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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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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
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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 Gentamycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gentamycin, including repackagers and relabelers. The FDA regulates Gentamycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gentamycin 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 Gentamycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Gentamycin supplier is an individual or a company that provides Gentamycin active pharmaceutical ingredient (API) or Gentamycin finished formulations upon request. The Gentamycin suppliers may include Gentamycin API manufacturers, exporters, distributors and traders.
click here to find a list of Gentamycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gentamycin DMF (Drug Master File) is a document detailing the whole manufacturing process of Gentamycin active pharmaceutical ingredient (API) in detail. Different forms of Gentamycin DMFs exist exist since differing nations have different regulations, such as Gentamycin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gentamycin DMF submitted to regulatory agencies in the US is known as a USDMF. Gentamycin USDMF includes data on Gentamycin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gentamycin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gentamycin 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 Gentamycin Drug Master File in Japan (Gentamycin JDMF) empowers Gentamycin 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 Gentamycin JDMF during the approval evaluation for pharmaceutical products. At the time of Gentamycin 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 Gentamycin 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 Gentamycin Drug Master File in Korea (Gentamycin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Gentamycin. The MFDS reviews the Gentamycin KDMF as part of the drug registration process and uses the information provided in the Gentamycin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Gentamycin 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 Gentamycin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Gentamycin suppliers with KDMF on PharmaCompass.
A Gentamycin CEP of the European Pharmacopoeia monograph is often referred to as a Gentamycin Certificate of Suitability (COS). The purpose of a Gentamycin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Gentamycin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Gentamycin to their clients by showing that a Gentamycin CEP has been issued for it. The manufacturer submits a Gentamycin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Gentamycin CEP holder for the record. Additionally, the data presented in the Gentamycin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Gentamycin DMF.
A Gentamycin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Gentamycin 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 Gentamycin 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 Gentamycin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Gentamycin 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 Gentamycin 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 Gentamycin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Gentamycin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Gentamycin suppliers with NDC on PharmaCompass.
Gentamycin 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 Gentamycin 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 Gentamycin GMP manufacturer or Gentamycin GMP API supplier for your needs.
A Gentamycin CoA (Certificate of Analysis) is a formal document that attests to Gentamycin's compliance with Gentamycin specifications and serves as a tool for batch-level quality control.
Gentamycin CoA mostly includes findings from lab analyses of a specific batch. For each Gentamycin 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.
Gentamycin may be tested according to a variety of international standards, such as European Pharmacopoeia (Gentamycin EP), Gentamycin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Gentamycin USP).
