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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 |
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-09-21
Pay. Date : 2013-09-11
DMF Number : 12048
Submission : 1996-06-30
Status : Active
Type : II
Certificate Number : R1-CEP 1998-155 - Rev 10
Issue Date : 2019-02-18
Type : Chemical
Substance Number : 331
Status : Valid
Registration Number : 217MF10342
Registrant's Address : No. 6, Gaogang Avenue, Jiangyin Industrial Estate, Fuqing, Fuzhou, Fujian, China
Initial Date of Registration : 2005-07-27
Latest Date of Registration :
NDC Package Code : 67630-0003
Start Marketing Date : 2011-03-09
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
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DMF Number : 13704
Submission : 1998-09-01
Status : Active
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Certificate Number : CEP 2005-121 - Rev 02
Issue Date : 2024-10-21
Type : Chemical
Substance Number : 331
Status : Valid
Registration Number : 220MF10041
Registrant's Address : Verovskova ulica 57, 1526 Ljubljana, Slovenia
Initial Date of Registration : 2008-02-05
Latest Date of Registration :
NDC Package Code : 48866-8256
Start Marketing Date : 2013-07-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
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DMF Review : Reviewed
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Pay. Date : 2019-04-10
DMF Number : 30693
Submission : 2016-06-28
Status : Active
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NDC Package Code : 42513-0008
Start Marketing Date : 2014-09-22
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
VMF Number : 6155
Submission : 2016-07-01
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Submission : 2010-09-21
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NDC Package Code : 52946-0605
Start Marketing Date : 2010-04-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Submission : 1998-09-01
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Certificate Number : CEP 2024-008 - Rev 00
Status : Valid
Issue Date : 2025-10-14
Type : Chemical
Substance Number : 331
Certificate Number : R1-CEP 1998-155 - Rev 10
Status : Valid
Issue Date : 2019-02-18
Type : Chemical
Substance Number : 331
Certificate Number : CEP 2005-121 - Rev 02
Status : Valid
Issue Date : 2024-10-21
Type : Chemical
Substance Number : 331
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Gentamicin sulfate (for manufacturing purposes only)
Registration Number : 217MF10342
Registrant's Address : No. 6, Gaogang Avenue, Jiangyin Industrial Estate, Fuqing, Fuzhou, Fujian, China
Initial Date of Registration : 2005-07-27
Latest Date of Registration : 2012-08-13
Registration Number : 220MF10170
Registrant's Address : No. 6, Gaogang Avenue, Jiangyin Industrial Estate, Fuqing, Fuzhou, Fujian, China
Initial Date of Registration : 2008-07-24
Latest Date of Registration : 2011-10-21
Registration Number : 220MF10041
Registrant's Address : Verovskova ulica 57, 1526 Ljubljana, Slovenia
Initial Date of Registration : 2008-02-05
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NDC Package Code : 52946-0605
Start Marketing Date : 2010-04-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 69988-0065
Start Marketing Date : 2025-02-28
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Dosage Form (Strength) : POWDER (1kg/1)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 51552-0775
Start Marketing Date : 1998-04-01
End Marketing Date : 2026-03-03
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 67630-0003
Start Marketing Date : 2011-03-09
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Marketing Category : BULK INGREDIENT
NDC Package Code : 60592-301
Start Marketing Date : 2019-11-29
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NDC Package Code : 48866-8256
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NDC Package Code : 62991-1072
Start Marketing Date : 2011-03-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 42513-0008
Start Marketing Date : 2014-09-22
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 38779-0632
Start Marketing Date : 2014-06-16
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...
NDC Package Code : 51927-0252
Start Marketing Date : 2020-08-25
End Marketing Date : 2025-12-31
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VMF Number : 6155
Submission : 2016-07-01
Status : Active
Type : II
VMF Number : 5469
Submission : 1993-09-10
Status : Active
Type : II
VMF Number : 6065
Submission : 2013-12-23
Status : Active
Type : II
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Drugs in Development
Details:
Gentamicin is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Appendicitis.
Lead Product(s): Gentamicin Sulfate,Clindamycin Hydrochloride
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: ZonMw
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 21, 2025
Lead Product(s) : Gentamicin Sulfate,Clindamycin Hydrochloride
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : ZonMw
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Gentamicin is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Appendicitis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 21, 2025
Details:
Vancomycin is a Antibiotic drug candidate, which is currently being evaluated in clinical studies for the treatment of Pressure Ulcer.
Lead Product(s): Vancomycin Hydrochloride,Gentamicin Sulfate,Calcium Sulfate
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 05, 2025
Lead Product(s) : Vancomycin Hydrochloride,Gentamicin Sulfate,Calcium Sulfate
Therapeutic Area : Dermatology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Expanded Access Program (EAP) STIMULAN VG
Details : Vancomycin is a Antibiotic drug candidate, which is currently being evaluated in clinical studies for the treatment of Pressure Ulcer.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
February 05, 2025
Details:
Vancomycin is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pressure Ulcer.
Lead Product(s): Vancomycin Hydrochloride,Gentamicin Sulfate,Calcium Sulfate
Therapeutic Area: Dermatology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Antibiotic
Sponsor: MCRA
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 28, 2024
Lead Product(s) : Vancomycin Hydrochloride,Gentamicin Sulfate,Calcium Sulfate
Therapeutic Area : Dermatology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : MCRA
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Vancomycin is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Pressure Ulcer.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
February 28, 2024
Details:
BioLexa (gentamicin) is a patented, proprietary antimicrobial topical formulation being developed for treatment of atopic dermatitis. Bacterial biofilms are specialized communities consisting of bacteria adhered to a surface and to other bacteria.
Lead Product(s): Gentamicin Sulfate,Inapplicable
Therapeutic Area: Dermatology Brand Name: BioLexa
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 06, 2023
Lead Product(s) : Gentamicin Sulfate,Inapplicable
Therapeutic Area : Dermatology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Hoth Therapeutics Announces Positive Final Results from 14-day Phase 1b Clinical Trial of BioLexa
Details : BioLexa (gentamicin) is a patented, proprietary antimicrobial topical formulation being developed for treatment of atopic dermatitis. Bacterial biofilms are specialized communities consisting of bacteria adhered to a surface and to other bacteria.
Product Name : BioLexa
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 06, 2023
Details:
Ampicillin is a Antibiotic drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Premature Birth.
Lead Product(s): Ampicillin,Gentamicin Sulfate
Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: The University of Pittsburgh School of Medicine | Morgan Stanley Children’s Hospital | University of Louisville | Sharp Mary Birch Hospital for Women & Newborns | Children's Hospital of Philadelphia | Jefferson Medical College of Thomas Jefferson Universi
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 04, 2023
Lead Product(s) : Ampicillin,Gentamicin Sulfate
Therapeutic Area : Obstetrics/Gynecology (Women’s Health)
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : The University of Pittsburgh School of Medicine | Morgan Stanley Children’s Hospital | University of Louisville | Sharp Mary Birch Hospital for Women & Newborns | Children's Hospital of Philadelphia | Jefferson Medical College of Thomas Jefferson Universi
Deal Size : Inapplicable
Deal Type : Inapplicable
NICU Antibiotics and Outcomes (NANO) Follow-up Study
Details : Ampicillin is a Antibiotic drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Premature Birth.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
August 04, 2023
Details:
Ceftriaxone is a Antibiotic drug candidate, which is currently being evaluated in clinical studies for the treatment of Cholangitis.
Lead Product(s): Ceftriaxone,Gentamicin Sulfate,Cefuroxime Axetil,Ciprofloxacin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Antibiotic
Sponsor: ZonMw
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 02, 2023
Lead Product(s) : Ceftriaxone,Gentamicin Sulfate,Cefuroxime Axetil,Ciprofloxacin
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : ZonMw
Deal Size : Inapplicable
Deal Type : Inapplicable
Short-course Antibiotics vs Standard Course Antibiotics in Patients With Cholangitis
Details : Ceftriaxone is a Antibiotic drug candidate, which is currently being evaluated in clinical studies for the treatment of Cholangitis.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
March 02, 2023
Details:
Gentamicin is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Urinary Tract Infections.
Lead Product(s): Gentamicin Sulfate,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Northeast Ohio Medical University
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 27, 2023
Lead Product(s) : Gentamicin Sulfate,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Northeast Ohio Medical University
Deal Size : Inapplicable
Deal Type : Inapplicable
Single Dose Aminoglycosides for Acute Uncomplicated Cystitis in the Emergency Department Setting
Details : Gentamicin is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Urinary Tract Infections.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 27, 2023
Details:
BioLexa (gentamicin) is a patented, proprietary antimicrobial topical formulation being developed for treatment of diseases mediated by Staphylococcal biofilms. Bacterial biofilms are specialized communities consisting of bacteria adhered to a surface and to other bacteria.
Lead Product(s): Gentamicin Sulfate,Pentetic Acid
Therapeutic Area: Dermatology Brand Name: BioLexa
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: H.C. Wainwright & Co
Deal Size: $10.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement January 03, 2023
Lead Product(s) : Gentamicin Sulfate,Pentetic Acid
Therapeutic Area : Dermatology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : H.C. Wainwright & Co
Deal Size : $10.0 million
Deal Type : Private Placement
Details : BioLexa (gentamicin) is a patented, proprietary antimicrobial topical formulation being developed for treatment of diseases mediated by Staphylococcal biofilms. Bacterial biofilms are specialized communities consisting of bacteria adhered to a surface an...
Product Name : BioLexa
Product Type : Miscellaneous
Upfront Cash : Undisclosed
January 03, 2023
Details:
BioLexa (gentamicin) is a patented, proprietary antimicrobial topical formulation being developed for treatment of diseases mediated by Staphylococcal biofilms. The BioLexa formulation is optimized to prevent Staphylococcal biofilm formation.
Lead Product(s): Gentamicin Sulfate,Pentetic Acid
Therapeutic Area: Dermatology Brand Name: BioLexa
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: H.C. Wainwright & Co
Deal Size: $10.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement December 29, 2022
Lead Product(s) : Gentamicin Sulfate,Pentetic Acid
Therapeutic Area : Dermatology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : H.C. Wainwright & Co
Deal Size : $10.0 million
Deal Type : Private Placement
Hoth Therapeutics Announces $10 Million Private Placement Priced At-the-Market Under Nasdaq Rules
Details : BioLexa (gentamicin) is a patented, proprietary antimicrobial topical formulation being developed for treatment of diseases mediated by Staphylococcal biofilms. The BioLexa formulation is optimized to prevent Staphylococcal biofilm formation.
Product Name : BioLexa
Product Type : Miscellaneous
Upfront Cash : Undisclosed
December 29, 2022
Details:
Vancomycin is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Osteomyelitis.
Lead Product(s): Vancomycin Hydrochloride,Gentamicin Sulfate,Calcium Sulfate
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Antibiotic
Sponsor: MCRA
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 14, 2022
Lead Product(s) : Vancomycin Hydrochloride,Gentamicin Sulfate,Calcium Sulfate
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : MCRA
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Vancomycin is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Osteomyelitis.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
September 14, 2022
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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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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 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.
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.
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.
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.
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.
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.
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).
The FDA updates the NDC directory daily. The NDC numbers for Gentamicin 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 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 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 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.
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).
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