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VMF
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - 250MG **Federal Regist...DOSAGE - TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12623
DOSAGE - TABLET;ORAL - 500MG **Federal Regist...DOSAGE - TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12623
DOSAGE - INJECTABLE;INJECTION - 500MG/100ML
USFDA APPLICATION NUMBER - 18890
DOSAGE - INJECTABLE;INJECTION - 500MG/100ML
USFDA APPLICATION NUMBER - 18900
DOSAGE - GEL;TOPICAL - 0.75% **Federal Regist...DOSAGE - GEL;TOPICAL - 0.75% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19737
DOSAGE - GEL;VAGINAL - 0.75%
USFDA APPLICATION NUMBER - 20208
DOSAGE - GEL;VAGINAL - 1.3%
USFDA APPLICATION NUMBER - 205223
DOSAGE - CREAM;TOPICAL - 0.75%
USFDA APPLICATION NUMBER - 20531
DOSAGE - SUSPENSION;ORAL - 500MG/5ML
USFDA APPLICATION NUMBER - 216755
DOSAGE - GEL;TOPICAL - 1%
USFDA APPLICATION NUMBER - 21789
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EUROAPI
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ABOUT THIS PAGE
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PharmaCompass offers a list of Metronidazole 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 Metronidazole manufacturer or Metronidazole supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Metronidazole manufacturer or Metronidazole supplier.
PharmaCompass also assists you with knowing the Metronidazole API Price utilized in the formulation of products. Metronidazole API Price is not always fixed or binding as the Metronidazole Price is obtained through a variety of data sources. The Metronidazole Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A MetroGel-Vaginal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MetroGel-Vaginal, including repackagers and relabelers. The FDA regulates MetroGel-Vaginal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MetroGel-Vaginal 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 MetroGel-Vaginal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A MetroGel-Vaginal supplier is an individual or a company that provides MetroGel-Vaginal active pharmaceutical ingredient (API) or MetroGel-Vaginal finished formulations upon request. The MetroGel-Vaginal suppliers may include MetroGel-Vaginal API manufacturers, exporters, distributors and traders.
click here to find a list of MetroGel-Vaginal suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A MetroGel-Vaginal DMF (Drug Master File) is a document detailing the whole manufacturing process of MetroGel-Vaginal active pharmaceutical ingredient (API) in detail. Different forms of MetroGel-Vaginal DMFs exist exist since differing nations have different regulations, such as MetroGel-Vaginal USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A MetroGel-Vaginal DMF submitted to regulatory agencies in the US is known as a USDMF. MetroGel-Vaginal USDMF includes data on MetroGel-Vaginal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MetroGel-Vaginal USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of MetroGel-Vaginal 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 MetroGel-Vaginal Drug Master File in Japan (MetroGel-Vaginal JDMF) empowers MetroGel-Vaginal 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 MetroGel-Vaginal JDMF during the approval evaluation for pharmaceutical products. At the time of MetroGel-Vaginal 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 MetroGel-Vaginal 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 MetroGel-Vaginal Drug Master File in Korea (MetroGel-Vaginal KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of MetroGel-Vaginal. The MFDS reviews the MetroGel-Vaginal KDMF as part of the drug registration process and uses the information provided in the MetroGel-Vaginal KDMF to evaluate the safety and efficacy of the drug.
After submitting a MetroGel-Vaginal 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 MetroGel-Vaginal API can apply through the Korea Drug Master File (KDMF).
click here to find a list of MetroGel-Vaginal suppliers with KDMF on PharmaCompass.
A MetroGel-Vaginal CEP of the European Pharmacopoeia monograph is often referred to as a MetroGel-Vaginal Certificate of Suitability (COS). The purpose of a MetroGel-Vaginal CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of MetroGel-Vaginal EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of MetroGel-Vaginal to their clients by showing that a MetroGel-Vaginal CEP has been issued for it. The manufacturer submits a MetroGel-Vaginal CEP (COS) as part of the market authorization procedure, and it takes on the role of a MetroGel-Vaginal CEP holder for the record. Additionally, the data presented in the MetroGel-Vaginal CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the MetroGel-Vaginal DMF.
A MetroGel-Vaginal CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. MetroGel-Vaginal 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 MetroGel-Vaginal suppliers with CEP (COS) on PharmaCompass.
A MetroGel-Vaginal written confirmation (MetroGel-Vaginal WC) is an official document issued by a regulatory agency to a MetroGel-Vaginal manufacturer, verifying that the manufacturing facility of a MetroGel-Vaginal active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting MetroGel-Vaginal APIs or MetroGel-Vaginal finished pharmaceutical products to another nation, regulatory agencies frequently require a MetroGel-Vaginal WC (written confirmation) as part of the regulatory process.
click here to find a list of MetroGel-Vaginal 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 MetroGel-Vaginal as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for MetroGel-Vaginal 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 MetroGel-Vaginal 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 MetroGel-Vaginal and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a MetroGel-Vaginal NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of MetroGel-Vaginal suppliers with NDC on PharmaCompass.
MetroGel-Vaginal 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 MetroGel-Vaginal 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 MetroGel-Vaginal GMP manufacturer or MetroGel-Vaginal GMP API supplier for your needs.
A MetroGel-Vaginal CoA (Certificate of Analysis) is a formal document that attests to MetroGel-Vaginal's compliance with MetroGel-Vaginal specifications and serves as a tool for batch-level quality control.
MetroGel-Vaginal CoA mostly includes findings from lab analyses of a specific batch. For each MetroGel-Vaginal 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.
MetroGel-Vaginal may be tested according to a variety of international standards, such as European Pharmacopoeia (MetroGel-Vaginal EP), MetroGel-Vaginal JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MetroGel-Vaginal USP).
