Synopsis
Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
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1. Ab-vancomycin
2. Diatracin
3. Hydrochloride, Vancomycin
4. Sulfate, Vancomycin
5. Vanco Azupharma
6. Vanco-cell
7. Vanco-saar
8. Vancocin
9. Vancocin Hcl
10. Vancocine
11. Vancomicina Abbott
12. Vancomicina Chiesi
13. Vancomicina Combino Phar
14. Vancomicina Norman
15. Vancomycin
16. Vancomycin Hexal
17. Vancomycin Hydrochloride
18. Vancomycin Lilly
19. Vancomycin Phosphate (1:2)
20. Vancomycin Phosphate (1:2), Decahydrate
21. Vancomycin Sulfate
22. Vancomycin-ratiopharm
23. Vancomycine Dakota
1. Vancomycin Hydrochloride
2. Vancocin Hcl
3. 1404-93-9
4. Vancomycin Hydrochloride (extracted From Streptomyces Orientalis)
| Molecular Weight | 1485.7 g/mol |
|---|---|
| Molecular Formula | C66H76Cl3N9O24 |
| Hydrogen Bond Donor Count | 20 |
| Hydrogen Bond Acceptor Count | 26 |
| Rotatable Bond Count | 13 |
| Exact Mass | 1483.406877 g/mol |
| Monoisotopic Mass | 1483.406877 g/mol |
| Topological Polar Surface Area | 531 Ų |
| Heavy Atom Count | 102 |
| Formal Charge | 0 |
| Complexity | 2960 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 17 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 4 | |
|---|---|
| Drug Name | Vancocin hydrochloride |
| Active Ingredient | Vancomycin hydrochloride |
| Dosage Form | Capsule |
| Route | Oral |
| Strength | eq 125mg base; eq 250mg base |
| Market Status | Prescription |
| Company | Ani Pharms |
| 2 of 4 | |
|---|---|
| Drug Name | Vancomycin hydrochloride |
| Active Ingredient | Vancomycin hydrochloride |
| Dosage Form | Capsule; Injectable |
| Route | Injection; Oral |
| Strength | eq 750mg base/vial; eq 125mg base; eq 250mg base; eq 5gm base/vial; eq 500mg base/vial; eq 10gm base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Hospira; Sandoz; Watson Labs; Strides Pharma; Emcure Pharms; Mustafa Nevzat Ilac; Fresenius Kabi Usa; Sagent Pharms; Agila Speclts; Akorn |
| 3 of 4 | |
|---|---|
| Drug Name | Vancocin hydrochloride |
| Active Ingredient | Vancomycin hydrochloride |
| Dosage Form | Capsule |
| Route | Oral |
| Strength | eq 125mg base; eq 250mg base |
| Market Status | Prescription |
| Company | Ani Pharms |
| 4 of 4 | |
|---|---|
| Drug Name | Vancomycin hydrochloride |
| Active Ingredient | Vancomycin hydrochloride |
| Dosage Form | Capsule; Injectable |
| Route | Injection; Oral |
| Strength | eq 750mg base/vial; eq 125mg base; eq 250mg base; eq 5gm base/vial; eq 500mg base/vial; eq 10gm base/vial; eq 1gm base/vial |
| Market Status | Prescription |
| Company | Hospira; Sandoz; Watson Labs; Strides Pharma; Emcure Pharms; Mustafa Nevzat Ilac; Fresenius Kabi Usa; Sagent Pharms; Agila Speclts; Akorn |
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
API SUPPLIERS
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
Date of Issue : 2024-01-16
Valid Till : 2027-01-27
Written Confirmation Number : SD240011
Address of the Firm :
HRV Pharma - Market Expansion Leader in Pharmaceuticals.
Mesochem is focused on incessant innovation along with the R&D of new APIs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13652
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23594
Submission : 2010-02-25
Status : Inactive
Type : II
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13694
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13652
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13709
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17478
Submission : 2004-06-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13223
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13689
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 20614
Submission : 2007-06-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-24
Pay. Date : 2012-11-15
DMF Number : 13794
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-08
Pay. Date : 2012-10-31
DMF Number : 13691
Submission : 1998-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18497
Submission : 2005-07-05
Status : Inactive
Type : II
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DOSAGE - POWDER;INTRAVENOUS - EQ 1.25GM BASE/...DOSAGE - POWDER;INTRAVENOUS - EQ 1.25GM BASE/VIAL
USFDA APPLICATION NUMBER - 209481
DOSAGE - POWDER;INTRAVENOUS - EQ 1.5GM BASE/V...DOSAGE - POWDER;INTRAVENOUS - EQ 1.5GM BASE/VIAL
USFDA APPLICATION NUMBER - 209481
DOSAGE - POWDER;INTRAVENOUS - EQ 1.75GM BASE/...DOSAGE - POWDER;INTRAVENOUS - EQ 1.75GM BASE/VIAL
USFDA APPLICATION NUMBER - 209481
DOSAGE - POWDER;INTRAVENOUS - EQ 250MG BASE/V...DOSAGE - POWDER;INTRAVENOUS - EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 209481
DOSAGE - POWDER;INTRAVENOUS - EQ 2GM BASE/VIA...DOSAGE - POWDER;INTRAVENOUS - EQ 2GM BASE/VIAL
USFDA APPLICATION NUMBER - 209481
DOSAGE - POWDER;INTRAVENOUS - EQ 750MG BASE/V...DOSAGE - POWDER;INTRAVENOUS - EQ 750MG BASE/VIAL
USFDA APPLICATION NUMBER - 209481
DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 10GM B...DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 10GM BASE/VIAL
USFDA APPLICATION NUMBER - 210274
DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 1GM BA...DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 1GM BASE/VIAL
USFDA APPLICATION NUMBER - 210274
DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 500MG ...DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 500MG BASE/VIAL
USFDA APPLICATION NUMBER - 210274
DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 5GM BA...DOSAGE - POWDER;INTRAVENOUS, ORAL - EQ 5GM BASE/VIAL
USFDA APPLICATION NUMBER - 210274
DOSAGE - CAPSULE;ORAL - EQ 125MG BASE
USFDA APPLICATION NUMBER - 50606
DOSAGE - CAPSULE;ORAL - EQ 250MG BASE
USFDA APPLICATION NUMBER - 50606
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ABOUT THIS PAGE
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PharmaCompass offers a list of Vancomycin Hydrochloride 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 Vancomycin Hydrochloride manufacturer or Vancomycin Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Vancomycin Hydrochloride manufacturer or Vancomycin Hydrochloride supplier.
PharmaCompass also assists you with knowing the Vancomycin Hydrochloride API Price utilized in the formulation of products. Vancomycin Hydrochloride API Price is not always fixed or binding as the Vancomycin Hydrochloride Price is obtained through a variety of data sources. The Vancomycin Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Vancomycin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vancomycin Hydrochloride, including repackagers and relabelers. The FDA regulates Vancomycin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vancomycin Hydrochloride 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 Vancomycin Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vancomycin Hydrochloride supplier is an individual or a company that provides Vancomycin Hydrochloride active pharmaceutical ingredient (API) or Vancomycin Hydrochloride finished formulations upon request. The Vancomycin Hydrochloride suppliers may include Vancomycin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Vancomycin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Vancomycin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Vancomycin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Vancomycin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Vancomycin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Vancomycin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Vancomycin Hydrochloride USDMF includes data on Vancomycin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Vancomycin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Vancomycin Hydrochloride 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 Vancomycin Hydrochloride Drug Master File in Japan (Vancomycin Hydrochloride JDMF) empowers Vancomycin Hydrochloride 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 Vancomycin Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Vancomycin Hydrochloride 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 Vancomycin Hydrochloride 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 Vancomycin Hydrochloride Drug Master File in Korea (Vancomycin Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Vancomycin Hydrochloride. The MFDS reviews the Vancomycin Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Vancomycin Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Vancomycin Hydrochloride 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 Vancomycin Hydrochloride API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Vancomycin Hydrochloride suppliers with KDMF on PharmaCompass.
A Vancomycin Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Vancomycin Hydrochloride Certificate of Suitability (COS). The purpose of a Vancomycin Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Vancomycin Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Vancomycin Hydrochloride to their clients by showing that a Vancomycin Hydrochloride CEP has been issued for it. The manufacturer submits a Vancomycin Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Vancomycin Hydrochloride CEP holder for the record. Additionally, the data presented in the Vancomycin Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Vancomycin Hydrochloride DMF.
A Vancomycin Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Vancomycin Hydrochloride 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 Vancomycin Hydrochloride suppliers with CEP (COS) on PharmaCompass.
A Vancomycin Hydrochloride written confirmation (Vancomycin Hydrochloride WC) is an official document issued by a regulatory agency to a Vancomycin Hydrochloride manufacturer, verifying that the manufacturing facility of a Vancomycin Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Vancomycin Hydrochloride APIs or Vancomycin Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Vancomycin Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Vancomycin Hydrochloride suppliers with Written Confirmation (WC) 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 Vancomycin Hydrochloride as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Vancomycin Hydrochloride 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 Vancomycin Hydrochloride 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 Vancomycin Hydrochloride and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Vancomycin Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Vancomycin Hydrochloride suppliers with NDC on PharmaCompass.
Vancomycin Hydrochloride 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 Vancomycin Hydrochloride 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 Vancomycin Hydrochloride GMP manufacturer or Vancomycin Hydrochloride GMP API supplier for your needs.
A Vancomycin Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Vancomycin Hydrochloride's compliance with Vancomycin Hydrochloride specifications and serves as a tool for batch-level quality control.
Vancomycin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Vancomycin Hydrochloride 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.
Vancomycin Hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Vancomycin Hydrochloride EP), Vancomycin Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Vancomycin Hydrochloride USP).
