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USDMF
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34173
Submission : 2019-09-23
Status :
Type : II
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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Date of Issue : 2024-04-03
Valid Till : 2027-01-21
Written Confirmation Number : WC-0493
Address of the Firm : Unit-IV, Plot No: 34B, 40B & 60B, J.N. Pharma City, Thanam (V), Parawada (M), An...
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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
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DOSAGE - CREAM;TOPICAL - EQ 1% BASE
USFDA APPLICATION NUMBER - 19828
DOSAGE - LOTION;TOPICAL - EQ 1% BASE
USFDA APPLICATION NUMBER - 20209
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PharmaCompass offers a list of Oxiconazole Nitrate 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 Oxiconazole Nitrate manufacturer or Oxiconazole Nitrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Oxiconazole Nitrate manufacturer or Oxiconazole Nitrate supplier.
PharmaCompass also assists you with knowing the Oxiconazole Nitrate API Price utilized in the formulation of products. Oxiconazole Nitrate API Price is not always fixed or binding as the Oxiconazole Nitrate Price is obtained through a variety of data sources. The Oxiconazole Nitrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Oxiconazole Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxiconazole Nitrate, including repackagers and relabelers. The FDA regulates Oxiconazole Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxiconazole Nitrate 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 Oxiconazole Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxiconazole Nitrate supplier is an individual or a company that provides Oxiconazole Nitrate active pharmaceutical ingredient (API) or Oxiconazole Nitrate finished formulations upon request. The Oxiconazole Nitrate suppliers may include Oxiconazole Nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Oxiconazole Nitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxiconazole Nitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxiconazole Nitrate active pharmaceutical ingredient (API) in detail. Different forms of Oxiconazole Nitrate DMFs exist exist since differing nations have different regulations, such as Oxiconazole Nitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxiconazole Nitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Oxiconazole Nitrate USDMF includes data on Oxiconazole Nitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxiconazole Nitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxiconazole Nitrate 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 Oxiconazole Nitrate Drug Master File in Japan (Oxiconazole Nitrate JDMF) empowers Oxiconazole Nitrate 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 Oxiconazole Nitrate JDMF during the approval evaluation for pharmaceutical products. At the time of Oxiconazole Nitrate 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 Oxiconazole Nitrate suppliers with JDMF on PharmaCompass.
A Oxiconazole Nitrate written confirmation (Oxiconazole Nitrate WC) is an official document issued by a regulatory agency to a Oxiconazole Nitrate manufacturer, verifying that the manufacturing facility of a Oxiconazole Nitrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oxiconazole Nitrate APIs or Oxiconazole Nitrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Oxiconazole Nitrate WC (written confirmation) as part of the regulatory process.
click here to find a list of Oxiconazole Nitrate 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 Oxiconazole Nitrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Oxiconazole Nitrate 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 Oxiconazole Nitrate 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 Oxiconazole Nitrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oxiconazole Nitrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Oxiconazole Nitrate suppliers with NDC on PharmaCompass.
Oxiconazole Nitrate 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 Oxiconazole Nitrate 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 Oxiconazole Nitrate GMP manufacturer or Oxiconazole Nitrate GMP API supplier for your needs.
A Oxiconazole Nitrate CoA (Certificate of Analysis) is a formal document that attests to Oxiconazole Nitrate's compliance with Oxiconazole Nitrate specifications and serves as a tool for batch-level quality control.
Oxiconazole Nitrate CoA mostly includes findings from lab analyses of a specific batch. For each Oxiconazole Nitrate 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.
Oxiconazole Nitrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxiconazole Nitrate EP), Oxiconazole Nitrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxiconazole Nitrate USP).
