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Chemistry

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Also known as: Garamycin solution, Gentimicin sulfate solution, Gentamicin sulfate, 500x solution, Akos015895526, G0383
Molecular Formula
C21H45N5O11S
Molecular Weight
575.7  g/mol
InChI Key
NWQISSNHRDDWRM-UHFFFAOYSA-N

Gentamicin Sulfate
1 2D Structure

Gentamicin Sulfate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
2-[4,6-diamino-3-[3-amino-6-[1-(methylamino)ethyl]oxan-2-yl]oxy-2-hydroxycyclohexyl]oxy-5-methyl-4-(methylamino)oxane-3,5-diol;sulfuric acid
2.1.2 InChI
InChI=1S/C21H43N5O7.H2O4S/c1-9(25-3)13-6-5-10(22)19(31-13)32-16-11(23)7-12(24)17(14(16)27)33-20-15(28)18(26-4)21(2,29)8-30-20;1-5(2,3)4/h9-20,25-29H,5-8,22-24H2,1-4H3;(H2,1,2,3,4)
2.1.3 InChI Key
NWQISSNHRDDWRM-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC(C1CCC(C(O1)OC2C(CC(C(C2O)OC3C(C(C(CO3)(C)O)NC)O)N)N)N)NC.OS(=O)(=O)O
2.2 Synonyms
2.2.1 Depositor-Supplied Synonyms

1. Garamycin Solution

2. Gentimicin Sulfate Solution

3. Gentamicin Sulfate, 500x Solution

4. Akos015895526

5. G0383

2.3 Create Date
2009-08-08
3 Chemical and Physical Properties
Molecular Weight 575.7 g/mol
Molecular Formula C21H45N5O11S
Hydrogen Bond Donor Count10
Hydrogen Bond Acceptor Count16
Rotatable Bond Count7
Exact Mass575.28362844 g/mol
Monoisotopic Mass575.28362844 g/mol
Topological Polar Surface Area283 Ų
Heavy Atom Count38
Formal Charge0
Complexity717
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count13
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 NameGenoptic
PubMed HealthGentamicin
Drug ClassesAntibacterial, Antibiotic
Active IngredientGentamicin sulfate
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.3% base
Market StatusPrescription
CompanyAllergan

2 of 2  
Drug NameGenoptic
PubMed HealthGentamicin
Drug ClassesAntibacterial, Antibiotic
Active IngredientGentamicin sulfate
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.3% base
Market StatusPrescription
CompanyAllergan

API Reference Price

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04-Jan-2021
24-Feb-2025
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DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - EQ 0.3...DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - EQ 0.3% BASE;1%

USFDA APPLICATION NUMBER - 50586

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DOSAGE - OINTMENT;OPHTHALMIC - EQ 0.3% BASE;0...DOSAGE - OINTMENT;OPHTHALMIC - EQ 0.3% BASE;0.6%

USFDA APPLICATION NUMBER - 50612

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Looking for / Gentamicin Sulfate API manufacturers, exporters & distributors?

Gentamicin Sulfate manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Gentamicin 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 Gentamicin Sulfate manufacturer or Gentamicin Sulfate supplier for your needs.

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

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

API | Excipient name

Gentamicin Sulfate

Synonyms

Garamycin solution, Gentimicin sulfate solution, Gentamicin sulfate, 500x solution, Akos015895526, G0383

Gentamicin Manufacturers

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

Gentamicin Suppliers

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

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

Gentamicin USDMF

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

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

click here to find a list of Gentamicin suppliers with USDMF on PharmaCompass.

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

Gentamicin KDMF

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

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

After submitting a Gentamicin 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 Gentamicin API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Gentamicin suppliers with KDMF on PharmaCompass.

Gentamicin CEP

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

A Gentamicin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gentamicin 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 Gentamicin suppliers with CEP (COS) on PharmaCompass.

Gentamicin 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 Gentamicin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Gentamicin 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 Gentamicin 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 Gentamicin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gentamicin NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Gentamicin suppliers with NDC on PharmaCompass.

Gentamicin GMP

Gentamicin 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 Gentamicin 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 Gentamicin GMP manufacturer or Gentamicin GMP API supplier for your needs.

Gentamicin CoA

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

Gentamicin CoA mostly includes findings from lab analyses of a specific batch. For each Gentamicin 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.

Gentamicin may be tested according to a variety of international standards, such as European Pharmacopoeia (Gentamicin EP), Gentamicin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gentamicin 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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