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API SUPPLIERS
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USDMF
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
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Global Sales Information
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REF. STANDARDS & IMPURITIES
USP
ABOUT THIS PAGE
A Odyne manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Odyne, including repackagers and relabelers. The FDA regulates Odyne manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Odyne 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 Odyne manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Odyne supplier is an individual or a company that provides Odyne active pharmaceutical ingredient (API) or Odyne finished formulations upon request. The Odyne suppliers may include Odyne API manufacturers, exporters, distributors and traders.
click here to find a list of Odyne suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Odyne DMF (Drug Master File) is a document detailing the whole manufacturing process of Odyne active pharmaceutical ingredient (API) in detail. Different forms of Odyne DMFs exist exist since differing nations have different regulations, such as Odyne USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Odyne DMF submitted to regulatory agencies in the US is known as a USDMF. Odyne USDMF includes data on Odyne's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Odyne USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Odyne 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 Odyne Drug Master File in Japan (Odyne JDMF) empowers Odyne 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 Odyne JDMF during the approval evaluation for pharmaceutical products. At the time of Odyne 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 Odyne suppliers with JDMF on PharmaCompass.
A Odyne CEP of the European Pharmacopoeia monograph is often referred to as a Odyne Certificate of Suitability (COS). The purpose of a Odyne CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Odyne EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Odyne to their clients by showing that a Odyne CEP has been issued for it. The manufacturer submits a Odyne CEP (COS) as part of the market authorization procedure, and it takes on the role of a Odyne CEP holder for the record. Additionally, the data presented in the Odyne CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Odyne DMF.
A Odyne CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Odyne 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 Odyne suppliers with CEP (COS) on PharmaCompass.
A Odyne written confirmation (Odyne WC) is an official document issued by a regulatory agency to a Odyne manufacturer, verifying that the manufacturing facility of a Odyne active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Odyne APIs or Odyne finished pharmaceutical products to another nation, regulatory agencies frequently require a Odyne WC (written confirmation) as part of the regulatory process.
click here to find a list of Odyne 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 Odyne as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Odyne 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 Odyne 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 Odyne and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Odyne NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Odyne suppliers with NDC on PharmaCompass.
Odyne 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 Odyne 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 Odyne GMP manufacturer or Odyne GMP API supplier for your needs.
A Odyne CoA (Certificate of Analysis) is a formal document that attests to Odyne's compliance with Odyne specifications and serves as a tool for batch-level quality control.
Odyne CoA mostly includes findings from lab analyses of a specific batch. For each Odyne 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.
Odyne may be tested according to a variety of international standards, such as European Pharmacopoeia (Odyne EP), Odyne JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Odyne USP).
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