Certificate of Analysis) is a formal document that attests to COLY-MYCIN S-2's compliance with COLY-MYCIN S-2 specifications and serves as a tool for batch-level quality control.

    COLY-MYCIN S-2 CoA mostly includes findings from lab analyses of a specific batch. For each COLY-MYCIN S-2 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.

    COLY-MYCIN S-2 may be tested according to a variety of international standards, such as European Pharmacopoeia (COLY-MYCIN S-2 EP), COLY-MYCIN S-2 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (COLY-MYCIN S-2 USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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