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1. Garamycin Solution
2. Gentimicin Sulfate Solution
3. Gentamicin Sulfate, 500x Solution
4. Akos015895526
5. G0383
| Molecular Weight | 575.7 g/mol |
|---|---|
| Molecular Formula | C21H45N5O11S |
| Hydrogen Bond Donor Count | 10 |
| Hydrogen Bond Acceptor Count | 16 |
| Rotatable Bond Count | 7 |
| Exact Mass | 575.28362844 g/mol |
| Monoisotopic Mass | 575.28362844 g/mol |
| Topological Polar Surface Area | 283 Ų |
| Heavy Atom Count | 38 |
| Formal Charge | 0 |
| Complexity | 717 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 13 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 2 | |
|---|---|
| Drug Name | Genoptic |
| PubMed Health | Gentamicin |
| Drug Classes | Antibacterial, Antibiotic |
| Active Ingredient | Gentamicin sulfate |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.3% base |
| Market Status | Prescription |
| Company | Allergan |
| 2 of 2 | |
|---|---|
| Drug Name | Genoptic |
| PubMed Health | Gentamicin |
| Drug Classes | Antibacterial, Antibiotic |
| Active Ingredient | Gentamicin sulfate |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.3% base |
| Market Status | Prescription |
| Company | Allergan |
API SUPPLIERS
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USDMF
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| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
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Drugs in Development
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DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - EQ 0.3...DOSAGE - SUSPENSION/DROPS;OPHTHALMIC - EQ 0.3% BASE;1%
USFDA APPLICATION NUMBER - 50586
DOSAGE - OINTMENT;OPHTHALMIC - EQ 0.3% BASE;0...DOSAGE - OINTMENT;OPHTHALMIC - EQ 0.3% BASE;0.6%
USFDA APPLICATION NUMBER - 50612
Related Excipient Companies
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Coating Systems & Additives
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Fillers, Diluents & Binders
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REF. STANDARDS & IMPURITIES
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ABOUT THIS PAGE
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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.
A Gentamicin Sulfate, 100X Solution manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gentamicin Sulfate, 100X Solution, including repackagers and relabelers. The FDA regulates Gentamicin Sulfate, 100X Solution manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gentamicin Sulfate, 100X Solution 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 Sulfate, 100X Solution manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gentamicin Sulfate, 100X Solution supplier is an individual or a company that provides Gentamicin Sulfate, 100X Solution active pharmaceutical ingredient (API) or Gentamicin Sulfate, 100X Solution finished formulations upon request. The Gentamicin Sulfate, 100X Solution suppliers may include Gentamicin Sulfate, 100X Solution API manufacturers, exporters, distributors and traders.
click here to find a list of Gentamicin Sulfate, 100X Solution suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gentamicin Sulfate, 100X Solution DMF (Drug Master File) is a document detailing the whole manufacturing process of Gentamicin Sulfate, 100X Solution active pharmaceutical ingredient (API) in detail. Different forms of Gentamicin Sulfate, 100X Solution DMFs exist exist since differing nations have different regulations, such as Gentamicin Sulfate, 100X Solution USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gentamicin Sulfate, 100X Solution DMF submitted to regulatory agencies in the US is known as a USDMF. Gentamicin Sulfate, 100X Solution USDMF includes data on Gentamicin Sulfate, 100X Solution's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gentamicin Sulfate, 100X Solution USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gentamicin Sulfate, 100X Solution 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 Gentamicin Sulfate, 100X Solution Drug Master File in Japan (Gentamicin Sulfate, 100X Solution JDMF) empowers Gentamicin Sulfate, 100X Solution 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 Sulfate, 100X Solution JDMF during the approval evaluation for pharmaceutical products. At the time of Gentamicin Sulfate, 100X Solution 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 Sulfate, 100X Solution 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 Gentamicin Sulfate, 100X Solution Drug Master File in Korea (Gentamicin Sulfate, 100X Solution KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gentamicin Sulfate, 100X Solution. The MFDS reviews the Gentamicin Sulfate, 100X Solution KDMF as part of the drug registration process and uses the information provided in the Gentamicin Sulfate, 100X Solution KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gentamicin Sulfate, 100X Solution 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 Sulfate, 100X Solution API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gentamicin Sulfate, 100X Solution suppliers with KDMF on PharmaCompass.
A Gentamicin Sulfate, 100X Solution CEP of the European Pharmacopoeia monograph is often referred to as a Gentamicin Sulfate, 100X Solution Certificate of Suitability (COS). The purpose of a Gentamicin Sulfate, 100X Solution CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gentamicin Sulfate, 100X Solution EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gentamicin Sulfate, 100X Solution to their clients by showing that a Gentamicin Sulfate, 100X Solution CEP has been issued for it. The manufacturer submits a Gentamicin Sulfate, 100X Solution CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gentamicin Sulfate, 100X Solution CEP holder for the record. Additionally, the data presented in the Gentamicin Sulfate, 100X Solution CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gentamicin Sulfate, 100X Solution DMF.
A Gentamicin Sulfate, 100X Solution CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gentamicin Sulfate, 100X Solution 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 Sulfate, 100X Solution suppliers with CEP (COS) 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 Gentamicin Sulfate, 100X Solution as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gentamicin Sulfate, 100X Solution 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 Gentamicin Sulfate, 100X Solution 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 Gentamicin Sulfate, 100X Solution and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gentamicin Sulfate, 100X Solution NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gentamicin Sulfate, 100X Solution suppliers with NDC on PharmaCompass.
Gentamicin Sulfate, 100X Solution 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 Sulfate, 100X Solution 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 Sulfate, 100X Solution GMP manufacturer or Gentamicin Sulfate, 100X Solution GMP API supplier for your needs.
A Gentamicin Sulfate, 100X Solution CoA (Certificate of Analysis) is a formal document that attests to Gentamicin Sulfate, 100X Solution's compliance with Gentamicin Sulfate, 100X Solution specifications and serves as a tool for batch-level quality control.
Gentamicin Sulfate, 100X Solution CoA mostly includes findings from lab analyses of a specific batch. For each Gentamicin Sulfate, 100X Solution 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 Sulfate, 100X Solution may be tested according to a variety of international standards, such as European Pharmacopoeia (Gentamicin Sulfate, 100X Solution EP), Gentamicin Sulfate, 100X Solution JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gentamicin Sulfate, 100X Solution USP).
