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ABOUT THIS PAGE
A Dihydrocodeine Tartrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dihydrocodeine Tartrate, including repackagers and relabelers. The FDA regulates Dihydrocodeine Tartrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dihydrocodeine Tartrate 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 Dihydrocodeine Tartrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dihydrocodeine Tartrate supplier is an individual or a company that provides Dihydrocodeine Tartrate active pharmaceutical ingredient (API) or Dihydrocodeine Tartrate finished formulations upon request. The Dihydrocodeine Tartrate suppliers may include Dihydrocodeine Tartrate API manufacturers, exporters, distributors and traders.
click here to find a list of Dihydrocodeine Tartrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dihydrocodeine Tartrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Dihydrocodeine Tartrate active pharmaceutical ingredient (API) in detail. Different forms of Dihydrocodeine Tartrate DMFs exist exist since differing nations have different regulations, such as Dihydrocodeine Tartrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dihydrocodeine Tartrate DMF submitted to regulatory agencies in the US is known as a USDMF. Dihydrocodeine Tartrate USDMF includes data on Dihydrocodeine Tartrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dihydrocodeine Tartrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dihydrocodeine Tartrate suppliers with USDMF 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 Dihydrocodeine Tartrate Drug Master File in Korea (Dihydrocodeine Tartrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dihydrocodeine Tartrate. The MFDS reviews the Dihydrocodeine Tartrate KDMF as part of the drug registration process and uses the information provided in the Dihydrocodeine Tartrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Dihydrocodeine Tartrate 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 Dihydrocodeine Tartrate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Dihydrocodeine Tartrate suppliers with KDMF on PharmaCompass.
A Dihydrocodeine Tartrate CEP of the European Pharmacopoeia monograph is often referred to as a Dihydrocodeine Tartrate Certificate of Suitability (COS). The purpose of a Dihydrocodeine Tartrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dihydrocodeine Tartrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dihydrocodeine Tartrate to their clients by showing that a Dihydrocodeine Tartrate CEP has been issued for it. The manufacturer submits a Dihydrocodeine Tartrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dihydrocodeine Tartrate CEP holder for the record. Additionally, the data presented in the Dihydrocodeine Tartrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dihydrocodeine Tartrate DMF.
A Dihydrocodeine Tartrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dihydrocodeine Tartrate 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 Dihydrocodeine Tartrate 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 Dihydrocodeine Tartrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Dihydrocodeine Tartrate 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 Dihydrocodeine Tartrate 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 Dihydrocodeine Tartrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Dihydrocodeine Tartrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Dihydrocodeine Tartrate suppliers with NDC on PharmaCompass.
Dihydrocodeine Tartrate 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 Dihydrocodeine Tartrate 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 Dihydrocodeine Tartrate GMP manufacturer or Dihydrocodeine Tartrate GMP API supplier for your needs.
A Dihydrocodeine Tartrate CoA (Certificate of Analysis) is a formal document that attests to Dihydrocodeine Tartrate's compliance with Dihydrocodeine Tartrate specifications and serves as a tool for batch-level quality control.
Dihydrocodeine Tartrate CoA mostly includes findings from lab analyses of a specific batch. For each Dihydrocodeine Tartrate 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.
Dihydrocodeine Tartrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Dihydrocodeine Tartrate EP), Dihydrocodeine Tartrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dihydrocodeine Tartrate USP).
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